Biotechnology

Biotech firms that use living cells and genes to create new treatments — like cancer immunotherapies, gene therapies and many modern vaccines.

News moving Biotechnology
United States
Biotechnology▲

Moderna Fair Value Estimate Rises to US$122.67 on Cancer Vaccine Analyst Revisions

Moderna's fair value estimate has been lifted from US$119.56 to US$122.67 per share, according to updated modelling tied to analyst revisions on its intismeran cancer vaccine program. The change follows Phase 3 INTerpath-001 melanoma data that prompted target lifts or upgrades from BofA, Goldman Sachs, UBS, Barclays, RBC Capital and Morgan Stanley, with BofA setting a US$200 target and a Neutral rating and calling the readout a watershed moment for Moderna. William Blair moved to Outperform and Wolfe Research called the melanoma result de-risking for the broader intismeran platform, while RBC Capital described the data as a massive scientific breakthrough. On the bearish side, Citi and Rothschild & Co Redburn moved to Sell even as they raised targets to US$80 and US$81 respectively, citing questions on oncology revenue expectations and limited disclosure around efficacy metrics such as hazard ratios. The updated model also shifted the revenue growth assumption from 26.74% to 26.75%, the net profit margin from 17.25% to 17.20%, the future P/E from 80.90x to 83.10x, and the discount rate from 7.50% to 7.46%.
MRNA · Capital · Positive Fair value estimate raised to US$122.67 and multiple analyst price-target increases/upgrades followed the data readout.
MRNA · Technology · Positive Phase 3 INTerpath-001 melanoma data for the intismeran cancer vaccine prompted analyst target lifts and upgrades, de-risking the platform.
Read original ↗
Simply Wall St·2hRead more →
China
Biotechnology▲

Hybribio's Wholly-Owned Subsidiary Obtains Medical Device Registration Certificate for Vaginal Microorganism Nucleic Acid Detection Kit

Hybribio announced on October 11 that its wholly-owned subsidiary, Chaozhou Hybribio Biochemistry Co., Ltd., has recently obtained the Medical Device Registration Certificate of the People's Republic of China for in vitro diagnostic reagents issued by the National Medical Products Administration. The registered product is a vaginal microorganism nucleic acid detection kit using PCR-fluorescent probe method, valid from October 9, 2026 to October 8, 2031, primarily for the in vitro qualitative detection of nucleic acids of Trichomonas vaginalis, Gardnerella vaginalis, and Candida albicans in vaginal secretions. The company stated that obtaining this registration certificate will further improve its product portfolio for reproductive tract infection testing, meet diversified market demand, and support its goal of becoming a leading enterprise in nucleic acid molecular diagnostics. The announcement also cautioned that actual sales and profit contribution of the approved product are subject to factors such as market promotion effectiveness and actual demand, and remain uncertain; the company is currently unable to predict the impact on its future operating results. In the interim period of 2026, Hybribio achieved revenue of 300 million yuan and net profit attributable to the parent company of 31.26 million yuan.
300639.CS · Regulation · Positive Wholly-owned subsidiary obtained NMPA Medical Device Registration Certificate for its vaginal microorganism nucleic acid detection kit, expanding its approved product portfolio.
Read original ↗
财中社·13hRead more →
ChinaUnited States
Biotechnology▲

Baili Tianheng's Yizekang Combined with Radiotherapy for Head and Neck Squamous Cell Carcinoma Receives Clinical Trial Approval

Baili Tianheng announced that the company recently received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration. The clinical trial of its self-developed, world-first bispecific antibody drug conjugate Yizekang, also known as luncoitab, in combination with radiotherapy for locally advanced unresectable head and neck squamous cell carcinoma and other solid tumors has been approved. To date, the drug has initiated more than 45 clinical trials in China and the United States, including 20 Phase III clinical studies, and 9 indications have been included in the breakthrough therapy designation list by the Center for Drug Evaluation.
688506.CG · Regulation · Positive Baili Tianheng received NMPA clinical trial approval for Yizekang combined with radiotherapy in head and neck squamous cell carcinoma.
Read original ↗
科创板日报·13hRead more →
ChinaUnited States
Biotechnology▲

Baili Tianheng's Izabren Combined with Radiotherapy for Head and Neck Squamous Cell Carcinoma Clinical Trial Approved by NMPA

Baili Tianheng announced on October 11 that the company recently received the official approval of the Drug Clinical Trial Approval Notice from the National Medical Products Administration. Its self-developed, first-in-class drug Izabren (luncombe izabren, BL-B01D1/iza-bren) combined with radiotherapy for the treatment of locally advanced unresectable head and neck squamous cell carcinoma and other solid tumors has been approved for clinical trials. The announcement stated that Izabren is the world's first and only approved EGFR×HER3 bispecific antibody-drug conjugate, and has currently initiated more than 45 clinical trials for multiple tumor types in China and the United States, including 20 Phase III clinical studies (including Phase II/III). Izabren has 9 indications included in the National Medical Products Administration's Center for Drug Evaluation breakthrough therapy designation list, 2 indications included in the priority review designation list, and some indications have also received marketing approval from the National Medical Products Administration. In mid-2026, Baili Tianheng achieved revenue of 0.0 yuan and a net loss attributable to the parent company of 1.637 billion yuan.
688506.CG · Technology · Positive NMPA approved clinical trial of Baili Tianheng's first-in-class Izabren combined with radiotherapy for head and neck squamous cell carcinoma.
Read original ↗
财中社·13hRead more →
United States
Biotechnology▲

Natera Wins FDA Breakthrough Device Designation for Multi-Cancer Blood Test

The US Food and Drug Administration granted Breakthrough Device designation to Natera's multi cancer early detection blood test, a move that reshapes how investors frame the company's diagnostics pipeline. The designation follows a strong run in Natera's share price, with a 30-day return of 21.31%, a 90-day move of 48.44%, a year-to-date gain of 75.10%, and a 1-year total shareholder return of 136.73%. The stock's latest close of $400.71 sits above the most followed fair value estimate of $355.93, which implies the shares are 13% overvalued under a 7.5% discount rate. By contrast, the Simply Wall St discounted cash flow model estimates a future cash flow value of $599.47, suggesting the shares trade about 33% below that level. Natera's investment in new product launches such as Fetal Focus NIPT, Signatera Genome, and AI-based biomarkers, along with its R&D pipeline, positions it to capture growth from long-term trends in personalized medicine and early detection, though tighter reimbursement rules or sustained high R&D spending could pressure profitability.
NTRA · Regulation · Positive FDA granted Breakthrough Device designation to Natera's multi-cancer early detection blood test, a regulatory milestone for its diagnostics pipeline.
Read original ↗
Simply Wall St·1dRead more →
United States
Biotechnology▲

vTv Therapeutics Presents Data on Hypoglycemia Burden in Type 1 Diabetes at Breakthrough T1D Congress

vTv Therapeutics announced that Chief Medical Officer Thomas Strack presented new research on hypoglycemia-related burdens among adults with type 1 diabetes using automated insulin delivery systems at the inaugural Breakthrough T1D Clinical & Research Congress in Philadelphia. The study, commissioned by vTv and conducted by dQ&A Market Research, surveyed 674 adults with type 1 diabetes, of whom 429 were using automated insulin delivery systems. Among those AID users, 24% reported frequent Level 2 hypoglycemia, 12% reported a Level 3 event in the past 12 months, and 17% reported impaired awareness of hypoglycemia. After accounting for overlap across segments and weighting for A1C, approximately 54% of adults with type 1 diabetes using an AID system were estimated to experience at least one of four hypoglycemia-related burden dimensions. The research supports vTv's cadisegliatin, a potential first-in-class oral liver-selective glucokinase activator being evaluated as an adjunctive therapy to insulin for type 1 diabetes, which has received Breakthrough Therapy designation from the U.S. Food and Drug Administration.
VTVT · Technology · Positive New research on hypoglycemia burden in AID users supports vTv's cadisegliatin, a first-in-class oral glucokinase activator with FDA Breakthrough Therapy designation for type 1 diabetes.
Read original ↗
GlobeNewswire·1dRead more →
United States
Biotechnology▲

AbbVie Wins Two FDA Breakthrough Therapy Tags for Telisotuzumab Adizutecan

AbbVie received two FDA Breakthrough Therapy Designations for its experimental cancer drug telisotuzumab adizutecan in colorectal cancer and non small cell lung cancer. The designations apply to biomarker defined patient groups in those two large solid tumor indications, and they mark the first Breakthrough Therapy status for telisotuzumab adizutecan, which sits in AbbVie's antibody drug conjugate pipeline. Colorectal cancer and non small cell lung cancer together affect more than four million people worldwide each year, and the focus on biomarker defined groups, including c Met protein expressing NSCLC, points to narrower patient pools but potentially higher value treatment settings. The designations support the view that AbbVie needs its pipeline to replace aging blockbusters such as Humira and Imbruvica, with telisotuzumab adizutecan complementing oncology assets like etentamig. The next signpost is how the ongoing Phase 3 and Phase 2/3 telisotuzumab adizutecan studies progress and when AbbVie moves toward regulatory filings in colorectal cancer and non small cell lung cancer, building on the first in human M21 404 data.
ABBV · Technology · Positive FDA granted two Breakthrough Therapy Designations for AbbVie's experimental telisotuzumab adizutecan in colorectal and NSCLC, advancing its ADC pipeline.
Read original ↗
Simply Wall St·1dRead more →
ChinaHong Kong SAR China
Biotechnology▲

3SBio Signs MindRank AI Deal to Commercialize Oral GLP-1 Obesity Drug MDR-001

3SBio subsidiaries Zhejiang Sunshine Mandi and Zhejiang Wansheng have signed an agreement with MindRank AI to commercialize MDR-001, an oral GLP-1 candidate in Phase 3 obesity trials. The deal lands as 3SBio shares trade at HK$15.07, with a 1-year total shareholder return down 45.58 percent, a 30-day share price return down 6.69 percent and a year-to-date share price return down 38.69 percent, even as the 3-year total shareholder return is up more than 2x. On valuation, 3SBio trades at a P/E of 3.9x against a Hong Kong Biotechs industry average of 17.3x and a peer group average of 36.2x, with an estimated fair P/E of 8.2x. A discounted cash flow model puts 3SBio's estimated future cash flow value at HK$33.62 versus the current HK$15.07 share price. Recent declines in revenue and net income, combined with the weak 1-year return, could pressure sentiment if MDR-001 progress disappoints.
1530.HK · Demand · Positive 3SBio subsidiaries signed a deal with MindRank AI to commercialize the Phase 3 oral GLP-1 obesity candidate MDR-001, expanding its obesity drug pipeline.
MindRank AI Ltd · Demand · Positive MindRank AI signed the agreement with 3SBio to commercialize its oral GLP-1 candidate MDR-001.
603010.CG · Demand · Positive Zhejiang Wansheng is named as a 3SBio subsidiary signing the agreement to commercialize MDR-001.
Zhejiang Sansheng Wandi Pharmaceutical · Demand · Positive Zhejiang Sunshine Mandi is named as a 3SBio subsidiary signing the agreement to commercialize MDR-001.
Read original ↗
Simply Wall St·1dRead more →
China
Biotechnology▲

Akeso Doses First Patient in Phase III Perioperative Cadonilimab Colon Cancer Study

Akeso, Inc. announced that the first patient has been dosed in a Phase III clinical study evaluating cadonilimab, its first-in-class PD-1/CTLA-4 bispecific antibody, as monotherapy in the neoadjuvant/adjuvant perioperative treatment of resectable microsatellite instability-high or mismatch repair-deficient colon cancer. The trial, designated COMPASSION-40/AK104-313, marks a significant new indication for cadonilimab beyond gastric, lung, and cervical cancers, and is the 13th Phase III or registrational study of the therapy conducted globally. Colorectal cancer is among the malignancies with the highest incidence and mortality worldwide, and patients with MSI-H/dMMR colon cancer derive limited benefit from conventional perioperative chemotherapy, with pathological response rates of only approximately 7%. No immunotherapy has yet been approved anywhere for the perioperative treatment of localized MSI-H/dMMR colon cancer. Supporting evidence comes from a prior Phase II study of cadonilimab monotherapy as neoadjuvant treatment in MSI-H/dMMR colorectal cancer, where data presented at the 2024 ESMO Immuno-Oncology Congress showed a pathological complete response rate of 84.6% and a major pathological response rate of 100% among patients who proceeded to surgery, with a manageable safety profile.
9926.HK · Technology · Positive First patient dosed in Phase III trial of cadonilimab for perioperative MSI-H/dMMR colon cancer, a new indication with strong prior Phase II response data.
Read original ↗
PR Newswire·1dRead more →
United StatesJapan
Biotechnology▲

Natera Wins FDA Breakthrough Device Designation for Multi-Cancer Blood Test

The U.S. Food and Drug Administration granted Breakthrough Device designation to Natera's blood-based multi-cancer early detection assay, sending shares of the genetic testing company up 1.7% in the morning session. The regulatory decision followed the agency's evaluation of performance data spanning 12 cancer types, assessing the assay's sensitivity, specificity, and cancer signal origin performance. The FDA Breakthrough Devices Program is designed to expedite the development and review of medical devices that diagnose or treat life-threatening conditions. Natera shares were trading at $400.22, up 2.2% from the previous close, and the stock is up 74.9% since the beginning of the year. The move comes 17 days after the stock gained 5.2% on news that Japan's Pharmaceuticals and Medical Devices Agency granted regulatory approval for its Signatera test as a companion diagnostic in muscle-invasive bladder cancer, with a commercial launch in Japan planned for the first half of 2027.
NTRA · Regulation · Positive FDA granted Breakthrough Device designation to Natera's multi-cancer early detection blood test, expediting development and review.
Read original ↗
Yahoo Finance·1dRead more →
China
Biotechnology▼

Allist Responds to Failure of Furmonertinib Overseas Phase III Clinical Study

Allist responded to media on October 9 regarding the failure of the overseas Phase III clinical study of its core product furmonertinib, stating that the FURVENT study data require further analysis and that the company will determine subsequent development and regulatory communication plans. The company believes the FURVENT study results will not affect furmonertinib's sales in the third quarter or in the future, as current sales of the drug mainly come from the first-line treatment indication for EGFR-sensitive mutations. Allist said that at the subsequent global investigator meeting for the FURVENT study, experts believed furmonertinib met prior efficacy expectations for EGFR exon 20 insertion mutations; the chemotherapy arm's progression-free survival assessed by blinded independent central review differed substantially from investigator-assessed results, and apart from this difference, other data for furmonertinib performed well. On the same day, the National Healthcare Security Administration separately published the first batch of primary-level disease categories, including 31 DRG primary-level disease groups and 127 DIP primary-level disease categories, for local implementation reference.
688578.CG · Technology · Negative Overseas Phase III FURVENT study of core product furmonertinib failed, requiring further data analysis and uncertain regulatory path.
Read original ↗
21世纪经济·1dRead more →
China
Biotechnology▼

Pharmaron's Overseas Employee Shareholding Platform Plans to Transfer 1% Stake via Inquiry

Pharmaron announced that shareholder Pharmaron Holdings Limited plans to transfer 18.373 million shares of the company through inquiry, representing 1.00% of total share capital, with the reason being its own capital needs. The transferor is the company's overseas employee shareholding platform, with actual controller Boliang Lou. It is not a controlling shareholder of the company, but a person acting in concert with the actual controller and a shareholder holding more than 5% of shares. Its shareholders include directors and senior management of the company. The transferees are institutional investors, and the transferred shares cannot be sold within six months after the transfer. The lower limit of the inquiry transfer price shall not be less than 70% of the average stock trading price over the 20 trading days before the date of sending the subscription invitation. Huatai United Securities will determine the transfer price after the quotation based on the principles of price priority, quantity priority, and time priority. Financial data shows that in the first half of this year, the company's operating revenue was 7.595 billion yuan, up 17.92% year-on-year; net profit attributable to the parent was 750 million yuan, up 6.96% year-on-year; and non-GAAP net profit attributable to the parent was 693 million yuan, up 8.87% year-on-year. As of the close on October 9, Pharmaron fell 1.46% to 43.11 yuan per share, with a total market value of 79.21 billion yuan.
300759.CS · Capital · Negative Overseas employee shareholding platform plans to transfer 1% stake via inquiry due to its own capital needs, signaling potential selling pressure.
Read original ↗
读创财经·1dRead more →
China
Biotechnology▼

Jindike halts sales of core quadrivalent flu vaccine; full-year revenue may fall below 100 million yuan, triggering delisting risk warning

Jindike issued a risk warning announcement on the evening of October 9, saying that because the World Health Organization adjusted the recommended composition of influenza vaccines, the company will no longer sell its core product, the quadrivalent influenza vaccine, in this flu season. The newly approved trivalent influenza vaccine has no products available for sale yet, so full-year revenue may fall below 100 million yuan and the company may fail to return to profitability. If the annual report triggers the financial delisting risk warning condition, the Shanghai Stock Exchange will impose a delisting risk warning on the company's shares. According to the recommended composition for the 2026-2027 Northern Hemisphere influenza vaccines published by the World Health Organization and the Chinese National Influenza Center, the B/Yamagata lineage virus has been removed, and quadrivalent influenza vaccines containing that lineage no longer meet current seasonal vaccination demand, making trivalent influenza vaccines the main products promoted in the market. Jindike's operating revenue currently comes entirely from the quadrivalent influenza vaccine. The trivalent vaccine has just been approved and still needs to obtain a biological product batch release certificate before it can be marketed, and sales are also constrained by the progress of local government procurement and bidding. As of the announcement date, no trivalent vaccine is available for sale. The company listed on the STAR Market in 2021, with operating revenue of 318 million yuan in its first year of listing. Since then, performance has continued to deteriorate, with net profit negative for three consecutive years: a loss of 70.99 million yuan in 2023, a loss of 93.5 million yuan in 2024, and a loss widening to 178 million yuan in 2025. In the first half of 2026, revenue was 910,900 yuan, down 74.15 percent year on year, and net profit attributable to the parent company was negative 51.07 million yuan, with the loss widening 28.79 percent year on year. As of the close on October 9, Jindike traded at 19.17 yuan per share, up 5.21 percent, with a total market value of 2.362 billion yuan.
688670.CG · Regulation · Negative WHO composition change removed the B/Yamagata lineage, making Jindike's only revenue-generating quadrivalent flu vaccine unsellable and triggering a delisting risk warning.
Read original ↗
中国基金报·1dRead more →
United States
Biotechnology

Vertex Pharmaceuticals Rises 1.36% as Earnings Report Nears

Vertex Pharmaceuticals shares closed up 1.36% at $510.08, outpacing the S&P 500's 0.6% gain. The drugmaker is scheduled to report earnings on November 2, 2026, with analysts projecting earnings of $4.84 per share, representing year-over-year growth of 0.83%, and revenue of $3.4 billion, up 10.43% from the year-ago period. For the full year, the Zacks Consensus Estimates call for earnings of $18.86 per share and revenue of $13.21 billion, changes of +2.5% and +10.09% respectively from last year. The Zacks Consensus EPS estimate has moved 1.03% lower within the past month, and Vertex Pharmaceuticals currently carries a Zacks Rank of #3 (Hold). The stock trades at a Forward P/E ratio of 26.69, a premium to its industry's average of 23.15, and has a PEG ratio of 1.95 versus the Medical - Biomedical and Genetics industry average of 1.7.
VRTX · Capital · Neutral Shares rose 1.36% ahead of its Nov 2 earnings report, with analyst estimates and a Zacks #3 (Hold) rank cited; no company-specific development beyond the upcoming earnings and valuation context.
Read original ↗
Zacks Investment Research·1dRead more →
United States
Biotechnology▼

CytoMed Therapeutics Gets Nasdaq Notice Over Sub-$1 Bid Price

CytoMed Therapeutics announced Friday that it received a Nasdaq notice of non-compliance after its closing bid price stayed below $1 for 30 consecutive business days. The company has until April 5, 2027, to restore compliance by keeping its closing bid price at or above $1 for at least 10 consecutive business days. CytoMed may qualify for another 180-day extension if it meets Nasdaq's other listing requirements, including the minimum market value of publicly held shares. A written notice outlining its intention to cure the deficiency must be submitted to Nasdaq during the second period, with a reverse stock split among the possible measures. Shares fell 5.81%.
GDTC · Regulation · Negative CytoMed received a Nasdaq non-compliance notice for its sub-$1 bid price, threatening delisting unless it cures the deficiency.
Read original ↗
Seeking Alpha·1dRead more →
SingaporeUnited States
Biotechnology▼

CytoMed Therapeutics Gets Nasdaq Bid Price Deficiency Notice

CytoMed Therapeutics Limited said it received a notice from Nasdaq on October 6, 2026, stating that the closing bid price of its ordinary shares had been below the minimum US$1.00 per share requirement under Nasdaq Listing Rule 5550(a)(2) for the last 30 consecutive business days. The Singapore-based clinical stage biopharmaceutical company, which trades on Nasdaq under the symbol GDTC, said the notification letter has no current effect on the listing or trading of its ordinary shares. Under Nasdaq Listing Rule 5810(c)(3)(A), CytoMed has a 180 calendar day compliance period, running until April 5, 2027, to regain compliance. The company would regain compliance if its closing bid price is US$1.00 per share or higher for at least ten consecutive business days at any point during that period, and if it fails to do so by April 5, 2027, it may be eligible for an additional 180-day compliance period provided it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, apart from the minimum bid price requirement. CytoMed said the letter does not affect its business operations and that it intends to take all reasonable measures to regain compliance within the prescribed grace period.
GDTC · Regulation · Negative CytoMed received a Nasdaq bid price deficiency notice for trading below the $1.00 minimum, triggering a compliance period under Nasdaq Listing Rule 5550(a)(2).
Read original ↗
GlobeNewswire·1dRead more →
United States
Biotechnology▲

Moderna shares surge on news of US-private partnership to develop cancer vaccines

Shares of Moderna and Novavax rose today after The New York Times reported that the US National Institutes of Health, or NIH, plans to launch a public-private partnership to accelerate the development of personalized cancer vaccines. The vaccine project is expected to begin in December, focusing on pancreatic cancer, liver cancer, and colorectal cancer, as well as certain tumors in children. Previous trials have used mRNA technology to train the body's immune system to recognize and attack proteins specific to cancer cells. The positive reaction to the news was most evident for Moderna, which is developing personalized mRNA cancer vaccines together with Merck. Moderna's share price has soared more than 600% since the start of this year, making it the best-performing stock among the companies used to calculate the S&P 500 index.
MRNA · Technology · Positive NIH public-private partnership to accelerate personalized mRNA cancer vaccines directly benefits Moderna's cancer vaccine program with Merck.
NVAX · Technology · Positive Novavax shares rose on the NIH cancer vaccine partnership news, though the article does not detail its specific role.
Read original ↗
InfoQuest·1dRead more →
United States
Biotechnology▲

Vertex Reports ALYFTREK Restored Pancreatic Function in Young Children With Cystic Fibrosis

Vertex Pharmaceuticals announced new interim data showing that ALYFTREK, or vanzacaftor/tezacaftor/deutivacaftor, restored exocrine pancreatic function in some children with cystic fibrosis ages 2 to 5, allowing them to stop pancreatic enzyme replacement therapy. The data, presented as a late breaker poster at the North American Cystic Fibrosis Conference, came from 48 children enrolled in the PERT discontinuation substudy VX22-121-106 Cohort 2, part of an ongoing open-label extension study in that age group. After at least 48 weeks of treatment, mean fecal elastase-1 was 239.7 micrograms per gram, a mean increase of 110.2 micrograms per gram from baseline, and 48.6 percent of children reached the pancreatic sufficiency threshold of at least 200 micrograms per gram. Of the 48 children eligible for the substudy, 18, or 37.5 percent, successfully discontinued pancreatic enzyme replacement therapy for a mean duration of 8.6 weeks, and across the full enrolled cohort of 66 children, 50 percent were not on the therapy at the data cut. Carmen Bozic, Vertex's chief medical officer, said the findings represent a profound shift in understanding the benefits of treating cystic fibrosis in its earliest stages, noting that pancreatic failure had long been considered irreversible. Vertex also presented additional abstracts at the conference, held October 7 to 10 in Atlanta, on clinical and real-world evidence for CFTR modulators, including a post-hoc analysis of reduced intravenous antibiotic use with VNZ/TEZ/D-IVA in patients 12 and older and a natural history study of exocrine pancreatic function in infants under 12 months. The use of ALYFTREK in children 2 to 5 years old is investigational.
VRTX · Technology · Positive Interim data showed ALYFTREK restored exocrine pancreatic function in young children with cystic fibrosis, allowing some to stop enzyme replacement therapy.
Read original ↗
Business Wire·1dRead more →
United States
Biotechnology▲

bioAffinity Technologies Closes $4 Million Registered Direct Financing

WallachBeth Capital announced that bioAffinity Technologies has closed a registered direct offering of common stock to an institutional investor at $6.122 per share, or $6.115 per pre-funded warrant, priced at-the-market under Nasdaq rules. The gross proceeds to the company were approximately $4 million before deducting placement agent fees and other offering expenses. In a concurrent private placement, bioAffinity also closed warrants to purchase up to an aggregate 980,072 shares of common stock at an exercise price of $6.122 per share, with the pre-funded warrants carrying an exercise price of $0.007 per share; both sets of warrants become exercisable following stockholder approval and expire five years from that approval. WallachBeth Capital acted as sole placement agent for the offering. bioAffinity, a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, intends to use the net proceeds for working capital, to support expected growing sales for CyPath Lung, its noninvasive test for lung cancer, and general corporate purposes.
BIAF · Capital · Positive bioAffinity closed a $4M registered direct financing, providing working capital to support CyPath Lung sales growth.
WallachBeth Capital · Capital · Positive WallachBeth Capital acted as sole placement agent for bioAffinity's $4M registered direct offering.
Read original ↗
PR Newswire·1dRead more →
United StatesUnited Kingdom
Biotechnology▲

Moderna stock jumps 9% on planned national cancer vaccine effort

Moderna stock popped 9% on Friday after the New York Times reported new details about an effort to accelerate cancer vaccine development, with investors seeing the mRNA biotech company in particular as a beneficiary. Other pharmaceutical stocks, including Pfizer, BioNTech, and Merck, also rose. According to the New York Times, the new initiative is a public-private partnership, similar to the effort that produced COVID-19 vaccines, that involves the National Institutes of Health, the NIH's nonprofit arm, researchers, pharmaceutical and biotech companies, advocacy groups, other nonprofits, and patients. Stacey Adam, a senior clinical officer at the NIH's foundation, told the New York Times that she expects the program to launch in December, and in 2024 the UK launched a similar program called the Cancer Vaccine Launch Pad. Moderna is viewed as a leader in mRNA cancer treatments, and the stock soared in August on positive results for a melanoma treatment developed with Merck; year to date, Moderna stock is up 627%.
MRNA · Demand · Positive Moderna is seen as a key beneficiary of the planned national public-private cancer vaccine effort, given its mRNA cancer treatment leadership.
MRK · Demand · Positive Merck rose as part of the cancer vaccine initiative news; its mRNA melanoma treatment with Moderna is cited as context.
Read original ↗
Yahoo Finance·1dRead more →
United States
Biotechnology▲

bioAffinity Technologies Closes $4 Million Registered Direct Financing

bioAffinity Technologies has closed a registered direct offering of common stock to an institutional investor at $6.122 per share, or $6.115 per pre-funded warrant, priced at-the-market under Nasdaq rules, alongside a concurrent private placement of warrants. The private placement covers warrants to purchase up to an aggregate 980,072 shares of common stock at an exercise price of $6.122 per share, while the pre-funded warrants carry an exercise price of $0.007 per share; both sets of warrants become exercisable following stockholder approval and expire five years from that approval. Gross proceeds from the offering totaled approximately $4 million before deducting placement agent fees and other offering expenses, with WallachBeth Capital, LLC serving as sole placement agent. bioAffinity said it intends to use the net proceeds for working capital, to support expected growing sales for CyPath Lung, its noninvasive test for lung cancer, and for general corporate purposes. The common stock was offered under a shelf registration statement on Form S-3, File No. 333-275608, declared effective by the SEC on November 27, 2023.
BIAF · Capital · Positive bioAffinity closed a $4M registered direct offering plus warrants, raising capital for working capital and CyPath Lung sales growth.
WallachBeth Capital · Capital · Neutral WallachBeth Capital served as sole placement agent on the $4M offering, a transactional role rather than a company-specific financial event.
Read original ↗
Business Wire·1dRead more →
United States
Biotechnology▲

AbbVie Revenue Rises 10.2% as Skyrizi and Rinvoq Offset Humira's 35.9% Decline

AbbVie grew total revenue 10.2% to $16.99 billion last quarter even as Humira sales fell 35.9% to $756 million, with the company's newer immunology drugs carrying the growth. Skyrizi brought in $5.505 billion, up 24.4%, and Rinvoq added $2.525 billion, up 24.5%, lifting total immunology sales to $8.786 billion, up 15.1%. Neuroscience contributed $3.228 billion, up 20.3%, while oncology slipped 1.5% to $1.650 billion and aesthetics edged up 0.3% to $1.282 billion. Adjusted earnings per share came in at $3.65, up 22.9%, against GAAP earnings of $2.03, and management guides to full-year adjusted EPS of $13.87 to $14.07. AbbVie recently closed its purchase of Apogee Therapeutics at $135.11 per share in cash, for a total equity value of $10.9 billion, a deal the company says will reduce adjusted EPS by $0.14 this year and approximately $0.46 in 2027, with accretion beginning in 2032. At a forward P/E of 18.97 as of October 6, AbbVie trades essentially in line with the sector's 18.84 but above its own five-year average of 14.51, a premium that leans on expected EPS growth of 16.14% in 2027.
ABBV · Capital · Positive AbbVie grew total revenue 10.2% to $16.99B with adjusted EPS up 22.9% to $3.65 and raised full-year EPS guidance.
ABBV · Demand · Positive Skyrizi and Rinvoq sales rose ~24% each, lifting total immunology revenue 15.1% and offsetting Humira's 35.9% decline.
Read original ↗
Insider Monkey·2dRead more →
United States
Biotechnology▲

Intellia Therapeutics Jumps 7.6% on FDA Priority Review for CRISPR HAE Therapy

Intellia Therapeutics shares rallied 7.6% in the last trading session to close at $12.6, a move that appears to reflect growing investor confidence in the company's regulatory progress and financial position. The FDA accepted the biologics license application for lonvoguran ziclumeran, or lonvo-z, Intellia's investigational CRISPR-based treatment for hereditary angioedema, under Priority Review with a March 10, 2027 decision date. The company also secured an OrbiMed debt facility of up to $400 million in September, including $75 million upfront, to help support development and potential commercialization. Intellia is expected to post a quarterly loss of $0.82 per share in its upcoming report, a year-over-year change of +10.9%, on revenues of $10 million, down 27.5% from the year-ago quarter, while the consensus EPS estimate for the quarter has remained unchanged over the last 30 days. The stock currently carries a Zacks Rank #3 (Hold).
NTLA · Regulation · Positive FDA accepted the BLA for lonvo-z under Priority Review with a March 10, 2027 decision date
NTLA · Capital · Positive Secured an OrbiMed debt facility of up to $400 million, including $75 million upfront, to fund development and commercialization
OrbiMed · Capital · Neutral OrbiMed provided Intellia a debt facility of up to $400 million; mentioned only as the lender
Read original ↗
Zacks Investment Research·2dRead more →
China
Biotechnology▼

Bioperfectus Technologies Board Rejects Controlling Shareholder's Board Renewal Proposal with Five Votes Against

Bioperfectus Technologies disclosed late on October 8 that its third board of directors, at its eighteenth meeting, voted down a proposal from controlling shareholder Shaoxing Runkang Biomedical Equity Investment Partnership to convene an extraordinary general meeting to consider board renewal, with four votes in favor, five against, and zero abstentions. Runkang Biomedical sent a letter on September 22 requesting that an extraordinary general meeting be held before October 23, 2026, and nominated Fang Yongsheng, Hu Yuanyuan, Hou Wenshan, Jin Jing, and Dong Jingnan as non-independent director candidates for the fourth board, and Gao Guangxia, Yang Shunhai, and Liu Xiaolun as independent director candidates. Chairman Wang Guoqiang, directors Liang Kecheng and Guo Haitao, employee director Jia Zhaoqiang, and independent director Liu Xiaolun cast opposing votes. Wang Guoqiang stated that the seal on the controlling shareholder's documents differs from the company's records regarding its engraving and filing, leaving the seal's validity in dispute, and that the lawsuit seeking Runkang Biomedical's dissolution is still pending, making conditions premature for convening an extraordinary general meeting to consider the renewal. The announcement also clarified that the five directors opposed advancing the renewal process before the relevant major matters are investigated and disclosed in accordance with the law, not the company's lawful and compliant pursuit of renewal. Runkang Biomedical holds 27.53 percent of the listed company's total share capital. Liang Xilin, Taizhou Shuoyue Equity Investment Partnership, and Fang Yongsheng hold 71.88 percent, 20.13 percent, and 7.99 percent of its interests respectively. Liang Xilin has filed a lawsuit seeking Runkang Biomedical's dissolution and has reported to the public security authorities on grounds of misappropriated funds, which has been accepted. The company cautioned that if the court ultimately orders Runkang Biomedical's dissolution, Fang Yongsheng will no longer serve as its executive partner, and there is a risk of change in the company's controlling shareholder and actual controller.
688399.CG · Regulation · Negative Board rejected controlling shareholder's proposal to convene an EGM for board renewal, citing disputed seal validity and pending dissolution lawsuit, creating governance uncertainty.
闰康生物 · Regulation · Negative Its board renewal proposal was voted down by the listed company's board, and it faces a pending lawsuit seeking its dissolution.
Read original ↗
每日经济新闻·2dRead more →
ChinaSwitzerlandColombia
Biotechnology▲

MicuRx Pharmaceuticals Signs Exclusive License Agreement for MRX-23 with Milestone Payments Capped at 750 Million US Dollars

MicuRx Pharmaceuticals has signed an exclusive license agreement and a platform technology collaboration agreement with Switzerland's ClearideBio for the MRX-23 project. The nominal cap on milestone payments for the development, registration, and sales of MRX-23 totals 223 million US dollars, while the cap for all platform collaboration projects, if all options are exercised and all milestones are achieved, totals 750 million US dollars. Under the agreement, an upfront payment of 1 million US dollars is payable as agreed after the agreement takes effect and is non-refundable, and near-term development milestone payments are triggered by the first approval of a clinical trial application for the licensed product. Biwin Storage Technology announced that as of September 30, 2026, it had cumulatively repurchased 1,044,700 shares, accounting for 0.22 percent of total share capital, with a total payment of 222 million yuan. The repurchase plan is expected to involve a total amount of 200 million to 250 million yuan. Sino Medical Sciences Technology's coronary balloon dilatation catheter has received approval from Colombia's INVIMA and obtained a medical device registration certificate. Jiangsu Jindike Biotechnology's trivalent influenza vaccine has obtained a drug registration certificate, but the company expects full-year revenue may fall below 100 million yuan and it will not be able to turn a profit. If it triggers the financial delisting risk warning conditions, the Shanghai Stock Exchange will impose a delisting risk warning on the company's shares.
688108.CG · Regulation · Positive Coronary balloon dilatation catheter received INVIMA approval and medical device registration certificate in Colombia.
688373.CG · Capital · Positive Signed exclusive license and platform collaboration agreement for MRX-23 with up to $750M in milestone payments plus $1M upfront.
688525.CG · Capital · Positive Announced cumulative share repurchases of 1,044,700 shares for 222 million yuan under its buyback plan.
688670.CG · Regulation · Neutral Trivalent influenza vaccine obtained drug registration certificate, but company warns full-year revenue may fall below 100 million yuan and it will not turn a profit, risking delisting warning.
ClearideBio Therapeutics AG · Capital · Positive Signed exclusive license and platform technology collaboration agreement with MicuRx for MRX-23.
Read original ↗
科创板日报·2dRead more →
China
Biotechnology▲

Konruns Pharmaceutical Has Repurchased 2 Million Shares for 78.43 Million Yuan

Konruns Pharmaceutical announced on October 9 that as of September 30, 2026, the company had repurchased 2 million shares, accounting for 1.24% of total share capital, with a repurchase amount of 78.43 million yuan and a repurchase price range of 28.36 yuan to 51.4 yuan per share. In the first half of 2026, Konruns Pharmaceutical achieved revenue of 463 million yuan and net profit attributable to the parent of 95.72 million yuan.
603590.CG · Capital · Positive Konruns Pharmaceutical repurchased 2 million shares for 78.43 million yuan, a buyback that is positive for the stock.
Read original ↗
财中社·2dRead more →
China
Biotechnology▲

Olymvax Biopharmaceuticals Wins First-Instance Ruling in Technology Transfer Contract Dispute, Core Counterclaim Upheld

Olymvax Biopharmaceuticals disclosed a litigation progress announcement on the evening of October 9. The first-instance judgment in a technology transfer contract dispute has been served. The court found the plaintiff to be in breach of contract, and the listed company's core claim to terminate the contract was upheld. The case stems from a Technology Transfer Contract signed on June 22, 2011. Plaintiff Wang Jianhua filed suit in December 2025, claiming product royalties and liquidated damages totaling 19.2 million yuan, which was amended to 20.88 million yuan in January 2026. The company subsequently filed a counterclaim, seeking confirmation of contract termination and demanding a refund of the price plus liquidated damages totaling 9.7 million yuan. The court found that the plaintiff failed to fully perform contractual obligations and constituted a breach, and that the contract was terminated on January 27, 2026. It ordered the company to pay the plaintiff 2 million yuan and the plaintiff to pay the company 1 million yuan in liquidated damages. After offsetting the two amounts, the company's actual net burden is 1 million yuan. Of the plaintiff's 20.88 million yuan claim, the 2 million yuan awarded is less than one-tenth of the amount sought. The company's full-year 2025 revenue was 704 million yuan and net profit attributable to the parent was 22.2601 million yuan. The 1 million yuan net expense has limited impact on current-period profit and loss, but the case is still within the appeal period and the first-instance judgment has not yet taken effect. On the operational side, the company achieved revenue of 361 million yuan in the first half of 2026, up 18.14 percent year on year. Affected by factors including back taxes, net profit attributable to the parent was negative 32.8726 million yuan, swinging from profit to loss year on year. Its recombinant Staphylococcus aureus vaccine completed unblinding of the Phase III clinical trial in July 2026, with protective efficacy reaching 73.25 percent, exceeding the pre-specified 60 percent target, making it the world's first Staphylococcus aureus vaccine to complete Phase III clinical trials. The company aims to formally file for production approval before the end of 2026.
688319.CG · Regulation · Positive First-instance court upheld the company's core claim to terminate the technology transfer contract and found the plaintiff in breach, leaving only a 1 million yuan net burden versus the 20.88 million yuan sought.
Read original ↗
证券时报·2dRead more →
China
Biotechnology▼

Pharmaron Shareholder Plans Inquiry-Based Transfer of 18.373 Million Shares, 1.00% of Total Share Capital

Pharmaron announced that shareholder Pharmaron Holdings Limited plans to transfer 18.373 million company shares through an inquiry process, representing 1.00% of the company's total share capital. The reason for the transfer is the shareholder's own capital needs. The transferees will be institutional investors with appropriate pricing capability and risk tolerance, and the transferred shares may not be further transferred within six months of receipt.
300759.CS · Capital · Negative A major shareholder plans to transfer 18.373 million shares (1.00% of capital) due to its own capital needs, signaling potential selling pressure.
Read original ↗
China
Biotechnology▼

Jindike halts sales of quadrivalent flu vaccine, trivalent not yet available; full-year revenue may fall below 100 million yuan, triggering delisting risk warning

Jindike announced on October 9 that it had received a Drug Registration Certificate for its split-virion influenza vaccine approved and issued by the National Medical Products Administration, marking the market approval of its trivalent influenza vaccine. The company's current operating revenue comes entirely from its quadrivalent influenza vaccine. However, because the World Health Organization and the Chinese National Influenza Center removed the B/Yamagata lineage virus from the recommended composition, the trivalent influenza vaccine has become the main product promoted in the market this flu season. The company will no longer sell the quadrivalent influenza vaccine this flu season and will sell only the trivalent influenza vaccine. Since the trivalent product has just been approved and can be marketed only after obtaining a biological product batch release certificate, and is also affected by the progress of local government procurement and bidding, the company currently has no trivalent influenza vaccine available for sale. The company's estimates show that full-year operating revenue is expected to be below 100 million yuan and that it will not be able to turn a profit. If operating revenue for this year is below 100 million yuan and net profit is negative, the company will trigger a financial delisting risk warning. In the first half of 2026, Jindike achieved revenue of 910,000 yuan and a net loss attributable to the parent company of 51.07 million yuan.
688670.CG · Regulation · Negative Jindike halted quadrivalent flu vaccine sales and has no trivalent product available, so full-year revenue may fall below 100 million yuan, triggering a delisting risk warning.
Read original ↗
财中社·2dRead more →
China
Biotechnology▼

Jindike's trivalent flu vaccine approved for registration; full-year revenue may fall below 100 million yuan, risking delisting risk warning

Jindike announced that the company recently received the Drug Registration Certificate for its split-virion influenza vaccine approved and issued by the National Medical Products Administration. Affected by the WHO's adjustment of recommended influenza vaccine components, the company will no longer sell the quadrivalent influenza vaccine this flu season and will only sell the trivalent influenza vaccine. Because the product has just been approved, there are no products available for sale yet, and the company has missed the window for large-scale sales. Based on preliminary estimates, full-year revenue is expected to possibly fall below 100 million yuan and the company may not be able to turn a profit. If it triggers financial delisting risk warning conditions, the Shanghai Stock Exchange will impose a delisting risk warning on the company's stock.
688670.CG · Regulation · Negative Trivalent flu vaccine approved but company misses sales window, full-year revenue may fall below 100 million yuan, risking delisting risk warning.
Read original ↗
科创板日报·2dRead more →
China
Biotechnology▼

Board Rejects Shareholder's Proposal for Extraordinary General Meeting at Bioperfectus Technologies; Seal Validity Dispute Draws Attention

Bioperfectus Technologies announced on October 8 that the eighteenth meeting of its third board of directors was held on October 2, 2026, to review the proposal on agreeing to the controlling shareholder's request to convene an extraordinary general meeting. The result was 4 votes in favor, 5 against, and 0 abstentions, so the proposal was not passed. Directors who voted against included Wang Guoqiang, Liang Kecheng, Guo Haitao, Jia Zhaoqiang, and independent director Liu Xiaolun. Wang Guoqiang's main reason for opposition was that the controlling shareholder's relevant documents are subject to a dispute over seal validity, and the lawsuit for dissolution of the controlling shareholder is still pending, which could have a major impact on the company's control. The reasons given by the other opposing directors also involved the seal validity dispute and information asymmetry. The company also received a regulatory work letter from the Shanghai Stock Exchange, with the matter for handling being precisely the board resolution and related issues. In the first half of 2026, Bioperfectus Technologies achieved revenue of 147 million yuan and net profit attributable to the parent company of 19.56 million yuan.
688399.CG · Regulation · Negative Board rejected the controlling shareholder's request to convene an extraordinary general meeting amid a seal-validity dispute and an ongoing dissolution lawsuit, and the Shanghai Stock Exchange issued a regulatory work letter on the matter.
Read original ↗
财中社·2dRead more →
China
Biotechnology▲

Shanghai RAAS Has Repurchased 17.0032 Million Shares for a Total of About 85.6859 Million Yuan

Shanghai RAAS disclosed the latest progress of its share repurchase on October 9. As of September 30, 2026, the company had repurchased a total of 17.0032 million shares through a dedicated securities account for share repurchases by centralized bidding, accounting for 0.258% of the company's total share capital. The highest transaction price in this repurchase was 5.12 yuan per share, and the lowest was 4.93 yuan per share. The total transaction amount was about 85.6859 million yuan, excluding transaction costs such as trading commissions.
002252.CS · Capital · Positive Shanghai RAAS repurchased 17.0032 million shares for about 85.69 million yuan, a buyback that returns capital to shareholders.
Read original ↗
上海证券报·2dRead more →
China
Biotechnology▼

BioPerfectus Board Rejects Controlling Shareholder's Proposal to Convene Extraordinary General Meeting

Jiangsu BioPerfectus Technologies Co., Ltd., referred to as BioPerfectus, stock code 688399 on the Shanghai Stock Exchange, announced on October 9 that the proposal regarding agreeing to the controlling shareholder's request to convene an extraordinary general meeting was not approved by the company's board of directors, and the board does not agree to convene an extraordinary general meeting. The announcement shows that BioPerfectus received a request letter on September 22, 2026, from its controlling shareholder, Shaoxing Runkang Biomedical Equity Investment Partnership, referred to as Runkang Biomedical, proposing that the company's board convene an extraordinary general meeting to consider proposals related to the election of a new board. The voting result on the above proposal was 4 votes in favor, 5 against, and 0 abstentions. Directors Wang Guoqiang, Liang Kecheng, Guo Haitao, and Jia Zhaoqiang, along with independent director Liu Xiaolun, voted against, with reasons largely focused on disputes over the validity of seals and multiple matters pending verification. The announcement disclosed that these directors opposed advancing the board election process before relevant major matters are clarified and disclosed in accordance with the law, rather than opposing the company's lawful and compliant advancement of the election. Currently, the controlling shareholder Runkang Biomedical is involved in litigation. Liang Xilin, as a limited partner of Runkang Biomedical, has filed a lawsuit with the Shangyu District People's Court in Shaoxing, Zhejiang Province, seeking an order to dissolve Runkang Biomedical. As of the announcement date, the case is still in progress. In addition, Liang Xilin has reported to the public security authorities on the grounds that Runkang Biomedical's funds were misappropriated, and the authorities have accepted the case and issued a case acceptance receipt. BioPerfectus stated that if the court ultimately rules to dissolve Runkang Biomedical, Fang Yongsheng will no longer serve as the executive partner of Runkang Biomedical, and there is a risk of change in the company's controlling shareholder and actual controller.
688399.CG · Regulation · Negative Board rejected the controlling shareholder's request to convene an EGM to elect a new board, amid seal-validity disputes and pending verification of major matters.
绍兴闰康生物医药股权投资合伙企业(有限合伙) · Regulation · Negative The partnership's EGM request was rejected by the board and it is involved in litigation seeking its dissolution.
闰康生物 · Regulation · Negative Its request to convene an extraordinary general meeting for a board election was rejected by BioPerfectus's board, and it faces a dissolution lawsuit from limited partner Liang Xilin.
Read original ↗
经济参考网·2dRead more →
United States
Biotechnology▼

Newron Reviews FDA Clinical Hold Feedback as ENIGMA-TRS 1 Nears Enrollment Completion

Newron Pharmaceuticals said it has received the anticipated written communication from the U.S. Food and Drug Administration regarding the clinical hold at U.S. study centers in its Phase 3 ENIGMA-TRS 2 study of evenamide, and is reviewing the feedback and preparing its response. The FDA's concern relates to the known risk that certain sodium channel blockers may trigger arrhythmias, and the agency noted four deaths among patients treated with evenamide across all clinical studies to date versus one death among placebo patients; three of the four evenamide deaths were considered unrelated by investigators, while one was deemed possibly related. Newron said the four deaths represent an incidence of 0.56% versus 0.27% for placebo, and that when adjusted for treatment duration the mortality rate was 1.31 per 100 patient-years for evenamide compared with 1.81 per 100 patient-years for placebo. The company said it has not observed a pattern of cardiac abnormalities or arrhythmias across more than 10,000 ECGs from approximately 700 evenamide-treated subjects, and is evaluating additional cardiac screening and monitoring measures for ENIGMA-TRS 2. Enrollment in ENIGMA-TRS 1 is expected to be completed by mid-October, with topline 12-week data expected in Q1 2027, while ENIGMA-TRS 2 enrollment continues outside the U.S. with additional clinical sites being added as planned.
NWRN.SW · Regulation · Negative FDA clinical hold over evenamide arrhythmia/death risk and pending response create regulatory uncertainty for its lead program
Read original ↗
NewMediaWire·2dRead more →
United States
Biotechnology▲

Sionna Therapeutics to Present Cystic Fibrosis Data at 2026 NACFC

Sionna Therapeutics announced it will present new data on its NBD1 stabilizers at the 2026 North American Cystic Fibrosis Conference in Atlanta, Georgia, held October 7-10, 2026. The oral presentation covers previously disclosed post hoc analyses of the PreciSION CF Phase 2a trial of SION-719 added to Trikafta; although the trial missed its key activity endpoint, analyses excluding three participants with PK patterns consistent with dosing non-adherence showed a mean placebo-adjusted sweat chloride reduction of 8.6 mmol/L, and identified lower exposures of all three Trikafta components plus a potential interaction between SION-719 and the potentiator ivacaftor. Sionna said these findings, together with favorable Phase 1 safety, tolerability and PK results, support advancing SION-451 plus SION-2222 into AscenSION CF, an open-label, 28-day Phase 2a proof-of-concept trial assessing sweat chloride, safety and PK in adults with CF homozygous for F508del, expected to begin in the first quarter of 2027. A poster presents preclinical data showing that NBD1 stabilizers SION-451 and SION-719, in combination with complementary modulators including SION-2222 and SION-109, improved CFTR trafficking and function up to wild-type levels across primary human bronchial epithelial cells from F508del/F508del and F508del/null donors, supporting their potential to benefit a broad population of people with CF.
SION · Technology · Positive Sionna will present new NBD1 stabilizer data at NACFC 2026, with preclinical results showing CFTR function improved up to wild-type levels, supporting advancement of SION-451 plus SION-2222 into the AscenSION CF Phase 2a trial.
Read original ↗
GlobeNewswire·2dRead more →
United States
Biotechnology▲

Vaxcyte Raises US$1b After Positive Phase 3 VAX-31 Data

Vaxcyte has raised roughly US$1b through concurrent common stock, pre funded warrant and convertible note offerings, following positive Phase 3 data for its VAX 31 pneumococcal vaccine candidate. The financing came after the Phase 3 OPUS 1 readout, and the company's shares have traded at US$66.96, with a 7 day share price return of 17.68% and a year to date share price gain of 44.12%. The 1 year total shareholder return of 64.36% and 5 year total shareholder return of 175.56% reflect momentum reinforced by the OPUS 1 update and the US$1b mix of equity and convertible note financing completed this week. Vaxcyte is currently trading at 3.6x book value, compared with 2x for the wider US Biotechs group and 9.3x for closer peers, while a widely followed narrative framework anchors fair value closer to $75 using a 7.51% discount rate. Completion of a dedicated large scale manufacturing facility with Lonza, build out of a high volume fill finish line in North Carolina and plans to build commercial supply ahead of a possible VAX-31 launch could support stronger net margins, though OPUS-2 or OPUS-3 data or higher than modeled manufacturing costs could reset expectations.
PCVX · Capital · Positive Vaxcyte raised ~US$1b via common stock, pre-funded warrants and convertible notes after positive Phase 3 VAX-31 data.
PCVX · Technology · Positive Positive Phase 3 OPUS 1 readout for its VAX-31 pneumococcal vaccine candidate drove the financing.
LONN.SW · Demand · Positive Vaxcyte is completing a dedicated large-scale manufacturing facility with Lonza, a concrete capacity/order development for Lonza.
Read original ↗
Simply Wall St·2dRead more →
AustraliaUnited States
Biotechnology▲

Editas upgraded by Wells Fargo after Australia clears gene editing trial

Editas Medicine traded higher on Thursday after Australian authorities cleared a Phase 1/2 trial for the company's gene-editing therapy EDIT-401, and Wells Fargo upgraded the biotech to Overweight from Equal Weight in reaction. The Cambridge, Massachusetts-based company said the Human Research Ethics Committee of Australia approved the initiation of its Phase 1/2 Strive trial for EDIT-401 in patients with hyperlipidemia. Strive is designed to test a single dose of the in vivo gene editing medicine in heterozygous familial hypercholesterolemia, a genetic disorder characterized by high levels of low-density lipoprotein cholesterol, also known as bad cholesterol. Wells Fargo analyst Yanan Zhu called the initiation of what the company described as the first-in-human clinical trial of EDIT-401 a key step towards unlocking a highly differentiated LDL-C approach, and raised his price target on the stock to $6 from $4, reflecting revised probability of success assumptions for EDIT-401. Initial safety and tolerability data from Strive are expected in Q1 2027, ahead of topline safety and efficacy data from Part 1 of the study anticipated later that year.
EDIT · Capital · Positive Wells Fargo upgraded Editas to Overweight and raised its price target to $6 from $4 on revised EDIT-401 success assumptions.
EDIT · Regulation · Positive Australian ethics committee cleared the Phase 1/2 Strive trial for EDIT-401, enabling the first-in-human study.
Read original ↗
Seeking Alpha·2dRead more →
NetherlandsEuropean UnionGermanyBelgiumDenmarkFranceIrelandItaly+3
Biotechnology

Dutch Court Blocks Merck's Keytruda SC in Eight European Markets

A Dutch patent court has ruled in favor of Halozyme Therapeutics, finding that Merck's subcutaneous formulation of Keytruda infringes one of Halozyme's MDASE patents covering technology used to deliver drugs through subcutaneous injection. The ruling orders Merck to stop manufacturing and selling Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands, and bars Merck from letting its affiliates continue selling the drug in those markets, including through its European marketing authorization. The order does not affect the intravenous version of Keytruda, which remains available to patients because it is not covered by Halozyme's patent or the injunction. It marks the second legal victory for Halozyme over Keytruda SC, following a December 2025 German preliminary injunction that stopped Merck from distributing or offering the drug in Germany, and Halozyme has also filed a separate U.S. patent infringement lawsuit alleging that Keytruda SC, marketed as Keytruda Qlex, infringes 15 of its MDASE patents. Merck said it strongly disagrees with the Dutch decision, considers Halozyme's patent invalid globally and the infringement allegation without merit, and is evaluating its next steps. The ruling is a setback for Merck as it seeks to expand Keytruda's use ahead of the loss of U.S. patent protection for the original formulation, with biosimilar competition potentially beginning in December 2028; the IV and SC versions together generate nearly half of Merck's topline. Halozyme said the MDASE technology in the Merck dispute is separate from its ENHANZE technology and licensing program, which is a major source of royalty revenue and has been used in 10 commercialized products across more than 100 markets, including Johnson & Johnson's Darzalex and argenx's Vyvgart. Halozyme shares have surged 65% year to date compared with the industry's 1% growth.
HALO · Regulation · Positive Dutch patent court ruled in Halozyme's favor, blocking Merck's Keytruda SC in eight European markets over its MDASE patent.
MRK · Regulation · Negative Injunction bars Merck from making and selling Keytruda SC in eight European markets, a setback to expanding the drug ahead of patent loss.
Read original ↗
Zacks Investment Research·2dRead more →
United States
Biotechnology▲

Madrigal Pharmaceuticals Publishes Secondary Analysis of Phase 3 MAESTRO-NASH Trial

Madrigal Pharmaceuticals drew fresh attention after publishing a secondary analysis of its Phase 3 MAESTRO-NASH trial, indicating that Rezdiffra's liver benefits appeared consistent across several common MASH genetic risk variants. The company's shares have eased in recent months, down 9.86% on a 30 day basis and 17.87% year to date, though the 1 year total shareholder return of 11.62% and a 5 year total shareholder return near 6x suggest longer term momentum has remained strong. Madrigal last closed at $487.72, while the most widely followed fair value narrative sits higher at $678.71 based on a 7.16% discount rate, a gap that keeps attention on how Rezdiffra and its MASH footprint could support the valuation story. The rapid uptake and long-term patent protection of Rezdiffra, supported by a new U.S. patent that extends exclusivity to 2045, provides decades of protected revenue opportunity. The story could still change quickly if Rezdiffra underwhelms in later stage data, or if rivals and payer pushback squeeze long term uptake.
MDGL · Technology · Positive Secondary analysis of Phase 3 MAESTRO-NASH shows Rezdiffra's liver benefits consistent across common MASH genetic risk variants, supporting the drug's clinical profile.
Read original ↗
Simply Wall St·2dRead more →
United States
Biotechnology▲

AbbVie's Temab-A Wins Two FDA Breakthrough Therapy Tags in CRC and NSCLC

AbbVie announced that the FDA has granted two Breakthrough Therapy designations to its investigational next-generation antibody-drug conjugate telisotuzumab adizutecan, known as Temab-A or ABBV-400, for two different cancer indications: colorectal cancer and non-small cell lung cancer. One designation covers Temab-A in combination with bevacizumab for adults with refractory, metastatic colorectal cancer previously treated with fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and, if indicated, anti-EGFR monoclonal antibody therapy. The second designation is for Temab-A as a monotherapy in adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer who previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. The two new designations mark the first Breakthrough Therapy designations for Temab-A, and both were based on data from the first-in-human M21-404 study. AbbVie is also evaluating Temab-A in other advanced solid tumors, including head and neck squamous cell carcinoma, gastroesophageal adenocarcinoma, pancreatic ductal adenocarcinoma and ovarian cancer, through a development program that includes several phase III and phase II/III studies.
ABBV · Technology · Positive FDA granted two Breakthrough Therapy designations to AbbVie's investigational ADC Temab-A for colorectal and non-small cell lung cancer.
Read original ↗
Zacks Investment Research·2dRead more →

Drag with two fingers to move the chart