Autoimmune & Immunology Therapeutics

Roche announced new one-year data from the Phase III MEERKAT and SANDCAT studies showing that investigational vamikibart sustained improvements in vision and reductions in macular thickness in adults with uveitic macular edema at 52 weeks compared with a sham procedure. The results were presented at the American Academy of Ophthalmology 2026 Annual Meeting in New Orleans. The FDA has accepted Roche's Biologics License Application for vamikibart for the treatment of UME, with an approval decision expected by July 2027; if approved, vamikibart would be the first non-steroid targeted treatment for UME. Regulatory submissions have also been filed and accepted in the European Union, China and Japan. In both trials, a numerically higher proportion of vamikibart-treated patients achieved vision gains than those on sham treatment on the primary endpoint, and key secondary endpoints showed sustained improvements in best corrected visual acuity and central subfield thickness. Vamikibart was well tolerated with a low incidence of treatment-related ocular adverse events and intraocular inflammation events, and approximately two-thirds of eligible patients required no retreatment after 16 weeks.

argenx halted its Phase 3 Sjögren's trial for futility while reporting encouraging data for FB102 in celiac disease, a mixed pipeline update that reshapes expectations for the company's future earnings. The news comes after argenx delivered a share price gain of 185.3% over the past 5 years. On valuation, argenx trades at about 29.7x earnings, above the broader biotech industry average of roughly 25.0x but below the peer group average of about 36.3x. The halted Sjögren's trial removes one potential earnings stream, while the FB102 celiac data points to a different route to future profits, leaving investors to weigh near-term pipeline risk against an already established earnings base. Community views on argenx are split, with a bull case putting the stock 43% undervalued and a bear case putting it 6% overvalued.

TRex Bio, an Eli Lilly-backed developer of immunoregulatory medicines targeting tissue regulatory T-cell biology, closed its first day of trading Friday at its IPO price of $14. Shares opened at $13.50 and traded mostly below $14 throughout the day, though they briefly shot up to $15.50 right before the market close. In after-hours trading, the share price stood at $14.52. The company had priced its $117M U.S. IPO at $14 per share, after earlier targeting up to $133M.

Johnson & Johnson will report its third-quarter 2026 results on Oct. 13, with the Zacks Consensus Estimate pegged at $25.37 billion in sales and $2.66 per share in earnings. Over the past 60 days, the consensus estimate for 2026 earnings has declined from $11.48 to $11.21 per share, while the 2027 estimate has fallen from $12.81 to $12.17. J&J has an Earnings ESP of +2.10% and a Zacks Rank #3 (Hold), and it exceeded earnings expectations in each of the trailing four quarters, delivering an average surprise of 1.39%. Within the Innovative Medicine segment, consensus estimates stand at $4.33 billion for Darzalex, $2.24 billion for Tremfya and $1.07 billion for Erleada, while Stelara sales are seen at $634.0 million and Imbruvica at $602.0 million, with Stelara's loss of exclusivity having cut the segment's growth by 760 basis points in the second quarter. The MedTech segment carries a consensus estimate of $8.77 billion, and J&J still expects to generate more than $100 billion in revenues in 2026 after $49.4 billion in the first half.

Novartis received FDA approval to expand the label of its oral Bruton's tyrosine kinase inhibitor Rhapsido, also known as remibrutinib, to treat adults with symptomatic dermographism inadequately controlled by H1 antihistamines. The decision makes Rhapsido the only prescription treatment approved in the United States for both chronic spontaneous urticaria and symptomatic dermographism, the two most common forms of chronic hives, extending the drug's commercial reach beyond chronic spontaneous urticaria. The approval was supported by results from the phase III RemIND trial, in which 29.3% of patients receiving Rhapsido achieved a complete response at week 12 compared with 14% for placebo, with responses observed as early as week 2. Rhapsido's safety profile in symptomatic dermographism was consistent with that seen in chronic spontaneous urticaria through week 24, with common adverse events including nasopharyngitis, bleeding, headache, nausea and abdominal pain. Novartis plans to submit the complete RemIND study data to regulatory authorities worldwide where appropriate, and is also evaluating remibrutinib in cold urticaria, cholinergic urticaria, hidradenitis suppurativa and food allergy, following positive topline results from the phase III REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis.

Halozyme Therapeutics extended its ENHANZE collaboration with argenx to cover two more exclusive targets, bringing the total to eight. Under the expanded agreement, Halozyme is eligible for milestone payments tied to development and commercial progress, plus royalties on net sales of ENHANZE-based products. The deal adds fresh attention to the company's partnership-driven revenue model, which already generates more than $1 billion annually in ENHANZE royalties. Recent headlines also include a Dutch court injunction against Merck's Keytruda SC and the return of commercial leader Jim Daly to Halozyme's board. The stock last closed at $110.79, up 40.92% over the past 90 days, with a five-year total shareholder return of 200.24%.

Johnson & Johnson raised its 2026 outlook after second-quarter sales increased 6.6% to $25.3 billion, with adjusted EPS up 4.7% to $2.90 and full-year adjusted EPS guidance lifted to $11.60-$11.75. Management now expects reported sales of $100.8 billion-$101.4 billion, putting the company on track to cross $100 billion in annual revenue for the first time. JPMorgan raised its target to $285 from $270 on September 29 while staying Neutral, and UBS holds a Buy rating with a $320 target on above-consensus revenue and EPS estimates through 2030-2032. On the pipeline side, BofA raised its peak psoriasis sales estimate for ICOTYDE to $4.5 billion from $2.4 billion on September 29, lifting expected market share to 18% from 10%, after ICOTYDE showed sustained plaque-psoriasis skin clearance through Week 112 in data released October 2. The company ended the second quarter with approximately $21 billion in cash and marketable securities against $49 billion of debt, and year-to-date free cash flow reached roughly $8.7 billion.

Matchpoint Therapeutics has closed a $150 million Series B financing co-led by Nextech Invest and Norwest. New investors Invus, BB Biotech, T1D Fund, and BOLD Longevity Growth participated, alongside founding investors Access Biotechnology and Atlas Venture, lead Series A investor Sanofi Ventures, Digitalis Ventures, and all other existing investors. Proceeds will support progression of the lead asset MPT-062, an oral first-in-class T cell modulator, to clinical proof-of-concept, with clinical development to begin in 2027, and advancement of the company's broader pipeline, including an additional program funded by Novartis through their July 2025 agreement. Kanishka Pothula, Managing Partner at Nextech Invest, and Brian Matesic, Principal at Norwest, will join Matchpoint's Board of Directors in connection with the financing. Matchpoint is a privately held biotechnology company based in Watertown, Massachusetts, developing oral medicines for autoimmune and inflammatory diseases.

Novartis will present 46 abstracts from its multiple sclerosis portfolio at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting, including a late-breaking abstract featuring positive Phase III REMODEL-1/-2 results for remibrutinib, an oral BTK inhibitor, in relapsing multiple sclerosis. A second late-breaking abstract will present new Kesimpta, or ofatumumab, data in pediatric MS, where approved treatment options remain limited. Additional Kesimpta presentations will cover final efficacy, safety and tolerability, and healthcare resource utilization results from the Phase 3b STHENOS study in treatment-naive relapsing MS patients, interim breastmilk excretion results from the Phase 4 KATHAROS study, and pregnancy and infant outcomes from the PRIM study. Following the REMODEL data presentation, Novartis will host a conference call for investors to provide updates on the data and the potential for remibrutinib in MS. The REMODEL-1/-2 results will be presented orally on October 23, and the NEOS pediatric study results will be presented earlier the same morning.

Guggenheim named Zura Bio a top pick in the biotechnology sector, reiterating its Buy rating and $20 price target ahead of the company's Phase II TibuSHIELD readout in hidradenitis suppurativa, expected in the fourth quarter of 2026. Analysts said the 16-week topline results for tibulizumab, an IL-17A x BAFF bispecific antibody, represent a key catalyst for the stock, and Guggenheim argues that hidradenitis suppurativa treatment has reached an efficacy ceiling, with newer drugs such as sonelokimab and abdakibart struggling to exceed roughly 15-20% placebo-adjusted HiSCR75 response rates. The firm calls tibulizumab the most advanced bispecific in hidradenitis suppurativa because it blocks both IL-17A on the T-cell side and BAFF on the B-cell side in a single molecule, a dual mechanism it expects could deliver broader control across moderate-to-severe Hurley stages, including late-stage disease. Guggenheim describes buy-side expectations as "moderately low" and sees limited downside beyond the binary readout, because ZURA also has an SSc Phase II readout in 1H27, a planned PMR study and earlier pipeline assets; its $20 target comes from a sum-of-the-parts model, with about $12 per share from HS, $7 from SSc and $1 from the pipeline, using a 10% discount rate and no terminal value, and modeling roughly $1.6B in peak HS sales. The brokerage outlines three scenarios for TibuSHIELD measured by placebo-adjusted HiSCR75: an upside case, assigned 25% probability, assumes a result above 20% and implies a stock price near $15; a base case, with 40% probability, assumes 15-20% and implies $8-10; and a bear case, with 35% probability, assumes a non-significant result or new adverse events and implies $2.50-3.00.

Johnson & Johnson reported new two-year Phase 3 ICONIC-TOTAL data showing its oral peptide ICOTYDE, or icotrokinra, maintained skin clearance and consistent safety in adults and adolescents with high-impact plaque psoriasis through Week 112. The results highlight ICOTYDE's potential as a once-daily, targeted oral alternative for difficult-to-treat areas such as scalp, genital skin, hands, feet and nails. The company's narrative projects $120.5 billion in revenue and $28.6 billion in earnings by 2029, requiring 7.2% yearly revenue growth and a $7.6 billion earnings increase from $21.0 billion today, with a $270.59 fair value implying 6% upside. Some of the lowest-estimate analysts saw 2029 earnings at about US$22.6 billion and still worried that slower ICOTYDE or TREMFYA uptake could keep margins under pressure. The update reinforces Johnson & Johnson's Innovative Medicines story at the margin but does not change the near-term focus on STELARA loss of exclusivity and ongoing talc litigation as the key swing factors for the stock.

TRex Bio, an anti-inflammatory drug developer backed by Eli Lilly, disclosed details of its upcoming U.S. listing, seeking to raise up to $133M on Nasdaq. In a Monday SEC filing, the San Francisco-based biotech said it intends to sell 8.3M shares at $14 to $16 each, which would raise $133.3M at the top of the range and value the company at $439.1M. TRex Bio expects roughly $128.7M in net proceeds, assuming underwriters fully exercise an option to buy up to 1.25M additional shares over 30 days. The company has pharmaceutical collaborations with Lilly and Johnson & Johnson, and its investor syndicate includes Pfizer Ventures, Janus Henderson, and Alexandria Ventures. Lilly has expressed interest in participating in the offering to keep its current 19.9% stake unchanged, TRex Bio said. Its lead assets, TRB-061 and TRB-071, target atopic dermatitis, alopecia areata, and other autoimmune and inflammatory diseases; topline Phase 1a/b data for TRB-061 are expected in mid-2027, while TRB-071 is set to enter a Phase 1 trial in the first half of 2027.

Regeneron Pharmaceuticals said its net income per diluted share will take a roughly $0.18 hit in the third quarter of 2026 from an R&D-related pre-tax charge of about $22 million, disclosed days after it announced an expanded collaboration with its French partner Sanofi. The acquired in-process research and development charge reflects asset acquisitions as well as upfront, milestone, and other payments paid on equity in connection with collaboration and licensing agreements. On Thursday, Regeneron and Sanofi agreed to expand their long-standing collaboration in a deal worth up to $8 billion, including $1 billion paid to the U.S. drugmaker to develop and commercialize four long-acting immunology therapies. The sixth amendment to the 2009 deal also requires the companies to share global profits on newly licensed products equally and Regeneron to drop a lawsuit against the Paris-based pharma giant.

Spyre Therapeutics announced the pricing of an underwritten public offering of 4.12 million shares of common stock at $85.00 per share, for expected gross proceeds of approximately $350 million. The company has also granted the underwriters a 30-day option to purchase up to an additional $52.5 million of common stock under the same terms. The offering is expected to close on or about October 7, 2026. Spyre intends to use the net proceeds to advance its clinical pipeline across Gastroenterology, Rheumatology, and Dermatology, funding preclinical work, clinical trials, manufacturing, and Phase 3 readiness. The funds will also support a new initiative to advance SPY072 into late-stage development for hidradenitis suppurativa, with any remaining proceeds directed toward ongoing research and development, working capital, and general corporate purposes.

CSL and Alentis Therapeutics have entered an exclusive global partnership to co-develop and co-promote lixudebart for rare kidney, liver, and other diseases. Under the agreement, CSL will arrange an initial payment of $355M to Alentis, which is also eligible for up to $1.2B in commercial milestone payments, bringing the total deal value to $1.55B. The companies will share global profits 55% to CSL and 45% to Alentis once the drug is commercialized. CSL will fund Phase 2 and planned Phase 3 studies of lixudebart in AAV-RPGN while advancing Phase 2 programs in FSGS and PSC. Lixudebart is currently being evaluated in the Phase 2 RENAL trial for AAV-RPGN, a rare autoimmune disease that can cause rapid kidney function loss and irreversible kidney damage.

Vor Biopharma reported a post hoc analysis from a China-based Phase 3 trial showing that telitacicept produced deep, durable clinical responses and was generally well tolerated over 48 weeks in adults with generalized myasthenia gravis. The analysis highlighted that most patients who reached minimal symptom expression maintained it and spent much of their remaining follow-up in this state. The new data reinforce the depth and durability of response but do not materially change the key near-term catalyst, the UPSTREAM global Phase 3 topline readout in 2027, or the central risk that global data might not match prior China experience. The results sit beside Vor's completion of enrollment in the global UPSTREAM Phase 3 gMG trial in early September 2026. Vor Biopharma's narrative projects $111.0 million revenue and $19.1 million earnings by 2029, implying an earnings decrease of $608.7 million from $627.8 million today, and forecasts a $39.00 fair value, a 109% upside to its current price.

Novartis has entered into a licensing and option agreement with China's Abogen Biosciences to advance RNA-encoded therapeutics, according to a statement on Friday. Abogen will receive an upfront payment of $575 million, and, if all options on all programs are exercised, Abogen is eligible to receive up to approximately $7.2 billion in potential milestone payments, plus potential royalties on future product sales. The agreement includes an exclusive worldwide license to Abogen's lead asset, ABO2203, a novel mRNA-encoded CD19xCD3 T-cell engager designed to reset B cells by directing endogenous production of T-cell engagers in vivo, with the potential to transform treatment for patients with autoimmune diseases. The Swiss drugmaker also holds the exclusive option to license a number of next-generation therapeutic assets developed on Abogen's proprietary RNA platform.

French pharmaceutical giant Sanofi and U.S. biopharmaceutical company Regeneron Pharmaceuticals announced on the 1st that they will jointly develop four new drugs under a contract worth up to $8 billion and will settle their previous litigation. Sanofi will pay $1 billion upfront and an additional $7 billion upon achieving milestones. The two companies will split the development costs and future profits of the four new drugs, with Regeneron leading research and development and Sanofi handling global sales if the drugs are approved. The four new drugs include a candidate treatment for atopic dermatitis, which is currently in early-stage clinical trials. Sanofi's new Chief Executive Officer, Belén Garijo, said on an investor conference call that "mutual trust will guide this expanded partnership," adding that the partnership includes clear divisions of roles and accountability for both companies.

Regeneron shares fell 4% after the biotech company expanded its immunology alliance with Sanofi on terms that left the economics of its blockbuster drug Dupixent untouched. Under the deal, Sanofi will pay Regeneron $1 billion upfront and up to $7 billion in development, regulatory, and commercial milestones for four next-generation, long-acting antibodies, with the two drugmakers splitting global development costs, commercialization expenses, and future profits equally. The agreement settles prior litigation but leaves the existing Dupixent profit-sharing terms unchanged, disappointing investors who had hoped a renegotiation would yield better economics on the franchise; nearly a quarter of investors surveyed by RBC Capital sought more constructive terms, according to Investing.com. Sanofi shares rose roughly 2% in European trading, according to Reuters, while Regeneron reversed an early morning gain, later trading at $736.56, down 2.9% from the previous close. Regeneron is down 5.1% since the start of the year and trades 13.6% below its 52-week high of $852.03.

Roche Holding received FDA acceptance of its New Drug Application for fenebrutinib in multiple sclerosis under priority review. The filing covers fenebrutinib as an oral BTK inhibitor for both relapsing and primary progressive forms of multiple sclerosis. If approved, fenebrutinib could become the first high efficacy oral BTK inhibitor targeting both relapse control and disability progression in MS, adding an oral, CNS penetrant option alongside Ocrevus in Roche's neurology offering. Roche Holding is a CHF279.4 billion pharmaceuticals and diagnostics group, and the milestone reinforces the view that late stage assets like fenebrutinib can help offset ongoing loss of exclusivity and pricing pressure. The key signpost now is the FDA's priority review timeline for fenebrutinib, including the final decision date and any label details regulators set, with three Phase III trials supporting the filing.

AbbVie has landed on Zacks.com's list of the most searched stocks, drawing fresh attention to the drugmaker's near-term outlook. For the current quarter, AbbVie is expected to post earnings of $3.85 per share, a change of +107% from the year-ago quarter, while the Zacks Consensus Estimate has moved -0.1% over the last 30 days. The consensus earnings estimate of $14.05 for the current fiscal year indicates a year-over-year change of +40.5%, and the next fiscal year's consensus of $16.12 points to a change of +14.8%. On the top line, the consensus sales estimate for the current quarter of $17.36 billion indicates a year-over-year change of +10%, with current and next fiscal year estimates of $67.56 billion and $73.39 billion indicating changes of +10.5% and +8.6%. In the last reported quarter, AbbVie posted revenues of $16.99 billion, up +10.2% year over year, and EPS of $3.65 versus $2.97 a year ago, beating the Zacks Consensus Estimate of $16.81 billion by +1.07% on revenue with an EPS surprise of +0.27%. The recent change in the consensus estimate, along with three other factors related to earnings estimates, has resulted in a Zacks Rank #3 (Hold) for AbbVie, and the stock is graded C on the Zacks Value Style Score.

Johnson & Johnson's economic moat rests on its ability to keep producing drugs rather than on any single drug, with the company's medical device business adding long-term hospital contracts that make switching suppliers closer to a retraining exercise than a purchasing decision. The company is worth about $638 billion and turns 29.19% of its $97.93 billion in revenue into operating profit, while return on equity reaches 25.74% and free cash flow ran to $16.89 billion over the past twelve months. Revenue grew 6.60% last quarter, and the balance sheet carries $49.04 billion of debt. On September 29, Bank of America raised its peak sales estimate for the oral psoriasis treatment Icotyde to $4.5 billion, from $2.4 billion previously, a test of whether the pipeline can replace revenue lost to patent expiries. Johnson & Johnson has spent years managing talc claims, and the shares now trade near 31 times trailing earnings but only about 21 times what analysts forecast for next year, on a yield of 2.02%.