Teva Pharmaceuticals announced new post hoc data from the pivotal Phase 3 SOLARIS trial showing that its investigational once-monthly subcutaneous long-acting injectable olanzapine, TEV-'749, achieved high rates of stabilization and long-term efficacy in adults with schizophrenia. In the open-label long-term treatment period, 231 of 411 participants, or 56 percent, achieved stabilization, and among those 231 stabilized participants only 10, or 4 percent, relapsed. Among 183 participants treated with TEV-'749 for six or more months, 39, or 21 percent, met criteria for remission. Separate analyses simulating inpatient switching found that initiating TEV-'749 one day after the last dose of oral or short-acting intramuscular olanzapine produced predictable olanzapine exposures within established oral therapeutic ranges, and a metabolic outcomes analysis found TEV-'749's profile consistent with daily oral olanzapine with no clear dose-dependent pattern. The findings were presented at Psych Congress in New Orleans, and a PDUFA decision from the FDA is expected for TEV-'749 in the fourth quarter of 2026, while the European Medicines Agency accepted the Marketing Authorization Application in May 2026. TEV-'749 is not approved by any regulatory authority for any use at this time.
New Phase 3 SOLARIS post hoc data show TEV-'749 achieved high stabilization (56%) and low relapse (4%) in schizophrenia, supporting its efficacy profile.
LB Pharmaceuticals Fair Value Estimate Rises to US$58.00 on LB-102 Outlook
Analysts raised their fair value estimate for LB Pharmaceuticals to US$58.00 from US$53.38, an increase of about 8.7%, as views on LB-102 shifted. Several firms, including Guggenheim, Needham, Canaccord, Stifel, BMO Capital, H.C. Wainwright and Clear Street, see prior amisulpride experience and internal trial data as reducing perceived development risk, with Guggenheim calling LB Pharmaceuticals a best idea and Clear Street citing a highly favorable risk reward profile. Needham pointed to NOVA-1 schizophrenia data for LB-102 and described efficacy and safety as best in class, while BMO Capital and H.C. Wainwright focused on progress across the pivotal NOVA-2 and broader LB-102 clinical program. Stifel and BMO Capital both raised price targets into the low to mid US$50s after engaging with management and reviewing trial plans. On the bearish side, Roth Capital moved to a Neutral rating with a US$35 target, arguing that while LB-102 development risk appears to be easing, the product profile may be more competitive than transformational in tolerability and commercial differentiation, and that the shares already reflect expectations for better than competitive efficacy and a cleaner tolerability profile.
LB Pharmaceuticals Presents Preclinical Data on LB-102 Mechanism at ECNP Congress
LB Pharmaceuticals announced the presentation of four posters at the 39th European College of Neuropsychopharmacology Congress in Munich, Germany, running October 10-13, 2026. The posters cover new preclinical data on LB-102's differentiated mechanism of action, the pivotal Phase 3 program in schizophrenia known as NOVA-2 and NOVA-3, the ongoing late-stage Phase 2 ILLUMINATE-1 trial in bipolar depression, and a previously reported analysis of LB-102's impact on cognitive performance from the Phase 2 NOVA-1 trial in schizophrenia. The preclinical data showed that LB-102 can modulate dopamine signaling through engagement of pre-synaptic D2 autoreceptors, increasing dopamine neurotransmission, which the company said supports a potential mechanism for addressing the hypodopaminergic state associated with anhedonia and diminished motivation in depression. A post hoc analysis of the Phase 2 NOVA-1 trial found that the dose-dependent, statistically significant improvements in cognitive performance were primarily a direct effect of LB-102 rather than an indirect consequence of the drug's effect on total schizophrenia symptoms. LB-102 is a novel, once-daily, orally administered investigational small molecule engineered as a modification to amisulpride, and the company believes it has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States.
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative Technology
LBRX · Technology · Positive Presented preclinical data on LB-102's differentiated mechanism and Phase 2/3 trial results supporting its antipsychotic and cognitive effects.
AB Science Posts €10.4 Million H1 2026 Operating Loss, Names Stéphane Ledermann CEO
AB Science reported an operating loss of €10.4 million for the first half of 2026, compared with a loss of €2.7 million a year earlier, and announced the appointment of Stéphane Ledermann as Chairman and Chief Executive Officer. The wider loss was mainly due to a €6.5 million provision tied to the Research Tax Credit dispute with French tax authorities, following an unfavourable Paris Administrative Court ruling on 22 September 2026; net income came to -€9.0 million versus -€5.2 million in the first half of 2025. Revenue, consisting solely of veterinary drug Masivet sales, was €498 thousand, down slightly from €515 thousand, while cash and cash equivalents stood at €8.9 million as of 30 June 2026, supplemented by €16.5 million raised through private placements in July and August 2026. The company also obtained clinical trial insurance for its Phase 3 amyotrophic lateral sclerosis study with a liability limit of €25 million that can be increased to €39 million, and reported a 67% overall response rate in Stage 3 of the Phase 1 AB8939 plus Venetoclax study in relapsed or refractory acute myeloid leukaemia. AB Science said it expects to resume the Phase 1 acute myeloid leukaemia study in the first quarter of 2027 and the Phase 3 ALS study in the fourth quarter of 2027, and will hold a web conference on 14 October 2026 to present its new roadmap.
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative Capital
AB.PA · Capital · Negative H1 2026 operating loss widened to €10.4M, driven by a €6.5M provision from the unfavorable Research Tax Credit ruling
AB.PA · Technology · Positive Reported 67% overall response rate in Stage 3 of the Phase 1 AB8939 plus Venetoclax AML study and secured clinical trial insurance for the Phase 3 ALS study
Teva Fair Value Raised to US$45.30 as Analysts Back CNS Transformation
Teva Pharmaceutical Industries' fair value estimate was lifted from US$42.00 to US$45.30, an increase of about 7.9%, as analysts back the company's central nervous system transformation. The revised valuation came alongside a revenue growth adjustment from 2.25% to 1.94%, a net profit margin move from 13.09% to 15.01%, and a future P/E trimmed from 27.13x to 25.76x, while the discount rate held steady at 8.64%. TD Cowen initiated coverage with a US$55 price target, and Oppenheimer initiated with an Outperform rating and a US$50 price target, pointing to an acceleration phase and expected 2026 sales of US$3.7b from Austedo, Ajovy, and Uzedy. Both firms highlight Teva's approved neuropsychiatry and central nervous system agents as a key driver of growth potential, though Oppenheimer's multiyear launch cycle implies the company still needs consistent execution across a relatively narrow set of products. Teva is a global biopharma company combining a large base of generic and biosimilar products with a growing therapeutics pipeline that includes olanzapine LAI, ecopipam, DARI, emrusolmin, and duvakitug.
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▲Capital
TEVA · Capital · Positive Fair value raised to US$45.30 and TD Cowen/Oppenheimer initiated coverage with US$55 and US$50 price targets on Teva's CNS transformation.
Buchang Pharma obtains drug registration certificate for atomoxetine hydrochloride oral solution
Buchang Pharma announced on October 9 that the company recently received the Drug Registration Certificate for atomoxetine hydrochloride oral solution approved and issued by the National Medical Products Administration. The indication of this drug is for the treatment of attention deficit hyperactivity disorder, or ADHD, in children and adolescents aged 6 years and older.
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative Regulation
603858.CG · Technology · Positive Buchang Pharma received a Drug Registration Certificate for atomoxetine hydrochloride oral solution to treat ADHD in children and adolescents.
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.
Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▼Regulation
NWRN.SW · Regulation · Negative FDA clinical hold over evenamide arrhythmia/death risk and pending response create regulatory uncertainty for its lead program