Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients.
The independent data monitoring committee overseeing Cortexyme Inc.’s phase II/III trial of atuzaginstat (COR-388), a gingipain inhibitor for patients with Alzheimer’s disease, has recommended the study continue to its one-year endpoint.
Rare disease-focused Ovid Therapeutics Inc. has paused development of its investigational Angelman syndrome therapy, OV-101, after initial phase III results showed no difference between the drug and a placebo.
Investors in Minerva Neurosciences Inc. on Dec. 1 gave a chilly reception to reported FDA feedback on the company's experimental treatment for the negative symptoms in schizophrenia, roluperidone. Though the drug failed to deliver statistically significant differences vs. placebo in a phase III study this year, CEO Remy Luthringer outlined a potential path to NDA filing for the candidate using a modified intent-to-treat analysis of the trial and evidence from other ongoing evaluations.
DUBLIN – Noema Pharma AG closed a €54 million (US$59.8 million) series A round to take forward four clinical-stage assets it has in-licensed from Roche Holding AG. The drug candidates are being lined up for orphan neurological indications that fall outside of Roche’s strategic focus.
The whopper deal between Biogen Inc. and Sage Therapeutics Inc. – a global collaboration and licensing deal involving the latter’s zuranolone (also known as SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders, as well as SAGE-324 for essential tremor (ET) and neurological disorders – drew mixed reviews from Wall Street. And, for Biogen investors, the would-be Alzheimer’s disease (AD) therapy aducanumab remains front of mind.
HONG KONG – Gemvax & Kael Co. Ltd. reported the full results from a phase II trial in Korea for GV-1001 (tertomotide), its telomerase modulator, in Alzheimer’s disease, showing a statistically significant improvement in neuropsychiatric inventory and an improvement trend in Alzheimer’s Disease Cooperative Study-Activities of Daily living, the study’s two secondary endpoints.
Shares of Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) fell 66.3% to $4.02 on Nov. 17 following news that its autologous cell therapy candidate, Nurown, missed the primary efficacy endpoint of a phase III amyotrophic lateral sclerosis (ALS) study.
Even as Alkermes plc works to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, labeling talks are underway for the compound, an oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the firm said, and shares (NASDAQ:ALKS) hardly moved, closing Nov. 17 at $18.30, up 45 cents.
Mymd Pharmaceuticals Inc., the privately held developer of a synthetic derivative of tobacco alkaloids for the potential treatment of autoimmune diseases and age-related disorders, will soon list on Nasdaq via its acquisition of former point-of-care testing company Akers Biosciences Inc., shares of which (NASDAQ:AKER) climbed 29.1% to $2.22 on Nov. 12. The combined company, to be headquartered in Baltimore, will retain Mymd's name and adopt the trading symbol MYMD. Concurrent with the merger, Akers is raising $18 million in a private placement priced at-the-market.
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