DUBLIN – Obseva SA's stock plunged 65% Thursday on news that it was terminating development of its in vitro fertilization (IVF) drug, nolasiban, after it missed the primary endpoint of a confirmatory phase III trial. The result blindsided both Obseva and investors, as the outcome was at odds with that of a previous phase III study, Implant 2, which had demonstrated a statistically significant and clinically relevant improvement in the rate of successful pregnancy at 12 weeks.
Emerging from the tsunami of abstracts from the nearly here American Society of Hematology (ASH) annual meeting in Orlando, Fla., were data that sent some stocks upward on Wednesday. Most notably, Constellation Pharmaceuticals Inc. (NASDAQ:CNST) was a huge winner as its shares nearly doubled in value as they closed at $28,10, up $13.33, for a gain of 90.25%.
Supernus Pharmaceuticals Inc. CEO Jack Khattar said the phase III failure in the study called P301 with SPN-810 (molindone hydrochloride) was "very puzzling" to the Rockville, Md.-based firm, which will be "digging very deep into the data" with hopes of figuring out what went wrong. Shares (NASDAQ:SUPN) closed Wednesday at $19.93, down $9.20, or 31.6%.
Corey Carter, whose company Epicentrx Inc. just dosed its first patient in a phase III trial for treating third-line and beyond small-cell lung cancer (SCLC), has made studying the disease a life goal. "With my military background, I noticed that smoking rates are higher there," Carter, the company's president and CEO, told BioWorld. "That's when it became important to me. Then, also, my dad had small-cell lung cancer."
Amgen Inc. and Revolution Medicines Inc. will collaborate on a clinical trial evaluating the combination of RMC-4630, Revolution's SHP2 inhibitor, and Amgen's AMG-510, a KRAS-G12C inhibitor. Amgen will conduct the phase Ib trial to treat patients with advanced solid tumors harboring the KRAS G12C mutation and Revolution will provide Amgen with RMC-4630.
San Diego-based Otonomy Inc.'s launch of the phase I/II trial for OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss brought renewed investor attention to the company, consigned to the back burner after a late-stage failure.
LONDON – Nyxoah SA reported positive clinical results for Genio, its lead-free, battery-less implantable neurostimulation device, showing it resulted in a significant reduction of the severity of obstructive sleep apnea (OSA), the world's most common sleeping disorder.
Navidea Biopharmaceuticals Inc. disclosed positive results from the first interim analysis of its ongoing NAV3-31 phase IIb study. Analysis shows the data support Navidea's hypothesis that Tc 99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA).
BEIJING Shanghai-based Visen Pharmaceuticals is pushing its long-acting growth hormone therapy, which is also the first of its kind in China, one step closer to the NDA-stage after receiving clearance from Chinese regulators this week to start a phase III trial.