Roche Holding AG and PTC Therapeutics Inc. together with their partner, the SMA Foundation, reported success in part two of the pivotal Sunfish study testing their survival motor neuron-2 splicing modifier risdiplam in patients with type 2 or 3 spinal muscular atrophy (SMA).
Shares of Nextcure Inc. (NASDAQ:NXTC) have alternately been up sharply lately or down dramatically. Following the weekend release of updated positive clinical data from its NC-318 phase I/II study, the share price nosed down 52.9% Monday.
Most weight loss interventions target obese or super-obese patients who have adjacent comorbidities, such as type 2 diabetes or sleep apnea. But Boston-based Gelesis aims to change that with its hydrogel pill Plenity.
Within the first few minutes of a key opinion leader webinar on Alzheimer's disease sponsored by AC Immune SA, CEO Andrea Pfeifer brought up the decision by Biogen Inc. to file for regulatory approval of amyloid beta targeter aducanumab in early AD, based on results from a subset of patients in the phase III study called Engage.
In the wake of each dosing arms' failure to hit the primary endpoint in Anaptysbio Inc.'s phase IIb study of etokimab to treat moderate to severe atopic dermatitis (AD), the stock dropped steeply and the company postponed initiating its phase IIb etokimab trial in eosinophilic asthma until it analyzes the phase IIb result.
Penumbra Inc. reported final results from its IDE trial of the Indigo Aspiration system at the Vascular Interventional Advances (VIVA) annual meeting in Las Vegas. The Alameda, Calif.-based company said that the EXTRACT-PE trial met its primary endpoints in patients with acute pulmonary embolism (PE).
Allena Pharmaceuticals Inc.'s phase III URIROX-1 trial of reloxaliase hit its primary endpoint, with a statistically significant reduction in urinary oxalate (Uox) in patients with enteric hyperoxaluria (EH), while its phase II Study 206 trial showed reduced plasma oxalate reduction in patients with EH and advanced chronic kidney disease (CKD).
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%.