Despite Provention Bio Inc.'s phase IIa top-line data showing PRV-6527 in Crohn's disease did not differentiate from placebo, the company's stock was bumped back less than 1% on Tuesday as it continued to ride high after June's massive leap on heartening data about the company's type 1 diabetes trial of teplizumab.
Biogen Inc.'s decision to file for approval early next year of beta-amyloid-targeting aducanumab (adu) in Alzheimer's disease (AD) based on fresh analysis of a bigger phase III dataset juiced the stock and induced shock at the same time, as Wall Street pressed company officials for details on their rationale behind the move.
HONG KONG - China and U.S.-based I-Mab Biopharma Co Ltd. has won two IND clearances for TJ-202/MOR-202 from China's National Medical Products Administration (NMPA).
A tepid reception to new top-line phase III data on the long-acting growth hormone (GH) somatrogon nudged Opko Health Inc. shares (NASDAQ:OPK) about 4 cents higher to $2.13 Monday, leaving it overshadowed by competitor Ascendis Pharma A/S, the developer of Transcon-hGH. Ascendis' shares (NASDAQ:ASND) rose 4.5% to $103.36.
Benefit for patients with disease that has spread to the brain put a special shine on top-line data rolled out by Seattle Genetics Inc. (Seagen) from the HER2Climb study, an experiment to test the oral small-molecule tyrosine kinase inhibitor (TKI) tucatinib, designed as highly selective for HER2 without significantly knocking down EGFR.
The pipeline shift made public Thursday by Syros Pharmaceuticals Inc. may have been presaged by analysts, who in August sounded lukewarm about the Cambridge, Mass.-based firm's prospects as they stood then.
Israel's Protalix Biotherapeutics Inc., the first company to gain FDA approval for a protein therapy produced by plant cell cultures in 2012, has moved one step closer to seeking FDA approval for a second such product with new phase III data supporting its experimental therapy for Fabry disease.
Eli Lilly and Co.'s $1.48 billion acquisition of Armo Biosciences Inc., intended to broadly bolster its immuno-oncology program, fell short of that goal in its first big test, a phase III trial in second-line pancreatic cancer called Sequoia.
BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. became the latest Chinese biotech to enter the country's fierce CAR T race, after China regulators granted an IND approval to CT-103A, a fully-human BCMA CAR T for treating relapsed or refractory multiple myeloma.