LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC).
A late-stage test of Takeda Pharmaceutical Co. Ltd.'s oral suspension of the steroid budesonide for the treatment of eosinophilic esophagitis (EoE) achieved both its co-primary endpoints, improving histologic and dysphagia symptom responses vs. placebo during the first pivotal phase III study of an EoE treatment ever to be reported in the U.S. The study, part of the largest EoE clinical program globally to date, also met secondary endpoints, including improvements from baseline to final treatment as measured by an established patient-reported outcome measurement.
As TG Therapeutics Inc.'s phase IIb win in the follicular lymphoma (FL) cohort of the Unity-NHL pivotal experiment testing umbralisib charmed Wall Street, CEO Michael Weiss told investors that the New York-based company is "completely committed to getting our marginal zone lymphoma [MZL] filing in on time and getting to the market" soon. Nobody's forgetting about the opportunity in chronic lymphocytic leukemia (CLL), either.
Upbeat top-line data for New York-based Iveric Bio Inc.'s phase IIb trial testing Zimura in dry age-related macular degeneration propelled the company stock (NASDAQ:ISEE) 82.8% upward in Monday's trading, a big success in a company that rebranded itself earlier this year.
With Stifel analysts recently setting a $41 price target for Urogen Pharma Ltd. and interim data in hand from the trial in bladder cancer with UGN-102, hopes are high that the drug's approach – having already proved its mettle in UGN-101 against low-grade upper tract urothelial cancer (UTUC) – will yield durable results. Shares (NASDAQ:URGN) have been trading at around $22, closing Friday at $21.97.
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.
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