LONDON – A high level U.K. group, involving industry, academia, patients, health technology assessment and regulatory representatives, has set out guidelines for designing complex cancer trials and is calling for their rapid implementation to reduce clinical development timelines.
A closely watched bid by Incyte Corp. to tackle acute graft-vs.-host-disease (GVHD) with the JAK1 inhibitor itacitinib has fallen flat in pivotal testing, leaving analysts skeptical about the drug's future and pessimistic about the company's R&D chops.
While Novan Inc.’s phase III failure in treating molluscum contagiosum for patients ages 6 months and older battered its stock Friday, the company intends to take the positive data it gleaned to the FDA to discuss an NDA submission and a possible phase III trial for next year.
Nearly four years after its start, a phase III trial of Gamida Cell Ltd.'s ex vivo expanded cord blood candidate, omidubicel, for hematologic malignancies is fully enrolled, the company said.
With many on Wall Street transfixed by the three injectable calcitonin gene-related peptide (CGRP) therapies cleared in the prophylactic migraine market, Satsuma Pharmaceuticals Inc.’s prospects with STS-101 may have gone overlooked, at least until lately.
Positive top-line data from two pivotal phase III studies of acne vulgaris treatment Twyneo from Sol-Gel Technologies Ltd. is doing the stock end-of the-year favors as shares closed up 19% at $17.50 on Tuesday.
PERTH, Australia – On the heels of a $1.15 billion deal between Roche Holding AG and Sarepta Therapeutics Inc. for Sarepta’s gene therapy to treat Duchenne muscular dystrophy (DMD), another therapy to treat DMD is emerging from Down Under.
Shares of Cambridge, Mass.-based Wave Life Sciences Ltd. (NASDAQ:WVE) lost 49.5% of their value, or $7.82, to close at $7.99 as investors learned of top-line data from the ongoing phase Ib/IIa Precision HD2 trial testing WVE-120102 in Huntington’s disease.
The stock at Spring Bank Pharmaceuticals Inc. (NASDAQ:SBPH), after an especially rough Thursday, began healing a bit as investors took in the company’s decision to stop dosing and enrolling patients in its phase IIb Catalyst trials.
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