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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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TauRx Pharmaceuticals and Anavex Life Sciences presented positive results from their candidates at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco, CA.
Amid rampant buyout speculation, Mirati Therapeutics reported that it will continue its final analysis of the Phase III SAPPHIRE trial following an interim survival analysis.
GSK intends to file for approval of Jemperli in endometrial cancer after the checkpoint inhibitor met its primary endpoint in the Phase III RUBY trial.
The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.
The FDA has approved Rigel’s Rezlidhia for the treatment of adults with relapsed or refractory AML with a susceptible isocitrate dehydrogenase-1 mutation.
FUJIFILM Diosynth Biotechnologies is offering unique opportunities to join one of the top global CDMOs focused on solving some of the most complex healthcare challenges.
Athira Pharma’s experimental Alzheimer’s therapy, fosgonimeton, continues to show signs of being able to improve cognition and function in patients.
Eli Lilly’s investigational antibody donanemab met all of its primary and secondary endpoints in the Phase III TRAILBLAZER-ALZ 4 study, the company announced Wednesday.
Pfizer and Roivant have joined forces to form yet another Vant. The new entity will initially work to commercialize RVT-3101 for ulcerative colitis.
SQZ Biotechnologies is slashing 60% of its workforce and looking for a new CEO after initiating a strategic prioritization to focus on its cell therapy platform for solid tumors.