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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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Topline results from the Phase II TORREY study showed Gossamer Bio’s seralutinib met its primary efficacy endpoint in pulmonary arterial hypertension.
Mirati’s adagrasib demonstrated a solid safety profile in new data released Monday. Despite this, the company’s stock fell 8% in after-hours trading.
MEI Pharma, Inc. will have a strategic realignment that would see at least 30% of its workforce laid off and a pivot towards two of its earlier clinical-stage assets.
Monday, Verve Therapeutics revealed that the FDA has officially requested several buckets of additional safety information to lift the hold on its lead candidate, VERVE-101.
BioSpace is proud to present its NextGen Bio “Class of 2023,” a list of the hottest recently launched life sciences companies in North America.
SonoThera closed its Series A round of financing Monday, counting $60.75 million in earnings and will use these proceeds to advance its ultrasound-guided, non-viral gene therapy platform.
Novartis announced the Phase III PSMAfore trial of Pluvicto for PSMA-positive metastatic castration-resistant prostate cancer met its primary endpoint.
Janssen (Johnson & Johnson) is no longer in the running to acquire rare disease player Horizon Therapeutics, the company announced Saturday. This leaves Amgen and Sanofi at the bidding table.
Whether a job search is voluntary or not, months of interviews, wrangling over pay and benefits and evaluating options has a weighty psychological toll.
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.