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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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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Alto reported positive data from a first-of-its-kind Phase IIb trial of major depressive disorder candidate ALTO-100.
BioXcel Therapeutics subsidiary OnkosXcel announced positive Phase II results in patients with small cell neuroendocrine metastatic castration-resistant (SCNC) prostate cancer.
Following a banner year marked by the approval and launch of its diabetes drug Mounjaro, Eli Lilly revealed at the 41st J.P. Morgan Healthcare Conference that it was preparing for another big year.
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week.
In a fireside chat at the 41st J.P. Morgan Healthcare Conference in San Francisco, CEO Rick Gonzalez said AbbVie is well-positioned for continued growth.
Pfizer forecasts stable growth in the coming years, driven by a strong product push to cushion its non-COVID business and exclusivity losses.
In a presentation led by Robert J. Bradway, Amgen chairman and chief executive officer, the company covered recent acquisitions, Repatha and Lumakras updates, biosimilars and its broader financial outlook.
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week.
Tuesday, AbbVie partnered with Anima Biotech to discover and develop mRNA modulators in a collaboration of up to $582 million. The partnership will focus on three oncology and immunology targets.