Phase II
A request for additional data may cause a 3-month delay for potential approval of BioMarin Pharmaceutical’s hemophilia A gene therapy.
AbbVie’s investigational neurotoxin, designed to prevent postoperative atrial fibrillation, missed the primary endpoint in a Phase II trial, the company announced Monday.
Verve Therapeutics’ base editing program has been forced into a detour after the FDA placed a hold on its investigational new drug application. Beam has also posted its own regulatory update.
Biopharma’s efforts to conquer immunoglobulin A nephropathy were on full display at ASN’s Kidney Week as Ionis, Chinook and Vera all reported positive data.
In spite of positive Phase IIb results from a thrombosis prevention trial, Ionis is back on the market for a new partner after Bayer returned the rights to the drug to Ionis.
Regeneron called it quits on an experimental osteoarthritis pain treatment that has raised safety flags and an experimental antibody for cat-allergic asthma.
Flush with cash from the growing success of its chemotherapy drug, Exelixis dropped $100M on two collaboration deals this week to invest in promising early clinical assets.
A Data Safety Monitoring Board overseeing the Phase Ib/II trial assessing UniQure’s gene therapy for Huntington’s disease recommended that enrollment in the higher-dose cohort could resume.
The future of Editas Medicine’s EDIT-101 will be determined later in November after a data readout is available. The data could inform the company whether there is a potential commercial path forward.
Unity announced advances in diabetic macular edema via Phase II study results, potentially allowing its recipients to return to tasks of daily living, like driving.
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