GSK
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While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in September 2025 came below analyst expectations in a Phase Ib/IIa AATD study.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Ahead of GSK are Bristol Myers Squibb and Merck, which have already won FDA approvals for subcutaneous formulations of their respective PD-1 blockers Opdivo and Keytruda.
The star of the acquisition, anti-IgE antibody ozureprubart, is being tested as a prophylactic treatment for food allergies, potentially setting up a competition for GSK with Roche’s Xolair.
Though specific data for bepirovirsen remain under wraps, GSK plans to file for approval in the first quarter of 2026.
The Massachusetts biotech will also be eligible to milestone payments, though the exact amount has yet to be disclosed.
The FDA rejected the use of Exdensur, however, for chronic rhinosinusitis with nasal polyps.
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting neurological diseases. Some failures split up partners, and one particularly egregious case even led to the demise of an entire company.
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