FDA Nominee Advances as Biotech Companies Face Challenges

Senate Committee Approves Makary for FDA Leadership

The Senate Health, Education, Labor and Pensions Committee has voted 14-9 to advance President Donald Trump's nominee, Dr. Martin Makary, to lead the Food and Drug Administration (FDA). The full Senate will soon vote on Makary's nomination, with Committee Chairperson Bill Cassidy praising the nominee for his commitment to innovation while maintaining FDA's rigorous review standards. However, Senator Bernie Sanders voiced opposition, citing concerns about drug affordability.

Biotech Firms Adopt Defensive Measures Amid Activist Pressure

Acelyrin and Pliant Therapeutics have implemented "poison pill" strategies in response to activist investor Tang Capital Partners acquiring stakes in their companies. These measures aim to protect the firms from potential takeover attempts. Acelyrin, which plans to merge with Alumis, has already rejected one offer from Tang. Pliant, meanwhile, is reassessing its strategy following the discontinuation of its primary clinical trial.

Industry Restructuring and Pipeline Shifts

Sutro Biopharma announced a significant restructuring, including a 50% reduction in its workforce and a strategic realignment of its drug pipeline. The company is deprioritizing its lead program, luveltamab tazevibulin, and shifting focus to its exatecan antibody-drug conjugate. As part of this transition, Jane Chung will succeed Bill Newell as CEO. Sutro reported $317 million in cash and cash equivalents at the end of 2024.

CMS Refines Drug Cost Reduction Initiatives

The Centers for Medicare and Medicaid Services (CMS) has canceled two of its three pilot programs aimed at reducing drug costs and improving access to genetic medicines. The remaining program focuses on coordinating Medicaid coverage across states to enhance access to gene therapies for sickle cell disease. This decision comes as part of broader changes implemented by the agency's innovation center.