Biopharma: Ma-kary On My Wayward Son - Resignation of FDA Commissioner May Renew Sector Uncertainty

Research evidence excerpt

Biopharma: Ma-kary On My Wayward Son - Resignation of FDA Commissioner May Renew Sector Uncertainty

acting or future permanent commissioner

would maintain the program, expand it, or allow it to atrophy. Among our universe, CMPS

(COMP360) and RVMD (daraxonrasib) have most recently appeared on track to receive a CNPV,

which we had estimated could meaningfully accelerate these launch timelines. Companies that

could benefit directly from the proposed one-trial policy - the future of which is also now more

unclear - had included those which already ran several studies that had mixed data (MLTX, REGN)

and those in areas where multiple trials were traditionally needed and are (or will likely) still

being conducted but only one might need to hit to get over the line (NMRA, KYMR, APGE, CTNM,

ACAD, BHVN, OCUL).

Beyond leadership continuity, Makary's departure also risks reopening wounds at an agency

that had only recently begun to stabilize following a turbulent stretch of operational

disruption. DOGE cuts and reductions in force (RIFs) in early 2025 meaningfully disrupted

FDA operations, with our earlier analysis suggesting a drop in on-time approval rates, though

these had stabilized more in recent months, and approval cadences had begun to normalize.

Makary’s departure could potentially exacerbate existing issues at the Agency (staffing and

morale challenges) and additional friction around ongoing review processes could result in

delayed timelines, and inject further uncertainty into the regulatory planning assumptions of

companies across our coverage universe. Additionally, we note that the PDUFA re-negotiation

for the next-cycle ('28-'32) is in progress with final submission deadline January 15, 2027, and a