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This is the most consequential FDA leadership story since Makary took office. Whatever you think of his tenure, Makary moved fast. The CNPV program approved Foundayo in 50 days, Otarmeni (gene therapy for hearing loss) followed under CNPV, and Bizengri (bile duct cancer) was approved May 9 under an accelerated review program. The Expedited IND pathway proposed in the FY2027 budget could reshape Phase 1 access. The Real-Time Clinical Trial initiative launched with AstraZeneca and Amgen. Psychedelic CNPVs were issued. The RP1 rejection signaled a higher bar for single-arm oncology studies. All of these decisions were driven by Makary's office. His departure raises immediate questions: does the CNPV program continue? Does the Expedited IND pathway survive the budget process without its champion? Does the RTCT pilot proceed this summer? STAT reported that both CDER divisions are already headed by acting directors. Former FDA Chief Scientist Jesse Goodman said there is "a vacuum that has created a lot of gaps in expertise and experience." The triggers for Makary's ouster were reportedly political: Trump rebuked him for not approving flavored e-cigarettes fast enough, and anti-abortion groups were angry about his handling of mifepristone. The pharmaceutical industry's regulatory initiatives were not the cause of his departure, but they may be the casualty. 👉 Read Full Analysis

Trump Approved a Plan to Fire FDA Commissioner Makary

What Happened: On Friday May 8 at approximately 3:30 PM ET, the Wall Street Journal reported that President Trump was planning to fire FDA Commissioner Marty Makary. Bloomberg, Reuters, STAT, and Politico confirmed with their own sourcing within hours. Reuters reported that two White House advisers said the decision was "not final," while a third source close to the White House said the commissioner "is done" and Trump "signed off."

The Triggers: STAT reported that Makary's tenure had been "tumultuous, marked by personnel drama, departures of longtime staff, and controversy over political pressure impeding the FDA's scientific process." Two specific issues appear to have precipitated the decision. First, Trump reportedly rebuked Makary over the weekend of May 2 to 3 for not approving flavored e-cigarettes quickly enough, a product Trump pledged to protect during the 2024 campaign. Second, Makary's handling of mifepristone angered anti-abortion groups and some Republican lawmakers, who felt he was "slow-walking" the FDA's own safety review of the drug.

The Succession: The White House is considering Kyle Diamantas, currently FDA Deputy Commissioner heading the food group, as acting commissioner. Potential nominees for the permanent role include Stephen Hahn (FDA commissioner 2019 to 2021) and Brett Giroir (former acting commissioner and assistant HHS secretary). The agency is already operating with acting directors in both CDER divisions. Tracy Beth Høeg is acting director of CDER.

Executive Impact: Makary was confirmed in March 2025 and served approximately 14 months. During that time, he launched or championed more regulatory initiatives than any FDA commissioner in recent memory:

Every one of these initiatives is now at risk of stalling, being reversed, or losing institutional momentum during a leadership transition. For companies with CNPV filings planned (Revolution Medicines, Lilly T2D), the near-term question is whether the program continues operating during a transition or pauses until a new commissioner is confirmed.

Odyssey Therapeutics IPOs at $304M as 2026 Biotech IPO Wave Continues ODYS

Odyssey Therapeutics debuted on Friday via an upsized $304M IPO, according to Fierce Biotech. BioPharma Dive noted that nine of the 11 biotechs to go public in 2026 have raised at least $250M in their initial stock sales, the most in a single year since 2021. Total 2026 biotech IPO proceeds now exceed $3.2B, following recent debuts from Seaport Therapeutics and Hemab Therapeutics.

Angelini Pharma Acquires Catalyst Pharmaceuticals CPRX

Italy's Angelini Pharma announced a definitive agreement to acquire Catalyst Pharmaceuticals for $31.50/share in cash, according to The Pharma Letter. Catalyst markets Firdapse (amifampridine) for Lambert-Eaton myasthenic syndrome. The deal continues the trend of European pharma companies acquiring U.S. rare disease assets.

FDA Approves Bizengri Under Accelerated Review

The FDA approved Partner Therapeutics' Bizengri (zenocutuzumab) for adults with a rare form of bile duct cancer on May 9, under an accelerated review program. The approval occurred just hours before reports of Makary's planned departure emerged.

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💊 The Succession Landscape

Kyle Diamantas (Acting): Currently runs FDA's food group. Unknown regulatory philosophy on drugs. Would be a placeholder while a permanent nominee is confirmed. Low probability of major drug policy changes during his tenure.

Stephen Hahn (Nominee): FDA Commissioner 2019 to 2021. Oversaw emergency use authorizations for COVID vaccines. Known to the industry. Would likely maintain institutional continuity and support data-driven regulatory decisions. The most "continuity" choice.

Brett Giroir (Nominee): Former HHS assistant secretary and acting FDA commissioner (briefly). More politically aligned with current administration priorities. Could accelerate some initiatives (flavored vapes, as Trump wants) while deprioritizing others (Expedited IND, RTCT).

📊 2026 Biotech IPO Scorecard

Total 2026 biotech IPO proceeds now exceed $3.2B across 11 companies. Nine of 11 raised at least $250M. Key names: Kailera ($625M), Generate:Biomedicines ($400M), Eikon Therapeutics ($381M), Odyssey ($304M), Seaport Therapeutics, Hemab Therapeutics.

For context, full-year 2025 biotech IPO proceeds were approximately $1.8B (J.P. Morgan). 2026 has already nearly doubled that through May. The IPO window is the most open since 2021. The key driver: strong M&A premiums (34% to 140% in Q1) give public market investors confidence that late-stage biotechs have exit optionality.

🎯 Catalyst Calendar: May 2026 Forward

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