FDA leadership in crisis — multiple outlets report Trump will fire Commissioner Makary after 14 turbulent months. Leqembi SC review extended three months to August 24. Bayer acquires Perfuse for $2.45B; Daiichi Sankyo takes $610M ADC manufacturing hit; Gilead targets $1B in Yeztugo sales.
Auto-generated from the episode script. Deal names link to their scorecard in the database.
The Wall Street Journal reports President Trump has approved a plan to fire FDA Commissioner Marty Makary, throwing the agency's regulatory leadership into uncertainty after a turbulent fourteen-month tenure.
Meanwhile, the Leqembi subcutaneous decision gets pushed three months, Daiichi Sankyo takes a $610 million ADC manufacturing hit, and Bayer writes a $2.45 billion check to get back into pharma M&A.
Welcome to The Pharma Closeout for Friday, May eighth, 2026. I'm Alex Mercer.
And I'm Maya Patel. Let's get into it.
The top story has nothing to do with a molecule and everything to do with the regulatory apparatus. Multiple outlets report that President Trump has signed off on a plan to dismiss FDA Commissioner Marty Makary. The Wall Street Journal broke it this afternoon, with Bloomberg, Reuters, STAT, and Politico all confirming through independent sources. Makary served roughly fourteen months — a tenure ambitious in scope, turbulent in execution.
Turbulent undersells it. Personnel departures, clashes with career scientific staff, political pressure from incompatible directions. Anti-abortion groups pushed for faster action on a mifepristone safety review. The White House reportedly wanted him to greenlight flavored vapes to appeal to younger voters. He was caught between constituencies he couldn't simultaneously satisfy.
Two White House advisers told Reuters a final decision has not been made. But when four major outlets are independently aligned on direction, that qualifier reads more like process language than genuine uncertainty.
And the institutional backdrop makes this worse than a single personnel change. The CDC director role is vacant. No permanent surgeon general. The FDA itself has leadership gaps below the commissioner level. A new commissioner requires Senate confirmation. The health regulatory infrastructure is thinning out at the top with no quick replacement mechanism.
Here's the detail that tells you how real this feels inside the building. Today — the same day these firing reports broke — the FDA issued a press release announcing the seventh approval under the CNPV pilot program, quoting Makary by name. And STAT reported he was absent from the FDA's annual staff 5K on the White Oak campus, an event he was scheduled to address and run. Two agency sources confirmed he wasn't there. Meanwhile, the dozens of initiatives he championed — shortened review timelines, the CNPV pilot itself, the food dye campaign, the misleading ads crackdown — all sit in limbo until a successor decides what carries forward.
Which means the immediate industry question is operational, not political. Every company with a PDUFA date in the next sixty days, every program in the CNPV pipeline, now factors in a leadership transition with no named successor. Leadership changes don't pause the review clock, but they absolutely shift prioritization and resource allocation inside the agency. If you have an active NDA or BLA under review, sizing that transition risk for your specific program — that's the assignment this weekend.
That regulatory uncertainty is the overhang. But shift to the deal side, and this week has been anything but quiet. Bayer agreed to acquire Perfuse Therapeutics for up to $2.45 billion, centered on a mid-stage glaucoma therapy. Marcus Webb has the structural read.
Bayer has been functionally absent from pharma M&A for years. This is potentially their largest drug company acquisition in recent years Paying up to $2.45 billion for a mid-stage ophthalmology asset tells you they see glaucoma as significantly underserved relative to the opportunity. The "up to" structure means heavy milestone consideration — they're pricing Phase 3 success they haven't generated yet.
Bayer's return to the table fits a broader pattern. Yesterday, Angelini agreed to acquire Catalyst Pharmaceuticals in a significant all-cash deal centered on rare neurological diseases — the fourth biotech acquisition announced just this month. On a different register, Daiichi Sankyo disclosed a significant financial hit from ADC manufacturing overcapacity They'd aggressively locked in contracts with manufacturing organizations ahead of projected Enhertu demand. Endpoints reported a broader extraordinary loss approaching a billion dollars when additional charges are included.
The Daiichi write-down is a signal the whole ADC sector should internalize. The industry has been building capacity on the assumption that demand scales with approvals. When the company that anchors the entire modality is writing off manufacturing contracts, every mid-cap ADC developer needs to stress-test its own capacity assumptions against actual commercial traction — not projections.
Brighter news from Gilead. The company raised its 2026 Yeztugo sales target to a billion dollars after reporting solid first-quarter revenue growth — they're calling it an unprecedented launch trajectory. And Novo Nordisk hiked guidance on the Wegovy pill's fast start, more evidence that the oral GLP-1 market is building alongside injectables rather than cannibalizing them.
A billion in Yeztugo's first full year would validate the long-acting prevention model broadly. The real test is year two — when you move past motivated early adopters into the populations where daily pill adherence has always broken down. That's where twice-yearly dosing either proves durable or doesn't.
Rapid-fire on financing and clinical data. Odyssey Therapeutics priced its upsized IPO at $279 million on a second attempt. The majority of biotech IPOs this year have successfully raised substantial capital — strongest window since 2021. Artiva raised substantial capital on the back of encouraging RA data. And in Duchenne, a brutal stretch: Entrada lost more than half its market cap on Phase 1/2 disappointment, Sarepta's gene therapy sales are declining further, and Capricor is suing its own partner NS Pharma over pricing disputes for deramiocel ahead of an FDA decision.
The Artiva data point to flag: strong ACR50 response rates in refractory RA patients with an allogeneic NK cell therapy, plus FDA alignment on a Phase 3 registrational trial this year. If that signal holds in a larger dataset, it's a meaningful new entrant in a population that has cycled through biologics without adequate response. Duchenne, by contrast, remains one of the most unforgiving development corridors in the industry — and this week underscored that in every direction.
That deal activity is the backdrop. Now on the regulatory side — a date we've been tracking just moved.
The Leqembi subcutaneous autoinjector. We're tracking an upcoming PDUFA decision date. That date is no longer operative. Eisai and Biogen announced today that the FDA extended the review by three months, pushing the new action date to August 24th.
Every month of delay widens the window for Lilly's donanemab. The subcutaneous formulation was the convenience play designed to move Leqembi beyond the infusion-center bottleneck — and that argument just got pushed to late summer.
Separately, the FDA approved Bizengri — zenocutuzumab — for NRG1 fusion-positive cholangiocarcinoma under the CNPV pilot program. The pivotal study demonstrated a meaningful overall response rate in the patient population studied. Partner Therapeutics is the sponsor. The drug already carries accelerated approval in NRG1-positive lung and pancreatic cancers — they're systematically building a biomarker-defined franchise across tumor types rather than chasing individual indications.
The CNPV program that enabled that approval is itself entering uncertain territory. A June 4th public meeting is scheduled on the program's eligibility criteria and review procedures. And Sanofi pulled its Tzield application from the program this week after reports of political appointee interference in the review process.
Layer on a potential commissioner exit, and the regulatory strategies companies have built around CNPV timelines face genuine uncertainty. For sponsors with active applications in that pipeline, modeling what a leadership transition means for their specific review tempo just moved from theoretical exercise to immediate priority.
What to watch heading into next week. The Argenx Vyvgart sBLA for seronegative myasthenia gravis has an upcoming PDUFA decision date — that could land over the weekend, so set alerts. An upcoming PDUFA decision is expected for the Enhertu sBLA in neoadjuvant HER2-positive breast cancer. Daiichi Sankyo's full earnings early next week should clarify whether the $610 million ADC write-down was the complete picture. And the question hanging over all of it — whether the Makary reports become a formal exit by Monday.
The Argenx decision carries the most near-term competitive weight. A seronegative MG label expansion would meaningfully widen Vyvgart's addressable population and reshape the FcRn competitive conversation from strong to potentially dominant.
That is your Pharma Closeout for Friday, May 8th. Reports of Makary's firing reshaping the FDA landscape, Leqembi pushed to August, Bayer and Angelini writing multi-billion-dollar checks, Gilead targeting a blockbuster year for Yeztugo, and Daiichi Sankyo's ADC manufacturing reckoning rippling through the sector. This industry never takes a week off, and we won't either. If this briefing saves you time, follow us on Spotify and drop a rating — it helps others in the space find us.
Big week, and a lot still in motion. Go enjoy the weekend, and we'll see you Sunday.
The daily Closeout in under 15 minutes — trial readouts, FDA decisions, and the deal math behind them. Free.
Subscribe →