CSL Flags $5B Vifor Impairment as Shares Hit Nine-Year Low

FDA Commissioner Makary is out as of today — and the person stepping in, Kyle Diamantas, built his career in food safety, not drug approvals.

BMS just committed up to fifteen-point-two billion across thirteen Hengrui assets, and Lilly published Lancet data proving the oral step-down model for obesity maintenance. Full day.

Welcome to The Pharma Closeout for Tuesday, May twelfth, 2026. I'm Alex Mercer.

And I'm Maya Patel.

Makary's departure was a question of when, not if. The White House had been signaling for weeks. BioPharma Dive described a tenure marred by leadership upheaval, mass layoffs, political pressure, and public clashes with drugmakers. He's the fourth high-profile health official out the door this year, per NBC. The outcome is resignation rather than termination, but the downstream effect is identical — the FDA has no confirmed leader and no nomination timeline.

The acting appointment is where this gets operationally concrete. Diamantas ran food regulation at the agency. He's a lawyer by training — not a clinician, not a drug reviewer. Career review staff will keep processing NDAs and BLAs on schedule. That machinery doesn't stop. What's at risk are the commissioner-level programs that needed political sponsorship to survive.

Which is exactly what we've been tracking. The drug approval accelerator pilot, the AEMS surveillance expansion — both were Makary-era initiatives that required top-down cover to gain traction. Without a permanent commissioner championing them, they lose momentum at best and get quietly archived at worst. Senate confirmation for a replacement typically drags for months.

So companies with any regulatory interaction more complex than a standard review cycle just lost their interlocutor. Advisory committee strategy, breakthrough therapy negotiations, novel endpoint discussions — all benefit from knowing who's setting the agency's strategic direction. Right now, nobody knows. And that uncertainty accrues cost every week the seat stays empty.

Shifting to the deal side, and it's a significant one. Bristol Myers Squibb and China's Hengrui Pharma announced a strategic alliance today — thirteen programs spanning oncology, hematology, and immunology, worth up to fifteen-point-two billion dollars. Expected close, third quarter. Let me bring in Marcus Webb on the architecture.

BioPharma Dive ranks this as the second-largest China-to-West licensing pact since early twenty-twenty-five, trailing only AstraZeneca's eighteen-point-five billion tie-up with CSPC in January. BMS has been at a strategic crossroads — Endpoints ran a deep dive on make-or-break pipeline decisions just last week — and this deal reads as the answer: go deep into Chinese innovation to rebuild ahead of the patent cliffs.

Thirteen early-stage assets is a volume play on optionality. Most won't reach pivotal trials — that's the base rate for programs at this stage. BMS needs two or three winners to justify the economics, and the bilateral structure means Hengrui carries equal skin in making the discovery engine deliver. But geopolitical risk runs parallel to the science risk here. Whether China-originated assets stay commercially navigable in Western markets over the next five years is the bet underneath the numbers.

The other headline moving markets today — Lilly. Two late-phase maintenance trials reported out, SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN, published simultaneously in The Lancet and Nature Medicine. SURMOUNT-MAINTAIN enrolled four hundred forty-one participants. ATTAIN-MAINTAIN, three hundred seventy-six. The numbers: patients switching from Wegovy to oral Foundayo showed minimal weight regain over a year. Zepbound to Foundayo, five kilograms. stepping down from maximum-dose Zepbound to the maintenance dose showed meaningful weight loss maintenance. And patients who stayed on Zepbound max dose kept all of their prior weight loss.

significant weight loss maintained when switching from Wegovy to oral Foundayo. strong majority of revenue from Zepbound — those are the efficacy estimand numbers that will anchor the commercial story. And recall the Foundayo label came through in April with no food or water intake restrictions, which is the convenience wedge against every oral competitor in development. What Lilly demonstrated here is the clinical rationale for a treatment paradigm: initiate on injectable, transition to daily oral for indefinite maintenance. That's a franchise architecture, not a trial result. LLY closed up two-point-three-seven percent, and Novo's oral amycretin program now has a very specific benchmark to clear.

Also worth noting — Rigel Pharmaceuticals licensed Veppanu, the vepdegestrant PROTAC degrader, from Pfizer and Arvinas for eighty-five million upfront plus substantial additional milestone payments. FDA approved it May first for ESR1-mutated breast cancer. Pfizer and Arvinas shepherded it through approval and immediately handed off commercialization — Veppanu is now Rigel's fourth marketed product, per Reuters.

The ESR1-mutated, post-endocrine-therapy population is clinically well-defined but commercially narrow — narrow enough that neither originator wanted to build launch infrastructure at that scale. Rigel picks up a marketed asset with milestone upside. The broader read-through is what this tells you about where PROTAC commercial ceilings sit in solid tumors today.

Quick hits to round out the pipeline. Alkermes reported positive Phase 3 results from REVITALYZ evaluating Lumryz in idiopathic hypersomnia — that's the sodium oxybate franchise from their two-point-four-billion-dollar Avadel acquisition. Primary endpoint met in a randomized withdrawal design, sNDA planned by year-end. BioMarin is already trimming headcount at recently acquired Amicus—standard integration work following a major rare disease acquisition. And GSK struck a marketing deal with Sino Biopharmaceutical to broaden access to hepatitis B drug bepirovirsen in China — another data point in the accelerating wave of Western-Chinese pharma partnerships.

The Lumryz result carries the most strategic weight in that batch. Expanding from narcolepsy into IH roughly doubles the addressable population and validates the Avadel acquisition thesis at a critical moment for Alkermes. Pair that with BMS-Hengrui and GSK-Sino, and the pattern is unmistakable — the industry is rebuilding its pipeline through partnerships, not just internal R&D. That trend is accelerating.

On the regulatory side — beyond the leadership vacuum — the Leqembi subcutaneous autoinjector review just got more interesting. FDA extended the PDUFA to August twenty-fourth after requesting additional information. Career reviewers will process it on schedule. The concern isn't the review mechanics — it's any pre-market deliberation or label negotiation that benefits from having an engaged commissioner in the chair.

Outside the U.S., the EU reached a provisional deal on the Critical Medicines Act — a supply-chain resilience framework landing right as Endpoints flagged emerging disruptions from the Iran conflict hitting pharma manufacturing upstream.

The Act requires member states to conduct supply vulnerability assessments and stockpile critical APIs — this is enforceable regulation, not voluntary guidance. For any company with European manufacturing footprint or API sourcing through geopolitically exposed corridors, the procurement strategy conversation needs to start now, not when implementation begins.

Looking ahead — Isomorphic Labs, Google DeepMind's drug discovery spinout, is in advanced talks to raise more than two billion dollars. Endpoints raised five burning questions about what that capital actually buys in AI-driven development. The answer will tell us whether the AI-pharma thesis is maturing or just inflating.

Bayer's CEO signaled what he called a careful but aggressive return to pharma M&A, even as biosimilar competition carves into Eylea sales. After the Perfuse deal we covered last week, Bayer is telegraphing that more acquisitions are coming — and the market will want to see where the firepower lands.

And a note on market context — healthcare outperformed meaningfully today, up one-point-seven-seven percent versus sixteen basis points for the S&P. Drug manufacturers led at one-point-seven-five. Meanwhile, that hantavirus-driven biotech surge from yesterday? Already gone. Novavax gave back five percent, Emergent dropped one. Evercore called it last week: no meaningful revenue opportunity.

The COVID trading playbook doesn't map onto every pathogen headline. That lesson apparently needs re-learning every few quarters.

That is your Pharma Closeout for Tuesday. Makary exits, the FDA enters a leadership vacuum, BMS bets fifteen-point-two billion on Hengrui, Lilly proves the oral step-down model works with hard data in The Lancet and Nature Medicine, and Rigel picks up what Pfizer and Arvinas didn't want to commercialize. If this briefing keeps you sharp, follow us on Spotify and drop a rating — takes five seconds and helps people across the industry find us. We'll be back tomorrow.

Grab some rest tonight. Tomorrow's going to be just as full. See you then.