FDA Commissioner Makary Resigns; BMS-Hengrui $15.2B 13-Asset Alliance

A decade-long monopoly in BCL-2 ends today. The FDA approves BeOne Medicines' Beqalzi for mantle cell lymphoma, and AbbVie's Venclexta finally has company.

Meanwhile, Takeda axes forty-five hundred jobs in a billion-dollar restructuring, Lilly and Novo drop dueling obesity data on the exact same day, and the FDA now has three empty chairs at the top.

Welcome to The Pharma Closeout for Wednesday, May thirteenth, twenty-twenty-six. I'm Alex Mercer.

And I'm Maya Patel. Let's get into it.

Late this afternoon, the FDA green-lit Beqalzi — that's sonrotoclax — from BeOne Medicines. The indication: relapsed or refractory mantle cell lymphoma in adults after at least two prior systemic lines, including a BTK inhibitor. It's another novel drug approval in a robust approval year. And per Reuters, Beqalzi is the first BCL-2 inhibitor approved for MCL — and the first new entrant in the entire BCL-2 class since Venclexta's original approval in 2016.

The indication matters more than the mechanism here. Venclexta's labels sit in CLL and AML. BeOne carved out MCL — a setting where BTK resistance is accelerating and post-second-line options thin out fast. This was a deliberate flanking move into underserved territory, not a head-on challenge to AbbVie's core franchise.

And BeOne is a China-origin biotech, now operating across six continents. After yesterday's BMS-Hengrui fifteen-point-two-billion-dollar alliance, this is the second consecutive day a Chinese-developed oncology asset has rewritten part of the competitive map.

Though the near-term threat to Venclexta is contained. Different indication, different patient population. The real exposure for AbbVie begins if BeOne pursues expansion studies into CLL or AML — a second BCL-2 option in those settings gives payers pricing leverage they have not had in a decade and reopens the combination landscape across hematology.

The market reads it the same way — AbbVie showed modest upward movement today. Nobody is pricing an immediate franchise hit.

Because it isn't one. Not yet. But the BCL-2 class was a single-drug category for ten years. That just changed — and it does not change back.

That competitive reshuffling is one kind of industry pressure. Shifting to the deal side — Takeda is eliminating a substantial number of roles this fiscal year, representing a notable percentage of its workforce, per Endpoints. Savings target: one-point-two-six billion dollars by twenty-twenty-eight, with approximately six hundred thirty-three million in gross savings this year. Restructuring costs alone represent a substantial financial commitment. The incoming CEO inherits a years-long slim-down and is clearly accelerating it.

She is not starting fresh — she is finishing what the Weber era began, building a leaner cost base ahead of patent expirations. Forty-five hundred roles in a single fiscal year makes this one of the largest pharma workforce actions we've tracked in twenty-twenty-six. Valneva announced cuts of up to fifteen percent of staff on the same day as the travel vaccine market disappoints relative to post-pandemic expectations. Different company, different scale, same structural pressure to resize.

Quick deal note — Assertio accepted a buyout from Zydus Worldwide at a significant valuation. That's a meaningful premium over the prior Garda offer and significantly above the pre-rally price. Zydus targets a Q2 close and delisting. Now — obesity. Novo and Lilly both released new data today, and the timing is not a coincidence. Lilly's SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN data position low-dose Zepbound and oral Foundayo as step-down maintenance options after initial weight loss. Lilly shares responded — up two-point-six-one percent.

Maintenance is quietly becoming the most consequential competitive front in obesity — let me walk through the economics. Lilly's model compresses the expensive injectable induction phase, then transitions patients to oral maintenance at lower per-patient cost. That reshapes the budget impact models payers actually use for formulary decisions. Novo releasing competing data on the exact same day tells you they recognize this threat clearly. We have been tracking this dynamic all year, and today crystallizes it — the franchise that wins on durable, cost-efficient maintenance wins the next decade of formulary positioning.

Two more. Tessera Therapeutics reported that its in-vivo gene editing approach edits eighty-five percent of blood cells via infusion for sickle cell disease. No myeloablative conditioning. No autologous cell processing. Delivered as an infusion — a fundamentally different model. And Galapagos formally completed its rebrand to Lakefront Biotherapeutics, effective May eighth. The Gilead partnership, the filgotinib disappointment — one of biotech's most closely watched value-destruction stories, now formally closed and renamed.

On Tessera — the eighty-five percent headline is peripheral blood editing. Impressive, but the metric that determines a functional cure is long-term hematopoietic stem cell engraftment. They are reporting strong rewriting efficiency in LT-HSCs in non-human primates with sustained stability over an extended observation period. Preclinical, yes. But if that stem cell durability holds through IND-enabling work, the entire autologous cell therapy paradigm — Casgevy included — faces a fundamentally different competitive reality.

One last market note — the hantavirus cruise ship rally from last week is cooling fast. Novavax dropped five percent, Emergent BioSolutions and Inovio each fell about one percent after the initial surge. Analysts are calling it overdone — hantavirus transmission dynamics bear no resemblance to SARS-CoV-2. Moderna retains the most legitimate angle given pre-existing research, but the pandemic reflex trade produces diminishing returns each time the market runs it.

On the regulatory side, the FDA's leadership vacuum deepened this week, and the implications are becoming systemic. Makary's resignation Monday leaves the agency with temporary directors in three top positions simultaneously. Kyle Diamantas is acting commissioner, but BioPharma Dive is reporting renewed uncertainty across the biotech sector — and Reuters has previously flagged that some companies are moving early-stage trials outside the US entirely in response to the upheaval.

Replimune surged over eight percent Monday on the read that deregulatory pressure might ease for certain accelerated approval candidates. Broader sector sentiment held constructive today — drug manufacturers up one-point-five-five percent, biotech up one-point-zero-nine.

That Replimune move is a directional bet on an agency that currently has no confirmed leadership to set that direction. Companies with near-term PDUFA dates are not uncertain about their science — they are uncertain about the institutional consistency of the review itself.

Also worth noting on the regulatory front — Pfizer expanded Hympavzi in Europe. The European Commission cleared marstacimab for both hemophilia A and B patients with factor inhibitors in the adolescent and adult populations. The BASIS trial showed a significant reduction in treated annualized bleeding rate versus on-demand bypassing agents.

The pending US filing covers a broader population, including pediatric inhibitor patients. If that clears, Hympavzi becomes Pfizer's anchor hemophilia asset after they pulled Beqvez from the market. The commercial weight riding on that US review is substantially higher than the EU headline alone would suggest.

Looking ahead. The Lilly-Novo maintenance narrative runs through Q2 and Q3 — watch for payer-level differentiation on step-down protocols, because that is where prescribing behavior separates these franchises beyond top-line efficacy. Separately, Merck KGaA's new CEO Beckmann is publicly signaling M&A dependence for growth. Endpoints also notes their CDMO clients are stockpiling amid the Iran conflict, supporting near-term guidance — but the M&A signal puts the market on watch for sizable transactions in the coming quarters.

One geopolitical thread worth tracking — FiercePharma flagged the conspicuous absence of pharma CEOs from Trump's trade delegation to China. Tech and energy sent representatives. Pharma did not. Read that against the BMS-Hengrui deal, ongoing tariff talks, and regulatory scrutiny of China-origin licensing — the industry is calculating exactly how close to Beijing it wants to be seen right now.

And the FDA's three-vacancy situation needs resolution before it becomes a systemic bottleneck. Every pending application is affected.

Whoever fills those seats shapes accelerated approval standards, IRA negotiation posture, and the regulatory pathway for China-origin assets. That is not a governance headline — it is a direct input into every commercial plan in the industry right now.

That is your Pharma Closeout for Wednesday. BeOne's Beqalzi cracks a decade-long BCL-2 monopoly in mantle cell lymphoma. Takeda cuts deep with forty-five hundred roles and a billion-dollar savings target. Lilly and Novo go head to head on obesity maintenance. And the FDA is running three leadership positions on temp staff while an entire industry waits for direction. If this briefing is part of how you stay current, follow us on Spotify, Apple Podcasts, or wherever you listen, and drop us a rating — it genuinely helps. We are back tomorrow.

Go enjoy your evening. See you tomorrow. ### Episode Metadata **Title:** BeOne's Beqalzi Wins FDA Approval, Breaking BCL-2 Monopoly; Takeda Cuts 4,500 Jobs; Lilly-Novo Obesity Showdown | May 13, 2026 **Description:** FDA approves Beqalzi (sonrotoclax) for mantle cell lymphoma — the first new BCL-2 inhibitor in a decade, directly challenging AbbVie's Venclexta franchise. Takeda slashes 4,500 jobs in a $1.26B restructuring; Lilly and Novo duel with new obesity maintenance data on the same day. **Tags:** BeOne, Beqalzi, sonrotoclax, BCL-2 inhibitor, mantle cell lymphoma, AbbVie, Venclexta, Takeda, restructuring, layoffs, Eli Lilly, Novo Nordisk, obesity, GLP-1, Zepbound, Foundayo, Tessera Therapeutics, sickle cell disease, gene editing, FDA, FDA leadership, Makary, Assertio, Zydus, Pfizer, Hympavzi, hemophilia, Valneva, Galapagos, Lakefront Biotherapeutics, Merck KGaA, hantavirus, Replimune, pharma, pharmaceutical, clinical trials, biotech, drug approvals #