Last Week Tonight in BioPharma: Week of May 11th, 2026
Novo's early responders play, cleaning house at the FDA, IsoMorphic's $2.1B round, and more!
Welcome back to Last Week Tonight in BioPharma (LWTB). What a week!
This week, BMS wrote a $600M check to Hengrui as part of a staggering $15.2B China licensing deal. Novo dropped new obesity data showing high-dose WEGOVY hitting 28% weight loss in a group of fast-responders, but could this data actually speak to a long-term trend in obesity that backfires against Novo and Lilly? Meanwhile, BeOne get's its BCL-2 inhibitor BEQALZI across the FDA finish line for relapsed or refractory mantle cell lymphoma. Oh, and the FDA’s entire top-level of leadership got the axe.
All that and more below. Let’s get into it!
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Recently, I did a deep dive into the myelofibrosis landscape, in which I examine why there are STILL so many JAK inhibitors and whether we are on the verge of seeing a major step-change in efficacy like we’ve seen in other blood cancers.
📡 PRESS RELEASE DECODER
What the press releases actually mean
FDA Grants Accelerated Approval to BeOne’s BEQALZI (sonrotoclax) for R/R Mantle Cell Lymphoma
📅 May 13, 2026 | 🏢 BeOne Medicines ( ONC 0.00%↑ ) | 💊 BEQALZI (sonrotoclax) | 🏷 FDA Accelerated Approval
The FDA granted accelerated approval to BeOne Medicines’ ($ONC) BEQALZI (sonrotoclax) for relapsed or refractory mantle cell lymphoma (R/R MCL) on May 13, making it the first and only BCL-2 inhibitor cleared in this indication. The approval marks the 14th novel drug FDA has approved so far in 2026, per the agency’s running tally.
Sonrotoclax is a next-generation BCL-2 inhibitor designed to address some of the resistance mechanisms and tolerability issues seen with venetoclax (AbbVie’s ($ABBV) VENCLEXTA). BeOne’s press release framed this as validation of its hematology pipeline following its high-profile rebrand away from the BeiGene name, a move designed to reposition the company’s U.S. commercial identity amid ongoing geopolitical scrutiny of China-linked biotechs.
MCL is a rare and aggressive B-cell lymphoma with limited options after BTK inhibitor failure. The accelerated approval pathway means BeOne will need to confirm clinical benefit in a post-marketing confirmatory trial, but the commercial window is open now. Reuters noted that this positions sonrotoclax directly against the venetoclax franchise, which generated over $2.5 billion in sales last year across indications for AbbVie and its collaboration partner Roche/Genentech.
🧠 BPS Take: The AbbVie/Genentech venetoclax franchise is a $2.5B-plus-per-year business built largely on CLL and some AML sales that has faced no in-class challengers. Venetoclax is an effective drug, but requires a 5-week dose ramp up to minimize the risk of tumor lysis syndrome (TLS). Sonrotoclax has been designed with a much cleaner profile and more refined chemistry. Sonrotoclax landing in MCL first is a smart foot-hold securing move, enabling BeOne to play in an indication where venetoclax has no market presence as they build into the much larger CLL opportunity. Sonrotoclax is already approved in China in both CLL and MCL and BeOne has four Phase 3 studies in CLL ongoing to be used to file in western markets.
Novo Nordisk Drops an "Early Responder" Analysis at ECO. The Real Target? Eli Lilly.
📅 May 12 | 🏢 Novo Nordisk ( NVO 0.00%↑ ) | 💊 WEGOVY HD (semaglutide 7.2 mg) | 🏷 STEP UP Sub-Analysis (ECO 2026)
Novo Nordisk ($NVO) presented new sub-analyses from the STEP UP trial at the European Congress on Obesity (ECO) in Istanbul this week, highlighting weight loss outcomes with WEGOVY HD (semaglutide 7.2 mg) stratified by speed of initial response.
The STEP UP trial enrolled 1,407 adults with obesity (BMI ≥30, no type 2 diabetes) and ran for 72 weeks, double-blind, with three arms: semaglutide 7.2 mg, semaglutide 2.4 mg, and placebo. The primary results, already published in The Lancet Diabetes & Endocrinology, showed 20.7% mean weight loss on the 7.2 mg dose, 17.5% on 2.4 mg, and 2.4% on placebo.
The new sub-analysis introduced an “early responder” classification: patients who lost 15% or more of body weight by week 24. On the 7.2 mg dose, 26.9% of patients met that threshold and went on to lose 27.7% of body weight at week 72. On 2.4 mg, 20.9% qualified as early responders, losing 24.8% at week 72. Non-early responders on the 7.2 mg dose lost 15.4% on average; non-early responders on 2.4 mg lost 13.2%.
🧠 BPS Take: As a product-positioning tactic, this is a sharp move by Novo. The headline number here is 28% weight loss and fast-onset (15% loss) in roughly a quarter of the patients on high-dose semaglutide. Drawing attention to that high-end number compares favorably to tirzepatide, who at the same conference showed SURMOUNT-MAINTAIN data proving that tirzepatide (ZEPBOUND) at max dose sustains 22.4% weight loss through 112 weeks, and published ATTAIN-MAINTAIN data showing patients can switch from injectable ZEPBOUND to oral FOUNDAYO and keep most of the weight off. Lilly’s is trying to position FOUNDAYO as the long-term weight maintenance option, while Novo is trying to highlight the “rapid weight loss” message, while also trying to subtly strike a favorable efficacy comparison to the average ZEPBOUND patient.
But here is where this may backfire for Novo over the long run. By publishing an early-responder analysis, Novo is implicitly acknowledging that GLP-1 response is not uniform. About 27% of patients are early responders on the high dose. That means roughly 73% are not. Novo is essentially segmenting its own market. Right now, that segmentation works in their favor because 27.7% is a great headline. But what happens when the next wave of competitors enters the obesity space with non-GLP-1 mechanisms? Those companies don't need to beat semaglutide in the full population. They just need to target the 73% of patients who are NOT early responders on semaglutide and offer them something better than 15%.
This is especially relevant given the emerging pharmacogenomics data. A major study published in Nature in April 2026 (23andMe, n=27,885 GLP-1 users) identified a missense variant in the GLP1R gene (rs10305420, Pro7Leu) that significantly predicts weight loss response to semaglutide and tirzepatide. The T allele carriers lost meaningfully more weight (additional ~0.76 kg per allele). They also found that response varies significantly by sex (women respond better, 12.2% vs. 10.0% BMI loss in men), ancestry (European ancestry most responsive), and T2D status (patients with diabetes lose ~2.87 percentage points less). Across all non-genetic factors combined, only about 21% of variance in weight loss was explained. Adding genetics bumped it to 25%. We might be moving moving toward a world where “who responds to GLP-1s” is a genetically answerable question.
And that’s the strategic risk for Novo and Lilly alike. Once you can genotype/phenotype for GLP-1 response, the obesity market stops being a one-size-fits-all blockbuster story and starts looking more like precision oncology, where companion diagnostics and patient selection define clinical and commercial outcomes. The non-GLP-1 pipeline is projected to hit $15.5 billion by 2031 (up from ~$310 million in 2026, per GlobalData). Those later entrants would love nothing more than a companion diagnostic or patient segmentation strategy that identifies the patients who won’t respond well to semaglutide or tirzepatide and routes them toward alternative mechanisms instead.
🌐 CONNECTING THE DOTS
When the outside world meets biopharma
FDA Commissioner Makary Resigns, Then the Entire Leadership Layer Falls Apart in 72 Hours
📅 May 12-14, 2026 | 🏢 FDA / Policy | 💊 N/A | 🏷 Regulatory Leadership + Industry Response
Marty Makary resigned as FDA Commissioner on May 12, just 13 months into his tenure and on the eve of his Senate Appropriations testimony on the FY2027 FDA budget. The exit was reportedly made under White House pressure after Trump signed off on a plan to oust him, driven in part by Makary’s refusal to approve flavored vapes. Kyle Diamantas, the FDA’s Deputy Commissioner for Food and a JD by training with no medical background, was named acting commissioner. RFK Jr. posted on X that the search for a new commissioner “is already underway.”
But Makary’s exit was just the start. By Friday night, the FDA’s leadership had been gutted across all three critical positions:
Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research (CDER), was fired on May 15 after she refused to sign a resignation letter.
Høeg was the fifth CDER leader in a single year, following the departures of George Tidmarsh, Richard Pazdur, and others. Michael Davis, CDER’s deputy director, is now acting director.
Katherine Szarama, who had been acting director of the Center for Biologics Evaluation and Research (CBER) for all of 10 days after replacing Vinay Prasad (who himself departed for the second time in April), is also out. Karim Mikhail, former CEO of Amarin who joined FDA last year, is now acting CBER director.
Jim Traficant, FDA chief of staff since last March, was also ousted on Friday.
To summarize the state of affairs: as of this weekend, the FDA has no permanent commissioner, no permanent CDER director, no permanent CBER director, and no chief of staff. All top positions are filled by acting officials operating under a 210-day federal authority limit.
The downstream effects are already visible. Reuters spoke to seven biotech executives, investors, and consultants this week who confirmed that mass FDA layoffs, the revolving door at the commissioner level, and general Trump-era restructuring are pushing smaller biotechs to file Phase 1 INDs in the EU and Australia first. Peter Kolchinsky at RA Capital ($9B AUM) said: “We know that across our companies, the discussions include whether to go ex-U.S. because of recent FDA uncertainty.” One biotech CEO told Reuters their company plans to seek EMA approval to run early-stage oncology trials in three European countries, at roughly $1M in additional filing costs, saying: “The irony of this is it goes against the grain of ‘America First’, because we are offshoring away from the U.S. over to Europe.” Another U.S. biotech opted to run two early-stage trials in Australia this month rather than the U.S. A third said at least two members of their eight-person FDA review team have left, threatening data review timelines.
🧠 BPS Take: Makary’s tenure was a mostly negative bag in my view. He directionally had it right on some things like: utilization of AI, CRL transparency, and speeding up review times, but none of those were ever applied consistently enough to result in more benefit than harm to the sector. Moreover, he really hired some problematic people, who he as a leader did not do a good job reigning in and did an equally job managing-up with his superiors like RFK and Trump.
What is alarming is what happened in the 72 hours after he left. The acting CDER head was fired. The acting CBER head (who had the job for 10 days) is gone. The chief of staff is gone. Apparently the Chief AI officer (which to be honest I didn’t know was a thing at the FDA) is also out.
The person now running the entire FDA is a food lawyer whose prior claim to fame was defending Abbott in an infant formula lawsuit (Abbott lost, paid $495M) and who is a close friend of Donald Trump Jr. A food lawyer running a drug-heavy agency is not a confidence-inspiring signal for anyone waiting on a PDUFA date.
This is just the cherry on top of all the turmoil, capriciousness, and inconsistency this FDA has demonstrated since Trump came into office for a second time. All of that compounds. The agency is operationally diminished at the absolute wrong time, as we fall further behind China in innovating new drugs and testing them in clinical trials. The biotech offshore migration story is the direct, logical consequence. When your fastest path to a Phase 1 readout runs through Melbourne or Amsterdam rather than Rockville, you file there.
I am not confident anyone of meaningful stature, competence, and leadership will take any of these roles. Several big name figures in the Biotech community are petitioning for Rick Pazdur to return. While he would be an experienced and perhaps stabilizing pick, why would anyone want this job if you have to compromise your morals to defend RFK’s ludicrous takes on health and wellness and push through the agenda of any random person who has the president’s ear?
💰 FOLLOW THE MONEY
Deals, dollars, and what they signal
BMS Pays $600M Upfront for $15.2B Hengrui Mega-Pact While $GSK Hands China HBV Launch to Sino Biopharmaceutical
📅 May 11-12, 2026 | 🏢 Bristol Myers Squibb ($BMY) + Hengrui Pharma ($1276.HK) + GSK ($GSK) + Sino Biopharm ($1177.HK) | 💊 13 early-stage oncology/hematology/immunology assets + bepirovirsen | 🏷 Strategic Licensing / Co-Development Alliance + China Commercialization Partnership
Bristol Myers Squibb ($BMY) and Hengrui Pharma ($1276.HK) announced a sweeping bilateral pact on May 12 worth up to $15.2 billion in total milestones. BMS pays $600 million upfront, plus $175 million on each of the first two anniversaries, to secure ex-China rights to four Hengrui oncology and hematology assets and joint discovery rights on five additional programs. Hengrui receives Greater China rights (mainland China, Hong Kong, Macau) to four BMS immunology assets and will lead early human development in that region. The transaction is expected to close in Q3 2026.
BMS CFO David Elkins had publicly flagged at a Citi event that China’s early-stage development speed is a competitive advantage, citing McKinsey data showing Chinese sponsors run proof-of-concept trials 50 to 70 percent faster than Western peers. This deal arrives roughly a year after Hengrui’s $12 billion licensing agreement with GSK, cementing Hengrui’s status as the most sought-after Chinese R&D partner in the industry right now.
One day earlier, on May 11, GSK ($GSK) moved in a different direction with China exposure by announcing an exclusive collaboration with SBP Group, the hepatology-focused unit of Sino Biopharmaceutical ($1177.HK), to support the China launch of bepirovirsen, a potential first-in-class antisense oligonucleotide for chronic hepatitis B. Under the 5.5-year supply arrangement, CTTQ purchases the drug from GSK while GSK retains all revenue recognition.
🧠 BPS Take: Two deals, two flavors of the same strategic logic: Western pharma cannot ignore China’s patient populations or its R&D throughput, regardless of geopolitical headwinds. I find the BMS/Hengrui structure particularly interesting because it is almost a trade of sorts. BMS buys into part of a Chinese pipeline, but it is also licensing its own immunology assets back into China through a local partner who will run early development there. That is a mature, cost-conscious way to keep China exposure without building out your own local clinical infrastructure. The $600 million upfront is real money on undisclosed early-stage assets, which tells you how seriously BMS is treating its post-REVLIMID pipeline rebuild. I am curious to see what targets and modalities end up coming out of Hengrui for this deal.
The GSK/Sino bepirovirsen deal is structurally simpler but strategically smart. GSK is not giving up economics; it is essentially buying a distribution army in a foreign market. If bepirovirsen clears China’s NMPA and delivers even modest functional cure rates, that 5.5-year supply pact becomes very valuable very fast.
I’ll also be watching whether these deals attract scrutiny under the BIOSECURE Act or successor legislation. Also watching how Hengrui’s stock responds over the next month, because if this gets blocked or renegotiated, the ripple effects for the entire wave of China in-licensing deals will be significant.
Isomorphic Labs Pulls In $2.1B Series B, Becoming the Largest Single Bet on AI Drug Discovery
📅 May 12, 2026 | 🏢 Isomorphic Labs (subsidiary of Alphabet, $GOOGL) | 💊 AlphaFold-derived AI drug design platform | 🏷 Mega Series B Financing
Isomorphic Labs, the DeepMind spinout founded by Demis Hassabis, closed a $2.1 billion Series B led by Thrive Capital, with participation from new investors MGX (the Abu Dhabi state-linked technology fund), Temasek, and CapitalG, alongside existing backers Alphabet ($GOOGL) and GV. BioSpace reports this is the second-largest biotech financing round ever recorded. Proceeds will fund expansion of the company’s generative drug-design models built on top of AlphaFold’s structural biology foundation.
Isomorphic has been operating largely in stealth on its own internal pipeline while licensing its platform capabilities to partners including Eli Lilly and Novartis. The fresh capital is expected to accelerate moving those computational designs into wet-lab validation and, eventually, clinical programs. Forbes describes the round as “the biggest bet yet on AI drug discovery,” framing the fundraise against a broader investor thesis that generative AI will compress preclinical timelines by years, not months.
🧠 BPS Take: $2.1 billion for a company with no approved drug and no disclosed Phase 1 data is a remarkable statement of faith in a platform. The investors backing Isomorphic Labs are overwhelmingly tech-first investors and mega-funds, rather than biotech VCs. While the headlines are biotech/drug development focused, Isomorphic is really being priced like a Tech/AI company and not a drug developer. Isomorphic is building upon AlphaFold’s protein prediction capabilities to also modeling potential druggable sites on the target and using AI to create several “keys” that fit into those binding pockets. Ultimately, these still need to tested in animals and then humans, but their platform can conceivably cut out a lot of the fat of generating drug leads in a program. The proof will be in the pudding, and IsoMorphic, with Google’s backing is partnered with multiple Big Pharmas on drug discovery collaborations. Let’s keep an eye on timelines to IND here and how quickly IsoMorphic is able to progress their own programs. As we’ve seen with other AI drug discovery companies, like Recursion, these tech-first companies can raise huge rounds, sign multiple big collabs, and get a several year grace period where they crank out several “cool” drug candidates before the pressure of actually getting drugs to work in the clinic sets in.
Create Medicines Raises $122M Series B to Bring RNA-Based In Vivo CAR-T Into the Clinic
📅 May 14, 2026 | 🏢 Create Medicines (private) | 💊 In vivo CAR-T platform (autoimmune + oncology) | 🏷 Series B Financing
Create Medicines, a Massachusetts-based biotech developing RNA-based in vivo CAR-T therapies, announced a $122 million Series B led by Newpath Partners, with ARCH Venture Partners and Hatteras Venture Partners joining the round. The company’s platform is designed to engineer CAR-T cells directly inside the patient’s body using RNA delivery, bypassing the costly and logistically complex ex vivo manufacturing process that currently limits conventional CAR-T to a small number of academic medical centers.
The round positions Create in the same rapidly consolidating in vivo CAR-T subspace as Lilly’s $7 billion acquisition of Kelonia earlier this year and the AbbVie ($ABBV) partnership with Capstan Therapeutics. STAT News notes that Create’s autoimmune disease focus mirrors where conventional ex vivo CAR-T has already shown dramatic early results, with the in vivo approach offering the potential to reach far more patients if manufacturing hurdles can be eliminated. Proceeds will fund IND-enabling studies and the company’s first clinical programs.
🧠 BPS Take: The in vivo CAR-T space is moving faster than almost any other subfield in cell and gene therapy right now. Create’s $122 million round is well-sized as it is one of the few in vivo companies with clinical data (in solid tumors to boot). From their corporate presentation, it appears they have a broad set of cell and antigen targeting technologies across oncology and autoimmune disease. Given the high density of players in this space, speaking to and proving differentiation in your vector’s targeting capabilities vs. competitors will be important, and Create does a good job explaining where they may be better than their peers. In solid tumors, they’ve already shown one partial response with a TROP2 CAR-myeloid cell program. It appears their approach in solid tumors is also guided at in vivo delivery into multiple cell types at once (NKs, Myeloids, T-cells, etc.) which is somewhat unique to them. More robust clinical data across all these programs will be the true test, but it is good to see companies speak to aggressively speak to differentiation against competitors early on. Create is definitely one to follow as we head into conference season, and given the penchant for Big Pharmas to acquire in vivo Cell Therapy companies early-on in their company life cycle, perhapsLet’s do a remixed version of this image. Make it “Week of May 11.” Also, only include logos for FDA, Novo Nordisk, and Bristol-Myers Squibb. they won’t be around for long.
Back next week with more BioPharma strategy takes! Share this with a friend or colleague if you found it helpful.
sharp! at ECO the main buzz was around precision obesity and i think in the next year or two we’ll get phenotypic data that allows for better segmentation of the drugs. will be interesting to see how that affects sales forecasting