Last Week Tonight in BioPharma: Week of June 22nd, 2026
Seagen ADC 2L NSCLC failure, Trump might be on retautride, US-China deal drama, and much more.
Welcome back to Last Week Tonight in BioPharma (LWTB). What a week!
Pfizer sees another of its Seagen ADCs stumble, the first CAR-T for solid tumors wins approval, Trump might be on retatrutride, and the US-China deals drama reaches new heights.
All that and much more below!
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I recently discussed three interesting cell therapy readouts from ASCO 2026 that demonstrate notable progress and the field, but also how these treatments can succeed commercially with the right strategy.
You can check that out by following the link below:
Cell Therapy is Making Progress Against Solid Tumors — But is Anyone Noticing?
Traditional autologous ex vivo cell therapy has largely fallen out of favor. Attention (and dollars) are far more focused on in vivo approaches that massively condense the cost, speed, and complexity associated with the cell therapy supply chain.
📡 PRESS RELEASE DECODER
What the press releases actually mean
Pfizer’s Seagen-acquired ADC misses Phase 3 OS in 2L+ non-squamous NSCLC, third Seagen ADC disappointment puts the $43B deal back on trial
📅 June 23 | 🏢 Pfizer ($PFE) | 💊 sigvotatug vedotin (B7-H4 ADC) | 🏷 Phase 3 Failure
Pfizer reported that sigvotatug vedotin failed to significantly improve overall survival versus docetaxel in pretreated nonsquamous non-small-cell lung cancer. It is the third Seagen originated ADC to disappoint following two prior misses, and the first asset from the 2023 Seagen acquisition to read out in a Phase 3 lung setting.
Pfizer paid roughly $43B for Seagen in 2023. The asset was positioned as one of the platform’s lead expansion plays into a post-IO chemotherapy benchmark. The company has not yet disclosed full subgroup data, biomarker stratification, or whether it will pursue a confirmatory analysis or label-friendly subset.
Biopharma Dive and Fierce Biotech both note this is the first new ADC from the Seagen acquisition to read out in Phase 3, with the prior two misses coming from legacy Seagen-stage programs.
🧠 BPS Take: The gut reaction here may be that this makes the $43B Seagen deal look even worse. I agree with that to some extent. None of Seagen assets have amounted to much on Pfizer’s topline, perhaps save for Padcev. Unless there is some home run asset living within the ADC pipeline that we don’t know about, the Seagen acquisition continues to look like an “all-in” bet that won’t pay off. We do need to caveat this NSCLC readout a bit though. This was in 2L+ NSCLC in patients without actionable genomic alterations. This has historically been an absolute graveyard for randomized studies. The TROP2 ADCs most recently failed to beat chemotherapy in this setting. Once patients fail PD-1 based regimens in 1L NSCLC, nothing has seemed to work. Most companies with novel assets in NSCLC don’t even look to develop in 2L anymore, opting to just go straight to 1L in combination with PD-1 instead. So given the high bar here, this asset may still have some potential in 1L NSCLC. We’ll just have to wait and see.
FDA Reopens AdComm Path for Previously-Rejected Replimune RP1 and Capricor Deramiocel, Reverses Regenxbio Navsunli CRL — The New CBER/CDER Are Revisiting Makary-Prasad-Era Decisions
📅 June 22 to June 26 | 🏢 FDA / Replimune ($REPL) / Capricor Therapeutics ($CAPR) / Regenxbio ($RGNX) | 💊 RP1 + nivolumab (melanoma), deramiocel (DMD cardiomyopathy), Navsunli / RGX-121 (Hunter syndrome / MPS II) | 🏷 Regulatory Reversals (Bundle)
Three regulatory decisions originally made under former Commissioner Marty Makary and former CBER Director Vinay Prasad got revisited in a single week. On June 26, the FDA accepted Replimune's third BLA resubmission for RP1 in combination with nivolumab for advanced melanoma as a complete class 1 response with an August 2, 2026 goal date, and notified the company to expect an Advisory Committee meeting in late July — the first AdComm in RP1's regulatory history after two prior rejections. On June 23, the FDA reversed its earlier position on Capricor's deramiocel BLA in DMD cardiomyopathy, scheduling an AdComm for July 29, 2026 after initially telling the company "an Advisory Committee meeting is not indicated at this time." And in late June, Regenxbio announced alignment with the FDA on the path forward for Navsunli (RGX-121), the AAV9 gene therapy for Hunter syndrome / MPS II, following the February 7, 2026 Complete Response Letter. A Type A meeting is expected in July with BLA resubmission planned for Q3 2026 using existing data.
🧠 BPS Take: This is not a broad regulatory tide lifting every cell and gene therapy program. It is the new CBER and CDER leadership working to rewind a backlog of decisions from the previous regime that were politically unpopular. Replimune’s RP1 AdComm is the FDA saying the rejection should have gone to public review the first time, not that oncolytic virus programs broadly have a clearer path. Capricor’s deramiocel AdComm is the same dynamic in DMD cardiomyopathy. Regenxbio’s CRL reversal is the FDA acknowledging the resubmission can proceed on existing data. Perhaps the string that ties all of this together is a reversion back to a more normal understanding of unmet need and a more liberal use of AdComs as a regulatory tool. All of this is occurring under the leadership of an interim commissioner. There is no guarantee that a new leader won’t exact their own personally-motivated agenda, but what has been clear from the Makary-Prasad era is that the FDA has received an outsized amount of mainstream media attention for the wrong reasons. Whoever the new permanent leader is would likely be someone who stays under the radar.
China NMPA Approves CARsgen’s Satri-cel as World’s First CAR-T for Solid Tumors — Claudin18.2+ Gastric/GEJ Cancer
📅 June 22, 2026 | 🏢 CARsgen Therapeutics ($CARS.HK / 2171.HK) | 💊 satricabtagene autoleucel (satri-cel, CT041) | 🏷 Regulatory Approval / Cell Therapy / Solid Tumors
China’s NMPA approved satri-cel, an autologous Claudin18.2-directed CAR-T, for adults with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma who have failed ≥2 prior lines. This is the first CAR-T globally to win approval in a solid tumor.
Pivotal data (CT041-ST-01, Phase 2): Median PFS 3.25 mo vs 1.77 mo for physician’s choice chemo; median OS 7.92 mo vs 5.49 mo. CARsgen pairs the cell product with a preconditioning regimen of low-dose nab-paclitaxel layered on top of standard lymphodepletion. Pricing is set at ~¥990,000 (~$146,000), and the product is on China’s new Commercial Health Insurance Innovative Drug List. Satri-cel also holds U.S. FDA RMAT designation in the same indication. Phase 1 work in pancreatic cancer is ongoing.
🧠 BPS Take: CAR-Ts have finally made it into solid tumors, which is a tremendous achievement for the class writ-large, even if this approval is restricted to China. Would this translate to the US/EU markets though? The magnitude of efficacy here is modest, with roughly 2-month improvement in PFS and OS. With the caveat that this was an entirely Chinese population, you have to ask yourself whether that level of benefit would drive commercial uptake in the US/EU if data were recapitulated here. The $150K price tag is amazingly cheap for an auto CAR-T and illustrates the COGS chasm between China and the West. There is almost no way that a US version would be priced that way. Still, this biomarker-defined slice (Claudin18.2+, HER2-) might be the right approach needed to make this sort of drug successful outside of China too. Perhaps not in end-stage gastric cancer, which is a relatively small population in the US to begin with before considering fitness for CAR-T, but moving it up into 2L+ setting vs. SoC. The target is clearly active, with zolbetuximab already approved in the 1L setting as well, so if Carsgen or other CAR-Ts advancing the same approach can find the right target patient population, perhaps there is a shot at an approvable and commercially viable product profile here in the west.
🌐 CONNECTING THE DOTS
When the outside world meets biopharma
STAT report sparks speculation that President Trump received compassionate use access to Lilly’s retatrutide; White House denies, but the political optics test for the GLP-1 category just arrived
📅 June 23 | 🏢 Eli Lilly ( LLY 0.00%↑ ) / FDA / White House | 💊 retatrutide (LY3437943, GIP/GLP-1/glucagon triple agonist) | 🏷 Compassionate Use / Policy / Mainstream Crossover
On June 23, STAT News reported that Eli Lilly and the FDA granted compassionate use access to retatrutide, Lilly’s investigational triple agonist for obesity, to a 79-year-old male patient with refractory obesity, obstructive sleep apnea, and pulmonary hypertension. The request was submitted in April 2026 by Ranganath Muniyappa, a senior clinician at the National Institutes of Health. The patient reportedly had taken Zepbound (tirzepatide) for approximately one year without sufficient weight loss response.
The patient’s age (79 at time of application, now 80), the political connectivity implied by an NIH senior clinician routing the request, and the timing prompted widespread speculation that the recipient was President Trump, who turned 80 on June 14. The White House issued sharp denials through senior deputy press secretary Kush Desai and communications director Steven Cheung, both publicly attacking the STAT reporter on X. The White House and HHS did not respond to STAT’s pre-publication inquiries asking directly whether the president was the recipient.
Trump’s most recent physical reported his weight at 238 pounds, up 14 pounds from April 2025, approaching the BMI threshold for clinical obesity. He has previously told the New York Times he “probably” should take weight loss medication. Retatrutide remains investigational, with TRIUMPH-1 Phase 3 data showing 28.3% mean weight loss at 80 weeks. Lilly is preparing a regulatory submission with PDUFA timing not yet disclosed.
🧠 BPS Take: The mainstream framing is “is Trump on a secret weight loss drug and got special treatment.” The biotech-relevant insight is that the most potent obesity drug in clinical development may be stuck with potentially radioactive political baggage that Lilly has little ability to dump.
Compassionate use approvals for obesity drugs are extraordinarily rare. The FDA’s expanded access program was designed for life-threatening illness without alternatives, and obesity has historically not cleared that bar even for severe phenotypes. That an NIH senior clinician routed a compassionate use request for an investigational obesity drug, that Lilly accepted it, and that the FDA approved it tells you the regulatory framework around what counts as “life-threatening” obesity is being stretched in real time. Pulmonary hypertension and severe sleep apnea give the case its clinical justification, but the precedent matters.
How does this affect Lilly’s corporate reputation ahead of retatrutide’s filing? If the speculation continues to dominate health-adjacent news cycles, Lilly faces a problem they cannot solve through normal regulatory communications. This starts to fit more into the “crisis PR” bucket. But if not, it leaves Lilly in an awkward position, having to navigate some hairy questions about special treatment, Trump, and quid pro quo. Maybe the patient is the president, in which case Lilly will have to navigate the appearance of preferential access to an unapproved drug for the executive who controls the regulator approving it. Or maybe the patient is someone else with similar political proximity (a member of Congress, a senior official, a family member), in which case the same optics apply at a smaller scale. Or maybe the patient is a genuinely anonymous private citizen with no political connection, in which case Lilly cannot say so without violating patient privacy, leaving the speculation to compound.
As is the case with most things Trump-related, the news cycles shifts so quickly, so the general public may not even care about this story since there will be another crazy story about Trump the following week to take its place, so most likely Lilly is in the clear on this.
BINSA Adds Biotech to Outbound Investment Restrictions, Serapha/YolTech Launch Tests the Limits Days Later — The China Biotech Debate Has a Concrete Test Case
📅 June 2 / June 23 | 🏢 House Select Committee on China / RA Capital / RTW Investments / YolTech Therapeutics / Beam Therapeutics ( BEAM 0.00%↑ ) / Boundless Bio ( BOLD 0.00%↑) | 💊 Biotech Investment National Security Act (BINSA) | SERP-01 (base editing for AATD) | 🏷 Policy + Reverse Merger / Series A
On June 2, Reps. John Moolenaar (R-MI) and Debbie Dingell (D-MI) introduced the Biotech Investment National Security Act (BINSA), a bipartisan bill that would add biotechnology to the COINS Act's outbound investment scrutiny framework. The bill targets licensing, joint ventures, and equity investments that could transfer pharmaceutical IP or manufacturing know-how to China-directed entities, with Treasury required to issue rules within one year.
BINSA followed two megadeals that became the symbolic triggers: BMS's $15.2B alliance with Hengrui Pharma and Pfizer's $10.5B Innovent collaboration. Roughly 100 U.S.-China biotech licensing deals have been announced since the start of 2025, with cross-border transaction value reaching ~$136B in 2025 alone, up from less than $5B in 2020.
Three weeks later, the debate got its test case. On June 23, RA Capital and RTW Investments announced a $230M Series A and reverse merger to launch Serapha Bio, built around SERP-01, an in vivo base editing program licensed from China-based YolTech Therapeutics. SERP-01 targets the same SERPINA1 E342K mutation as Beam Therapeutics' BEAM-302, using a comparable lipid-nanoparticle approach. YolTech retains China rights, a minority equity stake, and over $2B in milestone eligibility. Boundless Bio is dissolving its ecDNA cancer program and ceding 96.3% of the combined entity to Serapha. Boundless shares jumped 87% on the announcement. Beam-focused investors framed Serapha as a Chinese copycat of BEAM-302 underwritten by U.S. VC capital. RA Capital's Peter Kolchinsky pushed back in "The paradox of biotech protectionism," arguing that walling off China biotech weakens U.S. competitiveness.
🧠 BPS Take: BINSA's odds of passage on its own are low given how few bills this Congress has enacted and the looming November elections. The realistic path is folding it into a year-end spending package or defense authorization bill, which is exactly how BIOSECURE moved. There is enough anti-China momentum in Congress for companies with active China deals to plan as though some version of BINSA becomes law in 2027.
Serapha exposes how hard the policy is to operationalize. SERP-01 was developed in China but will be developed and commercialized in the U.S. by a U.S. company employing U.S. scientists. It's not even the first deal of its kind. Atlas Venture and Bain used the same playbook to build Aiolos Bio around a Hengrui-licensed asset, sold it to GSK for $1B, then repeated it with Kailera Therapeutics, which delivered one of 2026's largest biotech IPOs. The "U.S. company or Chinese company" question doesn't have a clean answer, and that ambiguity is what Kolchinsky's defense leans on. The real nuance lives in the gradient: which deal structures trigger review, at what threshold, with what carve-outs. BINSA's current draft focuses on equity investments and joint ventures with licensing as a softer category, which would arguably permit Serapha's structure as-written.
There is no formal patent infringement allegation against YolTech or Serapha, just speculation from loud voices on Twitter. But the structural parallel — same target mutation, same delivery format, same class of editing — is the kind of fact pattern that could trigger a more formal legal offensive. YolTech's leadership also includes Zi Jun Emma Wang, who previously worked at Beam, a detail that was publicly visible on YolTech's site until recently.
Ultimately, China isn't going anywhere. In a decade it could be another country that emerges as the next arbitrage opportunity. Big Pharma will always partner with what they feel are the best drugs at the best values, and we can't look to VCs to distribute capital with a "patriotism-first" mentality. Their business is generating returns for their LPs, and they'll go wherever the value creation is ripest. We need right-sized regulation that levels the playing field, but that won't matter if the U.S. doesn't fix the underlying reason these deals are attractive: it is faster and cheaper to generate Phase 1 human data in China than in the U.S. HHS has proposed a streamlining package with clearer pre-IND data requirements, flexible trial protocols, and a rolling FDA submission platform. The question is whether those proposals translate into timeline and cost reductions that actually shrink the arbitrage.
💰 FOLLOW THE MONEY
Deals, dollars, and what they signal
Lilly Joins $100M Absci Public Offering Alongside Five Other Institutional Investors — ABS-201 Hair Loss Asset Gets Strategic Capital
📅 June 24 | 🏢 Eli Lilly ($LLY) / Absci ($ABSI) | 💊 ABS-201 (anti-PRLR monoclonal antibody for androgenetic alopecia and endometriosis) | 🏷 Strategic Equity Investment (Public Offering)
On June 24, Absci ($ABSI) priced a $100M underwritten public offering of 13.5M shares at $7.41 per share with participation from Eli Lilly ($LLY), Adage, BVF Partners, Columbia Threadneedle, Invus, Redmile, and an additional large investment management firm. The offering closed on June 25. The structure is an underwritten public offering of common stock, not a strategic partnership, and Lilly is participating as one of several institutional buyers rather than as a sole strategic investor with negotiated rights.
Proceeds will fund advancement of ABS-201, Absci’s AI-designed anti-PRLR antibody, across androgenetic alopecia (pattern hair loss) and endometriosis. ABS-201 reported positive interim Phase 1 data from the HEADLINE trial earlier in June, with the asset positioned as a novel mechanism (prolactin receptor antagonism) versus the incumbent androgen-pathway treatments (finasteride, dutasteride) and the topical vasodilator standard (minoxidil). Absci stock surged on the financing announcement.
🧠 BPS Take: This is not a strategic partnership and should not be read as one. I’ve seen a lot of articles and takes pop up talking about this as though Lilly is moving heavily into hair loss or that this is setting up for them to eventually acquire Absci. That is a pretty big stretch in my opinion. Lilly is one of seven institutional buyers in a public offering, participating at the same $7.41 per share as everyone else in the syndicate, getting straight equity and nothing else. This feels more like Lilly’s corp dev arm staying close to an interesting small-cap doing something outside Lilly’s existing therapeutic footprint.
But if we are going to speculate a little bit, let me throw one interesting scenario at you. Lilly has been building LillyDirect as a cash-pay direct-to-consumer channel for Foundayo and Zepbound, and the telehealth players who serve as the actual front door for those drugs — Hims, Hers, Ro — also sell hair loss and sexual wellness treatments as their core verticals alongside GLP-1s. What if Lilly decides to integrate that front door one day? As Lilly’s portfolio of cash-pay-appropriate medicines expands beyond GLP-1s — hair loss with ABS-201 or similar in 2028-2030, sexual dysfunction, and other lifestyle-adjacent indications as employer plans push them out of insurance coverage — the strategic value of owning the full channel your self compounds. At some point, the math may tip and building or acquiring the front door becomes the obviously correct move rather than a speculative bet.
The other piece of the calculus that gets underweighted in telehealth coverage is the leverage asymmetry. Hims, Hers, and Ro built their growth primarily on compounded GLP-1s during the shortage window. As FDA enforcement on 503A and 503B compounding tightens, that revenue stream is structurally vulnerable. The telehealth players have shifted toward distributing branded Zepbound and Foundayo at no real margin, only to sell wraparound services and membership fees that actually drive their profitability. The asymmetry is in Lilly’s favor. If Lilly decided to restrict distribution arrangements with any specific telehealth player, that player’s business gets restructured overnight. The telehealth players have no equivalent leverage because they do not manufacture the drugs, they do not own the IP, and they cannot substitute. The GLP-1 market is functionally a two-player oligopoly between Lilly and Novo right now, with Lilly leading on growth and the next wave of efficacy via retatrutide. Once the compounding question is fully resolved by the FDA, Lilly’s structural leverage over the telehealth channel is essentially complete.
The Absci $100M is not evidence that this strategy is being executed. It is the kind of capital deployment that keeps the option open as the portfolio expands. ABS-201 is Phase 1 and may or may not be the asset that anchors a future Lilly cash-pay franchise. But the broader pattern — LillyDirect expansion, Foundayo’s cash-pay-first launch in April, equity participation in differentiated cash-pay assets — is consistent with a dominant company that has the strategic flexibility to own the front door (rather than rent it) if they want to.
Novartis pays $105M upfront for Antares’ “undruggable” cancer small molecules, discovery-stage deal with a $1.9B biobuck tail
📅 June 24 | 🏢 Novartis ( NVS 0.00%↑ ), Antares Therapeutics | 💊 Undisclosed small-molecule programs against traditionally “undruggable” oncology targets | 🏷 Licensing / Discovery Deal
Novartis and Antares Therapeutics entered a multi-target research collaboration with $105M upfront and up to $1.8B in milestones plus royalties, roughly $1.9B in headline biobucks per Reuters coverage.
Endpoints reports the lead programs are positioned as first-in-class, and Antares retains rights on some indications.
Fierce Biotech notes the deal sits at the upper end of recent discovery-stage upfront benchmarks.
🧠 BPS Take: As a reminder, Antares is a spinout of Scorpion Therapeutics, which carried over the leftover assets into Antares, after Lilly bought one of the Scorpion assets last year. $105M upfront and up to $1.9B in total value closely mirrors the Regeneron Parabilis numbers from a couple months ago ($125M upfront, up to $2.3B), however the Regeneron upfront contained a $75M equity investment with Parabilis IPO’ing shortly thereafter. Neither company has disclosed what targets they are going after, other than to say they are “historically undruggable”. There are a few major culprits that sit within that group: several targets within the RAS family, MYC, TP53, and WNT/Beta-catenin. I’m curious to see if any targets from these groups make the list and how they differ from Antares’ wholly owned programs that would conceivably make up the bulk of their company valuation.
Back next week with more BioPharma strategy takes! Share this with a friend or colleague if you found it helpful.