Last Week Tonight in BioPharma: Week of July 20, 2026
GSK becomes a commercial player in lung cancer, retatrutide raises concerns about cardiovascular risk, and Novo sues Lilly over its GLP-1 ads.
Welcome back to Last Week Tonight in BioPharma (LWTB). What a week!
This week, GSK cashed its first lung cancer chip from the $10.6B Nuvalent buy with an FDA approval for JIDEYTRO, Eli Lilly posts more pivotal retatrutide data but people are freaking out about the cardiovascular signal, and Novo Nordisk took Lilly to federal court over what it calls deceptive GLP-1 advertising.
All that and more below. Let’s get into it!
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Will That Be Cash or Credit?
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📡 PRESS RELEASE DECODER
What the press releases actually mean
GSK Gets Its First Lung Cancer Approval. The $10.6B Nuvalent Bet Just Started Paying Off.
📅 July 22, 2026 | 🏢 GSK ( GSK 0.00%↑ ) | 💊 JIDEYTRO (zidesamtinib) | 📋 FDA Approval
The FDA approved JIDEYTRO (zidesamtinib) on July 22, 2026 for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have previously received a ROS1 kinase inhibitor. The approval is based on the ARROS-1 Phase 1/2 trial, which enrolled 117 patients and showed an objective response rate of 44% (95% CI: 34-53%), with duration of response rates of 82% at six months and 69% at twelve months.
This is GSK’s first approved medicine in lung cancer, and it comes directly from the Nuvalent, Inc. portfolio acquired through GSK’s $10.6 billion acquisition announced in June. The label is specifically for patients who have already progressed on a prior ROS1 inhibitor, which positions JIDEYTRO in a second-line-plus setting against drugs like crizotinib and lorlatinib that patients would typically receive first.
The approval was granted under Commisioner’s National Priority Review voucher (CNPV) framework and came in two-months faster than expected.
🧠 BPS Take: There was little doubt that this drug would get approved, which is a big reason why GSK forked over nearly $11B for Nuvalent. This initial approval is a first step in GSK’s commercial foray into NSCLC and will lay the groundwork for anticipated approvals of neladalkib (NVL-655) for patients with ALK-altered NSCLC, which is currently under FDA review with a target decision date of November 27th. ROS1 mutated NSCLC is a relatively small market, but early commercial experience enables physicians to get experience with JIDEYTRO ahead of 1L data readouts. It also helps GSK build relationships with lung cancer docs who would be prescribers of neladalkib in the much larger ALK+ NSCLC setting. Nuvalent was GSK’s largest acquisition ever and the approval of JIDEYTRO is the starting gun for the hard part of late stage acquisitions — ramping up the sales of the drug you just bought to meet all the revenue projections that went into your deal model.
Lilly Closes Out the TRIUMPH Program: 21% Weight Loss in Diabetes, 23% in Cardiovascular Disease, and a Q1 2027 BLA on the Calendar
📅 July 23, 2026 | 🏢 Eli Lilly ( LLY 0.00%↑ ) | 💊 retatrutide (LY3437943) | 📋 Phase 3 Topline Data (TRIUMPH-2 + TRIUMPH-3) + BLA Filing Timeline
Eli Lilly announced on July 23, 2026, positive topline results from TRIUMPH-2 and TRIUMPH-3, two additional Phase 3 trials completing the TRIUMPH program for retatrutide. In TRIUMPH-2, adults with obesity or overweight and type 2 diabetes lost an average of 49.6 lbs (20.8%) at 80 weeks on the highest dose. In TRIUMPH-3, adults with severe obesity and established cardiovascular disease lost an average of 55.8 lbs (22.6%) at 80 weeks. Both trials met their primary endpoints.
These results complement the TRIUMPH-1 data released in May, where an all-comers obesity population achieved 30.3% weight loss at 104 weeks. The diabetic population (TRIUMPH-2) shows a weight loss ceiling that is lower than the all-comers number, which is consistent with what tirzepatide showed across its own program. The cardiovascular disease population (TRIUMPH-3) at 22.6% is competitive with what semaglutide showed in its SELECT trial population.
Notably in TRIUMPH-3 retatrutide showed a potentially negative cardiovascular signal when compared to placebo. There were 27 MACE-3 (cardiovascular death, heart attack, or stroke) events in participants randomized to retatrutide and 23 in those randomized to placebo, resulting in a hazard ratio of 1.12 (95.0% CI: 0.64 to 1.96). The study was not adequately powered to detect cardiovascular outcomes though.
Lilly plans to submit a Biologics License Application to the FDA in Q1 2027
🧠 BPS Take: The BLA designation instead of NDA is noteworthy here, as it would classify retatrutide as a biologic instead of a small molecule. This makes it eligible for more favorable exclusivity baseline before biosimilars can enter the market (12-years for biologics vs. 5-years for small molecule). If Lilly is able to pull this off it would also prevent compounders from being able to sell retatrutide whenever it launches, protecting it from the back-and-forth battle Lilly and Novo had with compounding pharmacies that marketed semaglutide and tirzepatide through tele-health channels. This is because under federal law, biological products approved under a BLA are entirely excluded from the statutory compounding exemptions that allow small-molecule chemical drugs to be duplicated during supply shortages.
The MACE signal here isn’t what you would like to see. Mechanistically GLP-1 and Glucagon agonism tend to increase resting heart rate. In a patient population that is already at higher CV risk, that doesn’t sound too great. However, I’ve seen way too many people get spun up about this as a definitive negative on retatrutide’s profile. Everyone in that camp needs to drink a can of “settle down juice”. Let’s remember this study wasn’t looking to measure CV outcomes. It looked at a few hundred patients over a short 80-week period. Even then, there was roughly 50 events that cropped up. One or two events swinging the other way and this would not be a story at all. CV outcomes trials are incredibly desired and prized for a reason. They are huge (often 10K patients) and are long, because it takes a while for sufficient number of cardiac events to accumulate in order to see a definitive signal. Semaglutide and other GLP-1s had similar stories where weight-loss focused studies showed neutral or numerically worse CV benefits, but when put to the true test in a CV outcomes study, they passed with flying colors. I am willing to bet the overwhelming weight loss patients are achieving with retatrutide will meaningfully outweigh any on-target heart rate increase and show a similar positive cardiac outcomes benefit as its predecessor GLP-1s have.
Vertex Was the Only Real Bidder for Crinetics
📅 August 4, 2026 (proxy filed) 🏢 Vertex ( VRTX 0.00%↑ ) acquiring Crinetics 💰 $85/share cash, ~$10B equity, 102% premium 📄 Proxy reveals Vertex was sole serious bidder; six other counterparties passed or capped at <$6B
The Crinetics proxy walks through the full deal timeline. Vertex first approached Crinetics on March 14 following a JPM26 meeting, submitted an initial $78/share bid on March 24 (rejected), and revised to $83 on April 19 (also rejected). Crinetics’s board, advised by Leerink and J.P. Morgan, canvassed six other potential acquirers. Three declined to engage, “Party A” concluded it could not exceed $6B and dropped out, and the final two also passed. Vertex moved to $84.50 on May 28, then landed at $85 on June 19 as its best-and-final. The board tried for $86 and got told no. Deal signed July 6.
🧠 BPS Take: One way to read this is that Vertex was bidding against itself, and Crinetics’ board did a good job extracting as much value as they could from Vertex, walking them up from $78 to $85 over three months.
Frankly, I am not that surprised that after the bank canvassed six other potential acquirers, none of them appeared all that interested. Pretty much all the other big acquirers aren’t in this rare-endocrine space and haven’t shown much attention towards it as of late. Crinetics also wasn’t some sexy buyout target prior to Vertex. To me, the play-by-play confirms that Vertex had deep conviction early on on the strategic fit of Crinetics and was committed to getting a deal done. The bank probably softly floated the opportunity out to other buyers to build leverage, but I doubt any found the same level of strategic fit or did the same depth of diligence as Vertex did. Vertex has nicely spread its bets across several relatively lower competition segments that (save for pain) command premium pricing — they’ve set themselves up to mostly play in spaces where the other big acquirers are largely absent. I really like that strategy for them.
These play-by-play proxy statements come out and everyone likes to overreact to the premiums when there was soft or little interest from other buyers. As we’ve discussed on BPS many times, none of that matters all that much in the grand scheme of things. The success or failure of this deal will depend on how well Vertex can commercialize these Crinetics assets — that’s the bulk of it. We’re not at the car lot haggling on the price of a used car, you know? We can Monday morning quarterback the premium all day if we wanted. But it really sounds like Crinetics was willing to go it alone, probably didn’t view themselves as a major takeout target, and when Vertex came along it forced them to think long and hard about what their takeout price should be. Just because you aren’t bidding against other buyers doesn’t mean your premium should immediately be lower. Maybe the seller never saw themselves selling until now.
🌐 CONNECTING THE DOTS
When the outside world meets biopharma
Novo Nordisk Takes Eli Lilly to Federal Court Over GLP-1 Ads
📅 July 21, 2026 | 🏢 Novo Nordisk ($NVO) vs. Eli Lilly ($LLY) | 💊 WEGOVY (semaglutide) vs. ZEPBOUND (tirzepatide) | 📋 Federal Lawsuit / Commercial Rivalry
Novo Nordisk filed suit against Eli Lilly in New Jersey District Court on July 21, 2026, alleging that Lilly has been running a nationwide pattern of deceptive advertising by comparing the highest doses of ZEPBOUND and MOUNJARO with lower doses of WEGOVY and OZEMPIC in commercial campaigns that ran during major sporting broadcasts and on TikTok and Facebook. John Kuckelman, Novo’s group general counsel, stated in an interview: “What has brought us to this moment is what we now see as a nationwide pattern, by Lilly, of deceptive advertising. They are intentionally confusing consumers.”
Novo brought its higher-dose 7.2 mg semaglutide to market in March 2026, achieving approximately 19% weight loss in clinical testing, but there has been no head-to-head trial comparing the highest dose of WEGOVY against ZEPBOUND. Lilly argues it is using results from the Surmount-5 head-to-head trial, which compared a lower dose of WEGOVY against ZEPBOUND and found 47% lower relative weight loss for the Novo product. Novo’s position is that those comparisons are now outdated given the availability of the higher-dose semaglutide. Novo is seeking a permanent injunction to pull the ads and require a corrective advertising campaign.
🧠 BPS Take: This lawsuit has some potentially damning reverberations for the sector if it goes Novo’s way. Novo is basically saying that Lilly needs to compare ZEPBOUND to high-dose WEGOVY, because that is where Novo’s data looks best now. This is despite the fact that there is no randomized study comparing ZEPBOUND to high-dose WEGOVY. So functionally, Novo is arguing that a cross-trial comparison is appropriate here, rather than the gold-standard in-trial comparison Lilly already did.
I am not a lawyer, but I think if Novo wins it sets a dangerous precedent. To be fair, Novo's legal angle isn't that SURMOUNT-5 is invalid, but that Lilly’s DTC ads obscure the dose details, making true data potentially deceptive under advertising law. The most likely outcome here is Lilly needing to use more specific language in its ads that more clearly and directly specify the WEGOVY dose ZEPBOUND was superior to.
Still, any company could “sue away” a competitor’s valid head-to-head study victory (for marketing purposes) if their drug later comes out with a higher dose that looks better. Taking that one step further, any company could “sue away” a competitor’s study data if their drug perhaps underperformed in that specific matchup relative to its historical best standalone readout. We already don’t see a ton of head-to-head studies between branded competitors due to the inherent commercial risk. This meaningfully diminishes the value of taking a head-to-head trial risk overall, other than if it is demanded by regulators for approval.
FDA AdCom Backs Six of Seven Compounded Peptides
📅 July 23–24, 2026 🏢 FDA Pharmacy Compounding Advisory Committee; HHS Secretary Robert F. Kennedy Jr. 📄 Six of seven peptides recommended for the 503A Bulks List (BPC-157, MOTS-c, KPV, TB-500, Epitalon, Semax); Emideltide voted down
The Compounding AdCom recommended six of seven peptides for the 503A Bulks List, opening a legal pathway for compounding pharmacies once rule-making completes. None have completed the human trials required for drug approval. FDA staff scientists recommended no votes across the board, citing absent human data, cancer and immune safety signals, and inconsistent chemical definitions. Eight new committee members were appointed pre-meeting, most with peptide industry ties.
🧠 BPS Take: Formalizing a compounding pathway for a gray-market problem is defensible. Right now there are thousands of people taking these peptides for various reasons from shady sources. My issue with all this is that the process to get here was so obviously hyper-political and not science-based. Using an AdCom stacked with peptide-industry members to grease the eventual legalization of these largely untested peptides just isn’t in the best interest of human health. Let’s run actual high quality studies and learn what these compounds do (good an bad) before making them easier to access.
GLP-1 compounders are a big winner from all this. As their ability to sell compounded GLP-1s diminish, a new opportunity to market peptides like BPC-157, TB-500, and MOTS-c for a number of largely unvalidated health benefits seems to be opening up. This is worse in a lot of ways than compounded GLP-1s. At least compounded GLP-1s had a reference product with legitimate clinical data. I worry that eventual misuse of these other peptides will lead to a lot of unfortunate and unforeseeable complications.
💰 FOLLOW THE MONEY
Deals, dollars, and what they signal
Sanofi Walks Away From Amlitelimab in Atopic Dermatitis. A Drug Once Billed as a Future Blockbuster Gets Quietly Shelved Under New Leadership.
📅 July 24, 2026 | 🏢 Sanofi ($SNY) | 💊 amlitelimab | 📋 Development Discontinuation
Sanofi announced on July 24, 2026, that it is discontinuing clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis. The decision was made as part of an ongoing strategic assessment of the pipeline and will not include any submission for global regulatory review. The company stated that while the ESTUARY Phase 3 long-term extension study showed maintenance of clinical response and an emerging safety profile, amlitelimab “would not represent a meaningful improvement to the standard of care for patients with AD.” A Phase 2 study of amlitelimab in celiac disease remains ongoing and is expected to read out in the second half of 2026.
Amlitelimab was previously positioned by Sanofi as one of its most important pipeline assets in immunology, billed alongside DUPIXENT (dupilumab) as a next generation mechanism targeting OX40L rather than the IL-4/IL-13 pathway. The discontinuation represents a significant de-risking of the Sanofi pipeline narrative in atopic dermatitis, where AbbVie ($ABBV) recently acquired Apogee Therapeutics for $10.9 billion specifically to get ultra-long-acting dosing in the same indication. The decision comes during a broader pipeline review under Sanofi’s recently installed CEO.
🧠 BPS Take: “Would not represent a meaningful improvement to the standard of care” means the drug wasn’t differentiated enough to be of commercial value, plain and simple. I am more curious about how new CEO, Belen Garijo looks to reshape Sanofi’s pipeline. This really feels the like the first in a number of dominoes set to fall. Prior CEO, Paul Hudson, was dead set on making Sanofi a premium player in immunology and reducing dependence on their Regeneron-partnered portfolio. That vision never really came to pass. Is this the first step in a larger pull back for Sanofi across all of immunology or just a scalpel level cut? I would imagine the new CEO will hold a “strategy day” of some sorts in the coming months to paint her vision for the company. The big questions for me beyond how she sees the company’s commitment to immunology being defined is what new areas does she want to get into? Right now vaccines have been Sanofi’s most stable driver outside of its Regeneron-partnered assets, will there be a change in that TA?. I think Sanofi is in for quite a lot of changes over the second half of the year.
Back next week with more BioPharma strategy takes! Share this with a friend or colleague if you found it helpful.
DISCLAIMER: Alright, legal department says I gotta say this: nothing in this post is financial, medical, legal, or any-other-kind-of advice. I’m just a guy on the internet with opinions, a penchant for clinical data, and an unhealthy obsession with BioPharma strategy. All views, opinions, and analyses are solely the work product of me and Big Pharma Sharma LLC — not my employer, clients, friends, associates, or anyone else who has ever been in the same meeting room as me. Do I have opinions on these companies, deals, and drugs? Obviously. Should you trade, invest, prescribe, or make life decisions based on them? Absolutely not. Manage your portfolio however you want, talk to actual licensed professionals, and please don’t hold me — or anyone adjacent to me — accountable when biotech does biotech things. You’ve been warned.