👋 Good morning! Some start their day off with a cup of coffee, maybe even a pastry. Not Novo Nordisk. The company kicked off its Monday morning filing a lawsuit. To each their own.

The Danish pharma giant is suing Hims & Hers for allegedly mass-marketing compounded, unapproved copies of its new oral Wegovy pill and injectable semaglutide products. Novo wants a permanent ban and damages, accusing the telehealth company of infringing patents and promoting drugs made with what it calls “inauthentic API.”

The drama escalated fast.

Last week, Hims unveiled a compounded semaglutide pill starting at $49 per month, triggering immediate backlash. FDA Commissioner Marty Makary publicly warned the agency would take “swift action” against companies mass-marketing illegal copycats. By Friday, HHS had referred Hims to the DOJ for investigation. Over the weekend, Hims abruptly backed down, saying it would stop offering the semaglutide pill after “constructive conversations.”

Markets picked a side. Hims shares fell nearly 25% Monday morning. Novo climbed roughly 5%.

Novo estimates 1.5 million Americans are currently using compounded GLP-1 drugs. With TrumpRx.gov now steering cash-pay patients toward branded options like Wegovy, this fight is no longer just about patents. It is about who controls the next phase of the GLP-1 gold rush.

And unlike tech, “move fast and break things” hits different when the thing is FDA-regulated medicine.

🧪 Lilly Buys Its Way Into In Vivo CAR-T for $2.4B
Eli Lilly is paying up to $2.4 billion in cash to acquire Orna Therapeutics and its circular RNA platform. The lead asset, ORN-252, is a CD19-targeting in vivo CAR-T candidate described as clinical trial-ready for B cell-driven autoimmune diseases. Orna combines engineered circular RNA with lipid nanoparticles to generate CAR-T cells directly inside the body. Lilly calls it a “broad platform” play aimed at long-term innovation in genetic medicine. Translation: obesity cash is funding next-gen cell therapy bets.

🤖 Takeda Swings $1.7B AI Discovery Deal
Takeda signed a multiyear collaboration with Iambic Therapeutics worth up to $1.7 billion in milestone payments. The deal gives Takeda access to Iambic’s generative AI platform, including NeuralPLexer, to accelerate small molecule design in oncology, GI, and inflammation. It is one of the largest AI drug discovery partnerships to date and blends software plus pipeline. AI hype is cooling in some sectors. In pharma, the checks are still clearing.

💰 Lilly and Innovent Ink $8.5B Biobucks Deal
Lilly is also doubling down in China, committing $350 million upfront to Innovent Biologics in a collaboration that could reach $8.5 billion in milestones. Innovent will advance oncology and immunology programs through Phase 2 before Lilly takes over global development outside China. The two companies have already partnered six times, but this structure signals something bigger: a repeatable cross-border pipeline engine.

💊 TrumpRx Goes Live
The White House officially launched TrumpRx.gov, a government-run portal directing patients to cash-pay options for 40 high-cost branded drugs. Participating companies include AstraZeneca, Lilly, Novo Nordisk, Pfizer, and EMD Serono. The site does not sell drugs directly. It lists prices using GoodRx-style technology and routes patients elsewhere. Roughly 85% of Americans have drug coverage, so the real audience is uninsured or high-deductible patients paying cash anyway.

🤝 CSL Eyes $328M Memo Antibody Pact
CSL signed a collaboration and option agreement with Memo Therapeutics that could total $328 million in biobucks. Memo’s recombinant polyclonal IgG platform uses microfluidic single-cell processing to replicate near-complete human antibody repertoires. CSL can exclusively license resulting products if it exercises its option. The pitch: lab-built polyclonals without relying on plasma donations.

🧬 FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy. The agency cited concerns about trial design, natural history controls, and biomarker endpoints, sending RGX-121 back for more data.

📈 Biogen Posts First Annual Growth Since 2019. Revenue hit $9.9 billion in 2025, up 2%, but the company forecasts a mid-single-digit decline in 2026.

💰 BMS Growth Portfolio Pulls $26.4B. Newer drugs drove 17% sales growth, offsetting a 16% drop in legacy brands like Revlimid and Pomalyst.

😲 Astellas’ Vyloy Sales Jump 426%. The CLDN18.2 cancer drug hit $125 million in Q3 as the company raised its full-year outlook despite a trial setback elsewhere.

🦴 Angitia Raises $130M for Bone Disease Pipeline. The Series D will push three candidates deeper into Phase 2 and 3 trials, including a BMP-6 therapy for spinal fusion.

🏭 Epinephrine Gets a Domestic Supply Boost. Fresenius Kabi and Phlow announced the first end-to-end U.S. manufacturing pact for epinephrine injections, targeting hospital supply by 2027.

Last year, biotech IPOs felt like a ghost town. This month, Nasdaq is starting to look busy again… and importantly, not desperate.

Belgium’s Agomab Therapeutics raised $200 million at $16 per share. SpyGlass Pharma followed with a $150 million debut. Eikon Therapeutics upsized its offering to $381 million, making it the largest biotech IPO since 2024. Veradermics priced at $17 and promptly doubled, closing its first day above $37. That kind of first-day pop does not happen in a fragile tape. That is institutional demand stepping back in.

And more are lining up. Flagship-founded Generate:Biomedicines filed to go public, aiming to fund GB-0895, its AI-engineered anti-TSLP antibody in Phase 3 for severe asthma. The pitch is straightforward and investor-friendly: durable six-month dosing, late-stage data, and a commercial path that is easy to model. After two years where preclinical platform stories struggled to clear the bar, late-stage clarity is winning.

But this is not a 2020-style free-for-all. The companies getting rewarded share a few traits: credible Phase 2 or Phase 3 programs, differentiated mechanisms, and real commercial logic. Hair loss with defined endpoints. Oncology programs with validated targets. Fibrosis and inflammation plays with comparables already on the market. Investors are not paying for vibes anymore. They are paying for line-of-sight revenue.

There is also a structural shift happening beneath the surface. Venture capital has been locked up in private biotech rounds for longer than usual, creating pressure to generate liquidity. At the same time, public biotech valuations have stabilized off their 2022–2023 lows, giving crossover investors confidence that downside may be more limited than it was during the rate-hike panic. The result: a narrow but functional IPO window.

Another key difference from the last cycle? Discipline on pricing. Most of these offerings are landing within or slightly above their expected ranges, not 2x above them. Bankers are reading the room. Companies are taking what the market gives them instead of swinging for peak-cycle multiples. That restraint may be exactly what keeps the window open longer.

None of this guarantees a sustained reopening. A few weak post-IPO performances could freeze activity again. But for now, the signal is unmistakable: capital is available for biotech companies that show data, differentiation, and a believable path to commercialization.

After two years of frozen windows, down rounds, and bridge financings, founders finally have an exit path that does not require selling the company outright. The IPO market is not euphoric. It is rational.

And in biotech, rational might be even better.

That is the average cost for Big Pharma to develop a single drug, according to Deloitte’s 2024 analysis. The timeline? Typically 10 to 15 years from discovery to approval.

When people ask why companies defend patents so aggressively, start there.

The GLP-1 lawsuit and AI lab headlines had Reddit busy this week.

😳 Move fast and break things doesn’t really work when the thing you’re breaking is patients. Several commenters compared Hims & Hers to a tech startup wandering into FDA territory like it forgot there are actual guardrails. Some framed the strategy as classic ask-for-forgiveness-later energy. Others blamed regulators for waiting too long to clamp down on compounders in the first place. Consensus: pharma is not SaaS.

🤭 Ginkgo rebrands every 18 months. A separate thread took aim at Ginkgo Bioworks, with skeptics calling it a hype machine and questioning what it actually produces. Supporters point to platform potential and long timelines. Critics call it techbro-meets-biotech. Either way, the debate proves one thing. Narrative still matters in public markets.

🤖 BMS Taps AstraZeneca’s AI Spinout. Bristol Myers Squibb will deploy Evinova’s AI “cost optimizer” across its global clinical portfolio to streamline trial design and cut expenses.

🏈 Novo Debuts at the Super Bowl. The pharma giant aired its first-ever Super Bowl commercial to promote the new Wegovy pill, complete with celebrity cameos.

🍄 Spravato Hits $1.7B Year. J&J’s esketamine nasal spray grew 69% in Q4 as AbbVie hints its own psychedelic candidate could be a “breakthrough type therapy.”

🪵 Äio Ferments Fat From Wood Waste
Estonian startup Äio uses precision fermentation to convert industrial byproducts from wood and dairy production into alternative fats. Its Flavoured Fat mimics traditional cooking fats while using 97% less land and 90% less water than palm oil production. The company says it is 10 times faster to produce and just secured a $1.4 million government grant to scale. Sustainable food tech just got a little richer.

♟️ February 10, 1996 — Deep Blue Wins Game One
IBM’s chess computer defeated world champion Garry Kasparov in the first game of their historic match. It was the first time a reigning champion lost to a machine under standard tournament conditions. Kasparov ultimately won the match, but the signal was clear. The machines were learning fast.

Between Super Bowl pharma ads and GLP-1 legal brawls, Monday may have felt a little intense.

If you called out with the “Super Bowl flu,” we get it. Welcome back. Consider this your official cure.

Side effects may include increased industry awareness, mild IPO optimism, and the sudden urge to read FDA warning letters for fun.

These statements have not, and never will be, evaluated by the FDA. 😎

That’s all for today. See you Thursday for the next issue. ✌️

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