👋 Good morning! Moderna thought it was sliding its mRNA flu shot into priority review. Instead, it got a Refusal to File letter.

The FDA declined to review mRNA-1010, citing concerns about the control arm used in the Phase 3 trial and saying it did not reflect the “best-available standard of care.” Moderna CEO Stéphane Bancel publicly pushed back, noting the design had been discussed with regulators before the trial began. In a rare move, Moderna published the FDA’s letter and requested a meeting to sort it out.

Why it matters: analysts had modeled roughly $750 million in 2028 revenue for the standalone flu shot plus the combo flu-COVID program that relies on the same data package. Those projections are now in limbo. Citi called it a sign of an “evolving regulatory environment.” Translation: the rulebook may not be what it was two years ago.

The vaccine remains under review in Europe, Canada, and Australia. Moderna says guidance is unchanged. But if seasonal respiratory vaccines were part of the road to 2028 cash break-even, that road just got a detour sign.

⚖️ AstraZeneca Faces China Indictment While Pledging $15B Investment
AstraZeneca’s China unit and former country head Leon Wang have been formally indicted over alleged illegal patient data collection and drug importation tied to unpaid taxes of roughly $3.5 million. Two former executives also face medical insurance fraud charges. The investigations date back to 2024 and have already caused operational disruption. Here’s the twist. AZ remains the largest foreign drugmaker in China with $5.5 billion in 2025 sales and just pledged $15 billion in new investment through 2030. Legal headwinds on one side. Massive capital commitment on the other. Welcome to geopolitics in pharma.

💰 Madrigal Drops $60M Upfront in $4.4B MASH siRNA Bet
Fresh off Rezdiffra becoming the first FDA-approved MASH drug, Madrigal is doubling down. The company licensed six preclinical siRNA programs from China’s Ribo Life Science in a deal worth $60 million upfront and up to $4.4 billion in milestones plus royalties. Rezdiffra is already expected to top $1 billion in 2025 sales. Now Madrigal wants combination and next-gen plays that silence genes driving liver disease. The MASH land grab is officially on.

🚀 Evommune Jumps 75% on Eczema Data
Evommune’s IL-18 fusion protein EVO301 delivered a 55% EASI reduction at Week 12 versus 22% for placebo in Phase 2a atopic dermatitis. The stock surged 75% in premarket trading. Analysts say the placebo-adjusted reduction is potentially competitive with Dupixent and Ebglyss. Not bad for a newly public biotech taking its first real swing.

🏗️ Fujifilm Opens £400M UK Biologics Expansion
Fujifilm Biotechnologies unveiled a £400 million (~$546 million) expansion in Teesside, creating the UK’s largest single-use biopharma CDMO facility. The site now boasts up to 19,000 liters of capacity and over 1.6 million square feet across campus. With antibody demand still high and customers seeking flexible manufacturing, Fujifilm is clearly betting that outsourcing is not slowing down anytime soon.

🧬 Merck Pushes Keytruda Into Ovarian Cancer
Thirteen years after its first approval, Keytruda just scored its first FDA nod in platinum-resistant ovarian cancer. The PD-1 giant becomes the first checkpoint inhibitor approved in this indication. Used with paclitaxel with or without Avastin in PD-L1-positive tumors, the label expansion adds yet another revenue stream to the industry’s most decorated immunotherapy franchise.

🤑 Novo Eyes 15M Medicare Patients. The company expects obesity drug coverage to gradually unlock a 15 million patient opportunity later this year.

💊 AstraZeneca Advances Oral GLP-1. Elecoglipron moves to Phase 3 after midstage wins, though weight loss numbers stay under wraps until June.

🛑 NIH Halts Xarelto Stroke Arm. Safety concerns and lack of efficacy shut down the rivaroxaban plus aspirin combo in Phase 3.

📈 Gilead Holds Steady at $29.4B in Revenue. HIV remains the engine with Biktarvy at $14.3 billion and Descovy up 31%.

🔄 CSL CEO Steps Down. Leadership change lands one day before earnings as shares remain under pressure.

🇲🇽 Moderna Expands to Mexico. A five-year pact will localize mRNA vaccine production and tech transfer.

😷 ILiAD Raises $115M. The oversubscribed Series B funds an intranasal whooping cough vaccine aiming for more durable protection.

📊 Incyte Grows Revenue 21%. Jakafi still dominates at $3.1 billion as the company builds out its oncology bench.

Everyone promised AI would discover miracle drugs overnight. What it is actually doing is cutting costs, accelerating workflows, and quietly boosting margins.

Pfizer says AI was the primary lever behind billions in spending reductions across R&D and admin functions. Not layoffs for the sake of optics. Productivity gains. The company is embedding AI across discovery, manufacturing, legal, and commercial teams while adding more than 1,200 GPUs to power the next wave. CFO Dave Denton says Pfizer can now take on more R&D substrate without blowing up the budget. In other words, same dollars, more shots on goal.

Eli Lilly is playing both offense and defense. On one hand, it is investing up to $1 billion with NVIDIA to crack harder drug discovery problems. On the other, it is deploying predictive models today through its TuneLab platform, running molecules through algorithms before they are ever synthesized. Lilly’s message is simple: predict first, experiment second.

Novartis and AstraZeneca are more pragmatic. AI is not magic. It will not spit out a blockbuster tomorrow. But AstraZeneca says AI has made early target validation more than 50% faster, and synthetic control arms are helping fine-tune clinical trial design. Speed and precision add up.

The reality check comes from Bristol Myers and others. The grand promise of AI uncovering entirely new biology is still emerging. There are encouraging data points, including AI-designed molecules hitting late-stage wins. But executives are clear-eyed. The revolution is incremental, not instantaneous.

So if you were expecting Skynet to hand pharma a cure for everything by next quarter, relax. The real AI story in 2026 is operational leverage. Faster design cycles. Smarter trials. Leaner infrastructure. The flash will come later. The cash flow impact is happening now.

That is how many blockbuster drugs AstraZeneca says it will have by 2030 as part of its $80 billion revenue ambition. With more than 100 Phase 3 trials underway and over 20 late-stage readouts coming in 2026, CEO Pascal Soriot calls this an unprecedented catalyst-rich period. Lofty goal. Even loftier pipeline.

Here’s what biotech Redditors are talking about:

💉 Moderna vs. FDA: “So Written Statements Mean Nothing?”
Reddit lit up after the FDA refused to review Moderna’s mRNA flu shot. The dominant tone: disbelief mixed with sarcasm. Commenters joked that you can align with the agency, get agreement in writing, then watch it evaporate after a regime change. Others argued regulators are drifting from science toward politics. The longer-term concern was more strategic: if billions and a decade of R&D can be sidelined despite prior alignment, why invest in U.S. drug development at all? Notably, almost no one in the thread sided with the FDA.

🤦‍♂️ Performance Review Whiplash: Feedback or Cost-Cutting?
One biotech professional asked Reddit whether a sudden negative performance review, after years of positive ones, was a red flag. They claimed their work habits hadn’t changed and flagged what they viewed as factual inaccuracies in the review. The community split into camps. Some suggested it could be a budgeting tactic to avoid raises or bonuses during tighter financial cycles. Others floated political explanations, like rubbing senior leadership the wrong way. A minority offered a harder truth: maybe the feedback wasn’t new… just ignored until it became formal. Consensus: document everything and never treat reviews as purely objective.

😳 Novartis CEO Pay Hits $32.4M. Shares at record highs and strong brand performance pushed compensation up 30%.

📺 FDA Flags Wegovy Ad. Untitled letters cite misleading claims in Novo’s first TV spot for its obesity pill.

✂️ CDC Grants on the Chopping Block. The Trump administration proposes cutting $600 million in public health funding across four Democrat-led states.

💇‍♀️ Pelage Pharma Tries to Regrow More Than Hope
Pelage Pharmaceuticals is targeting hair loss with PP405, a therapy designed to activate dormant follicle stem cells and regrow terminal hairs. Early androgenetic alopecia data sparked investor enthusiasm and online buzz in a market long dominated by minoxidil and finasteride. The company raised $120 million in a Series B and is moving into later-stage trials with recruitment demand already high, positioning itself as a potential self-pay disruptor in a decades-stagnant category.

🩺 February 12, 1404 — Anatomy Goes Public
Italian professor Galeazzo di Santa Sofia performed one of the earliest documented post-mortem autopsies for teaching purposes in Vienna. Students reportedly paid to watch. Long before modern clinical trials, medicine was already pushing to understand the body by looking inside it.

If you’ve ever walked out of a meeting thinking you absolutely crushed it… Only to get an email an hour later from your boss that says, “We need to talk.”

Congratulations. You now understand how Moderna feels.

Phase 3 data in hand. Alignment in writing. Then suddenly? “Yea, that’s not good enough.”

So go ahead… update the slides, reschedule the meeting, and do everything in your power to pretend you’re not annoyed.

That’s all for today. See you Tuesday for the next issue. 👋

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