👋 Good morning! Corcept Therapeutics and the FDA are officially that couple where one person is talking and the other is mentally planning dinner.

According to a newly released complete response letter, the FDA spent months telling Corcept some version of “this is not going to end well.” The agency flagged serious concerns about trial design, missing data, post-hoc gymnastics, and a development program that looked shaky at best. At one point, regulators even warned Corcept to expect “significant review issues” if it submitted its lead rare disease asset, relacorilant for Cushing’s syndrome.

Corcept submitted anyway.

When the FDA rejected it, Corcept’s CEO said the company was “surprised and disappointed.” The market responded with less confusion. The stock fell from $70 at year-end to the high $30s in a matter of weeks. The FDA, meanwhile, calmly documented that the pivotal trial likely overstated efficacy, another Phase 3 failed outright, and the subgroup analysis did not even reach nominal statistical significance.

Call it optimism. Call it confidence. Or call it the biotech equivalent of your spouse saying “are you even listening to me?” while you think to yourself “that’s a weird way to start off a conversation.”

🇨🇳 AstraZeneca Drops $1.2B on China GLP-1s One Day After a $15B China Pledge
The ink was barely dry on AstraZeneca’s $15 billion China investment announcement when the pharma cut another massive check. AstraZeneca is paying $1.2 billion upfront to CSPC Pharmaceuticals for ex-China rights to a once-monthly injectable obesity portfolio spanning eight programs. The deal includes up to $3.5 billion in development milestones and as much as $13.8 billion tied to sales. CSPC keeps China rights, while AstraZeneca doubles down on obesity and its increasingly explicit China strategy.

💸 Roche Pays $200M Upfront to Keep Its RNA Comeback Rolling
Roche is continuing its return to RNA by handing SanegeneBio $200 million for a global license to an RNAi program derived from the biotech’s platform. Sanegene will run early development before Genentech takes over clinical and commercial duties. The deal carries up to $1.5 billion in milestones plus royalties. Quietly, Roche is rebuilding muscle in a modality it once walked away from.

🏭 Lilly Commits $3.5B More to U.S. Manufacturing With Pennsylvania Plant
Eli Lilly unveiled plans for a more than $3.5 billion injectable and device manufacturing facility in Pennsylvania, rounding out its promised quartet of new U.S. plants. The site will support next-generation weight loss drugs including retatrutide and employ roughly 850 people. It is expected to come online in 2031. Lilly’s manufacturing arms race now spans Pennsylvania, Texas, Alabama, and Virginia.

🧪 Formation Bio Adds Another China Asset in a $500M Autoimmune Play
Formation Bio’s new subsidiary Kenmare Bio licensed a miR-124 activator from China’s Chia Tai Feng Hai in a deal worth up to $500 million. Formation gains global rights outside Greater China, while the seller takes equity and milestone upside. The AI-powered biotech is rapidly building a China-to-West pipeline strategy that looks increasingly intentional, not opportunistic.

💰 Lilly Writes $85M Check to Decode Autoimmune Disease
Repertoire Immune Medicines scored its biggest pharma partnership yet with an $85 million upfront deal from Eli Lilly. The collaboration could be worth up to $1.84 billion in milestones as the companies pursue tolerizing therapies designed to reset immune responses without broad suppression. Repertoire leads discovery, Lilly takes over development and commercialization. Big pharma continues to bet on immune system rewiring over brute-force immunosuppression.

🥊 Novo Nordisk’s CagriSema Beats Wegovy in Phase 3 Diabetes Trial
The combo shot delivered greater weight loss and glucose control than Wegovy, sharpening Novo’s rivalry with Lilly as it pushes for approval.

📈 Agomab Targets Up to $212M in a Rare Bright Spot for Biotech IPOs
The Belgian immunology biotech plans a Nasdaq debut valuing the company near $828 million if shares price at the top range.

✌️ Amgen Walks Away From a $400M Autoimmune Bet
Amgen exited its rocatinlimab pact with Kyowa Kirin after extensive Phase 3 trials failed to clarify the drug’s competitive edge.

🇩🇪 Vetter Commits €480M to New German Manufacturing Site
The CDMO plans to bring the facility online by 2031 with backing from European Commission aid and an eye toward 2,000 jobs.

🤝 Moderna Taps Recordati for a $160M Rare Disease mRNA Push
The partners will advance mRNA-3927 for propionic acidemia, with Moderna handling development and Recordati running commercialization.

🧊 Sanofi Puts Its mRNA Flu Vaccine on Ice
The pharma scrapped its Phase 1 program, signaling a broader strategic pullback rather than a one-off pipeline trim.

📉 Quince Stock Craters 90% After Phase 3 Failure
The biotech abandoned its lead program in ataxia-telangiectasia and is now preserving cash and exploring options.

💉 Skye Extends Obesity Study to Salvage 22.3% Weight Loss Data
A failed Phase 2 primary endpoint didn’t stop Skye from showing stronger long-term results in combination with semaglutide.

If biotech had a Super Bowl lineup, 2026 would be the year everyone circled in red ink. According to Evaluate, the 10 most anticipated drug launches of the year could generate a combined $45.9 billion in annual sales by 2032. That blows past Evaluate’s $29 billion figure for last year’s top 10 list.

Leading the charge are two familiar obesity heavyweights. Novo Nordisk’s CagriSema is projected to hit $17.2 billion in annual sales, while Lilly’s oral GLP-1 orforglipron could pull in $11.8 billion on its own. Those two alone match the entire projected total of last year’s top 10. Obesity is not just the headline. It is the whole marquee.

Behind them is a sharp drop-off, but still plenty of blockbuster ambition. The remaining eight launches span oncology, neurology, immunology, and rare disease, each forecast to land between $1.7 billion and $2.5 billion annually by 2032. Names on the list include programs from Gilead, Johnson & Johnson, AstraZeneca, and others chasing everything from breast cancer to essential tremor.

Of course, forecasts do not equal approvals. But Evaluate’s crystal ball has been unusually clear lately. Nine of 2025’s top 10 predicted launches cleared regulators on schedule, with only one late-stage stumble. If that streak holds, 2026 could deliver a flood of approvals that resets revenue expectations across the industry.

The real question is not whether these drugs can sell. It is whether they can survive pricing pressure, competition, and increasingly skeptical regulators long enough to earn those numbers. Big promises are easy. Big launches are harder.

That is the life expectancy gap between Americans in the top 1% and the bottom 50% by income. Hims & Hers cited the stat while teasing its upcoming Super Bowl ad, framing healthcare access as a growing class divide. Big message, big stage, and a reminder that biotech innovation means very different things depending on who can afford it.

😬 This Is Getting Awkward
Trump administration officials are openly clashing over whether COVID vaccines should remain on the U.S. market. ACIP vice chair Robert Malone hinted that if the FDA does not act, “other entities will,” while critics inside and outside government push for faster removals. Vaccine experts warn that sidelining shots could reverse years of progress and cost lives.

🤖 AI Can’t Dissect a Mouse
Reddit lit up after news that the Chan Zuckerberg Initiative is laying off staff while pivoting toward AI-powered biology. Scientists pushed back hard on the idea that algorithms can replace animal models, early validation work, or hands-on experimentation. The consensus was blunt. AI is a tool, not a lab replacement. At least not yet.

💊 TrumpRx Launch Delayed Amid Anti-Kickback Concerns
The White House paused rollout of its direct-to-patient drug marketplace with officials citing unresolved compliance questions.

👁️ Tenpoint Scores FDA Approval for Vision Correcting Eye Drop
Yuvezzi became the first approved combination therapy for age-related near-vision loss as Tenpoint closed an $85M Series B.

🏭 FDA Launches PreCheck to Speed U.S. Drug Manufacturing
The new pilot program launched Feb 1 aims to reduce friction in facility design and encourage domestic production.

🦾 Mendra Launches With $82M to Modernize Rare Disease Drugmaking
Founded by former BioMarin executives, Mendra plans to acquire rare disease assets and use AI to accelerate development, trial enrollment, and commercialization. Backed by OrbiMed, 8VC, and 5AM Ventures, the startup is betting that experience plus smarter tooling can outperform brute-force R&D. Rare disease, but big ambition.

👶 February 3, 1984 — A First in Human Embryo Transfer
Doctors at Harbor UCLA Medical Center announced the first successful birth from an embryo transferred between two women. The milestone helped pave the way for modern assisted reproductive technology and reshaped fertility medicine worldwide.

Next time someone asks if you read the feedback, just remember: Corcept read the FDA’s and hit submit anyway. 😆

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

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