Issue #53·

A pancreatic cancer drug just nearly doubled survival. Oncologists are stunned.

Revolution Medicines dropped Phase 3 data that almost no one thought was possible: a pill that nearly doubled survival in pancreatic cancer, the deadliest major malignancy in oncology. Meanwhile, a two-year-old company you've never heard of just pulled off the biggest biotech IPO in history, and a new report is calling Alzheimer's blockbuster drugs a bust.

Top Story Today

Pancreatic Cancer Just Lost Its Worst Winning Streak in Oncology

Pancreatic cancer has a 3% five-year survival rate once it spreads, and progress is usually measured in weeks. Revolution Medicines just shattered that ceiling: its oral drug daraxonrasib delivered median survival of 13.2 months versus 6.7 months for chemo in previously treated patients, a 60% reduction in the risk of death. The drug attacks KRAS in its active "on" state, hitting the mutation found in roughly 90% of pancreatic cancers. Reports now place Merck in acquisition talks at $28 to $32 billion, with full data headed to ASCO in May.

Why it matters: A near-doubling of survival in oncology's deadliest major cancer is the kind of result that rewrites treatment guidelines. With three Phase 3 programs running and Merck circling, this could become the most consequential oncology deal of the year.

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Clinical and Regulatory

The First-Ever Approved Drug for a Kidney Disease With Zero Options

For decades, FSGS patients had no approved treatments. Travere's Filspari just changed that, earning full FDA approval for patients aged 8 and older. The Phase 3 trial showed significant proteinuria reduction versus standard care, and remission meant only 3% progressed to kidney failure (compared to 11.2% without it). Travere's stock surged 33%, and analysts see $2 billion in potential sales.

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A $6 Billion Market Built on Drugs That Might Not Actually Work

A sweeping new review of anti-amyloid Alzheimer's drugs concluded their benefits are "too small to notice," despite billions in sales projections. Lecanemab's real-world advantage over placebo? About half a point on an 18-point cognitive scale. The Alzheimer's Association fired back, but the UK already rejected NHS funding for both major drugs. The amyloid hypothesis, which has dominated research funding for decades, is facing its loudest critics yet.

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The FDA Just Drained the Moat Around a $2 Billion Device Market

Non-invasive bone growth stimulators have been locked behind the FDA's toughest approval process since 1979. The agency just reclassified them to Class II, slashing the regulatory barrier that protected incumbents for nearly 50 years. Expect more competitors, lower prices, and a market shakeup starting May 18.

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Deals and Launches

Bristol Myers Squibb Handed Five Drugs to a Startup. Meet Beeline Medicines.

Beeline Medicines launched with $300 million and five autoimmune drug programs spun out of BMS, including a lupus candidate with FDA fast track designation. BMS kept nearly 20% equity, making this less of a breakup and more of a strategic outsourcing bet. Phase 2 lupus data is expected by late 2026.

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Aligos Sold China Rights to Its Hepatitis B Drug for Up to $445 Million

With a market cap under $50 million and cash running low, Aligos licensed its hepatitis B drug's Greater China rights to Amoytop for $25 million upfront and up to $445 million total. China has approximately 75 million chronic HBV patients, but Aligos keeps the U.S., Europe, and Japan. Shares jumped approximately 10%.

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J&J Paid $415 Million for This Eye Gene Therapy. MeiraGTx Just Bought It Back for $25 Million.

After a Phase 3 miss sent J&J packing, MeiraGTx reacquired its own gene therapy for X-linked retinitis pigmentosa at a 94% discount. The company believes secondary endpoints tell a stronger story than the headline suggests, and plans to file for approval in the U.S. and EU anyway. A $100 million stock offering funds the push.

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Funding and Financings

The Biggest Biotech IPO Ever Just Bet $625 Million on Your Waistline

Kailera Therapeutics, a two-year-old obesity drug company most people have never heard of, just priced the largest biotech IPO in history. Investor demand was so strong the offering upsized by nearly $100 million. The company has four clinical-stage GLP-1 programs, a CEO whose previous companies were acquired three times, and zero revenue. The obesity gold rush rolls on.

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AKT Inhibitors Keep Breaking Hearts. Terremoto Raised $108 Million to Try Again.

AKT-targeting cancer drugs have a brutal track record, but Terremoto just closed a $108 million Series C (bringing total funding to $358 million) on a bet that isoform-selective chemistry can succeed where brute-force approaches failed. Its lead drug is in Phase 1 for solid tumors.

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A Field That Didn't Exist a Decade Ago Just Dosed Its First Phase 2 Patient

Storm Therapeutics raised $56 million from existing investors (including Pfizer Ventures) and dosed the first patient in a Phase 2 sarcoma trial for STC-15, the most advanced RNA-modifying enzyme inhibitor in clinical testing. The drug targets METTL3, an enzyme that helps cancer cells thrive, and is given as an oral tablet. Phase 1 showed durable tumor regression across multiple sarcoma subtypes.

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