Issue #51·

A senator bet his life on an "undruggable" cancer drug. The data just landed.

A former U.S. senator enrolled in a trial for a drug that scientists said couldn't exist, and Phase 3 results show pancreatic cancer patients living nearly twice as long as those on chemo. Meanwhile, the FDA just sent 2,200 companies a not-so-friendly reminder about their missing trial data.

Top Story Today

A Senator Staked His Life on a Drug That Nearly Doubled Survival in Pancreatic Cancer

Former Senator Ben Sasse enrolled in a Revolution Medicines clinical trial after a stage 4 pancreatic cancer diagnosis, calling it his "best and only option." Days later, Phase 3 data validated the gamble: patients on daraxonrasib lived a median of 13.2 months versus 6.7 on chemo, nearly doubling survival and cutting the risk of death by 60%. The drug works by gluing the notoriously "undruggable" RAS protein to another molecule, blocking the growth signal that drives over 90% of pancreatic cancers. Revolution Medicines' stock surged 41% on the news.

Why it matters: For the first time, a therapy has nearly doubled overall survival in second-line pancreatic cancer, cracking a target that scientists considered impossible to drug. With frontline trials already underway and a high-profile patient bringing public attention, this could reshape treatment of one of oncology's deadliest diseases.

Read more →

Clinical and Regulatory

The FDA Just Told 2,200 Companies to Stop Hiding Their Trial Data

Nearly a third of clinical trials that should have results on ClinicalTrials.gov have reported nothing at all. The FDA contacted over 2,200 companies tied to 3,000 delinquent studies, warning that noncompliance notices (which become permanent public records) are next. No fines have been issued in five years, but the agency now has names, specific trials, and a new appetite for enforcement.

Read more →

Industry Shake-Ups

Astellas Paid $102M for a Stem Cell Bet. Eight Years Later, It's Walking Away.

Astellas is closing its Seattle stem cell unit and cutting 55 jobs, walking away from an acquisition that cost $102.5 million in 2018. The company invested heavily in regenerative medicine but never reached commercial viability. Manufacturing complexity, inconsistent efficacy, and a brutal translation gap from lab to clinic continue to haunt the field.

Read more →

The Schizophrenia App That Raised $50M

Click Therapeutics landed a $50 million Series D from Boehringer Ingelheim. Boehringer handed full commercialization rights back to Click, which must now sell an investigational prescription app for schizophrenia symptoms that has received FDA Breakthrough Device Designation in a category where the last major player, Pear Therapeutics, filed for bankruptcy in 2023.

Read more →

Get tomorrow's biotech intelligence before your competitors.

Join thousands of biotech professionals who start their day with our free, daily briefing.