Top Story Today
The $10 Million Drug That Just Humbled a Pharma Giant
Celcuity, a Minneapolis clinical-stage biotechnology company that paid $10 million for a shelved Pfizer compound in 2021, just beat Novartis's Piqray in a head-to-head Phase 3 trial for advanced breast cancer. Gedatolisib delivered statistically significant improvements in progression-free survival across two different drug combinations, both with better tolerability than Piqray (which forces roughly 25% of patients to discontinue due to severe side effects). The ASCO presentation on June 2 will reveal full data, with an FDA decision date already set for July 17, 2026.
Why it matters: A small biotech winning a direct Phase 3 comparison against a marketed pharma drug is exceptionally rare, and it could reset the standard of care for HR+/HER2- breast cancer, the most common subtype affecting roughly 70% of all breast cancer patients.
Read more →Deals & M&A
UCB Drops $2 Billion on a Company That Barely Existed 18 Months Ago
UCB is paying $2.2 billion for Candid Therapeutics, which launched from stealth in September 2024 with 17 employees and zero approved drugs. Candid's T-cell engagers (off-the-shelf biologics that force immune cells to destroy disease-causing B-cells) put UCB on a direct collision course with Gilead in the red-hot autoimmune disease space.
Read more →Clinical & Regulatory
One CRISPR Injection, 87% Fewer Attacks: Gene Editing's Biggest Milestone Yet
Intellia's Phase 3 data showed a single IV dose of its CRISPR therapy reduced hereditary angioedema attacks by 87%, with 62% of patients experiencing zero attacks over six months. If approved (FDA submission is already underway, targeting a 2027 launch), it would be the first systemically delivered in vivo CRISPR gene-editing therapy.
Read more →The White House Went Pro-Psychedelics, and Nobody Saw It Coming
Two months after reportedly blocking a psychedelics company's FDA voucher, the Trump administration signed an executive order calling these drugs "life-saving" and the FDA handed priority review vouchers to three psychedelic developers. The vouchers could compress FDA review from 10 months to approximately 6, with Compass Pathways, Usona Institute, and Transcend Therapeutics all receiving golden tickets.
Read more →