Top Story Today
1,400 Prescriptions, Two Days, and Most Pharmacies Hadn't Even Stocked It Yet
Eli Lilly's Foundayo, a new oral GLP-1 pill approved for obesity, racked up nearly 1,400 prescriptions in its first two days, mostly through a single direct-to-consumer channel before pharmacies even had it on shelves. The pill delivers about 12.4% weight loss, less than injectables like Zepbound (around 20%), but requires no needles, no food timing, and no refrigeration. Lilly is pricing it as low as $25 per month for insured patients and positioning it as maintenance therapy after injectable weight loss. Analysts are watching for $1.7 billion in 2026 sales, though Wall Street's reaction was mixed, with shares surging 3.8–6% on the FDA approval announcement before falling 2% the next trading day.
Why it matters: The oral GLP-1 market just got its proof of concept. If even a fraction of the 100+ million eligible U.S. adults choose a pill over a needle, Foundayo doesn't need to match injectable efficacy to become a blockbuster; it just needs to be the option patients actually stick with.
Read more →Clinical and Regulatory
The FDA Said No to This Cancer Drug. Then It Said No Again.
Replimune's melanoma therapy RP1 received its second FDA rejection in nine months, triggering 63 layoffs and a 75% stock collapse over five days. The agency's issue wasn't safety; it was trial design. The combination study with nivolumab couldn't isolate RP1's contribution to patient outcomes, and despite Replimune addressing every concern from the first rejection, the same objections resurfaced. Only one oncolytic virus therapy has ever been approved by the FDA, and this double rejection casts a long shadow over the many others in development.
Read more →Policy and Market Access
12 Peptides the FDA Banned in 2023 Are About to Hit Pharmacy Shelves Again
The FDA is planning to remove a group of peptides from its "banned from compounding" list, including popular substances like BPC-157 and TB-500, though the formal reclassification has not yet been published. No major new safety data prompted the reversal; the original safety nominations were simply withdrawn under the current administration. Compounding pharmacies and telehealth platforms are poised to capitalize, especially after the GLP-1 compounding crackdown left them searching for growth. Advisory committee meetings in July 2026 will determine whether the peptides earn a permanent spot.
Read more →