FDA Calendar
The FDA will rule on Kresladi (Rocket Pharma's gene therapy for LAD-I, second attempt), LNTH-2501 (Lantheus' radiopharmaceutical, March 29), Reproxalap (third filing for dry eye disease), and Linerixibat (bile acid transporter inhibitor). Kresladi represents the only curative option besides allogeneic HSCT for leukocyte adhesion deficiency. Investors are watching closely—Rocket shares closed Friday at $3.27, up 0.62%. The cluster of decisions could reshape small-cap biotech valuations mid-quarter.
RTT News · PDUFA Tracker · March 2026
Obesity
Eli Lilly's once-daily oral GLP-1 pill for obesity and type 2 diabetes is expected to reach the FDA in late March, setting up a potential approval by year-end. If successful, orforglipron could challenge Novo Nordisk's oral semaglutide (Wegovy pill) before it even launches widely in the U.S.
PharmaVoice · Obesity Pipeline
M&A
The sector's 2025 resurgence has left some biotechs trading at "bloated valuations," warn RBC analysts. Crowding into obesity, oncology, and rare disease could make 2026 M&A harder to justify. A run of negative readouts or FDA setbacks would deflate the rally quickly.
BioPharma Dive · Market Outlook