A Q1 2026 biotech catalyst calendar with PDUFA dates and notable watch candidates.
JAZZ — WATCH The author flags Jazz Pharmaceuticals' Feb 12 PDUFA for JZP-458 in acute lymphoblastic leukemia as notable because it could be significant given the company's existing oncology portfolio. The FDA decision date is the concrete catalyst.
JZP-458 for ALL could be significant given Jazz's existing oncology portfolio.
CRNX — WATCH The author highlights Crinetics' paltusotine for acromegaly as an oral therapy that could disrupt the injectable-dominated market. The Feb 28 PDUFA is the concrete catalyst.
Paltusotine for acromegaly is an oral therapy that could disrupt the injectable-dominated market.
CORT — WATCH The author says Corcept's CORT125134 is a second-generation Cushing's treatment with potential to expand its franchise. The Feb 18 PDUFA is the concrete catalyst.
Second-gen Cushing's treatment with potential to expand their franchise.
RYTM — WATCH The author notes Rhythm Pharma's IMCIVREE is already approved and seeking broader indications for rare obesity disorders. The March 14 PDUFA is the concrete catalyst.
IMCIVREE label expansion for rare obesity disorders. Already approved, seeking broader indications.
LNTH — WATCH The author argues Lantheus's LNTH-2501 is a next-gen PSMA imaging agent following the success of Pylarify. The March 29 PDUFA is the concrete catalyst.
LNTH-2501 is their next-gen PSMA imaging agent, following success of Pylarify.
IONS — WATCH The author says Ionis's inotersen for TTR amyloidosis adds to its antisense oligonucleotide portfolio. The March 27 PDUFA is the concrete catalyst.
Inotersen for TTR amyloidosis adds to their antisense oligonucleotide portfolio.