US FDA Sets August PDUFA Dates
FDA sets PDUFA dates for several biotech companies
REPL BMY MRK RARE BIIB JAZZ GILD ZYME LNTH Here are some of the key confirmed or reported upcoming PDUFA (Prescription Drug User Fee Act) target action dates for August: --MRNA expected on 8/5 — Drug mRNA-1010 (BLA). mRNA-based seasonal influenza vaccine for adults 50+. --LNTH expected on 8/13 — Drug MK-6240 (florzquinitau) (NDA).
PET Imaging agent for Tau in Alzheimer's Disease. --BMY expected on 8/17 — Drug iberdomide + daratumumab/dexamethasone (NDA).
Oral CELMoD (cereblon E3 ligase modulator) for relapsed/refractory multiple myeloma. --MRK PFE ALPMY expected on 8/17 Merck / Astellas / Pfizer — Drug Keytruda (pembrolizumab) + PADCEV (enfortumab vedotin) (BLA/supplement).
Combination for perioperative (neoadjuvant/adjuvant) treatment of muscle-invasive bladder cancer (cisplatin-eligible). --CAPR expected on 8/22 — Drug deramiocel (CAP-1002) (BLA).
Cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy (resubmission). --RARE expected on 8/23 — Drug DTX401 (BLA).
AAV Gene therapy for Glycogen Storage Disease Type Ia (GSDIa). --BIIB ESAIY expected on 8/24 — Drug LEQEMBI IQLIK (lecanemab subcutaneous; BLA).
At-home subcutaneous formulation for early Alzheimer's Disease. --JAZZ ZYME expected on 8/25 — Drug Ziihera (zanidatamab-hrii) (BLA).
Bispecific antibody for first-line HER2-positive gastroesophageal adenocarcinoma. --GILD expected on 8/27 — Drug bictegravir/lenacapavir (NDA).
Single-tablet combination for HIV (virologically suppressed adults; switch regimen).