5 Companies with Recent/Upcoming FDA Approval Decisions
We’re always excited to find bio/pharma companies nearing their 1st therapeutic product launch! ✨ Check out these 5 companies that have their final FDA approval decision (PDUFA) target date within the next 2 months.
ImmunityBio (NASDAQ: IBRX)
Drug/Therapy: Anktiva (N-803) + BCG
Indication: Bladder Cancer
PDUFA date: April 23, 2024
▹ resubmitted BLA
Day One Biopharmaceuticals (NASDAQ: DAWN)
Drug/Therapy: Tovorafenib
Indication: Relapsed or Progressive Pediatric Low-Grade Glioma
PDUFA date: April 30, 2024
▹ Granted Priority Review (NDA)
X4 Pharmaceuticals (NASDAQ: XFOR)
Drug/Therapy: Mavorixafor
Indication: WHIM Syndrome
PDUFA date: April 30, 2024
▹ Granted Priority Review (NDA)
Abeona Therapeutics (NASDAQ: ABEO)
Drug/Therapy: Pz-cel (prademagene zamikeracel)
Indication: Recessive dystrophic epidermolysis bullosa
PDUFA date: May 25, 2024
▹ Granted Priority Review (BLA)
Geron (NASDAQ: GERN)
Drug/Therapy: Imetelstat
Indication: Transfusion-dependent anemia in lower risk myelodysplastic syndromes patients
PDUFA date: June 16, 2024
▹ NDA, AdCom meeting (12:2) voted in favor
It can take a long time for a company to get its 1st approval ⏳
See table for info on timing of IPO to PDUFA dates for 5 near-term PDUFA dates👇
Median duration = 9yrs
For GERN - it took ~30 yrs to get to their 1st PDUFA date!?
▹ Looks promising for approval with recent positive Adcom
▹ Will there by CMC issues?
▹ Shifted focus ~2011 away from stem cells
Update (as shown in table):
▹ Congrats to IBRX and DAWN on approvals 🎉
▹ ABEO - Hopefully CRL issues can be overcome
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This article is not investment or legal advice.
Article history:
First published 4/25/24 EJV & AV
#IBRX #DAWN #XFOR #ABEO #GERN