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Dive into the Biopharma Space

Stay up-to-date on major biopharma news, deeper dives into specific companies and biopharma themes, and how it all relates to biopharma partners.

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)


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 Geron - 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 ImmunityBio and Day One on approvals! 🎉

▹ Abeona - Hopefully CRL issues can be overcome

See our free report with info about all the bio/pharma companies with PDUFA dates this quarter. 👉 CLICK HERE 👈

This article is not investment or legal advice.

Article history:

First published 4/25/24 EJV & AV


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