FDA accepted Abeona's BLA resubmission for pz-cel, setting a target action date of April 29, 2025.
Quiver AI Summary
Abeona Therapeutics Inc. announced that the FDA has accepted its resubmission of the Biologics License Application (BLA) for pz-cel, a gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), setting a target action date of April 29, 2025. The company has made progress towards commercialization, including engaging treatment centers and payors, and has received favorable Medicare reimbursement decisions. Additionally, Abeona has expanded its manufacturing capacity and secured new patents related to pz-cel for RDEB. The company reported a net loss of $30.3 million for the third quarter of 2024, as well as sufficient funds to continue operations into 2026, barring any revenue from pz-cel sales.
Potential Positives
- FDA acceptance of the BLA resubmission for pz-cel indicates progress towards regulatory approval and potential commercialization in 2025.
- Significant advancements in discussions with payors and onboarding treatment centers enhance the company’s commercial readiness and patient access for pz-cel.
- The issuance of new patents related to pz-cel strengthens the company's intellectual property position and potential market exclusivity for treating RDEB.
- The favorable reimbursement designation by the CMS facilitates efficient billing and enhances the potential market uptake of pz-cel post-approval.
Potential Negatives
- Significant net loss of $30.3 million in the third quarter of 2024, which is more than double the loss of $11.8 million in the same quarter in 2023, raising concerns about financial sustainability.
- Research and development expenses increased to $8.9 million from $7.1 million year-over-year, indicating rising costs that could strain resources.
- Overall cash reserves decreased from $123 million in June 2024 to $110 million in September 2024, suggesting potential financial instability going into future operational phases.
FAQ
What is the PDUFA target action date for pz-cel?
The PDUFA target action date for pz-cel is set for April 29, 2025.
What progress has Abeona made regarding pz-cel commercialization?
Abeona is ramping up commercial readiness and onboarding treatment centers while engaging payors for pz-cel.
Did the FDA request new clinical data for pz-cel approval?
No, the FDA did not request new clinical trials or clinical data for the approval of pz-cel.
What recent patent was issued related to pz-cel?
The U.S. Patent and Trademark Office issued U.S. Patent No. 12,110,504 for pz-cel, expiring on January 3, 2037.
How did Abeona's financial position change in Q3 2024?
Abeona reported a net loss of $30.3 million for Q3 2024, which has increased compared to the previous year.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ABEO Insider Trading Activity
$ABEO insiders have traded $ABEO stock on the open market 3 times in the past 6 months. Of those trades, 1 have been purchases and 2 have been sales.
Here’s a breakdown of recent trading of $ABEO stock by insiders over the last 6 months:
- MARK ALVINO sold 25,890 shares.
- CHRISTINE BERNI SILVERSTEIN sold 25,821 shares.
- LEILA ALLAND purchased 11,000 shares.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$ABEO Hedge Fund Activity
We have seen 37 institutional investors add shares of $ABEO stock to their portfolio, and 29 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- SUVRETTA CAPITAL MANAGEMENT, LLC added 3,685,503 shares (+inf%) to their portfolio in Q2 2024
- NANTAHALA CAPITAL MANAGEMENT, LLC added 1,159,397 shares (+50.2%) to their portfolio in Q2 2024
- LAURION CAPITAL MANAGEMENT LP added 859,950 shares (+132.9%) to their portfolio in Q2 2024
- WALLEYE CAPITAL LLC added 724,270 shares (+272.2%) to their portfolio in Q2 2024
- MILLENNIUM MANAGEMENT LLC added 690,103 shares (+34.7%) to their portfolio in Q2 2024
- PROPEL BIO MANAGEMENT, LLC removed 624,022 shares (-50.0%) from their portfolio in Q3 2024
- 683 CAPITAL MANAGEMENT, LLC added 600,000 shares (+inf%) to their portfolio in Q2 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
