RARE Submits BLA to the FDA for Sanfilippo Syndrome Gene Therapy [Yahoo! Finance]
Abeona Therapeutics Inc. (ABEO)
Last abeona therapeutics inc. earnings: 3/16 04:20 pm
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Source: Yahoo! Finance
the FDA for its UX111 (ABO-102) AAV gene therapy as a treatment for patients with Sanfilippo syndrome type A (MPS IIIA) under the accelerated approval pathway. Earlier this year, the FDA aligned with Ultragenyx, after a thorough evaluation, on the use of cerebral spinal fluid (CSF) heparan sulfate (HS) as a well-characterized biomarker to support an accelerated approval pathway for mucopolysaccharidoses (MPS) disorders, including Sanfilippo syndrome. Ultragenyx's BLA submission for UX111 is backed by data, including findings from the ongoing, pivotal phase I/II/III Transpher A study. Results show that treatment with UX111 led to a rapid and lasting reduction in HS levels in the CSF of patients with MPS IIIA. Additionally, maintaining lower CSF HS levels over time was linked to improved long-term cognitive development, contrasting with the decline observed in natural history data. The investigational gene therapy was overall well-tolerated in the study. Adverse events related to tr
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ABEO
News
- Abeona Therapeutics Inc (NASDAQ: ABEO) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- Abeona Therapeutics Inc (NASDAQ: ABEO) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Abeona Therapeutics Inc (NASDAQ: ABEO) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $15.00 price target on the stock.MarketBeat
- Critical Care Therapeutics Industry Opportunities by Drug Class and Application with Regional Market Breakdowns, 2025-2030: Integration of AI and ML in Drug Development Offers Untapped Opportunities [Yahoo! Finance]Yahoo! Finance
ABEO
Earnings
- 11/14/24 - Miss
ABEO
Sec Filings
- 12/20/24 - Form 8-K
- 11/14/24 - Form SC
- 11/14/24 - Form SCHEDULE
- ABEO's page on the SEC website