Abeona Therapeutics (ABEO) Announces EU Orphan Drug Designation for ABO-102 Gene Therapy in Sanfilippo Syndrome Type A
- Apple (AAPL) Tops Q4 EPS by 2c; Issues Solid Outlook
- Wall Street slips on earnings; Apple falls late after results
- Chipotle Mexican Grill (CMG) Posts Q3 EPS of $0.27; Comps Miss Views; Additional Stock Buyback Approved
- Pandora (P) Misses Q3 EPS by 1c, Q4 Revenue Guidance Falls Short
- After-Hours Movers 10/25: (OGXI) (AKAM) (VRTX) Higher; (EW) (NUVA) (CMG) (AAPL) Lower (more...)
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.
Abeona Therapeutics Inc. (NASDAQ: ABEO), a clinical- stage biopharmaceutical company focused on developing gene therapies for life-threatening rare diseases, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted Orphan Drug Designation for Abeona's lead gene therapy program ABO-102 for the treatment of patients with Sanfilippo syndrome type A (MPS IIIA), a rare autosomal recessive disease that causes neurocognitive decline, speech loss, loss of mobility, and premature death in children.
"Receiving European Union (EU) orphan drug designation is an important milestone that delivers significant commercial benefits to our company as we advance our innovative portfolio of gene therapy products," stated Timothy J. Miller, Ph.D., President & CEO of Abeona Therapeutics Inc. "The benefits and incentives associated with these designations, including marketing exclusivity, are strategically important from a regulatory and commercial perspective and potentially value-creating for shareholders."
Abeona's MPS IIIA program, ABO-102, has previously been granted FDA Orphan Product Designation in the USA and received the Rare Pediatric Disease Designation as a pre-requisite part of the Priority Review Voucher (PRV) process.
About European Union (EU) Orphan Drug Designation: The European Commission grants orphan drug designation status to provide incentives to develop medicinal products to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the European Union. The orphan drug designation provides Abeona with incentives and benefits in the EU, including reduced fees and protection from market competition once ABO-102 is approved for the treatment of MPS IIIA patients.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Abeona Therapeutics (ABEO) Granted U.S. FDA Fast Track Designation for ABO-102 in Sanfilippo Syndrome Type A
- Diplomat Pharmacy (DPLO) CFO Sean Whelan to Step Down; Paul Urick Promoted to President
- PRGX Global (PRGX) to Acquire SaaS P2P SIM Service Provider Lavante
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!