Ocugen's Vision Loss Gene Therapy Receives Orphan Drug Tag In Europe

  • The European Commission has designated Orphan Medicinal Product status to Ocugen Inc's (NASDAQ: OCGN) OCU400 (AAV5-hNR2E3) to treat both retinitis pigmentosa (RP) and Leber Congenital amaurosis (LCA).
  • Orphan medicinal product benefits include protocol assistance, reduced regulatory fees, research grants, and ten years of market exclusivity following regulatory approval.
  • This month, Ocugen teamed up with India's Bharat Biotech to co-develop COVID-19 vaccine candidate Covaxin for the U.S. market.
  • According to Form DEFA14A, the company proposed an increase in its authorized shares by 95 million.
  • Price Action: OCGN is down 15.9% at $7.72 in premarket trading on last check Tuesday.
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Posted In: BiotechNewsSmall CapFDAGeneralEuropean CommissionRetinitis Pigmentosa
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