Outlook Therapeutics Provides Corporate Update; Formal Review Process For ONS-5010 MAA By EMA Committee For Medicinal Products For Human Use Is Underway With Decision Date In H1 2024; Explores Expanded Relationship With Cencora
Portfolio Pulse from Benzinga Newsdesk
Outlook Therapeutics announced the formal review process for ONS-5010 by the EMA's Committee for Medicinal Products for Human Use, with a decision expected in H1 2024. The company is also exploring an expanded relationship with Cencora, has begun NORSE EIGHT with the first subject dosed, and plans to resubmit the ONS-5010 BLA by the end of CY2024.
February 14, 2024 | 1:17 pm
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Outlook Therapeutics is undergoing a formal review for ONS-5010 by the EMA, exploring an expanded relationship with Cencora, and has initiated the NORSE EIGHT trial with plans for a BLA resubmission by end of CY2024.
The formal review process for ONS-5010 by the EMA and the planned BLA resubmission are significant regulatory milestones that could positively impact Outlook Therapeutics' stock in the short term. The initiation of the NORSE EIGHT trial and potential expanded partnership with Cencora further support the company's development pipeline and strategic growth, likely contributing to positive investor sentiment.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100