Why Is Retinal Disease-Focused Outlook Therapeutics Stock Plunging Today?
Portfolio Pulse from Vandana Singh
Outlook Therapeutics Inc's stock is plunging after the company announced the completion of Type A Meetings with the FDA regarding the Complete Response Letter (CRL) for ONS-5010, a drug under development to treat Wet Age-Related Macular Degeneration. The FDA has requested an additional clinical trial for the approval of ONS-5010, which could delay the resubmission of the drug's Biologics License Application until the end of 2024 and approval until mid-2025.
November 02, 2023 | 4:30 pm
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NEGATIVE IMPACT
Outlook Therapeutics' stock price is expected to be negatively impacted in the short term due to the FDA's request for an additional clinical trial for ONS-5010, which will delay the drug's potential approval.
The FDA's request for an additional clinical trial for ONS-5010 means a delay in the potential approval of the drug, which is a significant setback for Outlook Therapeutics. This news is likely to negatively impact investor sentiment and result in a decrease in the company's stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100