Outlook Therapeutics (NASDAQ:OTLK) stock is taking a beating on Wednesday after getting a rejection letter from the Food and Drug Administration (FDA).
That letter has to do with its biologics license application (BLA) for ONS-5010. This is a treatment in development at the company for wet age-related macular degeneration (AMD). The letter from the FDA has it rejecting the company’s BLA.
Unfortunately for OTLK stock, the FDA didn’t approve the BLA due to chemistry manufacturing and controls (CMC) issues, lack of evidence, and observations from pre-approval manufacturing inspections. That’s despite the agency confirming the positive results of the drug from two clinical trials.
What’s Next for OTLK Stock?
Russell Trenary, President and CEO of Outlook Therapeutics, said this about the news in a press release:
“We will request a formal meeting as soon as possible with the FDA to further understand the BLA deficiencies and how best to resolve them. Following this meeting with the FDA, the Company will be able to discuss next steps and the expected timing for resolution.”
It makes sense that OTLK stock is falling alongside the response letter from the FDA. It has poured a large amount of resources into developing ONS-5010. Its shares could recover if it can overcome the issues listed by the FDA. However, failure to do so would likely result in further losses.
OTLK stock has some 10 million shares trading hands alongside the FDA news. For the record, its daily average trading volume is about 1.7 million shares. This movement also has the stock down 78% on Wednesday morning as investors sell their shares.
Traders looking for more of the most recent stock market news on Wednesday are going to want to keep reading!
We have all of the most recent stock market news that traders need to know about today! A few examples include why shares of Top KingWin (NASDAQ:TCJH) and AgileThought (NASDAQ:AGIL) stock are up today, as well as the biggest pre-market stock movers this morning. All of that info is available at the links below!
More Wednesday Stock Market News
- Why Is Top KingWin (TCJH) Stock Up 39% Today?
- Why Is AgileThought (AGIL) Stock Up 116% Today?
- Today’s Biggest Pre-Market Stock Movers: 10 Top Gainers and Losers on Wednesday
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
