Galera Therapeutics (NASDAQ:GRTX) stock is falling hard on Thursday following a drug rejection by the Food and Drug Administration (FDA).
In a Complete Response Letter (CRL), the FDA rejected the company’s New Drug Application (NDA) for avasopasem manganese. This is a potential treatment for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer that are undergoing standard-of-care treatment.
According to the FDA’s CRL, the Phase 3 clinical trial of avasopasem manganese and additional data from its GT-201 trial don’t offer enough support to approve the drug. The FDA says there isn’t sufficient evidence that Galera Therapeutics’ treatment is effective and safe for reducing oral mucositis in head and neck cancer patients.
Mel Sorensen, M.D., president and CEO of Galera Therapeutics, said the following about the FDA’s response:
“This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis. We continue to believe in avasopasem’s potential to bring a meaningful benefit to these patients, who currently have no FDA-approved drugs for this debilitating condition.”
What’s Next for GRTX Stock
Galera Therapeutics is already planning to meet with the FDA to better understand its CRL. However, today’s decision means it has to take certain actions to reduce costs. That includes winding down its commercial readiness plans while reducing its workforce.
With this news comes heavy trading of GRTX stock today as investors sell the shares. This has more than 7 million shares of the stock changing hands as of this writing. For the record, its daily average trading volume is closer to 1.1 million shares.
GRTX stock is down 82.5% as of Thursday morning.
Investors can find more of the latest stock market news worth reading about below!
We’ve got all of the most recent stock coverage traders need to know about on Thursday! A few examples include why shares of PHAXIAM Therapeutics (NASDAQ:PHXM) and Capri (NYSE:CPRI) stock are up today, as well as the biggest pre-market stock movers this morning. All of this news is ready to go at the following links!
More Thursday Stock Market News
- Why Is PHAXIAM Therapeutics (PHXM) Stock Up 37% Today?
- Why Is Capri (CPRI) Stock Up 58% Today?
- Today’s Biggest Pre-Market Stock Movers: 10 Top Gainers and Losers on Thursday
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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.
