Abeona Therapeutics (NASDAQ:ABEO) stock is falling on Tuesday after getting a Complete Response Letter (CRL) from the Food and Drug Administration (FDA).
The FDA’s CRL notes that the regulator needs additional Chemistry Manufacturing and Controls (CMC) information from Abeona Therapeutics. As such, the agency refused to approve Pz-cel.
Abeona Therapeutics intends to provide the FDA with this information but can’t do so in a manner that is timely for the agency. This also prevents the Biologics License Application (BLA) from treating patients with recessive dystrophic epidermolysis bullosa.
Abeona Therapeutics CEO Vish Seshadri said the following about the news:
“We are already hard at work generating the additional CMC information, and we expect that all of FDA’s requests will be addressable in a reasonable timeframe. We anticipate completing the BLA resubmission in the third quarter of 2024 with necessary updates to fully satisfy all the deficiencies outlined in the CRL.”
How This Affects ABEO Stock
Investors will note that ABEO stock is seeing heavy trading on Tuesday following the CRL from the FDA. That has more than 253,000 shares of the company’s stock changing hands as of this writing. That’s quickly closing in on its daily average trading volume of about 369,000 shares.
ABEO stock is down 45.1% as of Tuesday morning.
Investors who are seeking out more of the most recent stock market stories today are in luck!
We offer all of the biggest stock market stories worth reading about on Tuesday! A few examples include what has shares of Pineapple Energy (NASDAQ:PEGY) and HWH International (NASDAQ:HWH) stock up today as well as the largest pre-market movers this morning. All of that info is available at the links below!
More Tuesday Stock Market News
- Why Is Pineapple Energy (PEGY) Stock Up 44% Today?
- Why Is HWH International (HWH) Stock Up 43% Today?
- Today’s Biggest Pre-Market Stock Movers: 10 Top Gainers and Losers on Tuesday
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.
