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By David Bautz, PhD NASDAQ:ABEO READ THE FULL ABEO RESEARCH REPORT Business Update CRL Issued for Pz-cel BLA On April 22, 2024, Abeona Therapeutics, Inc. (NASDAQ:ABEO) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel). The agency did not identify any
The complete response letter for Abeona’s treatment is one of several manufacturing setbacks for cell and gene therapy developers in recent years.
Receives FDA Complete Response Letter (CRL) based on need for additional CMC information CRL did not identify deficiencies related to clinical efficacy or clinical safety data in BLA, and no new clinical studies requested by FDA to support approval Anticipates completing and submitting requested CMC information in 3Q 2024 Conference call and webcast on Tuesday, April 23, 2024 at 8:30 a.m. ET to provide details on the requested CMC information CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona
CLEVELAND, April 01, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). On March 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to seven individuals hired by Abeona, which equity awards relate to, in the
We can readily understand why investors are attracted to unprofitable companies. By way of example, Abeona Therapeutics...
Completion of FDA Inspections Marks Progress Towards PDUFA Date
- FDA completed Pre-License Inspection of Abeona’s Cleveland manufacturing facility, as well as inspection of clinical trial sites for pz-cel pivotal Phase 3 VIITAL™ study -CLEVELAND, March 18, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the full year of 2023 and provided an update on progress toward achieving key corporate objectives. Abeona also announced today that the U.S. Food and Drug Administration (FDA) has completed a Pre-License
Usually, when one insider buys stock, it might not be a monumental event. But when multiple insiders are buying like...
Steven Cohen (Trades, Portfolio)'s investment firm, Point72 Asset Management, has recently bolstered its portfolio with an additional stake in Abeona Therapeutics Inc (NASDAQ:ABEO). The transaction, which took place on December 31, 2023, saw the firm add 468,670 shares to its holdings in the biopharmaceutical company. This move reflects Cohen's strategic investment decisions and his firm's confidence in the future of Abeona Therapeutics.
Key Insights The considerable ownership by individual investors in Abeona Therapeutics indicates that they collectively...