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Abeona Therapeutics Inc. - $ABEO STOCK NEWS

Welcome to our dedicated page for Abeona Therapeutics news (Ticker: $ABEO), a resource for investors and traders seeking the latest updates and insights on Abeona Therapeutics stock.

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Abeona Therapeutics Inc. (Nasdaq: ABEO) granted equity awards to new non-executive employees under Nasdaq Listing Rule 5635(c)(4). The Compensation Committee approved restricted stock equity awards totaling up to 37,200 shares of common stock for ten new hires. One-third of the shares will vest yearly over three years, contingent on continued employment.

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Rhea-AI Summary

Abeona Therapeutics Inc. announced the pricing of an underwritten offering of common stock and pre-funded warrants, expected to generate approximately $75 million in gross proceeds. The offering includes both new and existing investors, with the funds intended for the resubmission of its BLA, commercialization of its product candidate pz-cel, and general corporate purposes.

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Abeona Therapeutics received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) to treat patients with recessive dystrophic epidermolysis bullosa (RDEB). The CRL highlighted the need for additional Chemistry Manufacturing and Controls (CMC) information, with no deficiencies in clinical efficacy or safety data. Abeona plans to submit the requested CMC data by 3Q 2024 and expects a BLA resubmission by then. The FDA did not request new clinical trials, and the application is based on positive Phase 3 and Phase 1/2a study results.
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Abeona Therapeutics Inc. granted equity awards to new non-executive employees, totaling up to 31,000 restricted shares of common stock. The awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4) and will vest yearly over three years.
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Abeona Therapeutics Inc. reported financial results for 2023, with the FDA completing a Pre-License Inspection of its Cleveland manufacturing facility for pz-cel BLA. The FDA also inspected clinical trial sites for the pivotal Phase 3 VIITAL™ study, with no Form 483 observations noted. The FDA's review of the pz-cel BLA is ongoing, targeting a PDUFA date of May 25, 2024. Abeona also secured a $50 million credit facility, with cash runway guidance into Q1 2025. Full-year 2023 financial results showed $52.6 million in cash and investments, with $3.5 million in license and other revenues. Research and development expenses were $31.1 million, leading to a net loss of $54.2 million for 2023.
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Abeona Therapeutics Inc. (ABEO) granted equity awards to new non-executive employees, totaling up to 25,500 restricted shares of common stock. The awards vest yearly over three years, subject to continued employment. The grants aim to attract and retain talent, aligning with Nasdaq regulations.
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Abeona Therapeutics Inc. (Nasdaq: ABEO) granted equity awards to new non-executive employees in accordance with Nasdaq Listing Rule 5635(c)(4). The Compensation Committee of Abeona’s Board of Directors granted up to 81,000 restricted shares of Abeona common stock to three individuals, with one-third vesting yearly on each anniversary of the Grant Date, fully vesting on the third anniversary, contingent on continued employment.
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Abeona Therapeutics Inc. (Nasdaq: ABEO) provided an update on the review process by the U.S. FDA for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB). The FDA completed a Bioresearch Monitoring (BIMO) inspection of Abeona and the BLA mid-cycle review meeting, with no observations or FDA Form 483s issued during the inspection. The FDA reaffirmed the PDUFA target action date of May 25, 2024, for an approval decision on the pz-cel BLA, indicating progress towards bringing the therapy to patients.
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Abeona Therapeutics Inc. (Nasdaq: ABEO) has secured a $50 million credit facility with Avenue Venture Opportunities Fund, L.P. to support the launch and commercialization of pz-cel, an investigational treatment for patients with recessive dystrophic epidermolysis bullosa. The FDA has granted Priority Review with a PDUFA target action date of May 25, 2024 for the Biologics License Application for pz-cel.
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Rhea-AI Summary
Abeona Therapeutics Inc. (Nasdaq: ABEO) granted equity awards to new non-executive employees, issuing up to 81,000 restricted shares of common stock. The shares will vest yearly on each anniversary of the Grant Date, fully vesting on the third anniversary, subject to continued employment.
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Abeona Therapeutics Inc.

Nasdaq:ABEO

ABEO Rankings

ABEO Stock Data

120.36M
19.08M
4.94%
59.94%
7.29%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
United States of America
CLEVELAND

About ABEO

abeona therapeutics inc. (nasdaq: $abeo), is a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare genetic diseases. abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases. abeona's lead programs include abo-102 (aav-sgsh), an adeno-associated virus (aav) based gene therapy for sanfilippo syndrome type a (mps iiia) and eb-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (rdeb). abeona is also developing abo-101 (aav-naglu) for sanfilippo syndrome type b (mps iiib), abo-201 (aav-cln3) gene therapy for juvenile batten disease (jncl), abo-202 (aav-cln1) for treatment of infantile batten disease (incl), eb-201 for epidermolysis bullosa (eb), abo-301 (aav-fancc) for fanconi anemia (fa) disorder and abo-302 using a novel crispr/cas9-based gene editing approach to gene t