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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.

Abeona Therapeutics Inc. (NASDAQ: ABEO) is a prominent clinical-stage biopharmaceutical company dedicated to the development of innovative gene therapies for life-threatening rare genetic disorders. By leveraging cutting-edge biotechnology, Abeona is making significant strides in transforming treatment paradigms for diseases with high unmet medical needs.

Core Business
Abeona's primary focus is on gene therapies and plasma-based products aimed at rare genetic diseases. The company's leading programs include pz-cel (prademagene zamikeracel, formerly known as EB-101), an investigational autologous gene-corrected epidermal graft for treating recessive dystrophic epidermolysis bullosa (RDEB), and several adeno-associated virus (AAV)-based gene therapies. These include therapies for Sanfilippo syndrome types A and B, juvenile Batten disease, infantile Batten disease, and Fanconi anemia.

Recent Achievements and Current Projects
In recent developments, Abeona completed its first U.S. Biologics License Application (BLA) submission for pz-cel in September 2023. The FDA's Priority Review of this application has a target action date of May 25, 2024. Moreover, the company has initiated commercial readiness activities, including discussions with treatment sites and payer engagements, anticipating a potential U.S. launch. Abeona's financial condition has been significantly bolstered by a $75 million underwritten offering in May 2024 and a $50 million credit facility obtained in January 2024.

Strategic Partnerships and Financial Highlights
Abeona's collaborations with institutional investors and organizations like Taysha Gene Therapies have been instrumental in advancing its clinical programs. With a robust balance sheet, the company raised an additional $25 million in July 2023 to support commercial preparations, and as of the latest financial reports, holds sufficient resources to fund operations into 2026.

Product Pipeline
Abeona's development portfolio includes:

  • pz-cel for RDEB
  • abo-102 for Sanfilippo syndrome type A
  • abo-101 for Sanfilippo syndrome type B
  • abo-201 and abo-202 for juvenile and infantile Batten disease
  • abo-301 for Fanconi anemia
  • abo-302 utilizing CRISPR/Cas9-based gene editing
  • EB-201 for epidermolysis bullosa

Through its fully integrated cell and gene therapy cGMP manufacturing facility, Abeona is equipped to support both clinical and potential commercial production needs.

Looking Forward
With its strong pipeline and strategic financial maneuvers, Abeona Therapeutics is well-positioned to achieve critical milestones in the near future. The company remains committed to bringing transformative therapies to patients with unmet needs, driving forward its mission to change the landscape of gene therapy.

News

Abeona Therapeutics Provides Regulatory Update on Pz-cel

Rhea-AI Summary
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 Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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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 Reports Full Year 2023 Financial Results and Announces Completion of FDA Inspections

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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 Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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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 Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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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 Announces Progress Update on Pz-cel Biologics License Application (BLA)

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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 Announces $50 Million Credit Facility

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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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Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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 Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)

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Abeona Therapeutics Inc. (ABEO) announced that the U.S. FDA has accepted and granted Priority Review for the Biologics License Application (BLA) for pz-cel, an investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). The FDA has set a target action date of May 25, 2024, and does not plan to hold an Advisory Committee meeting for the pz-cel application. The BLA is supported by clinical efficacy and safety data from the pivotal Phase 3 VIITAL™ study and confirmatory evidence from a Phase 1/2a study, with both studies showing sustained wound healing and pain reduction. The grant of Priority Review status makes Abeona eligible for a Priority Review Voucher.
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Abeona Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Developments

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Abeona Therapeutics Inc. (Nasdaq: ABEO) completed its first-ever U.S. Biologics License Application (BLA) submission for pz-cel in recessive dystrophic epidermolysis bullosa (RDEB). The FDA's decision on priority review and acceptance of BLA is expected by late-November 2023. The company also initiated commercial readiness activities for a potential U.S. launch of pz-cel. Abeona reported financial results for Q3 2023 and provided corporate updates, highlighting substantial progress in late-stage clinical development and manufacturing of autologous engineered cell therapies.
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FAQ

What is the current stock price of Abeona Therapeutics (ABEO)?

The current stock price of Abeona Therapeutics (ABEO) is $5.7 as of December 20, 2024.

What is the market cap of Abeona Therapeutics (ABEO)?

The market cap of Abeona Therapeutics (ABEO) is approximately 247.8M.

What does Abeona Therapeutics Inc. specialize in?

Abeona Therapeutics focuses on developing gene therapies for life-threatening rare genetic diseases.

What are Abeona's leading programs?

Abeona's leading programs include pz-cel (prademagene zamikeracel) for RDEB and several AAV-based gene therapies for various genetic diseases.

What is the current status of pz-cel?

pz-cel has completed its first U.S. BLA submission and is under Priority Review by the FDA, with a target action date of May 25, 2024.

What recent financial milestones has Abeona achieved?

Abeona raised $75 million through an underwritten offering in May 2024 and secured a $50 million credit facility in January 2024.

What is Abeona's strategy for commercial readiness?

Abeona has initiated commercial readiness activities, including discussions with treatment sites, payer engagement, and hiring key commercial roles.

How is Abeona's financial health?

Abeona has a strong financial position with sufficient resources to fund operations into 2026, supported by recent fundraising activities.

Where is Abeona's manufacturing facility located?

Abeona's fully integrated cell and gene therapy cGMP manufacturing facility is located in Cleveland, Ohio.

What diseases are targeted by Abeona's gene therapies?

Abeona targets a range of genetic disorders including Sanfilippo syndrome types A and B, juvenile and infantile Batten disease, epidermolysis bullosa, and Fanconi anemia.

Has the FDA provided any feedback on Abeona's BLA for pz-cel?

The FDA issued a Complete Response Letter (CRL) requesting additional CMC information but did not identify any deficiencies related to clinical data.

What are Abeona's future plans?

Abeona plans to address the FDA's requests for CMC information, resubmit the BLA in the second half of 2024, and focus on launching pz-cel commercially upon approval.

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Abeona Therapeutics Inc.

Nasdaq:ABEO

ABEO Rankings

#3677 Ranked by Market Cap
N/A Ranked by Dividends

ABEO Stock Data

247.78M
41.25M
5.1%
77.54%
6.09%
Biotechnology
Pharmaceutical Preparations
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