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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.

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Abeona Therapeutics (Nasdaq: ABEO) has announced the granting of equity awards to nine new non-executive employees. The awards, approved under Nasdaq Listing Rule 5635(c)(4), consist of 44,700 restricted shares of Abeona common stock. The shares will vest in three equal annual installments, with full vesting occurring on the third anniversary of the Grant Date, contingent upon continued employment. The equity awards were approved by the Compensation Committee of Abeona's Board of Directors on November 30, 2024, as material inducement to employment.

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Abeona Therapeutics reported Q3 2024 financial results and corporate updates. The FDA accepted their BLA resubmission for pz-cel in recessive dystrophic epidermolysis bullosa, setting a PDUFA date of April 29, 2025. The company's cash position was $110.0 million as of September 30, 2024. Q3 net loss was $30.3 million, with R&D expenses of $8.9 million and G&A expenses of $6.4 million. CMS granted a product-specific procedure code for pz-cel and assigned it to Pre-MDC MS-DRG 018. The company secured new patents for pz-cel treatment and expanded its Cleveland facility for manufacturing capacity.

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Abeona Therapeutics announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for pz-cel, an investigational autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). The FDA set a PDUFA target action date of April 29, 2025. The BLA resubmission includes clinical data from the Phase 3 VIITAL™ study and a Phase 1/2a study with up to 8 years of follow-up. If approved, pz-cel would be the first autologous, cell-based gene therapy for RDEB, designed to provide collagen VII expression through COL7A1 gene integration.

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Abeona Therapeutics (Nasdaq: ABEO) announced its management team's participation in two upcoming investor conferences in November 2024. The company will attend the Truist Securities BioPharma Symposium for investor meetings on November 7, and the Stifel 2024 Healthcare Conference on November 18, which includes a fireside chat at 4:10 p.m. ET and investor meetings. A live webcast of the fireside chat will be available on Abeona's website investor section, with a replay available for a time.

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Abeona Therapeutics (Nasdaq: ABEO) has announced new equity awards for nine recently hired non-executive employees. The Compensation Committee approved restricted stock awards totaling 27,500 shares of common stock as employment inducements. These awards will vest over three years, with one-third of the shares vesting annually on the grant date anniversary. Full vesting will occur on the third anniversary, contingent on continued employment.

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Abeona Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for pz-cel, its investigational gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). The resubmission addresses Chemistry Manufacturing and Controls items identified in the previous Complete Response Letter (CRL) from April 2024. The CRL did not identify any clinical efficacy or safety concerns, and no new clinical trials were requested. The BLA is supported by data from the Phase 3 VIITAL™ study and a Phase 1/2a study. The FDA's review period will be either 2 or 6 months, depending on classification as Class 1 or Class 2.

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Abeona Therapeutics Inc. (Nasdaq: ABEO) has announced the granting of equity awards to new non-executive employees. The Compensation Committee of Abeona's Board of Directors approved these awards on September 30, 2024, in accordance with Nasdaq Listing Rule 5635(c)(4). The awards, granted to eight new hires, consist of restricted stock equity awards totaling up to 23,100 restricted shares of Abeona common stock. The vesting schedule for these awards is as follows:

  • One-third of the shares will vest yearly on each anniversary of the Grant Date
  • Full vesting will occur on the third anniversary of the Grant Date
  • Vesting is subject to continued employment with Abeona on the applicable dates
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Abeona Therapeutics (Nasdaq: ABEO) has announced its participation in three upcoming investor conferences in September 2024:

  • Wells Fargo Healthcare Conference on September 5, featuring investor meetings
  • H.C. Wainwright Annual Global Investment Conference on September 10, including a company presentation at 1:30 p.m. ET and investor meetings
  • Cantor Global Healthcare Conference on September 19, featuring a fireside chat at 9:45 a.m. ET and investor meetings

Live webcasts of the presentation and fireside chat will be available on the Investors section of Abeona's website under 'Events'. Replays will also be accessible for a time after the events.

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Abeona Therapeutics (Nasdaq: ABEO) has announced new employee inducement grants in accordance with Nasdaq Listing Rule 5635(c)(4). On August 31, 2024, the company's Compensation Committee granted restricted stock equity awards to four new non-executive employees, totaling up to 8,600 restricted shares of Abeona common stock. These awards are designed as a material inducement to employment.

The vesting schedule for these restricted stock awards is as follows: one-third of the shares will vest yearly on each anniversary of the Grant Date. Full vesting will occur on the third anniversary of the Grant Date, subject to each employee's continued employment with Abeona on the applicable vesting dates.

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Abeona Therapeutics (Nasdaq: ABEO) has appointed two new independent members to its Board of Directors: Bernhardt G. Zeiher, MD, FCCP, FACP, and Eric Crombez, MD. Dr. Zeiher brings over 20 years of drug development experience, having overseen the approval of 15 new treatments for serious diseases. Dr. Crombez, currently Chief Medical Officer at Ultragenyx Pharmaceutical, offers extensive expertise in clinical development programs for rare genetic disorders.

The appointments come at a important time for Abeona as it focuses on bringing pz-cel to patients with recessive dystrophic epidermolysis bullosa and seeks to advance its pipeline. Both new board members bring diverse drug development expertise that could prove valuable for Abeona's future strategies and growth.

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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.

Abeona Therapeutics Inc.

Nasdaq:ABEO

ABEO Rankings

ABEO Stock Data

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