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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.

Rhea-AI Summary
Abeona Therapeutics Inc. has granted equity awards to new non-executive employees, in accordance with Nasdaq Listing Rule 5635(c)(4). The awards consist of up to 59,600 restricted shares of Abeona common stock, with one-third of the shares vesting yearly on each anniversary of the Grant Date. The awards will be fully vested on the third anniversary of the Grant Date, subject to continued employment with Abeona.
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Abeona Therapeutics submits BLA for EB-101 to FDA seeking approval as a treatment for RDEB, requests Priority Review to shorten review period to 6 months. BLA supported by clinical data from Phase 3 study and Phase 1/2a study. Potential approval expected in Q2 2024.
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Abeona Therapeutics appoints Madhav Vasanthavada as Chief Commercial Officer and Head of Business Development, preparing for potential launch of EB-101
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Abeona Therapeutics Inc. management team to participate in investor conferences in September 2023.
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Abeona Therapeutics intends to submit a Biologics License Application (BLA) to the FDA for EB-101, its cell therapy for patients with RDEB. The FDA agrees that clinical data supports the BLA submission. Additional data and reports requested by the FDA will be included. The company is on track for a planned BLA submission in Fall.
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Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for Q2 2023 and progress towards BLA submission for EB-101 for recessive dystrophic epidermolysis bullosa. The company raised $25 million to fund pre-commercial launch activities, strengthening its balance sheet. Cash on hand and proceeds from the offering projected to fund operations into Q4 2024. EB-101 manufacturing runs completed, additional data submitted to FDA, pre-BLA meeting briefing package submitted, and positive efficacy and safety data from pivotal Phase 3 VIITAL study presented. Completed pre-IND meetings for two preclinical gene therapy product candidates. Cash, cash equivalents, restricted cash, and short-term investments totaled $37.1 million as of June 30, 2023, estimated to be sufficient to fund operations into Q4 2024. License and other revenues in Q2 2023 were $3.5 million, research and development expenses were $8.5 million, and general and administrative expenses were $5.0 million. Net loss attributable to common shareholders was $16.7 million for Q2 2023.
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Abeona Therapeutics has completed the submission of the briefing package to the FDA for its pre-BLA meeting in August 2023. The meeting aims to discuss the format, content, and acceptability of the anticipated BLA for EB-101, Abeona's investigational cell therapy for recessive dystrophic epidermolysis bullosa. Additional data has been generated to establish comparability between retroviral vectors from two different sources, which will be included in the briefing package. The company plans to submit the EB-101 BLA in the third quarter of 2023.
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Abeona Therapeutics closes registered direct offering, raising $25 million for the commercialization of EB-101
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Abeona Therapeutics Inc. has raised $25 million through an at-the-market offering to fund the launch preparations for the EB-101 Biologics License Application (BLA) submission. The company has entered into agreements with existing investors for the issuance and sale of shares and pre-funded warrants. The offering is expected to close on July 6, 2023.
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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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United States of America
CLEVELAND