Abeona Therapeutics

Abeona Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of gene therapy for severe and life-threatening rare diseases. It programs include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA), and ABO-101 (AAV NAGLU), an AAV based gene therapy for Sanfilippo syndrome type B (MPS IIIB). The company was founded in 1974 and is headquartered in New York, NY.

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Abeona Therapeutics excels in Q4 with EB-101 advancements and growth prospects

Abeona Therapeutics showcased strong financial performance and clinical advancements with EB-101 in Q4 2022.
While facing challenges in pricing negotiations and upcoming competition, the company is well-positioned for growth.
Opportunities lie in partnerships for commercialization, market acceptance of EB-101, and the potential of gene therapy programs.

Abeona Therapeutics reports strong Q1 performance and eyes future growth

Abeona Therapeutics showcased strong performance in Q1 2023 with positive data from EB-101 and AAV ophthalmology programs, driving patient confidence and market positioning.
The company's engagement with stakeholders, successful completion of key submission steps, and promising proof-of-concept data present opportunities for future growth.
Challenges include aligning pricing considerations post VIITAL results, meeting submission requirements, and addressing analyst inquiries on program priorities and study findings.

Abeona Therapeutics advances EB-101 with $100M voucher, faces commercialization challenges

Abeona Therapeutics showcased progress on EB-101 and financial stability despite a net loss in Q2 2023.
Challenges include financial losses, commercial launch readiness, and securing partnerships.
Opportunities lie in potential BLA approval, market expansion, and advancements in AAV-based therapies.
The company's focus on EB-101 and strategic planning for commercialization are key strengths.

Abeona Therapeutics advances BLA submission for pz-cel, eyes commercialization

Abeona Therapeutics is making significant strides in product approval and commercialization strategies.
The company's financial stability and market-focused approach position it well for future growth.
While challenges exist, opportunities for expansion through FDA approval and market engagement are promising.

Abeona Therapeutics advances towards U.S. commercialization with FDA acceptance

Abeona Therapeutics showcased strong progress towards U.S. commercialization with FDA acceptance for pz-cell BLA. The company's financial performance for 2023 was solid, and engagement with key stakeholders bodes well for market entry. Challenges in FDA response timelines and manufacturing inspections need careful management.

Abeona Therapeutics advances pz-cel resubmission and strengthens financial position

Abeona Therapeutics shows strong progress in addressing regulatory and commercialization aspects for pz-cel
Financial stability improved through successful underwritten offering, enhancing market position
Challenges remain in FDA feedback, site onboarding, PRV market dynamics, and self-launch commitment
Clear opportunities exist in collaborations, market potential, growth timeline, and strategic positioning

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Abeona Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of gene therapy for severe and life-threatening rare diseases. It programs include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA), and ABO-101 (AAV NAGLU), an AAV based gene therapy for Sanfilippo syndrome type B (MPS IIIB). The company was founded in 1974 and is headquartered in Cleveland, OH.

Abeona Therapeutics said on Monday the U.S. health regulator had declined to approve its treatment for a rare skin blistering condition.

US FDA declines to approve Abeona's skin disorder treatment

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 Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel).

Abeona Therapeutics Provides Regulatory Update on Pz-cel

- 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 - - 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 -

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

- On track for PDUFA target action date of May 25, 2024 - CLEVELAND, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced, as part of the review process by the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB), completion by the FDA of both a Bioresearch Monitoring (BIMO) inspection of Abeona and the BLA mid-cycle review meeting. The BIMO inspection was conducted from January 22, 2024 through January 24, 2024 at Abeona's headquarters in Cleveland, Ohio, and reviewed the conduct and practices that pertain to the clinical studies of pz-cel.

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

CLEVELAND, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has entered into a $50 million credit facility with the Avenue Venture Opportunities Fund, L.P. The credit agreement, which has a term of three and a half years, includes a first tranche of $20 million at closing, a second tranche of $10 million of committed capital, and an additional accordion option to upsize the credit facility by an additional $20 million upon satisfaction of certain terms and conditions.

Abeona Therapeutics Announces $50 Million Credit Facility

Abeona Therapeutics Inc shares jumped 15% to $4.96 in late-morning trading on Monday after the US Food and Drug Administration (FDA) said it would expedite a review of pz-cel (prademagene zamikeracel), the company's proposed treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare, inherited connective-tissue disorder.   The clinical-stage biopharmaceutical company had previously stated that it expected an FDA decision on priority-review status by late November.

Abeona Therapeutics stock climbs after drug candidate receives FDA Priority Review

- PDUFA target action date is May 25, 2024 - - FDA does not currently plan to hold Advisory Committee meeting for pz-cel BLA - CLEVELAND, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel), Abeona's investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 25, 2024.

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

Abeona Therapeutics Inc. (NASDAQ:ABEO ) Q3 2023 Results Conference Call November 13, 2023 8:30 AM ET Company Participants Greg Gin - Vice President of Investor Relations & Corporate Communications Vishwas Seshadri - President, CEO and Director Madhav Vasanthavada - Chief Commercial Officer & Head of Business Development Joseph Vazzano - Chief Financial Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Operator Greetings, and welcome to the Abeona Therapeutics Third Quarter 2023 Conference Call. [Operator Instructions].

Abeona Therapeutics Inc. (ABEO) Q3 2023 Earnings Call Transcript

Abeona's first-ever U.S. Biologics License Application (BLA) submission completed in September 2023 FDA decision on priority review and acceptance of BLA for pz-cel (prademagene zamikeracel, formerly known as EB-101) in recessive dystrophic epidermolysis bullosa (RDEB) expected by late-November 2023 Initiated commercial readiness activities for potential U.S. launch of pz-cel CLEVELAND, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the third quarter of 2023 and provided corporate updates. “In the third quarter, we made substantial progress in our evolution from a late-stage clinical development company to one with significant commercial opportunity,” said Vish Seshadri, Chief Executive Officer of Abeona.

Abeona Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Developments

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CLEVELAND, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of EB-101, its investigational autologous, engineered cell therapy, as a treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB). As part of the submission, Abeona requested a Priority Review, which, if granted, would shorten the FDA's review period to six months from the filing acceptance of the BLA, instead of 10 months under standard review.

Abeona Therapeutics Submits Biologics License Application to U.S. FDA Seeking Priority Review and Approval of EB-101 for the Treatment of Patients with Recessive Dystrophic Epidermolysis Bullosa

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CLEVELAND, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Madhav Vasanthavada, Ph.D., M.B.A. to the role of Chief Commercial Officer (CCO) and Head of Business Development (BD), effective immediately. In this capacity, in addition to his current BD responsibilities, Dr. Vasanthavada will oversee all aspects of commercial strategy, planning and operations as Abeona prepares for a potential launch of EB-101, its investigational, genetically engineered autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). Dr. Vasanthavada is a seasoned commercial executive bringing over 20 years of experience with leadership roles in sales, marketing, and market access in the life sciences industry, including launch experience with autologous cell therapies. Over the past year, as Abeona's Head of BD, Dr. Vasanthavada's efforts to assess EB-101's commercial opportunity informed the Company's strategy to prepare for a U.S. commercial launch without depending on a partner.

Abeona Therapeutics Appoints Madhav Vasanthavada, Ph.D., M.B.A. as Chief Commercial Officer

CLEVELAND, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its management team will participate in upcoming investor conferences in September 2023:

Abeona Therapeutics Announces Participation in Upcoming Investor Conferences

CLEVELAND, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the Company's intention to proceed with the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EB-101, its investigational autologous, engineered cell therapy, for patients with recessive dystrophic epidermolysis bullosa (RDEB) after the recent completion of a pre-BLA meeting with the FDA.

Abeona Therapeutics Announces Positive Pre-BLA Meeting with FDA for EB-101 and Plans for BLA Submission

Abeona Therapeutics Inc. (NASDAQ:ABEO ) Q2 2023 Results Conference Call August 8, 2023 8:30 AM ET Company Participants Greg Gin - Vice President of Investor Relations and Corporate Communications Vish Seshadri - Chief Executive Officer Joe Vazzano - Chief Financial Officer Madhav Vasanthavada - Vice President, Business Development Brian Kevany - Chief Technical Officer Conference Call Participants Maury Raycroft - Jefferies Kristen Kluska - Cantor Fitzgerald David Bautz - Zacks Small Capital Research Operator Good day, and welcome to the Abeona Therapeutics Second Quarter 2023 Update Conference Call [Operator Instructions]. As a reminder, today's conference is being recorded.

Abeona Therapeutics Inc. (ABEO) Q2 2023 Earnings Call Transcript

On track for Biologics License Application (BLA) submission in third quarter of 2023 Proceeds from $25 million registered direct offering in July allow initiation of pre-commercial launch activities for EB-101 Cash on hand plus proceeds from registered direct offering projected to fund operations into the fourth quarter of 2024 CLEVELAND, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2023 and provided an update on progress toward achieving key corporate objectives. “Abeona is at a pivotal moment in our history as we are busy finalizing and planning to soon submit the BLA for EB-101 for the treatment of recessive dystrophic epidermolysis bullosa,” said Vish Seshadri, Chief Executive Officer of Abeona.

Abeona Therapeutics Reports Second Quarter 2023 Financial Results

CLEVELAND, July 28, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has completed the submission of the briefing package to the U.S. Food and Drug Administration (FDA) for the Company's pre-Biologics License Application (BLA) meeting in August 2023. The purpose of the pre-BLA meeting is to discuss with the FDA the format, content, and acceptability of the anticipated BLA for EB-101, Abeona's investigational autologous, engineered cell therapy for recessive dystrophic epidermolysis bullosa.

Abeona Therapeutics Announces Submission of Briefing Package for Pre-Biologics License Application (BLA) Meeting with FDA in August 2023

CLEVELAND, July 19, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has joined the Rare Disease Company Coalition (RDCC), an alliance of life science companies committed to discovering, developing, and delivering therapies for patients impacted by rare diseases. Abeona's Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., has been appointed to the RDCC's Board of Directors.

Abeona Therapeutics Joins Rare Disease Company Coalition

CLEVELAND, July 07, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the closing of its previously announced registered direct offering for total gross proceeds of $25 million, before deducting the placement agents' fees and other offering expenses.

Abeona Therapeutics Announces Closing of $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

CLEVELAND, July 03, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has raised $25 million at-the-market from select existing investors, primarily to fund initiation of the Company's launch preparations in anticipation of the EB-101 Biologics License Application (BLA) submission and potential approval.

Abeona Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

CLEVELAND, June 09, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received feedback from the U.S. Food and Drug Administration (FDA) on June 8, 2023, in which the Company gained the Agency's alignment on the data required to establish retroviral vector (RVV) comparability, a critical Chemistry, Manufacturing and Controls (CMC) component for the EB-101 Biologics License Application (BLA).

Abeona Therapeutics Announces Regulatory Update on Biologics License Application (BLA) for EB-101

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CLEVELAND, June 01, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Vish Seshadri, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Friday, June 9, 2023 at 9:00 a.m. Eastern time. The Company will also participate in one-on-one investor meetings at the conference.

Abeona Therapeutics to Present at the Jefferies Healthcare Conference

Abeona Therapeutics Inc. (NASDAQ:ABEO ) Q1 2023 Earnings Conference Call May 24, 2023 8:30 AM ET Company Participants Vishwas Seshadri - Chief Executive Officer Joseph Vazzano - Chief Financial Officer Dmitriy Grachev - Chief Medical Officer Brian Kevany - Chief Technical Officer, Head of Research Madhav Vasanthavada - Vice President, Business Development Greg Gin - Vice President, Investor Relations and Corporate Communications Conference Call Participants Maury Raycroft - Jefferies Kristen Kluska - Cantor Fitzgerald James Molloy - A.G.P./Alliance Global Partners Operator Greetings.

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