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.

Earnings data Q4 2020

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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.

CLEVELAND, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its management team will participate in upcoming investor conferences in November 2024:

Abeona Therapeutics® Announces Participation in November Investor Conferences

CLEVELAND, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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

CLEVELAND, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Company has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA or Agency) for prademagene zamikeracel (pz-cel), its investigational autologous cell-based gene therapy, as a potential new treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB).

Abeona Therapeutics® Completes Pz-cel Biologics License Application Resubmission to U.S. Food and Drug Administration

Abeona Therapeutics' Pz-cel, a gene-corrected cell therapy for RDEB, is expected to resubmit its BLA in 2H2024, targeting FDA approval by mid-2025. ABEO's AIM platform uses AAV vectors for targeted genetic material delivery, with a pipeline including therapies for genetic eye conditions and neurological diseases. Pz-cel offers long-lasting treatment for RDEB, addressing a substantial total addressable market.

Abeona Therapeutics Targets RDEB Market With Promising Pz-cel Therapy

CLEVELAND, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its management team will participate in upcoming investor conferences in September 2024:

Abeona Therapeutics® Announces Participation in Upcoming Investor Conferences

CLEVELAND, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Bernhardt G. Zeiher, MD, FCCP, FACP, and Eric Crombez, MD as new independent members to its Board of Directors. Dr. Zeiher brings more than 20 years of drug development experience where, in various roles, he oversaw the approval of 15 new treatments that addressed unmet needs in serious diseases with few to no treatment options. Dr. Crombez currently serves as Chief Medical Officer of Ultragenyx Pharmaceutical Inc. and brings extensive expertise in the development and execution of clinical development programs for rare genetic disorders.

Abeona Therapeutics® Announces Appointment of Bernhardt Zeiher, MD, FCCP, FACP, and Eric Crombez, MD to its Board of Directors

CMS grants ICD-10-PCS product-specific procedure code and favorable DRG assignment for pz-cel, supporting efficient hospital billing, reimbursement and patient access CMS grants ICD-10-PCS product-specific procedure code and favorable DRG assignment for pz-cel, supporting efficient hospital billing, reimbursement and patient access

Abeona Therapeutics® Announces Favorable Medicare Reimbursement Decisions for Pz-cel

Significant progress addressing CMC items noted in CRL BLA resubmission remains on track for 2H 2024 CLEVELAND, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2024 and recent corporate progress. “Having completed data generation for nearly all of the Chemistry Manufacturing and Controls deliverables outlined in the Complete Response Letter that we received in April 2024, we are on track to resubmit our Biologics License Application for pz-cel this year and, if approved, bring a treatment option to patients with recessive dystrophic epidermolysis bullosa,” said Vish Seshadri, Chief Executive Officer of Abeona.

Abeona Therapeutics® Reports Second Quarter 2024 Financial Results and Concludes Type A Meeting with FDA to Align on Upcoming Pz-cel BLA Resubmission

Abeona Therapeutics Inc.'s BLA resubmission of Pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa is expected 2nd half of 2024. If Pz-cel is approved by the FDA, the company believes that it could reach peak U.S. sales of >$500 million by year 5 of the gene therapy being sold. FDA approval of Pz-cel for RDEB would allow Abeona to obtain a Priority Review Voucher, which it could keep or sell to another company for a considerable amount of cash.

Abeona: BLA Resubmission Of Pz-Cel Gets Ball Rolling Towards Other Milestones

CLEVELAND and LONDON, July 11, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a cell and gene therapy company with proprietary adeno-associated virus (AAV)-based capsids, and Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, today announced an agreement by which Beacon will evaluate Abeona's patented AAV204 capsid for the development and commercialization of potential gene therapies for select ophthalmology indications.

Abeona Therapeutics and Beacon Therapeutics Announce Non-Exclusive Agreement for Beacon to Evaluate Therapeutic Potential of Abeona's Patented AAV204 Capsid for Select Ophthalmology Indications

CLEVELAND, July 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Abeona's Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., and Chief Commercial Officer, Madhav Vasanthavada, Ph.D., M.B.A., will participate in a virtual fireside chat at the Stifel Virtual Cell Therapy Forum on Tuesday, July 9, 2024 at 9:45 a.m. Eastern Time.

Abeona Therapeutics to Present at the Stifel Virtual Cell Therapy Forum

NEW YORK, NY / ACCESSWIRE / June 9, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Abeona Therapeutics Inc. ("Abeona" or the "Company") (NASDAQ:ABEO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Abeona Therapeutics Inc. - ABEO

NEW YORK , June 7, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Abeona Therapeutics Inc. ("Abeona" or the "Company") (NASDAQ: ABEO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Abeona Therapeutics Inc. - ABEO

CLEVELAND, June 03, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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

CLEVELAND, May 28, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its senior management team will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 11:30 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 Global Healthcare Conference

BLA resubmission anticipated in second half of 2024 Closed $75 million underwritten offering in May, extending expected cash runway into 2026 CLEVELAND, May 15, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2024 and recent corporate progress. “We are grateful to our existing as well as new investors who have demonstrated their support through the recent financing, which has extended our cash runway into 2026, well beyond anticipated regulatory milestones,” said Vish Seshadri, Chief Executive Officer of Abeona.

Abeona Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Progress

CLEVELAND, May 03, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) (“Abeona” or the “Company”) today announced the pricing of an underwritten offering of 12,285,056 shares of its common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656 shares of its common stock, at an offering price of $4.07 per share, which is equal to the closing price on Thursday, May 2, 2024, or $4.0699 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant. The pre-funded warrants will be immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the pre-funded warrants are exercised in full. The closing of the offering is expected to occur on or about May 7, 2024, subject to the satisfaction of customary closing conditions.

Abeona Therapeutics Announces Pricing of $75 Million Underwritten Offering of Common Stock and Pre-Funded Warrants

Abeona Therapeutics is a gene therapy company with a lead product candidate, Pz-cel, for recessive epidermolysis bullosa, or RDEB. Pz-cel has shown higher efficacy than the competition in treating larger skin lesions in RDEB. Despite receiving a complete response letter from the FDA, Abeona believes the manufacturing issues can be resolved and plans to submit a response by Q3 this year.

Buying The Dip In Abeona Therapeutics After The Recent Manufacturing-Related CRL

LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO) investors concerning the Company's possible violations of the federal securities laws. If you suffered a loss on your Abeona investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securitie.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of Investors

BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO) investors concerning the Company's possible violations of federal securities laws. On April 22, 2024, Abeona disclosed that it had received a Complete Response Letter (“CRL”) from the FDA regarding its recessive dystrophic epidermolysis bullosa treatment, pz-cel, stating that “the FDA noted that certain additional information.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of Investors

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces an investigation of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO) on behalf of investors concerning the Company's possible violations of federal securities laws. If you are a shareholder who suffered a loss, click here to participate. On April 22, 2024, Abeona disclosed that it had received a Complete Response Letter (“CRL”) from the FDA regarding its recessive dystrophic epidermolysis bullosa treatme.

The Law Offices of Frank R. Cruz Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of Investors

Abeona Therapeutics Inc. stock dropped by over half after receiving a Complete Response Letter from the FDA regarding its Biologics License Application for pz-cel. The FDA identified manufacturing issues that need to be resolved, delaying the potential approval of pz-cel. However, no issues were raised regarding efficacy and safety, nor are more trials required. Despite the setback, Abeona Therapeutics may present a buying opportunity as it bottoms out, with estimated peak revenue of over $500 million in the U.S. assuming approval.

Abeona Therapeutics Tanks On CRL From The FDA, But All Hope Is Not Lost

Abeona Therapeutics (NASDAQ: ABEO ) stock is falling on Tuesday after getting a Complete Response Letter ( CRL ) from the Food and Drug Administration (FDA). The CRL from the FDA notes that the regulator needs additional Chemistry Manufacturing and Controls ( CMC ) information from Abeona Therapeutics.

Why Is Abeona Therapeutics (ABEO) Stock Down 45% Today?

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).

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