reports
Abeona Therapeutics Reports First Quarter 2024 Financial Results and R...
Abeona Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Progress 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 be...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nas...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CLEVELAND, May 07, 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). On May 6, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to ten individuals hired by Abeona, which equity awards relate to, in the a...
Abeona Therapeutics Announces Pricing of $75 Million Underwritten Offe...
Abeona Therapeutics Announces Pricing of $75 Million Underwritten Offering of Common Stock and Pre-Funded Warrants 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 of...
Abeona Therapeutics Provides Regulatory Update on Pz-cel
Abeona Therapeutics Provides Regulatory Update on Pz-cel 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...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nas...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CLEVELAND, April 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). On March 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to seven individuals hired by Abeona, which equity awards relate to, in ...
Abeona Therapeutics Reports Full Year 2023 Financial Results and Annou...
Abeona Therapeutics Reports Full Year 2023 Financial Results and Announces Completion of FDA Inspections - 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 - CLEVELAND, March 18, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the full year of 2023 and provided an update on progress toward achieving key corporate objectives. Abeona also announced today that the U.S. Food and Drug Administration (FDA) has completed...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nas...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CLEVELAND, March 05, 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). On February 29, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to three individuals hired by Abeona, which equity awards relate to, ...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nas...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CLEVELAND, Feb. 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). On January 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to three individuals hired by Abeona, which equity awards relate to, in...
Abeona Therapeutics Announces Progress Update on Pz-cel Biologics Lice...
Abeona Therapeutics Announces Progress Update on Pz-cel Biologics License Application (BLA) - 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 BIM...
Abeona Therapeutics Announces $50 Million Credit Facility
Abeona Therapeutics Announces $50 Million Credit Facility 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. Proceeds from ...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nas...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CLEVELAND, Dec. 15, 2023 (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). On December 14, 2023, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to four individuals hired by Abeona, which equity awards relate to, in...
Abeona Therapeutics Announces FDA Accepts and Grants Priority Review f...
Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA) - 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 f...
Abeona Therapeutics Reports Third Quarter 2023 Financial Results and C...
Abeona Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Developments 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...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nas...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CLEVELAND, Nov. 01, 2023 (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). On October 31, 2023, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to five individuals hired by Abeona, which equity awards relate to, in ...
Abeona Therapeutics Submits Biologics License Application to U.S. FDA ...
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 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 sub...
Abeona Therapeutics Appoints Madhav Vasanthavada, Ph.D., M.B.A. as Chi...
Abeona Therapeutics Appoints Madhav Vasanthavada, Ph.D., M.B.A. as Chief Commercial Officer 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, genetical...
Abeona Therapeutics Announces Participation in Upcoming Investor Confe...
Abeona Therapeutics Announces Participation in Upcoming Investor Conferences 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: A company presentation at the H.C. Wainwright Annual Global Investment Conference on Wednesday, September 13, 2023 at 10:00 a.m. ET.A fireside chat at the Cantor Global Healthcare Conference on Tuesday, September 26, 2023 at 2:10 p.m. ET.A fireside chat at the Jefferies Cell & Genetic Medicine Summit on Wedne...
Abeona Therapeutics Announces Positive Pre-BLA Meeting with FDA for EB...
Abeona Therapeutics Announces Positive Pre-BLA Meeting with FDA for EB-101 and Plans for BLA Submission 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. At the meeting, Abeona reached alignment with ...
Abeona Therapeutics Reports Second Quarter 2023 Financial Results
Abeona Therapeutics Reports Second Quarter 2023 Financial Results 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...
Abeona Therapeutics Announces Submission of Briefing Package for Pre-B...
Abeona Therapeutics Announces Submission of Briefing Package for Pre-Biologics License Application (BLA) Meeting with FDA in August 2023 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 autolo...
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