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ABEO Abeona Therapeutics

Abeona Therapeutics Inc is a commercial-stage biopharmaceutical company. The company is focused on developing cell and gene therapies for life-threatening diseases. The company's ZEVASKYN (prademagene zamikeracel) is an autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with…

Assets on file: ABO-701, prademagene zamikeracel

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July 2027

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Decision-gradeMaterialNotableMinor
Aug 13, 2026
11:30 AM
ABEOAbeona Therapeutics

Abeona reports Q2 2026 ZEVASKYN revenue and commercial update

The 8-K provides a commercial update on ZEVASKYN, including Q2 revenue of $11.4 million (31% QoQ growth), five patients treated in Q2 and three in Q3-to-date, and expansion of the qualified treatment center network to seven sites. CMS NTAP status was secured effective October 1, 2026, to support Medicare patient access.

OtherSEC 8-K
Jun 4, 2026
11:30 AM
ABEOAbeona Therapeutics

Abeona completes Pre-IND meeting for ABO-701 prostate-cancer T-cell therapy

Company held a Pre-IND meeting with FDA on June 3, 2026 for ABO-701, an engineered T-cell therapy targeting PSMA in prostate cancer. Abeona continues to target an IND submission in 2027, though no official minutes have been received and the FDA may request additional data before accepting the filing.

OtherSEC 8-K
May 13, 2026
11:30 AM
ABEOAbeona Therapeutics

Abeona in-licenses ABO-701 (PSMA-SIR-T™) for prostate cancer

Abeona licensed ABO-701, a novel engineered T-cell therapy targeting PSMA, from Angeles Therapeutics. The company plans to file an IND and start first-in-human studies in the second half of 2027. Ophthalmology programs were deprioritized to focus on this new asset.

FDA designationSEC 8-K
Nov 12, 2025
12:30 PM
ABEOAbeona Therapeutics

Abeona: ZEVASKYN first patient treatment shifted to 4Q 2025

The company optimized a rapid sterility release assay after a false-positive result delayed release of a manufactured batch. Biopsy collection resumed in November 2025, moving the first anticipated commercial treatment from an earlier timeline to 4Q 2025. The company states it remains on track for its 2026 launch goals.

Trial registry changeSEC 8-K

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ABEO FDA Calendar & Catalysts — Abeona Therapeutics | Biopharma · FDA Approvals | SimianX AI