Biopharma · FDA Approvals · Stock
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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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.
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.
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.
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.
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