Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company, develops gene and cell therapies for life-threatening diseases. Its lead clinical program is EB-101, an autologous, engineered cell therapy that is in Phase III clinical trial for recessive dystrophic epidermolysis bullosa. The company develops ABO-503 for the treatment of X-linked retinoschisis; ABO-504 for the treatment of stargardt disease; and ABO-505 for the treatment of autosomal dominant optic atrophy. In addition, it is developing AAV-based gene therapy through its AIM vector platform programs. The company was formerly known as PlasmaTech Biopharmaceuticals, Inc. and changed its name to Abeona Therapeutics Inc. in June 2015. Abeona Therapeutics Inc. is headquartered in Cleveland, Ohio.

Abeona Therapeutics Inc.

(RTTNews) - Abeona Therapeutics Inc. (ABEO) Tuesday said that the U.S. Food and Drug Administration (FDA) has approved ZEVASKYN, the first cell-based gene therapy for the treatment of wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB), a serious and debilitating genetic skin disease.
There is no cure for RDEB and ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single application, the company noted.
The approval is based on the Phase 3 VIITAL study that showed statistically significant healing of 50 percent or more from baseline in large chronic RDEB wounds, and pain reduction as evaluated at six months after treatment.
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Abeona Therapeutics Says FDA Approved ZEVASKYN For Recessive Dystrophic Epidermolysis Bullosa

(RTTNews) - Health is not valued till sickness comes," said Thomas Fuller, a British scholar, and preacher, reminding us of the importance of well-being and the need to prioritize it before health issues arise. Every year, April 7 is observed as World Health Day, commemorating the founding of the World Health Organization in 1948. When illness strikes, seeking the right medicines and treatments is important for recovery.
Let's take a look at the biotech stocks facing FDA decision in April 2025.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Biotech Stocks Facing FDA Decision In April 2025

(RTTNews) - Abeona Therapeutics (ABEO) announced the FDA has accepted for review resubmission of Biologics License Application for prademagene zamikeracel, its investigational autologous cell-based gene therapy, as a potential new treatment for recessive dystrophic epidermolysis bullosa. The FDA has assigned a PDUFA target action date of April 29, 2025.
The BLA resubmission is supported by clinical efficacy and safety data after a one-time administration of pz-cel from the pivotal Phase 3 VIITAL study and a Phase 1/2a study with up to 8 years of follow-up.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Abeona: FDA To Review Resubmission Of BLA For Pz-cel - Quick Facts

Bargain hunters are wise to pay careful attention to insider buying, because although there are many various reasons for an insider to sell a stock, presumably the only reason they would use their hard-earned dollars to make a purchase, is that they expect to make money. Today we look at two noteworthy recent insider buys.
At MSCI (MSCI), a filing with the SEC revealed that on Thursday, CEO Henry A. Fernandez bought 13,000 shares of MSCI, at a cost of $465.92 each, for a total investment of $6.06M. MSCI is trading up about 0.7% on the day Friday. This buy marks the first one filed by Fernandez in the past year.
And at Abeona Therapeutics (ABEO), there was insider buying on Thursday, by SVP, General Counsel Brendan M. O'malley who bought 8,600 shares for a cost of $3.24 each, for a total investment of $27,864. Before this latest buy, O'malley made one other purchase in the past twelve months, buying $11,400 shares at a cost of $3.80 a piece. Abeona Therapeutics is trading up about 1.9% on the day Friday.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Friday 4/26 Insider Buying Report: MSCI, ABEO

Health care stocks gained late Tuesday afternoon, with the NYSE Health Care Index climbing 1.3% and the Health Care Select Sector SPDR Fund (XLV) adding 1.2%.
The iShares Biotechnology ETF (IBB) climbed 1.8%.
In corporate news, Sanofi (SNY) asked banks to submit proposals for roles on the potential spinoff or sale of its consumer health care business, Bloomberg reported Tuesday. Sanofi shares rose 1.4%.
Abeona Therapeutics (ABEO) plunged 53% after it said late Monday that it plans to resubmit its biologic license application for pz-cel after the US Food and Drug Administration asked for more data.
Danaher's (DHR) spiked more than 7% after the company reported fiscal Q1 adjusted earnings of $1.92 per diluted share, down from $2.05 a year earlier. Analysts polled by Capital IQ expected $1.71.
UnitedHealth (UNH) said it paid a ransom to protect patient data from disclosure following the February cyberattack on its subsidiary Change Healthcare, according to media reports. The company did not disclose the amount of the ransom it paid out, the reports said. UnitedHealth shares fell 1%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Health Care Sector Update for 04/23/2024: SNY, ABEO, DHR, UNH

As the saying goes, there are many possible reasons for an insider to sell a stock, but only one reason to buy -- they expect to make money. So let's look at two noteworthy recent insider buys.
On Tuesday, Abeona Therapeutics' Chief Executive Officer, Vishwas Seshadri, made a $87,800 buy of ABEO, purchasing 20,000 shares at a cost of $4.39 a piece. Seshadri was up about 14.7% on the buy at the high point of today's trading session, with ABEO trading as high as $5.04 in trading on Wednesday. Abeona Therapeutics is trading up about 13.8% on the day Wednesday. Before this latest buy, Seshadri made one other buy in the past year, purchasing $81,400 shares for a cost of $4.07 each.
And at AFLAC, there was insider buying on Tuesday, by Director Karole Lloyd who purchased 1,000 shares at a cost of $77.28 each, for a total investment of $77,280. AFLAC is trading up about 1.9% on the day Wednesday.
VIDEO: Wednesday 2/7 Insider Buying Report: ABEO, AFL
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Wednesday 2/7 Insider Buying Report: ABEO, AFL

(RTTNews) - Abeona Therapeutics Inc. (ABEO) said Wednesday that it plans to proceed with the submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration for EB-101, its investigational autologous, engineered cell therapy, for patients with recessive dystrophic epidermolysis bullosa after the recent completion of a pre-BLA meeting with the FDA.
In Wednesday pre-market trade, ABEO was trading at $4.43 up $0.32 or 7.97%.
At the meeting, Abeona reached alignment with the FDA that the EB-101 clinical efficacy and safety data appear adequate to support a BLA submission.
The Agency also agreed that retroviral vector manufactured at Abeona and Indiana University appear comparable based on the data that Abeona provided in its briefing book.
The FDA requested that Abeona include within its BLA submission additional background and data supporting the scientific rationale underlying its EB-101 potency and identity assays so that they can be fully evaluated by the Agency post-submission.
The Agency also requested that supplemental data pertaining to certain chemistry, manufacturing, and controls and clinical topics be included in the BLA package.
Abeona believes that it has the necessary supporting data in-hand to generate these additional reports, including those regarding potency and identity, to address the Agency's requests.
EB-101 has been granted Regenerative Medicine Advanced Therapy, Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations by the FDA.
For More Such Health News, visit rttnews.com
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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