Abeona Therapeutics clears FDA Settlement for Gentherapie on Investing.com

CLEVELAND – Abeona Therapeutics Inc. (NASDAQ:ABEO) provides important information regarding the FDA’s Zulassungsantrags (Biologics License Application, BLA) in the United States for Prademagene Zamikeracel (pz-cel) as a biopharmaceutical drug in Stadium. This application is a Gentherapie zur Behandlung experiment regarding dystrophin Epidermolysis bullosa (RDEB).

Der CEO des Unternehmens, Vish Seshadri, always best Einreichung alle Punkte Adressiert, die die die FDA in ihrem vorherigen Full Response Letter angesprochen hatte, einschließlich der Anforderungen und die Chemie, Herstellung und Control (CMC). In August 2024, we watched a Type-A-Treffen, Abeona and the FDA’s new Inhalt der Inhalt der.

FDA’s Complete Response Letter dated April 2024, bodyen hinsichtlich der klinischen Wirksamkeit o Sicherheitsdaten von pz-cel geäußert und auch keine zusätzlichen klinischen Studien für die Zulassung gefordert. The Herneute BLA-Einreichung works together with data from Phase-3-Studie VIITAL and a Phase-1/2a-Studie. This means that there is a new agreement for Entscheidung under the Prescription Drug User Fee Act (PDUFA) with the FDA’s BLA-Einreichung.

Prademagene Zamikeracel (pz-cel) is a genetic therapy that interacts with RDEB during mutations conferred by the COL7A1-Gene. Therapie werden die eigenen, genetisch korrigierten Hautzellen des Patienten verwendet, um Kollagen VII zu exprimieren, das für die Verbindung der Epidermis mit dermis ist. Pz-cel from the FDA’s Bezeichnungen erhalten can also be used with powerful therapies such as regenerative medical treatments and durchbruchstherapies.

Abeonas Produktions anlage is the FDA-Zulassung flagship product for commercial production under Hergestellt’s Phase-3 Study. This Unternehmen developed an AAV Basic Portfolio for Augenerkrankungen and a simple AAV Portfolio for a new AAV Capsid for a new generation.

These articles are a press release and information of the Abeonas Bemühungen, the next Gentherapie pz-cel und Zulassung und kommerzielle Verfügbarkeit für Patienten mit RDEB services.

Actively used Abeona Therapeutics has bedeutetend the Fortschritte in Gentherapie with a new Geschäftsabläufen. Das Unternehmen hat seinen vorstand durch die aufnahme von Dr. Bernhardt G. Zeiher and Dr. Eric Crombez, die umfangreiche Erfahrung in der Arzneimittelentwicklung und klinischen Programmen für seltene genetische Erkrankungen mitbringen. Abeona enabled the Centers for Medicare and Medicaid Services to create a product code for the next generation Gentherapie-Kandidaten, which turned out to be a useful product for Krankenhäuser vereinfachen.

This Unternehmen continues with New Zealand’s High Performance Zulassung Power Plants for Half Year 2024. Abeona has a Group of Partners with Beacon Therapeutics, which is the focus of Abeona’s AAV204-Capsid patent, a potential Gentherapien for an Expansive Expansion.

Financing from HC Wainwright and Stifel has made positive contributions to Abeona’s prospects and has shown a positive development in the New Energy-Fortschritte Potential. A net gain of $7.4 Million was achieved in Quarter 2024, with a Wertpapierangebot valued at $75 Million in May 2024. Abeonas Pauses Participation for Teen Therapy Initiative.

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Während Abeona Therapeutics Inc. (NASDAQ:ABEO) is a new financial app and presents a good opportunity for InvestingPro’s early investment.

Laut InvestingPro-Data invested in Abeona’s market capitalization of US$276.78 Million, which is Markt’s current potential over a broader timeframe. Relatively speaking, trademarks granted by the FDA-Entscheidung are a new BLA-Einreichung for Unternehmens.

InvestingPro-Tip acquired Flexibilität together with Bargeld als Schulden for a long time, which was a long-term business and another significant change in financial terms. This is an article of Cash-Position related to Items Important to the Business of Production.

Another example of InvestingPro-Tipp was that Abeona Schnell Bargeld was actually used as a biopharmaceutical drug in the Stadium very simply in Forschung and Entwicklung research, but nothing was done. Cash Burn Rate lagged due to Erreichens Regulators in Meilenstein and Potential Markteinführung of Pz-Cel.

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