ABEONA THERAPEUTICS INC. (NASDAQ:ABEO) Files An 8-K Other Events
Item 8.01.
On December 9, 2019, Abeona Therapeutics Inc. (the “Company”) issued a press release entitled “Abeona Therapeutics Cleared to Initiate Pivotal Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa.” The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
(d) Exhibits.
| 99.1 | Press release dated December 9, 2019, entitled “Abeona Therapeutics Cleared to Initiate Pivotal Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa.” |
ABEONA THERAPEUTICS INC. Exhibit
EX-99.1 2 ex99-1.htm Exhibit 99.1 Abeona Therapeutics Cleared to Initiate Pivotal Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa FDA removes clinical hold; Company may proceed with VIITALTM study Company expects to initiate study in the first quarter of 2020 Primary endpoint confirmed as proportion of wounds with greater than 50% healing at 3 months vs control wounds Majority of potential subjects have been pre-screened for the study NEW YORK and CLEVELAND,…
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About ABEONA THERAPEUTICS INC. (NASDAQ:ABEO)
Abeona Therapeutics, Inc. (Abeona), formerly PlasmaTech Biopharmaceuticals, Inc., is focused on developing and delivering gene therapy and plasma-based products for rare diseases. The Company’s lead programs are ABO-101 (AA9 NAGLU) and ABO-102 (scAAV9 SGHG), adeno-associated virus (AAV)-based gene therapies for Sanfilippo syndrome (Mucopolysaccharidosis (MPS) IIIA and IIIB) in collaboration with patient advocate groups, researchers and clinicians. The Company is also developing ABO-201 (scAAV9 CLN3) gene therapy for juvenile Batten disease (JBD), and ABO-301 (AAV LK19 FANCC) for Fanconi anemia (FA) disorder using a clustered, regularly interspaced short palindromic repeats (CRISPR)/Cas9-based gene editing approach to gene therapy program for rare blood diseases. It is developing rare plasma protein therapies, including PTB-101 SDF Alpha (alpha-1 protease inhibitor) for inherited chronic obstructive pulmonary disease. Its product pipeline also consists of MuGard and ProdiGard.