MOLECULIN BIOTECH, INC. (NASDAQ:MBRX) Files An 8-K Other Events
Item 8.01 Other Events.
MOLECULIN BIOTECH, INC. (NASDAQ:MBRX) Files An 8-K Other Events
On February 5, 2020, Moleculin Biotech, Inc. (the “Company”) issued a press release announcing it intends to discuss with the FDA and EMA (European Medicines Agency) plans to conduct a single arm Phase 2 trial that would serve as the basis for accelerated approval of Liposomal Annamycin (“Annamycin”) to treat relapsed or refractory acute myeloid leukemia (“AML”). This will follow the establishment of a recommended Phase 2 dose (“RP2D”) in the Company’s ongoing Phase 1 dose escalation trial in Europe.
A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Press Release dated February 5, 2020
Moleculin Biotech, Inc. Exhibit
EX-99.1 2 exh991-pressreleaseplansfo.htm EXHIBIT 99.1 Exhibit Exhibit 99.1 Moleculin to Seek Accelerated FDA Approval and Plans for Pivotal Phase 2 AML Trial Following Successful Completion of US Phase 1 TrialHOUSTON,…
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EX-99.1 2 exh991-pressreleaseplansfo.htm EXHIBIT 99.1 Exhibit Exhibit 99.1 Moleculin to Seek Accelerated FDA Approval and Plans for Pivotal Phase 2 AML Trial Following Successful Completion of US Phase 1 TrialHOUSTON,…
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hereAbout MOLECULIN BIOTECH, INC. (NASDAQ:MBRX)
Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company. The Company is focused on the development of anti-cancer drug candidates. Its lead drug candidate is liposomal Annamycin, which it refers to as Annamycin, an anthracycline intended for the treatment of relapsed or refractory acute myeloid leukemia (AML). Annamycin is a Phase II clinical-stage anthracycline and liposome formulated anthracycline that has been designed to eliminate cardiotoxicity and avoid the multidrug resistance mechanisms. It has over two other drug development projects in progress, one involving a portfolio of small molecules, which it refers to as the WP1066 Portfolio, focused on the modulation of key oncogenic transcription factors involved in the progression of cancer, and the WP1122 Portfolio, a suite of molecules targeting the metabolic processes involved in cancer in general, and glioblastoma. As of September 30, 2016, it had not generated any revenue from its operations.
