Flagship-founded Axcella Health is closing its doors, with stockholders approving the dissolution of the metabolic modulator biotech yesterday.
Axcella Announces Reverse Stock Split Effective September 19, 2023
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company focused on pioneering a new approach to address the biology of complex diseases using compositions of endogenous metabolic modulators (EMMs), today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 11,737,999 with claims covering methods of use of Candidate AXA1125, for treating a subject having post-acute sequelae of COVID-19 (PASC), a/k/a Long COVID, particularly fatigue. The patent was issued on August 29, 2023, with anticipated expiration in 2042.
Axcella Reports Second Quarter Financial Results and Provides Business Update
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the first quarter ended March 31, 2023 and provided a business update.
Axcella Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Axcella Announces FDA IND Clearance Supporting Regulatory Path to Registration of AXA1125 for Long COVID Fatigue
In December, Axcella laid off 85% of its workforce and said it was looking for “strategic alternatives,” but for now it’s still pushing forward with its long Covid trial plans.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, announced a regulatory path to registration of AXA1125 in the treatment of Long COVID Fatigue. The company reported that it had received regulatory guidance from The Medicines and Healthcare products Regulatory Agency (MHRA), the U.K.’s regulatory agency, supporting a single trial that could serve as the registration trial for patients with Long COVID fatigue, and aligning on key measurements, including primary endpoint and trial design. Axcella will be meeting with the MHRA in the near term to discuss the Innovative Licensing and Access Pathway (ILAP) application. The company further reported submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for a Phase 2b/3 trial.
After missing its primary goal in Phase IIa trials for its long Covid drug, Axcella Health announced Wednesday that it’s cutting 85% of its workforce, has hired a bank to explore strategic alternatives, and is reshuffling its pipeline.