Axcella Health Stock Price, News & Analysis

Axcella Therapeutics (Nasdaq: AXLA) announced two oral presentations on AXA1125 from its Phase 2a clinical trial for Long COVID Fatigue at the European Congress of Clinical Microbiology & Infectious Diseases in Copenhagen from April 15-18, 2023. Dr. Lucy E.M. Finnigan will detail results showing significant improvements in mental and physical fatigue among patients treated with AXA1125 compared to a placebo (p=0.0097). Additionally, biomarker analysis indicated enhanced mitochondrial function recovery and trends toward reduced plasma FGF-21 and serum lactate levels. The Phase 2b/3 study design for AXA1125 has received acceptance from both the FDA and U.K.'s MHRA. Axcella is focused on addressing the urgent need for effective Long COVID treatments, which affect millions globally.

Axcella Therapeutics (Nasdaq: AXLA) announced financial results for the fourth quarter and full year ended December 31, 2022, alongside a strategic shift to focus on Long COVID treatments. The company reported a net loss of $81.2 million for 2022, up from $64.6 million in 2021, attributed to increased clinical trial expenses and restructuring charges. Axcella successfully cleared its Investigational New Drug (IND) application for a Phase 2b/3 trial of AXA1125, which demonstrated significant improvements in fatigue in a previous Phase 2a trial. The company raised around $60 million to support ongoing trials, but its cash position decreased to $17.1 million by year-end 2022.

Axcella Therapeutics (Nasdaq: AXLA) announced FDA clearance for its Investigational New Drug application to initiate a phase 2b/3 trial of AXA1125 targeting Long COVID Fatigue. The trial is set to be the registration study and has gained acceptance from both U.S. and U.K. regulatory authorities. Positive results from a previous Phase 2a trial showed statistically significant improvements in mental and physical fatigue in patients treated with AXA1125. The study is expected to enroll participants with fatigue lasting over 12 weeks post-COVID-19 infection, aiming to provide a much-needed treatment for millions suffering from Long COVID Fatigue.

Axcella Therapeutics (Nasdaq: AXLA), a biotechnology company focused on treating complex diseases, announced that CEO Bill Hinshaw will provide a company update at the SVB Securities’ 2023 Global Biopharma Conference from February 14-16, 2023. Axcella will present on February 16 at 11:20 am ET. The virtual event can be accessed through a webcast, also available on the company’s website, where a replay will be hosted for 90 days. Axcella’s innovative approach utilizes multi-targeted endogenous metabolic modulators (EMMs) to address conditions like Long COVID and NASH, enhancing cellular energetics and restoring balance.

Axcella Therapeutics (Nasdaq: AXLA) has received regulatory guidance from the MHRA supporting a single trial for AXA1125 in treating Long COVID Fatigue. The company submitted an IND to the FDA for a Phase 2b/3 trial. The MHRA has aligned on key measurements and trial design for the registration trial. Axcella reported statistically significant improvements in mental and physical fatigue in patients from a Phase 2a trial. Long COVID affects approximately 100 million patients globally, with fatigue being a primary symptom, leading to substantial economic impacts. Axcella aims to advance its program rapidly, addressing urgent treatment needs.

Axcella Therapeutics (Nasdaq: AXLA) is shifting its strategic focus towards Long COVID to maximize shareholder value. The company is exploring strategic alternatives with an investment bank. Key updates include prioritizing the Long COVID Fatigue program and discontinuing the Phase 2b trial of AXA1125 in Nonalcoholic Steatohepatitis (NASH). Organizationally, Axcella is reducing its workforce by 85%. The company has also reached an agreement with SLR Investment Corp. to pay down debt obligations. Axcella is engaged with regulators in the U.S. and Europe to advance its Long COVID initiatives.