Welcome to our dedicated page for Axcella Health news (Ticker: AXLA), a resource for investors and traders seeking the latest updates and insights on Axcella Health stock.
Axcella Health Inc. (NASDAQ: AXLA) is reshaping biotechnology through its pioneering work with Defined Amino Acid Compositions (DAACs™) and the Axcelerator™ platform. This page provides essential updates on the company's clinical programs, strategic partnerships, and therapeutic innovations targeting liver diseases, metabolic disorders, and CNS conditions.
Investors and industry professionals will find comprehensive coverage of AXLA's progress in developing safer, amino acid-based therapies. Our news collection features verified updates on clinical trial milestones, regulatory developments, and research collaborations that demonstrate the company's scientific leadership.
Key content areas include advancements in DAAC-based treatments, updates from the Axcelerator™ drug discovery platform, partnership announcements with research institutions, and financial disclosures. Each update is curated to help stakeholders track the company's impact on complex disease treatment.
Bookmark this page for streamlined access to Axcella's latest developments. Check back regularly for authoritative reporting on breakthroughs in metabolic health solutions and novel therapeutic approaches emerging from AXLA's innovative pipeline.
Axcella (Nasdaq: AXLA) reported its financial results for Q2 2021, highlighting significant progress in clinical trials. The EMMPOWER Phase 2 trial for AXA1665 in overt hepatic encephalopathy and the EMMPACT Phase 2b trial for AXA1125 in nonalcoholic steatohepatitis were both initiated. As of June 30, 2021, Axcella reported cash and marketable securities of $78.9 million, down from $107.3 million at the end of 2020. The net loss for Q2 2021 was $15.9 million, compared to $13.9 million in the same period last year.
Axcella (Nasdaq: AXLA) has announced that it will report its second quarter 2021 financial results on July 29, 2021. The company, known for its innovative approach to treating complex diseases with endogenous metabolic modulator (EMM) compositions, will host a conference call at 8:30 a.m. ET. Interested parties can access the call via phone or through the company's website, where a webcast archive will be available for 90 days post-event. Axcella aims to address conditions like non-alcoholic steatohepatitis (NASH) and hepatic encephalopathy recurrence.
Axcella (Nasdaq: AXLA) has initiated patient screening for its global Phase 2 clinical trial of AXA1665, targeted at reducing the risk of recurrent overt hepatic encephalopathy (OHE). This multi-center trial, named EMMPOWER, involves 150 patients and assesses both efficacy and safety over 24 weeks, with a focus on improving neurocognitive function and reducing OHE events. The trial's principal investigator emphasizes the need for innovation in treating OHE, while Axcella's leadership touts AXA1665's potential as a first-line treatment for this serious condition.
Axcella (Nasdaq: AXLA) presented positive results from its AXA1665-002 clinical study at the Digestive Disease Week 2021 Annual Meeting. The study demonstrated that AXA1665, administered at doses of 29.4 g and 53.8 g, was safe and well tolerated in 60 subjects with hepatic insufficiency. Notably, the 53.8 g dose resulted in a statistically significant improvement in psychometric hepatic encephalopathy score (PHES). The company is now initiating a 24-week Phase 2 trial to explore AXA1665's efficacy in patients with advanced liver disease.
Axcella (Nasdaq: AXLA) has launched the EMMPACT Phase 2b clinical trial for AXA1125, targeting nonalcoholic steatohepatitis (NASH). The trial will enroll approximately 270 patients, assessing AXA1125's efficacy, safety, and histological impact over 48 weeks. Axcella's AXA1125 aims to address the complex mechanisms of NASH. This milestone follows the clearance of their IND application for AXA1125, indicating strong operational readiness. The trial will involve over 70 sites globally, utilizing non-invasive biomarkers alongside biopsy-confirmed outcomes.
Axcella (Nasdaq: AXLA) has activated clinical sites and initiated patient screening for its EMMPACT Phase 2b clinical trial of AXA1125, targeting NASH treatment. The trial will enroll about 270 patients, assessing the efficacy and safety of AXA1125 over 48 weeks. Primary endpoint focuses on histological improvements in NAFLD Activity Score, with secondary endpoints including fibrosis resolution. Axcella's CEO noted the trial's commencement as a significant milestone after clearing its IND application.
NASH affects up to 40 million in the U.S., with no approved treatments available.
Axcella (Nasdaq: AXLA) reported financial results for Q1 2021, highlighting significant progress in its EMM platform. The company’s IND applications for AXA1665 and AXA1125 were cleared by the FDA, paving the way for Phase 2 trials for both candidates targeting overt hepatic encephalopathy and nonalcoholic steatohepatitis, respectively. Axcella's cash reserves were $93 million, expected to last into Q3 2022, with a net loss of $15.2 million for Q1 2021. The company plans to expand its EMM pipeline and has appointed Dr. Alison Schecter as President of R&D.
Axcella (Nasdaq: AXLA), a clinical-stage biotechnology firm, announced it will report its first quarter 2021 financial results on May 6, 2021. The conference call will take place at 8:30 a.m. ET and will be accessible via telephone or webcast. The company focuses on developing endogenous metabolic modulator (EMM) compositions to treat complex diseases, with pipeline candidates targeting non-alcoholic steatohepatitis (NASH) and hepatic encephalopathy. Investors are encouraged to follow updates on the company's website as part of its material information disclosure.
Axcella (Nasdaq: AXLA) announced an oral presentation for its product candidate AXA1665 at the DDW 2021 conference, focusing on its efficacy in reducing recurrent overt hepatic encephalopathy (OHE). The presentation, titled 'A Novel, Precision-Engineered Amino Acid Composition, AXA1665, is Safe, Well-Tolerated and Improves Neurocognition and Physical Function in Child-Pugh A and B Subjects,' will be delivered by Dr. Arun Sanyal on May 23, 2021. The presentation aims to highlight AXA1665’s potential in enhancing patient outcomes related to hepatic encephalopathy.
Axcella (Nasdaq: AXLA) announced FDA clearance for its Investigational New Drug (IND) application for AXA1125, allowing it to enter a Phase 2b trial for treating nonalcoholic steatohepatitis (NASH), affecting up to 40 million Americans. The trial, set to begin in Q2 2021, will enroll approximately 270 patients across 70 sites, focusing on efficacy and safety. With previous promising results for AXA1125 in non-invasive biomarkers, the company aims to establish it as a first-line NASH treatment while addressing crucial unmet patient needs.
