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Axcella Health Inc. (NASDAQ: AXLA) is an innovative biotechnology company dedicated to pioneering new therapeutic solutions through its proprietary Defined Amino Acid Compositions (DAACs™). These compositions harness the essential signaling capabilities of amino acids to address and rectify dysregulated pathways, offering safer treatments for patients with complex diseases.
With the groundbreaking Axcelerator™ platform, Axcella is revolutionizing traditional drug discovery and development. This platform allows for the generation of comprehensive patient data in less than a year from the selection of an indication, significantly accelerating the process of bringing new therapies to market. The Axcelerator™ platform has already produced a robust pipeline of clinical programs targeting a wide range of conditions, including liver diseases, metabolic disorders, central nervous system (CNS) diseases, and orphan diseases.
Recent achievements by Axcella include notable advancements in its clinical programs. The company has made significant strides in developing treatments for liver diseases and metabolic disorders, leveraging its DAAC-based therapies to provide innovative solutions where traditional treatments fall short.
As a forward-thinking entity in the biotech space, Axcella has forged key partnerships to enhance its research and development capabilities. These collaborations are pivotal in supporting the company’s mission to deliver effective and safe therapeutic options for patients with complex and underserved medical needs.
Financially, Axcella continues to focus on sustainable growth and development. The company is actively engaged in securing funding to support its research initiatives and clinical trials. With a commitment to transparency and progress, Axcella regularly updates its investors and stakeholders on its financial condition, strategic goals, and operational milestones.
In summary, Axcella Health Inc. stands at the forefront of biotechnological innovation, offering cutting-edge solutions through DAAC therapeutics and the Axcelerator™ platform. The company’s dedication to improving patient outcomes and its proactive approach to drug development position it as a significant player in the biotech industry.
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.
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