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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 Therapeutics (Nasdaq: AXLA) announced it will present clinical data on plasma proteomic biomarkers for NASH at the AASLD Annual Meeting in Washington, D.C., from November 4-8, 2022. The presentation, titled Identifying Predictive Plasma Proteomic Biomarkers for Clinical™ Response to AXA1125, will occur on November 5, 2022, during a poster session. This research aims to enhance understanding of treatment responses using Axcella's innovative endogenous metabolic modulators (EMMs), which are designed to address complex diseases including NASH.
Axcella Therapeutics (Nasdaq: AXLA) reported promising results from its Phase 2 clinical trials for AXA1125 targeting Long COVID and Nonalcoholic Steatohepatitis (NASH). The company secured $34.2 million from a registered direct offering, enhancing its financial position. Positive interim data highlighted significant improvements in fatigue measures for Long COVID patients and liver stiffness for NASH. However, Axcella's cash position decreased to $25.4 million as of September 30, 2022, down from $55 million at year-end 2021, and it reported a net loss of $17.8 million for Q3 2022.
Axcella Therapeutics (Nasdaq: AXLA) has announced plans to report its third quarter 2022 financial results and business updates on November 1, 2022, at 8:30 am ET. The company is focused on treating complex diseases utilizing endogenous metabolic modulator (EMM) compositions. A conference call will be hosted, providing insights into its ongoing projects and developments. Axcella's pipeline includes candidates in Phase 2 for Long COVID and NASH.
Axcella Therapeutics (Nasdaq: AXLA) announced its participation in the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022. The company's management will engage in a fireside chat and hold one-on-one meetings, starting at 3:00 PM Eastern Time. Investors can access the webcast through the company’s website, with an archived replay available for 90 days. Axcella focuses on multi-targeted endogenous metabolic modulators to treat complex diseases, with significant developments in therapies for Long COVID and NASH.
Axcella Therapeutics (Nasdaq: AXLA) has completed a registered direct offering of 20,847,888 shares at $1.64 per share, raising gross proceeds of $34.2 million. The funds will support the Long COVID program, advance the EMMPACT Phase 2b clinical trial for NASH, and cover working capital needs. The offering closed on October 13, 2022, without underwriter fees. Additionally, Axcella announced new board appointments, including Robert Rosiello as Chairman, enhancing its leadership in therapeutics.
Axcella Therapeutics (Nasdaq: AXLA) announced encouraging interim results from the Phase 2b EMMPACT study of AXA1125 for non-alcoholic steatohepatitis (NASH). After 24 weeks, participants receiving AXA1125 showed statistically significant improvements in liver stiffness, alanine aminotransferase (ALT), and hepatic fat compared to placebo. These results affirm AXA1125's potential as a first-line treatment option for NASH, highlighting its safety and tolerability. The company expects to report topline results from the 48-week biopsy analysis in H1 2024.
Axcella Therapeutics (Nasdaq: AXLA) announced participation in the H.C. Wainwright Global Investment Conference from September 12-14, 2022, in New York City. Management will engage in a fireside chat on September 13 at 10:30 AM ET, accessible via webcast. A replay will be available for 90 days on the company's website. Interested investors can request one-on-one meetings, either virtually or in-person. Axcella is focused on treating complex diseases with endogenous metabolic modulator compositions, having candidates in development for Long COVID and NASH.
Axcella Therapeutics (AXLA) announced significant progress in its Phase 2A Long COVID trial, reporting that AXA1125 significantly reduced mental and physical fatigue in patients. Financially, the company reported cash reserves of $44.4 million as of June 30, 2022, down from $55.0 million at the end of 2021. R&D expenses increased to $16.9 million for Q2 2022, driven by ongoing clinical trials. The net loss for the quarter was $21.3 million, or $0.40 per share, compared to a loss of $15.9 million in Q2 2021. A conference call is scheduled for today at 8:30 AM ET to discuss details.
Axcella Therapeutics (Nasdaq: AXLA) announces positive topline results from a Phase 2a trial of AXA1125 for treating Long COVID fatigue. Subjects receiving AXA1125 showed significant improvements in mental (p=0.0097) and physical fatigue scores (p=0.0097) compared to placebo. Additionally, responders had better results on the 6-minute walk test. Importantly, there were no serious adverse events reported. Axcella plans regulatory meetings to discuss the next steps toward a registration trial.
Axcella Therapeutics (Nasdaq: AXLA) has prioritized its clinical development, announcing the completion of patient enrollment in its Phase 2a trial for Long COVID, with topline data expected in early Q3 2022. Interim data from the NASH trial is also anticipated in late Q3 2022. However, the company is suspending its Phase 2 trial for OHE due to enrollment challenges. Despite this, Axcella emphasizes the significance of AXA1125 in addressing Long COVID fatigue and plans to explore partnerships for AXA1665.
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