25-NSE - Axcella Health Inc. (0001633070) (Subject)

8-K - Axcella Health Inc. (0001633070) (Filer)

8-K - Axcella Health Inc. (0001633070) (Filer)

8-K - Axcella Health Inc. (0001633070) (Filer)

8-K - Axcella Health Inc. (0001633070) (Filer)

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DEF 14A - Axcella Health Inc. (0001633070) (Filer)

8-K - Axcella Health Inc. (0001633070) (Filer)

PRE 14A - Axcella Health Inc. (0001633070) (Filer)

Chardan Capital reiterated coverage of Axcella Health with a rating of Buy and set a new price target of $12.00 from $10.00 previously

Noble Capital Markets initiated coverage of Axcella Health with a rating of Outperform and set a new price target of $6.00

Goldman Sachs downgraded Axcella Health from Buy to Neutral and set a new price target of $5.00 from $9.00 previously

JP Morgan downgraded Axcella Health from Neutral to Underweight

HC Wainwright & Co. initiated coverage of Axcella Health with a rating of Buy and set a new price target of $14.00

Chardan Capital Markets resumed coverage of Axcella Health with a rating of Buy and set a new price target of $16.00 from $10.00 previously

Chardan Capital reiterated coverage of Axcella Health with a rating of Buy and set a new price target of $10.00 from $16.00 previously

– AXLA common stock expected to begin trading on a split-adjusted basis on September 19, 2023 – 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 its Board of Directors has approved a 1-for-25 reverse stock split of the Company's common stock. The reverse stock split will become effective at 5:00 p.m. Eastern Time on September 18, 2023, after close of trading on The Nasdaq Global Market. The Company's common stock is expected to commence trading on a split-adjusted basis when the markets open on Septembe

Claims cover methods of treating a subject presenting with fatigue from post-acute sequelae of COVID-19 (PASC), a/k/a Long COVID, with Candidate AXA1125 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 anticip

AXA1125 remains the most advanced product to help patients experiencing fatigue post acute COVID-19 The Company continues to pursue a strategic alternative for stakeholders 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 financial results for the second quarter ended June 30, 2023 and provided a business update. "Patients are seeking relief from Long COVID fatigue. Axcella's proprietary composition of amino acids in AXA1125 in Long COVID fatigue is potentially an important step to help people mainta

Long COVID Phase 2b/3 clinical trial may proceed under U.S. Investigational New Drug application MHRA guidance aligns on key measurements for a Long COVID registration trial, including primary endpoint and trial design elements Lancet eClinical Medicine published findings from the Phase 2a clinical trial of AXA1125 in Long COVID Fatigue online on April 14, 2023 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. "Patients are s

Dr. Lucy E.M. Finnigan will present on the Phase 2a clinical trial of AXA1125 in Long COVID Fatigue on April 18 Dr. Finnigan will also report on AXA1125 treatment effects on biomarkers of mitochondrial energetics and vascular endothelial function on April 17 Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced two oral presentations of results from the Phase 2a clinical trial of AXA1125 in the treatment of Long COVID Fatigue at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), as a hybrid event

Long COVID Phase 2b/3 study may proceed under U.S. Investigational New Drug application MHRA guidance aligns on key measurements for a Long COVID registration trial, including primary endpoint and trial design elements Axcella presented at Long COVID forum co-sponsored by BIO and Solve M.E. The Company repositioned its strategy to focus on Long COVID Engaged an investment bank to act as a strategic advisor as we explore a range of strategic alternatives to maximize stakeholder value 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, t

Phase 2b/3 study may proceed under U.S. Investigational New Drug application Study design now accepted by U.S. and U.K. regulatory authorities Axcella to present at Long COVID forum co-sponsored by BIO and Solve M.E. Axcella to host a conference call February 16 at 8:00 a.m. ET; To register, click here Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced its Investigational New Drug (IND) application to initiate a phase 2b/3 trial in the U.S. for AXA1125 in the treatment of Long COVID Fatigue has been cleared by the U.S. F

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 that CEO Bill Hinshaw will present a company update at SVB Securities' 2023 Global Biopharma Conference, taking place virtually February 14-16, 2023. Details for Axcella's participation are as follows: Date:   Thursday, February 16, 2023 Time:   11:20 am Eastern Time Webcast:   https://wsw.com/webcast/svb8/axla/1608786 The conference call webcast will be accessible in the Investors & News section on the company's website at www.axcellatx.com. An archive

MHRA guidance aligns on key measurements for a registration trial, including primary endpoint and trial design elements IND for phase 2b/3 trial submitted to the FDA Axcella to host a conference call Tuesday, January 24 at 8:00 a.m. ET; To register, click here 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

Move Positions Company to Best Focus on Long COVID Program Axcella Therapeutics (NASDAQ:AXLA), a biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announces a repositioning of its strategy to focus on Long COVID and realize value from its platform and current programs. The company has initiated a process to explore a range of strategic alternatives to maximize shareholder value and is working with an investment bank to act as a strategic advisor for this process. As part of this repositioning, and to align with its current capital constraints, the company is announcing a series of organiza

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Phase 2b/3 study may proceed under U.S. Investigational New Drug application Study design now accepted by U.S. and U.K. regulatory authorities Axcella to present at Long COVID forum co-sponsored by BIO and Solve M.E. Axcella to host a conference call February 16 at 8:00 a.m. ET; To register, click here Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced its Investigational New Drug (IND) application to initiate a phase 2b/3 trial in the U.S. for AXA1125 in the treatment of Long COVID Fatigue has been cleared by the U.S. F

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 that CEO Bill Hinshaw will present a company update at SVB Securities' 2023 Global Biopharma Conference, taking place virtually February 14-16, 2023. Details for Axcella's participation are as follows: Date:   Thursday, February 16, 2023 Time:   11:20 am Eastern Time Webcast:   https://wsw.com/webcast/svb8/axla/1608786 The conference call webcast will be accessible in the Investors & News section on the company's website at www.axcellatx.com. An archive

MHRA guidance aligns on key measurements for a registration trial, including primary endpoint and trial design elements IND for phase 2b/3 trial submitted to the FDA Axcella to host a conference call Tuesday, January 24 at 8:00 a.m. ET; To register, click here 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

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 that it plans to report its third quarter 2022 financial results and other business updates on November 1, 2022. The company will host a conference call at 8:30am ET that morning. Details for the webcast are as follows: Date: Tuesday, November 1, 2022 Time: 8:30 am Eastern Time Domestic: 1-877-407-9039 International: 1-201-689-8470 Conference ID: 13733798 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1577553&tp_key=73325b69f8

Subjects enrolled with biopsy confirmed NASH experienced clinically and statistically significant improvements in liver stiffness as measured by FibroScan, a non-invasive measure of liver fibrosis Subjects with NASH experienced clinically and statistically significant improvements in alanine aminotransferase (ALT), a measure of liver cell inflammation, at both dose levels of AXA1125 Findings demonstrate improvement in hepatic fat as measured by MRI-PDFF AXA1125 continues to demonstrate a safe and well tolerated profile Axcella to host a conference call today at 8:00 a.m. ET; To register, click here Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering

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 that management will participate in a fireside chat and one-on-one meetings at the H.C. Wainwright Global Investment Conference taking place September 12 – 14, 2022 both virtually and in-person in New York City. Details for the fireside chat are as follows: Date: Tuesday, September 13, 2022 Time: 10:30 am Eastern Time Webcast: https://journey.ct.events/view/6604fa89-69be-476a-b518-b615e1ac7fb6 The conference call webcast will be accessible in the Inv

Subjects with Long COVID receiving AXA1125 experienced a clinically and statistically significant improvement in mental (p=0.0097) and physical (p=0.0097) fatigue scores compared to placebo subjects Responders to AXA1125 demonstrated significantly improved scores during a 6 minute walk test No emergent adverse events (AEs) or serious adverse events (SAEs) occurred Regulatory meetings are planned to discuss a path to registration trial Axcella to host a conference call today at 8:00 a.m. ET; To register, click here Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic

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 that management will participate in a fireside chat and one-on-one meetings at the H.C. Wainwright Global Investment Conference taking place May 23 – 26, 2022 both virtually and in-person in Miami, Florida. Details for the fireside chat are as follows: Date:           Tuesday, May 24, 2022 Time:           2:30pm Eastern Time Webcast:           https://journey.ct.events/view/aab5cfb6-d963-46cc-91d6-a795c1b2436c The conference call webcast will be accessi

Conference call to take place at 8:30 a.m. ET 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 that it plans to report its fourth quarter and year end 2021 financial results and other business updates on March 30, 2022. The company will host a conference call at 8:30 a.m. ET that morning. The conference call webcast will be available in the Investors & News section on the company's website at www.axcellatx.com. To access the call via telephone, please dial (844) 808-7139 (U.S. toll free) or (412) 902-0127 (international) five

Conference call to take place at 8:30 a.m. ET Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it plans to report its second quarter 2021 financial results and other business updates on July 29, 2021. The company will host a conference call at 8:30 a.m. ET that morning. The conference call webcast will be available in the Investors & News section on the company's website at www.axcellahealth.com. To access the call via telephone, please dial (844) 808-7139 (U.S. toll free) or (412) 902-0127 (international) five minutes prior to t

Werner Brings More Than Two Decades of Pharmaceutical Leadership to the Role CAMBRIDGE, Mass., April 11, 2022 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, today announced it has strengthened its executive leadership team with the appointment of Michelle C. Werner to the dual role of CEO-Partner of Flagship Pioneering and Chief Executive Officer of Alltrna. Werner brings to Flagship significant experience as a global pharmaceutical leader spanning both Commercial and Research and Development (R&D) responsibilities.  Werner most recently served as Wo

CAMBRIDGE, Mass., Feb. 28, 2022 /PRNewswire/ -- Alltrna, a Flagship Pioneering company unlocking transfer RNA (tRNA) biology and pioneering tRNA therapeutics to regulate the protein universe and resolve disease, today announced the appointment of Anne Pariser, M.D., as Vice President, Medical and Regulatory Affairs. Prior to joining Alltrna, Dr. Pariser was the Director of the Office of Rare Diseases Research (ORDR) at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), whose mission is to advance rare diseases research through a variety of research programs. Prior to ORDR, she worked at the U.S. Food and Drug Administration (FDA) Center for

CAMBRIDGE, Mass., Feb. 15, 2022 /PRNewswire/ -- Invaio Sciences, Inc., a Flagship Pioneering company focused on unlocking the potential of the planet's interdependent natural systems to solve pressing agricultural, sustainability, and environmental challenges, today announced the appointment of Hugh Grant to its Board of Directors. Grant brings nearly 40 years of agricultural and corporate leadership, including as Chairman, President, and Chief Executive Officer of the former Monsanto Company, a global provider of technology-based solutions and agricultural products. During h

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 the appointment of Robert Crane as the company's new Chief Financial Officer. "Bob brings a wealth of life sciences experience to Axcella at an important and exciting juncture in the company's evolution," said Axcella President and Chief Executive Officer Bill Hinshaw. "We look forward to benefiting from his financial acumen, operational mindset and deep understanding of corporate value drivers as we approach multiple clinical readouts this year and the opportunity to scale our

CAMBRIDGE, Mass., Jan. 26, 2022 /PRNewswire/ -- Senda Biosciences, Inc., a company that is harnessing nature to program targeted, potent and tunable medicines, has appointed Stuart Milstein, Ph.D., to the newly created position of Senior Vice President and Head of Platform Biology. Dr. Milstein most recently served as the Vice President of platform biology at Korro Bio, Inc., and previously led the RNAi Lead Development group at Alnylam Pharmaceuticals, Inc. Dr. Milstein will be responsible for advancing Senda's platform and scaling the Company's efforts to unlock a new class of fully programmable medicines.

CAMBRIDGE, Mass., Jan. 25, 2022 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, announced today that Tom DiLenge has joined the company in a newly created role as Senior Partner, Global Public Policy, Regulatory & Governmental Strategy. In this role, DiLenge will lead and develop Flagship's public policy, regulatory, and government affairs functions to advance Flagship's priorities at the federal, state, and global levels. In addition, he will serve as an in-house advisor and expert resource to Flagship's ecosystem companies. Tom brings to Flagship Pi

Estepan brings to Cellarity's BOD deep experience and expertise in all aspects of finance, corporate strategy, investor relations, and business development, and a dedication to directly improving patient lives through innovation in medicine Cellarity, a life sciences company founded by Flagship Pioneering to transform the way medicines are discovered, announced today the appointment of Ian M. Estepan to its Board of Directors. Mr. Estepan currently serves as Executive Vice President and Chief Financial Officer (CFO) of Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases. At Sarepta and as a member of Sarepta's Executive Committee, he leads f

CAMBRIDGE, Mass., Nov. 15, 2021 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, announced today that Justine Levin-Allerhand, Ph.D., has joined the company in a newly created role as Senior Partner, Corporate Development. In this role, Levin-Allerhand will develop, lead, and implement best practices in Board governance, Board development, and Board member selection and recruitment across Flagship's enterprise of companies. In addition, she will advance corporate development broadly, including building new relationships with limited partners and building partnerships with aligned research and academic institutions.

New Board Members Will Help Advance ‘Gene Writing' Platform and Mission to Cure Disease by Writing in the Code of Life Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of Elliott Sigal, M.D., Ph.D. and Mary Rozenman, Ph.D. to the company's Board of Directors. This announcement represents the latest key development for Tessera, following the March appointments of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations, and a $230 million Series B fundraising round in January. "Elliott and Mary brin

AXA1665 IND application cleared by FDA for the reduction in risk of recurrent OHE AXA1125 IND application cleared by FDA for the treatment of NASH Initiation of AXA1665 Phase 2 and AXA1125 Phase 2b clinical trials expected shortly Company to host conference call at 8:30 a.m. ET today Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced financial results for the first quarter ended March 31, 2021 and provided a business update. "Already in 2021, we have made tremendous progress in advancing our EMM platform and our mission to brin