Emms

Axcella Announces Program Reprioritization and Corporate Restructuring

Retrieved on: 
Thursday, December 15, 2022
Health, Infectious Diseases, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, Biotechnology, Therapy, Security (finance), COVID-19, Homeostasis, Recurrence, Fatigue, IND, Regulation, Patient, Science, NASH, COVID, Non-alcoholic fatty liver disease, File, Compte rendu, Disclosure, Disease, FDA, Emms, FAQ, Hinshaw, Risk, Clinical trial, LSM, Safety, Regulation Fair Disclosure, OHE, EMM, Pharmaceutical industry, Long COVID

Axcella will reprioritize its efforts to focus on the significant unmet need and opportunity presented by Long COVID.

Key Points: 
  • Axcella will reprioritize its efforts to focus on the significant unmet need and opportunity presented by Long COVID.
  • Axcella is engaged in ongoing and productive reviews with regulators in the U.S. and Europe, and the company is aiming to advance its Long COVID Fatigue program into a potential registration trial.
  • Axcella will be discontinuing its ongoing Phase 2b clinical trial of AXA1125 in NASH, while keeping the option to revisit this program should resource availability change.
  • In September, Axcella reported positive data from a preplanned interim analysis from their trial of AXA1125 in NASH.

Axcella to Present at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting

Retrieved on: 
Thursday, November 3, 2022
Nursing, Biotechnology, Other Health, Health, General Health, Pharmaceutical, Research, Infectious Diseases, Genetics, Science, Clinical Trials, Booth, Disclosure, File, Homeostasis, Research, Recurrence, U.S. Securities and Exchange Commission, EMM, OHE, NASH, Biomarker, American Association for the Study of Liver Diseases, IND, Gastroenterology, Therapy, Institute of Liver and Biliary Sciences, Plasma, AASLD, Metabolism, Transplant, Review, Securities Act of 1933, FAQ, Annual general meeting, Liver disease, Risk, Anesthesiology, Surgeon, Radiology, Security (finance), American Association, Emms, Regulation, Association, Treatment, Patient, Regulation Fair Disclosure, Pharmaceutical industry, Medical imaging, Long COVID

With 8,000 attendees The Liver Meeting is the worlds premier meeting on liver disease.

Key Points: 
  • With 8,000 attendees The Liver Meeting is the worlds premier meeting on liver disease.
  • The information that we post on our website could be deemed to be material information.
  • Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs).
  • The companys unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials.

Axcella Reports Third Quarter Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 1, 2022
COVID-19, Infectious Diseases, Finance, Clinical Trials, Professional Services, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Homeostasis, Security (finance), Regulation Fair Disclosure, Fatty liver disease, LSM, Disclosure, Flagship Pioneering, Board of directors, Cirrhosis, COVID, Inflammation, Leadership, U.S. Securities and Exchange Commission, Regulation, SEC, Board, D, IND, Fibrosis, COVID-19, FAQ, Securities Act of 1933, File, EMM, KPA, Research, ALT, Emms, NASH, Metabolism, Private Securities Litigation Reform Act, Company, Therapy, Review, FDA, Patient, Compte rendu, Fatigue, Pharmaceutical industry, Long COVID

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 third quarter ended September 30, 2022 and provided a business update.

Key Points: 
  • 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 third quarter ended September 30, 2022 and provided a business update.
  • This has been an extremely exciting period for Axcella, said Bill Hinshaw President and Chief Executive Officer of Axcella.
  • Clinical Results in the Quarter:
    The quarter saw progress in the clinical development of AXA1125, an orally delivered potent and safe compound addressing two very large markets: Long-COVID and NASH.
  • This included the release of top-line results in Long COVID and an interim analysis of the Phase 2b EMMPACT trial in NASH.

Axcella Therapeutics to Report Third Quarter 2022 Financial Results on November 1, 2022

Retrieved on: 
Thursday, October 27, 2022
Health, Biotechnology, IND, File, FAQ, Regulation Fair Disclosure, U.S. Securities and Exchange Commission, Review, Securities Act of 1933, Emms, Regulation, Security (finance), Homeostasis, Disclosure, EMM, NASH, Pharmaceutical industry

The information that we post on our website could be deemed to be material information.

Key Points: 
  • The information that we post on our website could be deemed to be material information.
  • As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis.
  • Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs).
  • The companys unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials.

Axcella Therapeutics to Participate in the H.C. Wainwright 6th Annual NASH Investor Conference

Retrieved on: 
Friday, October 14, 2022
Health, Diabetes, Clinical Trials, General Health, Pharmaceutical, Biotechnology, U.S. Securities and Exchange Commission, EMM, Securities Act of 1933, Webcast, Regulation Fair Disclosure, Investor, Review, IND, Security (finance), NASH, FAQ, Regulation, Emms, File, Homeostasis, Disclosure, Pharmaceutical industry

An archive of the webcast replay will be available on the Companys website for up to 90 days.

Key Points: 
  • An archive of the webcast replay will be available on the Companys website for up to 90 days.
  • Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts.
  • Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs).
  • Axcellas pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and NASH.

Axcella Therapeutics Announces $34.2 Million Registered Direct Offering of Common Stock Priced At The Market: Appoints Two New Board Members

Retrieved on: 
Thursday, October 13, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, CFO, Compte rendu, EMM, Social Security Act 1938, Sale, Inari, Therapy, SEC, Regulation Fair Disclosure, Partner, Review, IND, Pfizer, Motivation, Patient, Security (finance), Long, Securities Act of 1933, Flagship Pioneering, Technology, NASH, Private Securities Litigation Reform Act, Board, Company, FAQ, Partnership, CEO, Emms, Regulation, U.S. Securities and Exchange Commission, File, Board of directors, Homeostasis, Fatty liver disease, Disclosure, Chief executive officer, McKinsey & Company, FDA, COVID-19, Leadership, Pharmaceutical industry, Share (finance), Long COVID, Flagship

Since this offering was made without an underwriter or a placement agent, Axcella did not pay any underwriting discounts in connection with the transaction.

Key Points: 
  • Since this offering was made without an underwriter or a placement agent, Axcella did not pay any underwriting discounts in connection with the transaction.
  • A final prospectus supplement, which contains additional information relating to the offering, has been filed with the SEC and is available on the SECs website at www.sec.gov .
  • He came to Flagship after a thirty-year career at McKinsey advising CEOs and Boards of leading healthcare, technology and consumer companies.
  • With Mr. Rosiello and Mr. Straight Nissen joining the Board, David Epstein will step down as Chairman and from the Board.

Axcella Announces Positive Interim Data from Phase 2b EMMPACT Study of AXA1125 in Nonalcoholic Steatohepatitis (NASH)

Retrieved on: 
Thursday, September 29, 2022
Health, FDA, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Regulation, EMM, Fatty liver disease, Inflammation, Safety, FAQ, COVID-19, Fibrosis, FDA, Biomarker, Securities Act of 1933, ALT, NASH, IND, Liver disease, Review, Private Securities Litigation Reform Act, Therapy, Metabolism, File, U.S. Securities and Exchange Commission, KPA, Emms, Compte rendu, Regulation Fair Disclosure, T2DM, Elastography, LSM, Cirrhosis, Security (finance), NIT, SEC, Mortality, Biopsy, National Institutes of Technology, Disclosure, Pharmaceutical industry

These interim results report findings regarding the effects of AXA1125 administration on selected outcome measures after 12- and 24-weeks of treatment.

Key Points: 
  • These interim results report findings regarding the effects of AXA1125 administration on selected outcome measures after 12- and 24-weeks of treatment.
  • Specifically, the study examines liver stiffness, changes of which have been correlated with improvements in liver fibrosis and outcomes in clinical studies.
  • Study participants were randomized 1:1:1 to receive either a placebo or 22.6g or 33.9g of AXA1125 twice daily.
  • Axcellas pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH).

Axcella Therapeutics to Participate in the H.C. Wainwright Global Investment Conference

Retrieved on: 
Monday, September 12, 2022
Health, Diabetes, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Regulation, EMM, Investor, FAQ, Homeostasis, Securities Act of 1933, NASH, IND, Review, File, U.S. Securities and Exchange Commission, Emms, Regulation Fair Disclosure, Security (finance), Disclosure, Pharmaceutical industry

The conference call webcast will be accessible in the Investors & News section on the companys website at www.axcellatx.com .

Key Points: 
  • The conference call webcast will be accessible in the Investors & News section on the companys website at www.axcellatx.com .
  • An archive of the webcast replay will be available on the Companys website for up to 90 days.
  • Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts.
  • Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs).

Axcella Reports Second Quarter Financial Results and Provides Business Update

Retrieved on: 
Friday, August 12, 2022
Biotechnology, Infectious Diseases, COVID-19, Health, Pharmaceutical, FDA, U.S. Securities and Exchange Commission, Compte rendu, Securities Act of 1933, Disclosure, Fatty liver disease, FAQ, Regulation Fair Disclosure, Private Securities Litigation Reform Act, SEC, Clinical trial, Leadership, IND, University of Oxford, Security (finance), Patient, Review, Therapy, NASH, COVID-19, Company, EMM, D, Research, Physician, Regulation, File, Emms, Pharmaceutical industry, Long COVID

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 second quarter ended June 30, 2022 and provided a business update.

Key Points: 
  • 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 second quarter ended June 30, 2022 and provided a business update.
  • We continued this leadership through the second quarter as we advanced the development of our two clinical programs for AXA1125.
  • The results were extremely encouraging and showed that administration of AXA1125 to patients significantly reduced mental and physical fatigue, said Bill Hinshaw, President and Chief Executive Officer of Axcella.
  • R&D Expenses: Research and development expenses for the quarter and six months ended June 30, 2022 were $16.9 million and $30.4 million, respectively.

Axcella Announces Highly Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID

Retrieved on: 
Tuesday, August 2, 2022
COVID-19, Infectious Diseases, FDA, Clinical Trials, Biotechnology, Managed Care, Health, Pharmaceutical, General Health, Infection, Securities Act of 1933, FAQ, University, Fatigue, Congress, Literature, EMM, U.S. Securities and Exchange Commission, Â, Disclosure, CEO, SEC, Biomarker, University of Oxford, Cardiology, Randomized controlled trial, File, Private Securities Litigation Reform Act, NASH, MRS, Associate, Emms, Chronic fatigue syndrome, Therapy, COVID-19, Safety, Regulation, Degenerative disease, Inflammation, Clinical trial, Review, FDA, Company, Security (finance), Patient, COVID, Regulation Fair Disclosure, Fatty liver disease, IND, Pharmaceutical industry, Medical imaging, Long COVID

The recent Congressional subcommittee on Long COVID stated that one million Americans have been pushed out of work due to Long COVID.

Key Points: 
  • The recent Congressional subcommittee on Long COVID stated that one million Americans have been pushed out of work due to Long COVID.
  • Additionally, it was stated that Long COVID contributed to approximately $1 trillion in lost earnings and $529 billion in increased medical spending.
  • Bill Hinshaw, CEO of Axcella, remarked, At Axcella, once we understood we had a potential Long COVID intervention we acted rapidly to test the hypothesis that we could address the high and growing need that exists for patients living with debilitating Long COVID fatigue.
  • Axcellas pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH).