The investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly decreased the risk of death or disease progression and increased progression-free survival compared with standard-of-care endocrine therapy for postmenopausal patients with estrogen receptor (ER)-positive/HER2-negative metastatic breast cancers that progressed on prior endocrine and targeted therapies, according to results from the...
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Stealth BioTherapeutics is planning a Phase 2a clinical trial of elamipretide (SS-31) as a treatment for people with vision loss and/or heart disease associated with Friedreich’s ataxia (FA). The company expects to use data from this study — planned to start later this year — in designing a pivotal clinical...
In patients with cystic fibrosis (CF) and Phe508del–gating or Phe508del–residual function genotypes, the use of elexacaftor (ELX)-tezacaftor (TEZ)-ivacaftor (IVA) triple therapy has demonstrated safety and efficacy, conferring additional benefits relative to prior cystic fibrosis transmembrane conductance regulator (CFTR) modulators. These were among the results of research recently published in The New England Journal of...
Washington DC – Eli Lilly’s Omvoh (mirikizumab) secured approval from the US Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis (UC) in adults after a past rejection earlier this year. In April, the agency rejected the biologic licence application (BLA) for Omvoh citing...
BOSTON, Mass. — Elicio Therapeutics, Inc., a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced that the first patient has been dosed at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research, New York, as part of the randomized Phase...
BOSTON, Mass. — Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the publication of promising preclinical data in Cancer Immunology Research, a journal of the American Association for Cancer Research (“AACR”). These preclinical data...
In April 2020, as the world went into lockdown and laboratories shuttered, Elizabeth Berry-Kravis was on the move. Her team’s clinical trial of a potential treatment for fragile X syndrome — one of the most common inherited forms of intellectual disability and a leading genetic cause of autism — was nearly complete. But she and her...
WALTHAM, Mass. – Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) today announced the addition of a new study arm in the ongoing global Phase 2 clinical program for ELX-02 for the treatment of cystic fibrosis (CF) in patients with at least one G542X allele. The Phase 2 clinical program now includes a...
PINE BROOK, N.J. and BASEL, Switzerland — Elusys Therapeutics and Lonza Sales AG entered into an agreement for the production of Anthim(TM), a therapeutic monoclonal antibody in late stage development for the treatment of anthrax infection. Under this agreement, Lonza will provide process development services and manufacturing capacity for this...
Elypta announces the enrollment of the first patient in the newly initiated AURORAX-0093A (AUR93A) study. AUR93A is intended to explore Elypta’s metabolism-based liquid biopsy platform for the prognosis of muscle-invasive bladder cancer (MIBC) before neoadjuvant chemotherapy. The first patient was enrolled at San Raffaele Hospital, Milan, Italy. AUR93A In AUR93A,...