RESEARCH TRIANGLE PARK, N.C. — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the independent Data Monitoring Committee (DMC) recommended continuation of the pivotal Phase 3 trial (PRESERVE 2), evaluating trilaciclib in combination with gemcitabine and carboplatin for the first line treatment of metastatic triple negative...
treatment News
BETHESDA, Md.– Gain Therapeutics, Inc., a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the publication of preclinical data identifying a novel class of small molecule allosteric regulators that demonstrate therapeutic potential for galactosidase beta 1 (GLB1)-related lysosomal storage...
ZUG, Switzerland — Galderma today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Applications for nemolizumab for the treatment of prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to inhibit...
KENSINGTON, Md. — Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, announces encouraging data with orally available small molecule GAL-201, showing its neuroprotective and symptomatic alleviation potential in...
LONDON – GammaDelta Therapeutics Ltd. (GDT), a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, today announced that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML). GDX012 is an allogeneic, non-engineered,...
TEMPE, Ariz. — GT Medical Technologies, Inc. (GT MedTech), a medical device company with the mission of improving the lives of patients with brain tumors, today announced it has enrolled the 100th patient in its ROADS clinical study. ROADS, or Radiation One and Done Study, is the randomized control trial...
SHANGHAI – Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) announces today that the clinical trial application of ASC42 to treat patients with primary biliary cholangitis (PBC) has been accepted for review by China National Medical Products Administration (NMPA). ASC42 is an in-house developed, novel...
SHANGHAI, China — Gannex Pharma Co., Ltd. a wholly-owned company of Ascletis Pharma Inc., announces today positive interim results from the 52-week Phase II clinical trial of thyroid hormone receptor β (THRβ) agonist ASC41 tablet for treatment of patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). ASC41 is liver-targeting and highly THRβ-selective. Once-daily...
SHANGHAI — Gannex Pharma Co., Ltd. (“Gannex”), a wholly-owned company of Ascletis Pharma Inc. (HKEX:1672) announces today that the safety, pharmacokinetics (PK), and pharmacodynamics (PD) data of ASC42, a novel farnesoid X receptor (FXR) agonist, in healthy subjects have been published on the journal Drugs in R&D. In-house developed by...
New Haven, CT – Gaucher disease treatment has come a long way in the past three decades. The United States Food and Drug Administration (FDA) approved the first enzyme replacement therapy (ERT) in 1991. That first approval opened the door for other ERT treatments and paved the road for substrate...