LUCIDITY met FDA-agreed-upon primary endpoint; avexitide demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003) LUCIDITY met all secondary endpoints showing consistent, highly statistically significant, and clinically meaningful reductions in Level 2 by self-monitoring of blood glucose (SMBG), Level 2 by CGM, and Level 3 hypoglycemic events Avexitide was generally well-tolerated with a favorable safety profile Amylyx plans t

Aug. 18, 2026 -- BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BH-30643 for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung can

ANS-858 is being developed to reduce pathological craving associated with alcohol and other substance use disorders. Amygdala's ALDH2 inhibitor platform offers additional therapeutic opportunities in binge eating, obesity, and precision oncology. PALO ALTO, Calif., Aug. 18, 2026 /PRNewswire/ -- Amygdala Neurosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ANS-858, enabling the Company to adva

Hoag Hospital joins Aqua Medical's multi-center RESTORE-I study as its Irvine Hoag team, led by Dr. Jennifer Phan, delivers a milestone procedure and Dr. Phan becomes the first woman interventional endoscopist in the U.S. to perform it. Aug. 18, 2026 -- Aqua Medical, Inc., a clinical-stage medical technology company advancing Endoscopic Metabolic Restoration, today announced the treatment of the first West Coast patient (second overall in the US) in the company's FDA-approved Investigational De

Aug. 18, 2026 -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, today announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM7004 for the treatment of advanced solid tumors. HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the Company's HBI

Shares in Amylyx Pharmaceuticals jumped more than 30% on Tuesday after the company reported that a Phase III study of avexitide in people with post-bariatric hypoglycaemia (PBH) met its primary endpoint, setting up an FDA filing for the GLP-1 receptor antagonist by the end of the year. "Together with the positive data generated across five previous clinical trials of avexitide in PBH, we believe the LUCIDITY results bring us one step closer to potentially delivering the first approved treatment

AKTX-101 demonstrated robust anti-tumor activity across multiple clinically relevant urothelial cancer preclinical models Data supports the potential of Akari’s novel PH1 RNA spliceosome-modulating payload to overcome payload-specific resistance Results strengthen the rationale for a differentiated ADC sequencing strategy as ADC use expands across oncology and more patients require treatment following relapse Akari advancing IND-enabling activities for AKTX-101 toward planned Phase 1 clinical d

CHARM Therapeutics announces formation of Clinical Advisory Board to support advancement of CHM-029, its next-generation menin inhibitor 18 August 2026 -- CHARM Therapeutics (“CHARM”, “The Company”), a biotechnology company addressing resistance in acute myeloid leukemia (AML) with a best-in-class menin inhibitor, announces the formation of its Clinical Advisory Board to support the advancement of CHM-029 into clinical studies for AML, an aggressive cancer of the blood and bone marrow. The Cli

— ONC-783 is the first-and-only clinical-stage T-cell engager targeting a cancer-specific glycoform of CD24 (neoCD24) — — Subcutaneous formulation designed to provide gradual systemic exposure, potentially mitigating CRS risk — Aug. 17, 2026 -- OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today announced dosing of the first patient following the clearance of the Investigational New Drug (IND) application for a

argenx said Monday the subcutaneous (SC) version of its human IgG1 antibody fragment Vyvgart (efgartigimod alfa), marketed as Vyvgart Hytrulo, cleared a Phase III trial in adults with autoimmune myositis. "For decades, people living with autoimmune myositis have relied on corticosteroids and broad immunosuppression," said Luc Truyen, chief medical officer of argenx, noting that "precision targeting of FcRn with [Vyvgart] can deliver meaningful benefit in this disease." The late-stage portion o