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

Otsuka Pharmaceuticals’ Voyxact is not the only IgA nephropathy drug that can slow the decline of kidney function. Vera Therapeutics’ Trutakna, which the FDA granted accelerated approval last month, showed “impressive” stabilization, analysts say. In June, Otsuka Pharmaceuticals touted data suggesting its IgA nephropathy drug Voyxact could slow the decline of kidney function in patients—a unique benefit, analysts said at the time. Now, Vera Therapeutics seems to have taken that distinguishing a

Bayer has announced that the National Medical Products Administration (NMPA) in China has accepted for review the application for aflibercept 8 mg (114.3 mg/ml solution for injection) to treat patients with visual impairment due to macular edema following Retinal Vein Occlusion (RVO) including central, branch, and hemiretinal vein occlusion. Macular edema following RVO is a significant cause of visual impairment worldwide, including in China, and can result in sudden and rapid vision loss. Dr.

The US Food and Drug Administration (FDA) has granted priority review designation for the new drug application for tinlarebant (LBS-008; Belite Bio) for the treatment of Stargardt Disease Type 1 (STGD1). The FDA has set a Prescription Drug User Fee Act date of February 12, 2027. According to the company, the filing was based on the results from the phase 3 DRAGON trial, which evaluated tinlarebant for the treatment of STGD1. In the study, tinlarebant demonstrated a statistically significant and

VEPPANU is the first and only FDA-approved PROTAC and has the potential to become an important new treatment option for adult patients with 2L+ ER+/HER2-, ESR1-mutated mBC Aug. 11, 2026 -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced VEPPANU (vepdegestrant) is now available by prescription in the United States for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal grow

- All 56 planned participants enrolled approximately five months after first patient dosing - Topline Phase 2 data expected in late 2026 - Positive data could support expansion of CNT201 into Peyronie's disease and cellulite Aug. 17, 2026 -- Connext, a specialty therapeutics company focused on developing innovative therapies for significant unmet medical needs, today announced that it has completed enrollment in the Phase 2 portion of its ongoing Phase 1/2 clinical trial evaluating CNT201 for t