In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Chiasma, Cstone, Eqrx, Omeros, Tetra, Turning Point, Zai Lab.
HONG KONG – Following a wave of concern about the efficacy of two COVID-19 vaccine candidates developed by China National Pharmaceutical Group (Sinopharm), interim analysis of an ongoing phase III trial, published May 26 in the Journal of the American Medical Association, has shown that adults receiving at least one dose of either of the company’s two inactivated SARS-CoV-2 vaccines had significantly reduced the risk of symptomatic COVID-19.
Bad regulatory news didn’t quash hopes for Travere Therapeutics Inc. with sparsentan, its dual-acting antagonist of the endothelin type A and angiotensin II type 1 receptors for focal segmental glomerulosclerosis (FSGS), a disease of kidney scarring.
The brakes have now been pumped twice at Larimar Therapeutics Inc. as the FDA placed a clinical hold on its CTI-1601 Friedreich’s ataxia (FA) clinical program, and the company won’t close on a planned $95 million private placement financing. Larimar’s stock (NASDAQ:LRMR) took a battering May 26 as shares slumped 33.46% to close at $8.99.
HONG KONG – Mitoimmune Therapeutics Inc., a company that earlier this year completed a ?27.5 billion (US$24.41 million) series B financing led by Korea Development Bank, has received investigational new drug approval in the U.S. for MIT-001, its anti-inflammatory and anti-necrotic agent, moving the company a step closer to entering the clinic.
Vectivbio Holding AG’s IPO last month shone light on short bowel syndrome (SBS), where the company has advanced the glucagon-like peptide-2 analogue apraglutide to the phase III stage. The company aims to show an advantage over same-class Gattex (teduglutide) from Takeda Pharmaceuticals Co. Ltd., cleared by the FDA in December 2012 for adults with SBS and in May 2018 for children at least 1 year of age.
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17.
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