Ascletis Pharma Inc.’s once-daily oral fatty acid synthase inhibitor, denifanstat, demonstrated statistically significant and clinically meaningful improvements compared to placebo, meeting all primary and secondary endpoints in a phase III trial for moderate to severe acne vulgaris.
Regenxbio Inc.’s gene therapy in treating Duchenne muscular dystrophy (DMD) produced positive initial phase I/II results from its first five patients. However, the company’s stock (NASDAQ:RGNX) shuddered on June 5 as shares closed at $8.36 each, a drop of 17% on the day.
Far from eliminating the need for weight-loss procedures, glucagon-like peptide-1 receptor agonists could drive more people to seek them out. At least that’s what Fractyl Health Inc. and Bariendo Inc. hope, and they have strong evidence to support their case with a recent meta-analysis showing that individuals discontinuing the popular weight loss medications regain all their weight and more within two years.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Beam, Maat, Pheast, Sanofi, Spinogenix, Teijin, Tenpoint.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agenus, Alto, Aspera, Bioage, Bionet, Chase, Haya, Intragrand, Jikang, Kiora, PT Bio Farma, Redwire, Senju, Talentec, Titan, Transpire, Zydus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amicus, Ascentage, Beyondspring, Cardiff Oncology, Corcept, Experimental Drug Development Centre, Genmab, Ichnos Glenmark, Immuneoncia, Immunitybio, Imunon, Innovent, Jazz, Johnson & Johnson, Kura, Kyowa Kirin, Nasus, OSE, PDS, Perspective, Remegen, Roche, Traws, Vigil Neuroscience.
New hires and promotions in the biopharma industry, including: A&As: Ability, Ardelyx, Asgard, Entrada, Harvard, Lobe, Priothera, Protara, Sernova, Tenpoint.
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