Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allurion, Astrazeneca, Denali, Kalvista, Lexeo, Mustang, Nurix.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alembic, Biotx.ai, Brii, Chugai, Gero, Heartbeat, Joincare, Laboratoires Théa, Lenz, Utility.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Apogee, Beyondspring, Blue Lake, Cogent, Cyanvac, Immix, Jasper, Yiviva.
New hires and promotions in the biopharma industry, including: Allarity, Baxter, Biocryst, Genelux, Immunoprecise Antibodies, Immuthera, Nervgen, Nuevocor, Sellas.
Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.
Veritas In Silico Inc. (VIS) entered a joint research agreement with Mitsubishi Gas Chemical Co. Inc. to use VIS’s mRNA structural motif analyzing platform technology, called Ibvis, to develop antisense oligonucleotide drug candidates.
In yet another fail for the Duchenne muscular dystrophy (DMD) field, Taiho Pharmaceutical Co. Ltd.’s pizuglanstat (TAS-205) did not meet the primary endpoint in a phase III trial. The phase III Reach-DMD trial, a randomized, placebo-controlled, double-blind and open-label, extension study of pizuglanstat in patients with DMD showed no significant difference in the mean change from baseline to 52 weeks in the primary endpoint of time to rise from the floor in the ambulatory cohort of the study.
Tickling Wall Street’s already strong interest in the mechanism of action was Aurinia Pharmaceuticals Inc., which June 30 made public positive results from the phase I single ascending-dose study with aritinercept (AUR-200), the company’s dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL).
A mixed bag of top-line phase II data prompted stellar stock results for Prokidney Corp. and its chronic kidney disease (CKD) and diabetes therapy, rilparencel. The results came from two arms of the study, each with its own treatment regime. The market heartily took to the results as the company’s stock (NASDAQ:PROK) closed 515% upward at $3.73 per share after starting the day under $1 each.
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