Top-line data from Maat Pharma SA’s phase III study of MaaT-013, an enema microbiome ecosystem therapy for acute graft-vs.-host disease, hit its primary endpoint. The milestone has prompted the company to think about filing an MAA submission for the treatment in Europe sometime in the middle of 2025, which is earlier than it had anticipated.
Yuhan Corp., Oscotec Inc. and Genosco Inc. were three companies with Asian ties to reap benefit from Johnson & Johnson’s stellar top-line Mariposa study results, wherein J&J’s Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) combo regimen beat out Astrazeneca plc’s standard of care in non-small-cell lung cancer (NSCLC).
Despite positive preliminary data from its early stage study of treating hives, Jasper Therapeutics Inc. saw its stock drop dramatically on Jan. 8. Results were from the ongoing phase Ib/IIa study of the monoclonal antibody and lead candidate briquilimab in treating chronic spontaneous urticaria, often referred to as hives. The results showed clinical responses across several of the dosing cohorts. The treatment also displayed a favorable safety profile.
Vir Biotechnology Inc.’s 2024 deal with Sanofi SA is starting to look like a pretty savvy move. The company, which picked up three clinical-stage dual-masked T-cell engagers (TCEs) and rights to the platform technology as part of a pipeline overhaul, reported phase I data for TCE programs targeting HER2 and PSMA that indicated promising efficacy with a low prevalence of the cytokine toxicity that has hampered other TCE programs.
Sana Biotechnology Inc. CEO Steve Harr said “cool and transformative science” led to his firm’s latest strides in type 1 diabetes, and the “very generalizable [clinical] result” cheered Wall Street, which led shares of the Seattle-based firm (NASDAQ:SANA) to close Jan. 8 at $4.30 up $2.65, or 160.6%. “I believe we now have all of the pieces in place to move forward rapidly,” Harr said.
Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy.
The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics that may well revolutionize treatments or become blockbusters. The 12th annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched.
Strong interim safety and efficacy data from Hoth Therapeutics Inc.’s phase IIa study of HT-001 helped boost the company’s stock (NASDAQ:HOTH) on Jan. 7 as shares rose 178% to close at $2.28 each.
Ophthalmic diseases specialist Oculis Holding AG announced positive phase II data showing its serum-glucose corticoid kinase-2 activator OCS-05 protected nerve cells and improved vision in patients with acute optic neuritis. The placebo-controlled, randomized trial assessed the neuroprotective effect of OCS-05 in combination with standard-of-care steroid injections, against steroids alone, with a benefit seen in preserving both ganglions and retinal cell nerve fibers.
Major depressive disorder (MDD) notched another late-stage failure in the form of Neumora Therapeutics Inc.’s data from the phase III Koastal-1 study, the first of three replicant trials in the pivotal program testing kappa opioid receptor antagonist navacaprant.
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