Positive Phase II data for Aptinyx’s novel NMDA receptor modulator are strong enough to take the product into a pivotal study in this difficult-to-treat area.
Aptinyx is to take its investigational treatment for post-traumatic stress disorder, NYX-783, into pivotal trials next year based on promising Phase II exploratory data just reported.
The novel NMDA receptor modulator produced significant and clinically meaningful results in the 153-patient study that were even more encouraging...
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The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.
The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.
The company plans to meet with the US FDA prior to submitting a BLA before the end of 2025 for its cancer vaccine as a first-line advanced melanoma treatment in combination with Keytruda.
Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.
CMO Shreeram Aradhye talks to Scrip about the promise shown by ianalumab, remibrutinib and a next-generation CAR-T for immunological disorders.
