DUBLIN – Allarity Therapeutics A/S plans to file an NDA with FDA for dovitinib in renal cell carcinoma (RCC) in the fourth quarter this year, after unveiling a new analysis at the European Society for Molecular Oncology’s virtual congress, which suggest that its companion diagnostic, DRP, can identify patients who obtain a survival benefit from the therapy.
Following two clinical trial disappointments, the newest being the phase III failure of ampreloxetine, Theravance Biopharma Inc. will restructure by laying off three-quarters of its staff and will stop developing all but two of its non-respiratory disease programs. The ampreloxetine study for treating symptomatic neurogenic orthostatic hypotension failed to meet its primary endpoint, the company announced Sept. 15. In late August, data from a phase IIb dose-finding study showed izencitinib, a gut-selective pan-JAK inhibitor for treating ulcerative colitis, failed to meet its primary endpoint.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
While privately held Calcimedica Inc. posted positive top-line results from a phase II study of its lead candidate in treating patients with severe COVID-19 pneumonia, Redhill Biopharma Inc. took a tumble as preliminary top-line data from a phase II/III study of opaganib in treating hospitalized COVID-19 patients showed the endpoints failed to achieve statistical significance.
A fourth child has died after developing liver complications on a trial of Astellas Pharma Inc.’s gene therapy for rare neuromuscular disease, after FDA advisers noted the problems on the ASPIRO study in a discussion on gene therapy safety. Last week, Astellas announced that it had stopped dosing on ASPIRO after a safety issue involving liver function emerged in the trial of the gene therapy AT-132, aimed at the life-threatening rare disease X-linked myotubular myopathy.
Shares of antibody drug conjugate developer Mersana Therapeutics Inc. (NASDAQ:MRSN) fell 39.1% to $8.56 on Sept. 10 after the company disclosed a second death from pneumonitis in the ongoing phase I trial testing its antibody drug conjugate, upifitamab rilsodotin against tumor types likely to express the sodium-dependent phosphate transport protein NaPi2b, such as ovarian cancer.
Apellis Pharmaceuticals Inc.’s win with one phase III trial and narrow miss with an identical one testing pegcetacoplan in geographic atrophy secondary to age-related macular degeneration caused Wall Street to punish the company while rewarding competitor Iveric Bio Inc.
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