Any lingering disappointment in the delay for Xenon Pharmaceuticals Inc.’s readout of the phase III X-Tole2 study testing azetukalner in focal onset seizures (FOS) appeared thoroughly extinguished as the company’s KV7 potassium channel opener yielded better-than-expected data, even besting earlier phase IIb findings and positioning the drug for an NDA submission later this year.
Investors looking for midteen percentage weight loss findings in Zealand Pharma A/S’s phase II study of once-weekly amylin analogue petrelintide were clearly disappointed by the actual 10.7% mean body weight reduction, as shares (Copenhagen:ZEAL) fell 36% March 6. But from the company’s standpoint, the combination of efficacy and safety data from the Zupreme-1 study bode well for a phase III trial expected to start later this year.
The OX40-targeting mechanism pursued by drug developers around the world found itself shadowed March 3 when Kyowa Kirin Co. Ltd. gave up work with rocatinlimab, a monoclonal antibody for which hopes had risen in moderate to severe atopic dermatitis, prurigo nodularis and moderate to severe asthma.
Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.
Pepgen Inc. is forging ahead with tests of PGN-EDODM1 in other territories after the U.S. FDA placed a partial hold on the Freedom2-DM1 phase II trial, a multiple ascending-dose, randomized, placebo-controlled experiment in myotonic dystrophy type 1 (DM1).
Can-Fite Biopharma Ltd.’s namodenoson met the safety endpoint in its phase IIa open-label study in advanced pancreatic ductal adenocarcinoma patients, a readout that left investors hopeful for survival data, expected to be disclosed later this year.
In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer.
Oddsmakers wasted no time figuring the market chances after Merck & Co. Inc. rolled out data from the phase III Litespark-011 study testing its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), when used with tyrosine kinase inhibitor Lenvima (lenvatinib, Eisai Co.) in advanced renal cell carcinoma.
Quell Therapeutics Ltd. has delivered the first clinical data indicating its chimeric antigen receptor (CAR) T regulatory cell therapy, QEL-001, can enable liver transplant patients to be weaned off long-term immunosuppression.
Another phase III failure of Theravance Biopharma Inc.’s norepinephrine reuptake inhibitor ampreloxetine to treat symptomatic neurogenic orthostatic hypotension, this time in patients with the rare disease multiple system atrophy, means the end of the company’s R&D efforts. Cutting its workforce in half and terminating all development of ampreloxetine, its only pipeline product, the Dublin-based company’s shares (NASDAQ:TBPH) sank by 26%, or $4.99, to close March 3 at $13.96.
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