The third of three late-stage studies from Bayer AG in treating menopausal symptoms with elinzanetant has produced positive data for a nonhormonal treatment. Women looking for a nonhormonal option specifically for vasomotor symptoms, more often called hot flashes, will find few choices.
Implications for Amgen Inc.’s same-class Tepezza (teprotumumab) of positive phase III data from Viridian Therapeutics Inc. with veligrotug in thyroid eye disease became a topic of talk on Wall Street talk. “I’m not drawing any clinical trial comparisons, you’ll have to reach your own conclusions,” CEO Steve Mahoney said during a conference call on the results.
More than three months ago, investors first learned that ivonescimab, a PD-1/VEGF-targeting bispecific antibody from Summit Therapeutics and Akeso Pharmaceuticals Inc., bested Keytruda (pembrolizumab) in PD-L1-positive non-small-cell lung cancer (NSCLC). At the 2024 World Conference on Lung Cancer over the weekend, Summit rolled out detailed data from the phase III Harmoni-2 trial, which included a nearly doubling of progression-free survival for ivonescimab compared to Merck & Co. Inc.’s established blockbuster drug.
Boosting shares by nearly 17% on Sept. 9, phase I data of Terns Pharmaceuticals Inc.’s glucagon-like peptide 1 (GLP-1) receptor agonist, TERN-601, demonstrated it was well-tolerated and led to a statistically significant weight loss across all three doses tested in healthy adults who were obese or overweight.
With positive first-in-human findings on board, Relay Therapeutics Inc. plans a pivotal study next year to test RLY-2608, an allosteric, pan-mutant and isoform-selective inhibitor of PI3K alpha in breast cancer. During a conference call on the data, TD Cowen analyst Yaron Werber noted that “next year’s going to be a pretty busy year for you. How fast can you start the phase III? Is there any way to pull it into the first half of the year as opposed to the second half?” CEO Sanjiv Patel said the company is “moving as fast as we possibly can,” and an update will be provided once a sit-down with regulators is finished.
More than three months ago, investors first learned that ivonescimab, a PD-1/VEGF-targeting bispecific antibody from Summit Therapeutics and Akeso Pharmaceuticals Inc., bested Keytruda (pembrolizumab) in PD-L1-positive non-small-cell lung cancer (NSCLC). At the 2024 World Conference on Lung Cancer over the weekend, Summit rolled out detailed data from the phase III Harmoni-2 trial, which included a nearly doubling of progression-free survival for ivonescimab compared to Merck & Co. Inc.’s established blockbuster drug.
Vor Biopharma Inc.’s trem-cel, a stem cell transplant designed to block the toxicity from cancer treatments, has produced some positive early stage results, including delayed relapse in patients. Phase I/IIa study data showed participants with relapsed/refractory acute myeloid leukemia benefited from trem-cel followed by treatment with Pfizer Inc.’s antibody-drug conjugate cancer fighter Mylotarg (gemtuzumab ozogamicin).
Cytokinetics Inc. CEO Robert Blum said his firm chalked “a watershed moment” during last weekend’s congress of European Society of Cardiology (ESC) in London, where further mid- and late-stage data were disclosed with the heart drug aficamten, a myosin inhibitor. South San Francisco-based Cytokinetics rolled out six presentations, including two late breakers, with four concurrent publications in medical journals.
With Novo Nordisk A/S hobbled by a complete response letter, Eli Lilly and Co. has forged ahead in developing a once-weekly type 2 diabetes treatment. Top-line data from Lilly’s phase III Qwint-1 and Qwint-3 studies of efsitora alfa showed noninferior average levels of blood glucose, A1C, compared to those using another daily basal insulin treatment.
Athira CEO Mark Litton said the firm is “evaluating all the options” after disclosing top-line results from its phase II/III Lift-AD clinical trial of fosgonimeton (fosgo), a hepatocyte growth factor-positive modulator, in patients with mild to moderate Alzheimer’s disease (AD). Javier San Martin, chief medical officer, said the company will schedule “a conversation at the right time” with the U.S. FDA.
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