Alkermes plc’s decision to explore separating its commercial-stage neuroscience business from earlier-stage oncology efforts – forming a distinct, publicly traded company to investigate cancer therapies – drove speculation about the launch of the firm’s Lybalvi (olanzapine and samidorphan), approved by the U.S. FDA in the middle of 2021 for schizophrenia and bipolar I disorder.
In relapsed/refractory acute myeloid leukemia (AML), an indication that still needs adequate standard-of-care therapy, Actinium Pharmaceuticals Inc.’s topline pivotal phase III data shone brightly with radiotherapy lead candidate Iomab-B.
Skeptical briefing documents pertaining to the U.S. FDA’s adcom meeting on Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) turned out predictive of the less-than-happy outcome, as the regulator’s Oncologic Drugs Advisory Committee (ODAC) turned thumbs down on the prospective drug for pediatric central nervous system/leptomeningeal metastasis from neuroblastoma.
Word from Talaris Therapeutics Inc. of a patient death in its phase III study called Freedom-1 with allogeneic cell therapy FCR-001 renewed speculation about the company’s odds in living donor kidney transplant patients, where Medeor Therapeutics Inc. also is advancing a late-stage candidate.
Briefing documents related to the Oct. 28 meeting of the Oncologic Drugs Advisory Committee (ODAC) to deliberate over Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) took aim at the company’s ongoing, pivotal experiment called Study 101, data from which the company highlighted in early October.
Higher-than-expected serum bicarbonate values in the placebo group foiled Tricida Inc.’s effort in its phase III renal outcomes trial to compare an untreated acidotic chronic kidney disease (CKD) population with those given veverimer. The hitch meant the company could not measure the oral, non-absorbed polymer’s ability to slow the disease in patients with metabolic acidosis, an estimated market of several million people in the U.S.
Immunic Inc. plans to forge ahead with oral psoriasis therapy IMU-935 despite stock-punishing results from a phase Ib trial that showed a higher placebo response than expected. Shares of the New York-based firm (NASDAQ:IMUX) closed at $2.08, down $7.12, or 77.4% after findings were made public from a preplanned interim group-level data analysis of the ongoing experiment, which is testing patients with moderate to severe disease. The group averages for Psoriasis Area and Severity Index (PASI) reductions in the two active arms failed to separate from placebo at four weeks, Immunic said. Although the active arms performed as intended, placebo decreases in PASI proved greater than hoped.
Galecto Inc.’s late-September news from its ongoing phase IIa trial with GB-2064 in myelofibrosis hiked shares of the Boston-based firm and piqued interest in the lysyl oxidase-like 2 (LOXL2) target, where such names as Gilead Sciences Inc. and Pharmaxis Ltd. also have been busy.
Positive phase I data from Dice Therapeutics Inc. with DC-806 in psoriasis sent shares (NASDAQ:DICE) on a wild ride, closing at $40, up $15.35, or 62%, on Oct. 11, 2022, and bolstered the case for oral drugs in psoriasis – an increasingly busy indication where discouraged patients often find themselves switching between therapies.
The closely watched pivotal phase III trial called Stellar by Merck & Co. Inc. with sotatercept delivered in a big way for the company, helping to validate the firm’s $11.5 billion buyout about a year ago of Acceleron Pharma Inc.
