Just seven months after in-licensing ocedurenone (KBP-5074) from KBP Biosciences Pte. Ltd. in a $1.3 billion deal, Novo Nordisk A/S halted its late-stage study after ocedurenone failed to significantly control hypertension in chronic kidney disease patients.
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
Annexon Inc.’s stock (NASDAQ:ANNX) climbed 31% June 4 following news that a single infusion of C1q protein complex inhibitor ANX-005 at the 30-mg/kg dose delivered a statistically significant 2.4-fold improvement in Guillain-Barré syndrome patients. Shares closed at $5.99, up $1.41.
An oral Bruton’s tyrosine kinase (BTK) inhibitor that Sanofi SA acquired in 2020 through its $3.68 billion buyout of Principia Biopharma Inc. is headed toward regulatory filings in the U.S and EU by the end of the year, following phase III data in immune thrombocytopenia.
Robust top-line phase III data showed Intra-Cellular Therapies Inc.’s marketed oral atypical antipsychotic drug, Caplyta (lumateperone), achieved statistically significant and clinically meaningful best-in-class results, potentially expanding its reach into the billion-dollar major depressive disorder market. The company’s shares (NASDAQ:ITCI) surged to a 52-week high of $84.89 throughout the day, closing at $79.84, up 23.3%, or $15.08, on April 16.
Less than two weeks after going public by way of the merger with Graphite Bio Inc., Lenz Therapeutics Inc. unveiled positive top-line data from its pair of phase III Clarity studies testing two formulations of the muscarinic acetylcholine receptor agonist aceclidine, LNZ-100 and LNZ-101, for presbyopia.
After trading as low as $2.04, shares of Palatin Technologies Inc. (NYSE:PTN) closed Feb. 28 down $1.57, or 39.7%, ending at $2.39 on word of results from the phase III pivotal Melody-1 trial with melanocortin pan-agonist PL-9643 vs. vehicle in dry eye disease.
South Korean biopharmaceutical firm GNT Pharma Co. Ltd. on Feb. 13 reported positive findings from a domestic phase III trial of its neuroprotectant therapy, nelonemdaz (NEU-2000), for patients with acute ischemic stroke.
Palo Alto, Calif.-based Bridgebio Pharma Inc. will hand over development and sales of its rare bone growth disorder therapy, infigratinib, in Japan to Kyowa Kirin Co. Ltd. under its latest exclusive licensing deal.
