The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.
Boston Scientific Corp. recently reported new four-year data on its Farapulse pulsed field ablation platform, which demonstrated that patients with paroxysmal atrial fibrillation achieved better long-term success than those treated with thermal ablation. The data come as sales of the Farapulse system in the U.S. have begun to slow amid rising competition from other PFA technologies, particularly Medtronic plc’s Affera platform.
Upstream Bio Inc.’s favorable top-line results from the phase II Valiant trial testing verekitug in adults with severe asthma were not enough to charm Wall Street, and shares of the firm (NASDAQ:UPB) closed Feb. 11 at $14.69, down $13.12, or 47%.
Moderna Inc. blamed a switcheroo by the U.S. FDA for the refusal-to-file (RTF) letter on the seasonal influenza vaccine mRNA-1010. Shares of the firm (NASDAQ:MRNA) closed Feb. 11 at $40.51, down $1.49, having traded as low as $36.66 as investors learned of the RTF letter, which Moderna said is “inconsistent with feedback” the company was given by regulators during pre-phase III as well as pre-BLA-submission talks.
The SEC filed civil charges against CBA Pharma Inc. and two top executives in U.S. district court, alleging they conducted a fraudulent securities offering that raised about $4.1 million from nearly 160 investors.
Novo Nordisk A/S’ television ad introducing the tablet form of its weight-loss drug, Wegovy (semaglutide), to American consumers didn’t pass regulatory muster.
As many had predicted following news of a clinical hold on the gene therapy last month, Regenxbio Inc. disclosed receipt of a complete response letter (CRL) regarding its BLA for RGX-121 (clemidsogene lanparvovec) in mucopolysaccharidosis II, an ultrarare neurodegenerative disease in dire need of new therapies.
Genentech Inc. is covering more bases in multiple sclerosis, with its latest swing on fenebrutinib hitting a rare phase III noninferiority win against Ocrevus (ocrelizumab) in primary progressive multiple sclerosis.
Wall Street pushback against relaxin player Tectonic Therapeutic Inc. was sharp, but a trial design that differs could save the drug from the fate of Astrazeneca plc’s long-acting relaxin-2 analogue, AZD-3427, which the pharma giant has “removed from phase II,” where it was being tested in a trial called Re-phire, because of less than ideal efficacy.
Marking an important day for those with atopic dermatitis, shares of two biopharmas surged on clinical data suggesting new biologics are on their way to help address 40% of patients with uncontrolled disease.
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