Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
For the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, the medical need and the effectiveness of Eli Lilly and Co.’s Alzheimer’s candidate, donanemab, outweighs the safety concerns and lack of data for underrepresented groups and special needs patients. The panel voted unanimously, 11-0, June 10 that the available data show donanemab is effective in treating Alzheimer’s in the population enrolled in Lilly’s clinical trials and that the benefits of the amyloid-targeting monoclonal antibody outweigh the risks in the study population of patients with mild cognitive impairment and mild dementia.
Abbott Laboratories received U.S. FDA clearance for its Lingo and Libre Rio over-the-counter continuous glucose monitoring systems, enabling it to challenge Dexcom Inc. in this rapidly growing market. Dexcom received FDA clearance for its OTC Stela continuous glucose monitor in March.
Geron Corp., a company founded more than three decades ago, is finally celebrating its first U.S. FDA approval. The agency cleared imetelstat, branded Rytelo, for use in transfusion-dependent anemia in adults with low- to intermediate-risk myelodysplastic syndromes, specifically those requiring four or more red blood cell units over eight weeks who have failed or no longer respond to erythropoiesis-stimulating agents (ESA) or who are not eligible for ESA treatment.
Phase II-stage Rapport Therapeutics Inc. began trading on Nasdaq June 7 under the ticker RAPP after pricing its IPO of 8 million shares at $17 each to raise $136 million, gaining $3.80, or 22.4%, to close its first day at $20.80. With offices in Boston and San Diego, Rapport is developing drugs for central nervous system (CNS) disorders. The IPO is expected to close June 10.
Two years after signing a $1.6 billion partnership with Marengo Therapeutics Inc., Paris-based Ipsen SA is back at it again, this time teaming up for two additional assets that target “cold” tumors in a deal that could bring privately held Marengo $1.2 billion. “We do something really novel and innovative and I think it’s very important to continue to validate it,” Marengo CEO Zhen Su told BioWorld, adding that with the newest deal, “we see validation all around this … It’s a success on success.”
Australian radiopharmaceutical company Telix Pharmaceuticals Ltd. announced its IPO on the Nasdaq to raise $200 million to advance its late-stage radiopharma candidates. Headquartered in Melbourne, Telix has operations in the U.S., Europe (Belgium and Switzerland) and Japan with an extensive pipeline of theranostic radiopharmaceutical candidates.
Moon Surgical SAS recently received U.S. FDA clearance for the commercial version of its Maestro surgical robotic system for laparoscopic procedures. The greenlight is “pretty massive” for the company as it will allow the robotic platform to be rolled out in the U.S., to help enhance the surgeon’s performance while carrying out procedures, Anne Osdoit, CEO of Moon Surgical, told BioWorld.
Washington-based Vanda Pharmaceuticals Inc. has faced a challenging few years involving a federal lawsuit against the U.S. FDA, patent infringement litigation, increasing generic competition and dwindling sales, as well as a complete response letter nixing plans to expand its melatonin receptor agonist Hetlioz (tasimelteon) into insomnia, yet it has recently received a higher, unsolicited acquisition offer of $466 million from a second company, Cycle Pharmaceuticals Ltd.
Trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugates became a topic of talk during the recent American Society of Clinical Oncology meeting in Chicago.
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