With the U.S. FDA’s approval of Orlynvah (sulopenem etzadroxil and probenecid) for uncomplicated urinary tract infections, Iterum Therapeutics plc can move on from regulatory delays and prepare to launch only the second FDA-approved treatment for the indication in the past 20 years.
Wall Street promptly began trying to weigh the compound’s marketplace odds after Merck & Co. Inc. detailed positive data from the phase IIb/III trial known as MK-1654-004 with clesrovimab, an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The results, plus interim findings from the ongoing phase III experiment dubbed MK-1654-007 were offered during IDWeek 2024 in Los Angeles.
Insider trading isn’t always about profits. Sometimes it’s avoiding losses. That’s the basis of the U.S. SEC’s complaint against Matthew Groom, an information technology consultant to Spero Therapeutics Inc. Groom agreed Sept. 15 to a $28,000 settlement to resolve the complaint stemming from a trade of Spero shares that enabled him to avoid $13,000 in losses when news of the company’s downsizing and issues with its lead product became public two years ago.
Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
Clostridioides difficile has been traditionally isolated from health care facilities' inpatients, but it is increasingly being identified in people who have not recently been hospitalized and is more and more found in community settings. Investigators from Perelman School of Medicine at University of Pennsylvania have developed an mRNA-LNP vaccine with promising results in preventing and controlling C. difficile infection.
SK Bioscience Co. Ltd., of Seongnam-si, South Korea, said Oct. 8 that it will acquire a $3 million stake in Fina Biosolutions LLC to become the first and sole strategic investor of the Rockville, Md.-based vaccine specialist. For SK Bioscience, the investment is slated to boost its vaccine R&D capabilities, the company said, which currently includes manufacturing of pneumococcal and typhoid conjugate vaccines.
The spread of drug-resistant bacteria is a global health concern and could once again become a leading cause of mortality. The World Health Organization has flagged carbapenem-resistant Acinetobacter baumannii as a top priority pathogen requiring innovative therapies for its management, which has a mortality rate of 25%-60% and caused more than 100,000 deaths worldwide in 2019. Therapy based on the use of bacteriophages (phages) to fight antibiotic-resistant bacteria is one such innovative strategy.
Moderna Inc.’s shares (NASDAQ:MRNA) sank 19% to a $64.11 low in early trading Sept. 12 as investors learned during the annual R&D Day event of a $1.1 billion reduction to R&D and the U.S. FDA’s reluctance to support an accelerated approval filing for its individualized neoantigen therapy for melanoma.
A drive to overcome the limitations of traditional antibodies led Toronto-based scientists Jean-Philippe Julien and Bebhinn Treanor to work toward discovering a multivalent, multispecific platform to develop therapies that can reach difficult targets. As a result, through the support of VC firm Amplitude Ventures, Radiant Biotherapeutics emerged in 2020 armed with what has become its Multabody platform.
With antimicrobial resistance growing to many first-line antibiotics, a key concern in the U.S. FDA’s approving an oral penem like Iterum Therapeutics International Ltd.’s tablet combining sulopenem etzadroxil and probenecid is that it could become a first-line, go-to drug in treating uncomplicated urinary tract infections and, possibly, more serious infections off-label.
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