Respiratory Syncytial Virus Vaccine (GSK)

Sales of GSKs top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical company down 3% in U.S. trading Wednesday.GSK, which had downgraded its vaccine sales forecasts in July, did so again Wednesday in reporting earnings for the third quarter. The company now expects vaccine sales to decline by low single digits versus last year.During the third quarter, sales of GSKs shingles vaccine dropped by 7% compared to the same period in 2023, while sales of its shot for respiratory syncytial virus, Arexvy, plunged by 72% year over year.In a presentation, GSK attributed the drop of Arexvy to several factors, including a narrower recommendation from the Centers for Disease Control and Prevention, prioritization of COVID vaccinations in the U.S. and lower rates of RSV infections this season.The decline mirrored that of Pfizers competing vaccine Abrysvo, sales of which came in lower this quarter compared to last years. Pfizer also cited the CDC recommendation, which focuses on vaccination for adults 75 years or older, as well as those between 60 and 74 years who are at higher risk of disease. Previously, the CDC had urged all adults 60 and older for whom both Arexvy and Abrysvo are approved to discuss vaccination with their doctor.However, GSK also pointed to how, in the third quarter last year, there was significant stocking of Arexvy during the shots first RSV season on the market. Arexvy and Abrysvo were approved by the FDA within weeks of each other last May, but Arexvy was able to grab a significant market share advantage.Competition appears to be stiffening, however. Pfizer said Tuesday that its shots market share climbed, noting its availability as a maternal vaccination and, most recently, in certain adults 18 years or older who are at high risk.During a conference call Wednesday, GSK commercial chief Luke Miels said Arexvy maintains strong leadership market share.We're still in the foothills of this vaccine's availability and usage, said Miels. In the U.S., we continue to make data available to [the CDCs advising committee] ACIP and to support them as they move towards making longer-term recommendations on the use of RSV vaccines.Both Pfizer and GSK believe that, at some point, revaccination will be needed to maintain adequate protection in older adults.Miels added that GSK expects annual peak sales of Arexvy can eventually reach higher than 3 billion pounds.Arexvy sales during the quarter totaled 188 million pounds, or about $244 million, versus 709 million pounds last year. Sales of its shingles shot Shingrix fell to 739 million pounds, or about $959 million, from 825 million pounds last year. '

Plus, news about Astellas, Clover, ElevateBio, Monopar, Idorsia and Neurocrine Biosciences: Vera Therapeutics plans $300M offering: The California biotech is selling shares after presenting Phase 2b data for an experimental drug called atacicept over the weekend. The company shared 96-week data for patients with immunoglobulin A nephropathy. — Kyle LaHucik Abeona Therapeutics resubmits rare skin disease therapy: Back in April, the FDA rejected Abeona’s cell therapy, called pz-cel, requesting more information about manufacturing. Abeona is developing pz-cel for recessive dystrophic epidermolysis bullosa, a rare genetic skin disease. — Lei Lei Wu Astellas yanks Izervay’s submission in Europe: The company said it withdrew its marketing authorization application for Izervay, a C5 protein inhibitor for geographic atrophy secondary to age-related macular degeneration. Astellas did not detail feedback from the Committee for Medicinal Products for Human Use, but said it is still “confident” in Izervay’s risk-benefit profile and will continue to engage with regulators in Europe and elsewhere. There are currently no treatments approved for GA secondary to AMD outside of the US, where Izervay was greenlit in August of last year. — Ayisha Sharma Clover releases early RSV vaccine data: The Shanghai-based biotech said its bivalent vaccine candidate, SCB-1019, produced “comparable” levels of RSV neutralizing antibodies to GSK’s Arexvy at 28 days in a Phase 1 test. Based on these data, Clover plans to advance the asset into studies focused on re-vaccination next year. — Ayisha Sharma ElevateBio lays off 4%: The genetic medicines company, which employs about 500 people, is ending its preclinical cellular engineering work, a spokesperson told Endpoints News on Monday. The Waltham, MA-based biotech laid off about 13% of its staff in October 2023. It’s one of the most well-funded private biopharma startups after having raised about $1.25 billion, including its $401 million Series D last year. Partnerships with companies like Novo Nordisk, Moderna, Kyverna and Affini-T are unaffected, the spokesperson confirmed. — Kyle LaHucik Monopar Therapeutics prices $19.2M offering: The Chicago-area biotech sold shares to Janus Henderson, RA Capital and others. A few days ago, Monopar licensed a Wilson disease drug candidate from AstraZeneca’s Alexion. — Kyle LaHucik Idorsia ends work with Neurocrine Biosciences: The companies were developing Idorsia’s T-type calcium channel blocker for patients with a rare form of pediatric epilepsy. The treatment failed a Phase 2 study in 2022, and further analysis led to the decision to stop work. — Jaimy Lee