Jazz names new CEO; Ultragenyx, Mereo shares slide on trial update
Today, a brief rundown of news involving Valneva and Jazz Pharmaceuticals, as well as updates from Ultragenyx Pharmaceutical, Nuclidium and Pharvaris that you may have missed.
The European Medicines Agency on Friday lifted its order to pause use of Valneva’s chikungunya vaccine in people aged 65 years and older. The decision to remove the restriction followed a review by the regulator’s safety committee, which concluded the shot, called Ixchiq, should only be given to people of any age if there “is a significant risk of chikungunya infection and after a careful consideration of the benefits and risks.” The EMA had limited the shot’s availability in May after 17 severe adverse events were reported, including two deaths. The Food and Drug Administration also temporarily suspended use of the vaccine in people at least 60 years of age.— Delilah Alvarado
Jazz Pharmaceuticals on Thursday named Renee Gala, a former Grail and Theravance Biopharma executive who joined Jazz in 2020, as the company’s successor to retiring CEO Bruce Cozadd. Gala’s promotion to CEO, from her current role as president and chief operating officer, will take effect next month. Jazz’s board of directors considered both internal and external candidates, lead independent director Rick Winningham said in a statement. “Among a field of highly capable and qualified candidates, Renee was the clear standout,” he added. Cozadd co-founded Jazz more than two decades ago and has led it through a $7 billion acquisition, a corporate tax inversion and the approval of several medicines. — Ned Pagliarulo
A closely watched clinical trial testing a drug from Ultragenyx Pharmaceutical and Mereo BioPharma will continue past a second interim analysis, disappointing both the companies and their investors, who had hoped the study would hit its goal early. The drug, called setrusumab, is being tested in children and young adults with osteogenesis imperfecta, a cluster of genetic disorders that tend to increase bone brittleness and cause frequent fractures. Shares in both companies fell this week after they said Wednesday that a Phase 3 study called Orbit would continue on to a final analysis after data monitors reviewed preliminary data. — Ned Pagliarulo
Radiopharmaceutical developer Nuclidium announced Thursday it has raised 79 million Swiss francs, or about $99 million, in venture financing to support its advancement into the clinic. The Series B round, which was co-led by Angelini Ventures, Kurma Growth Opportunities Fund, Wellington Partners and Neva SGR, will be used to develop both medicines and diagnostics, as well as expand its manufacturing. Nuclidium says it’s testing its experimental copper isotopes in breast and prostate cancers, as well as neuroendocrine tumors. — Gwendolyn Wu
Pharvaris expects to report the first Phase 3 results for its experimental hereditary angioedema therapy later this year, instead of in 2026 as originally anticipated, the company said Thursday. Pharvaris’ drug, deucrictibant, is an oral therapy being tested as a way to either prevent the disease’s hallmark swelling attacks or quickly treat the symptoms associated with them. Results from a late-stage study evaluating it as an on-demand treatment are coming first and, if positive, could position the company to challenge Kalvista Pharmaceuticals’ recently approved Ekterly. Pharvaris expects to file an approval application in the first half of next year, should the study succeed. — Ben Fidler
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