Second Half Milestones, KalVista’s Surprise Approval, Another RFK Jr. Lawsuit, More

While most of the U.S. was celebrating the 4th of July holiday, President Donald Trump was busy signing the One Big, Beautiful Bill into law. This wide-ranging tax law has a few implications for the biopharma industry, including expanded IRA exemptions for orphan drugs.  

Looking ahead to the second half of 2025, BioSpace reviews some of the upcoming catalysts highlighted by Jefferies’ “Halftime Show” report,including a highly anticipated Phase III readout for Eli Lilly’s oral obesity candidate orforglipron and an eye on rare disease decisions under the “new” FDA.  

Speaking of FDA decisions, this week kicked off with a surprise approval—that of KalVista’s Pharmaceuticals’ Ekterly for hereditary angioedema. The road to approval for Ekterly was not a smooth one, after the FDA delayed its target action date and Endpoints News reported that FDA Commissioner Marty Makary tried to have the application rejected.  

More regulatory controversy is afoot as Health Secretary Robert F. Kennedy Jr. is facing yet another lawsuit. A group of medical organizations have sued Kennedy and other health leaders in an attempt to reverse Kennedy’s recent decision to remove COVID-19 shots from the routine immunization guidelines for healthy children and healthy pregnant women. In other vaccine news, Kennedy endorsed the expanded use of RSV vaccines for people 50 through 59 years old who are at risk of severe disease—following the recommendation of the CDC vaccine advisory committee he turfed last month.  

This seeming reversal of sentiment largely mirrors the Secretary’s massive HHS overhaul, which has already seen several of these layoffs reversed. In ClinicaSpace this week, we take a deep dive into the numbers. Also in ClinicaSpace, we feature four therapies hanging tough in a troubled TIGIT space that has seen several companies burn billions of dollars on failed assets. And BrainStorm Cell Therapeutics is back in the news after signaling support for a Citizens’ Petition submitted to the FDA requesting the approval of its cell therapy NurOwn, whose Biologics License Application was withdrawn in 2023.  

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