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H2 2025 catalysts to watch, biopharma implications of President Trump’s tax law, KalVista’s new hereditary angioedema drug that Marty Makary reportedly tried to reject, another lawsuit aimed at Health Secretary Robert F. Kennedy Jr. and a plea from patients with ALS for access to BrainStorm’s NurOwn. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart 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. Finally, in BioPharm Executive , we take a deep dive into the burgeoning longevity space and unpack the short-lived marriage between Novo Nordisk and Hims & Hers Health.

The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart The U.S. Supreme Court closed out its session before breaking for summer on Friday, ruling that decisions around coverage of HIV PrEP drugs should be left up to the U.S. Preventive Services Task Force. The ruling thwarted a lawsuit brought by a group of insurance providers who challenged the Affordable Care Act’s requirement that they cover preventive medicines, such as HIV drugs, recommended by the task force. The high court also determined that members of this task force can be removed at will by HHS Secretary Robert F. Kennedy Jr. Speaking of HHS committees from which members have been removed at will by Kennedy, the CDC’s revamped Advisory Committee on Immunization Practices convened last week for its first meeting since the roster overhaul, where a vote on Merck’s recently approved RSV-targeting monoclonal antibody Enflonsia and a discussion around the inclusion of preservative thimerosal in influenza vaccines was on the docket, but an expected vote on Moderna’s mRNA-based RSV shot mRESVIA was not . Also dominating the headlines on Friday was the FDA’s decision to remove the Risk Evaluation and Mitigation Strategies (REMS) program from the six approved CAR T therapies it was applied to. Analysts and patient groups lauded the move, which is expected to potentially double access to these life-saving therapies, saying it reflects “thoughtful consideration of real-world evidence” and “regulatory trust.” Willliam Blair noted that it could be a “positive signal” to companies developing CAR T therapies for autoimmune diseases, which now includes AbbVie . In an all-cash buyout on Monday, the Illinois-based pharma dropped $1.2 billion for Capstan Therapeutics and its in vivo edited CAR T therapy for B cell–mediated autoimmune diseases. M&A has been on an uptick of late, and private equity companies —such as those that snapped up bluebird bio—are also getting in on the game. Finally, after Lykos Therapeutics’ high pro last summer, the psychedelics space is heating up once again. While a Phase III readout of Compass Pathways ’ psilocybin drug last week in treatment-resistant depression received a muted reaction from investors, the response to a Phase II readout for Beckley Psytech and atai Life Sciences ’ intranasal psychedelic was more positive.

Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart This week, BioSpace is at 50% power as Heather McKenzie and Jef Akst are off attending this year’s BIO Conference in Boston. The half-team discusses this week’s biggest news: the death of another patient who took Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys. The patient was a non-ambulatory teenager who experienced acute liver failure after receiving the gene therapy, which is the same cause of death for an Elevidys patient reported in March. Sarepta announced that it was halting treatments to non-ambulatory patients and on a media call discussed new steps in its therapeutic protocol for preventing further liver injuries. Elsewhere, mergers and acquisitions are surging across biopharma. Eli Lilly picked up the gene editing company Verve Therapeutics for $1.3 billion, which helped bolster the gene editing space—particularly after Sarepta’s report of the death. Supernus bought Sage Therapeutics for $795 million, five months after Sage rejected a smaller offer from Biogen. BioNTech also got in on the dealmaking, buying its German rival—scientifically and in the courtroom—CureVac for about $1.25 billion. The deal seemed focused mostly on CureVac’s early-stage cancer immunotherapy pipeline, but analysts were otherwise left scratching their heads on what BioNTech was getting for its money. Last week on The Weekly the team discussed the sudden dismissal of the CDC’s entire ACIP committee, and this week we have a new slate of members . The eight people replacing the 17 members that were removed last week include allies of HHS Secretary Robert F. Kennedy Jr., many of whom are vaccine skeptics who seem to share his skeptical view of vaccination in general.