Breakthroughs in Biotech & Pharma
- First Treatment for Bronchiectasis: The FDA has approved brensocatib (brand name Brinsupri) as the first and only therapy for non-cystic fibrosis bronchiectasis, a chronic lung disease affecting ~500,000 U.S. patients investor.insmed.com. Brensocatib is a first-in-class DPP1 inhibitor that targets neutrophil-driven inflammation. Experts heralded the approval as a “potential paradigm shift” in bronchiectasis care, since “for the first time, we have a treatment that directly targets neutrophilic inflammation”, offering a long-awaited option to manage this progressive respiratory condition 1 .
- Novartis’ Autoimmune Trial Hat-Trick:Novartis announced a trio of Phase 3 victories for its antibody drug ianalumab across multiple autoimmune diseases fiercebiotech.com fiercebiotech.com. In Sjögren’s syndrome, ianalumab became the first therapy to significantly reduce disease activity in global Phase 3 trials fiercebiotech.com. Just a day later, Novartis reported that ianalumab also hit the primary endpoint in immune thrombocytopenia (ITP), when added to standard care, by prolonging the time to treatment failure (i.e. maintaining safe platelet counts) fiercebiotech.com. The B-cell–targeting antibody is given as only four monthly doses, a short-course approach that could offer long-term disease control and extended treatment-free periods for patients fiercebiotech.com. “These positive topline results… highlight the potential of ianalumab, if approved, to deliver long-term disease control with four once-monthly doses and enable extended time off treatment,” said Novartis CMO Dr. Shreeram Aradhye 2 .
- Other R&D Highlights: Not all late-stage trials succeeded – Biohaven disclosed that its experimental OCD drug troriluzole failed to show benefit in a Phase 3 study, prompting the company to halt that program fiercebiotech.com. Meanwhile, the US government’s new health research agency ARPA-H made waves in science policy circles: its head of data resigned after ARPA-H controversially canceled a series of mRNA vaccine projects, a move that NIH’s leadership partly attributed to public distrust and politicization around vaccines 3 .
Big Deals and Industry Moves
- Cardinal’s $1.9B Urology Bet: U.S. healthcare giant Cardinal Health is acquiring Solaris Health – the nation’s largest urology practice management network – for $1.9 billion in cash pharmexec.com. Solaris will be folded into Cardinal’s “Specialty Alliance” physician network, expanding its reach in specialty care. Cardinal’s CEO Jason Hollar said the deal aligns with a strategic focus on specialty medicine growth, calling urology “an attractive specialty for us” and highlighting the combined capabilities it will bring to community urologists pharmexec.com. The acquisition, expected to close by year-end, will see Solaris’ leadership transition into advisory roles at Cardinal 4 .
- Bayer’s $1.3B KRAS Cancer Collaboration:Bayer struck a major partnership with California biotech Kumquat Biosciences, committing up to $1.3 billion for rights to an experimental cancer drug targeting the KRAS G12D mutation fiercebiotech.com. KRAS mutations drive many hard-to-treat cancers (G12D occurs in ~38% of pancreatic cancers) which long seemed “undruggable” fiercebiotech.com. With recent breakthroughs against KRAS G12C, Bayer is joining the race to target G12D. Kumquat’s KRAS<sup>G12D</sup> inhibitor just cleared FDA to begin human trials, slightly trailing rival programs, but Bayer’s hefty deal underscores the high stakes in this next wave of oncology R&D 5
