Key highlights from June:
- Biotech markets ticked up in June, with performance led by SMID-cap names, while specialty pharma turned positive on the year, but lagged other sub-sectors
- Deal activity increased compared to May, with 13 M&A and 14 licensing transactions announced (vs. 11 M&A and 9 licensing in May); 7 M&A deals exceeded $1bn, led by AbbVie/Apogee and GSK/Nuvalent which each exceed $10bn
- Biopharma IPO momentum continued in June, highlighted by Parabilis’ record-setting $670mm IPO (the largest venture-backed biotech IPO), Kardigan’s offering, and a backlog of 8 companies publicly on file with the SEC; recent IPO performance and M&A activity continue to support market receptivity
- Follow-on financing activity increased slightly, with 23 deals raising $4.1bn (vs. 22 deals / $3.7bn in May)
- Strong clinical execution continued to drive capital formation, with positive data propelling Definium Therapeutics (DT120 in major depressive disorder, ~+50%) and Tango Therapeutics (vopimetostat combination in MTAP-deleted pancreatic cancer, >+50%) higher and supporting sizeable follow-on financings ($700mm and $600mm, respectively); Abivax likewise reported positive Phase 3 data in ulcerative colitis, alleviating initial malignancy concerns and sending shares ~40% higher
- The FDA’s evolving regulatory posture remained a central theme in June, as the agency reversed course on uniQure’s Huntington’s disease gene therapy (AMT-130), clearing the company to pursue accelerated approval after previously deeming the data insufficient, marking the latest regulatory reversal following leadership changes at the agency
- The search for a permanent FDA Commissioner narrowed in June, with three finalists emerging to succeed Marty Makary: Heidi Overton, Jeffrey Vacirca, and Stephen Ferrara
- June featured several notable FDA approvals, including Tzield becoming the first therapy approved to delay insulin decline in children aged 8–17 with stage 3 type 1 diabetes, alongside the first approved regulatory T-cell (Treg) therapy for blood cancer transplant patients as well as Viridian Therapeutics, which secured approval of Lumvoa for thyroid eye disease, establishing the company’s first commercial product and introducing a new competitor to Amgen’s Tepezza