Key highlights from August:

• Biotech markets rallied broadly in August, led by micro-cap (+13.7%), small-cap (+12.9%) and large-cap (+11.4%) biotech, with the NBI up 8.4% and large pharma (+5.5%) lagging; specialty pharma again trailed, up just 1.8% in the month and 4.2% year-to-date versus 26.2% for biotech
• Deal activity held steady versus July, with 9 M&A and 16 licensing transactions announced (vs. 11 M&A and 15 licensing in July), and above the 7 M&A / 18 licensing pace of August 2025; 3 M&A deals exceeded $1bn, led by Curium/Lantheus at $8.0bn (29% premium to Lantheus’ unaffected 30-day VWAP), followed by Eli Lilly/Merida Biosciences ($2.9bn) and Jazz/Actio Biosciences ($1.3bn) 1
• Licensing skewed heavily toward milestone-weighted, China-outbound structures, with 4 transactions surpassing $1.0bn inclusive of milestones — Hanmi/Genentech in obesity ($2.3bn, 8% upfront), Alphamab/Pathos AI in TNBC ($2.2bn, 6% upfront), Haisco/Sentivera in Type 2 inflammation ($1.5bn, 5% upfront) and DualityBio/Genentech in solid tumors ($1.0bn, 4% upfront)
• Biopharma IPO momentum continued in August with five priced offerings (Vogenx, BlossomHill, Latigo, Braveheart and Attovia) against a backlog of 8 companies publicly on file; all five priced at or above the midpoint, with an average file-to-offer premium of 6.6% and mean T+1 performance of +19.6%, led by Braveheart (+66.7%)
• Reverse mergers paired with concurrent PIPEs remain an alternative path to public capital, with Werewolf/Ambros Therapeutics ($150mm concurrent private placement), Fulcrum/Slate Medicines and Skye/Redx Pharma announced in August; legacy public shareholders retained only ~5-7% of each combined company, while PIPE investors took up to ~48% (Skye/Redx), on which MTS Health Partners served as exclusive placement agent to Redx on its Series A and co-placement agent on the PIPE
• Follow-on activity maintained pace with 13 priced deals (vs. 14 in July), though aggregate capital fell to $1.8bn from $2.2bn and the average file-to-offer discount widened to (9.8%) from (8.6%); private financings were similarly steady at 16 deals but aggregate value dropped sharply to ~$1.0bn from $2.4bn, and micro-cap biotechs are increasingly pursuing recapitalizations, often raising capital in excess of their total market value
• Clinical results again cut both ways, as AbCellera’s ABCL635 hit its Phase 2 endpoint in menopausal vasomotor symptoms (placebo-adjusted reduction of 5.3 hot flashes per day, above the 2.1-3.3 range in the Veozah and Lynkuet pivotals; shares ~+32%) and Amylyx’s avexitide cut hypoglycemia events 55% in Phase 3 Lucidity (~+45%), while Sionna’s SION-719 missed in Phase 2a cystic fibrosis (~(90%)) and EyePoint’s Duravyu underperformed Eylea in Phase 3 wet AMD (~(70%)); catalyst-driven capital formation followed the data, with Amylyx ($500mm), AbCellera ($200mm) and Silence ($175mm) pricing behind readouts
• Merck and Moderna’s personalized mRNA cancer vaccine delivered the first Phase 3 win for an individualized neoantigen therapy, with the 1,137-patient INTerpath-001 trial in adjuvant melanoma showing statistically significant improvements in recurrence-free and distant metastasis-free survival and beating Keytruda monotherapy in resected melanoma; Moderna closed up 177%, adding $45bn of market cap, and Merck rose almost 13%
• Regulatory leadership and metabolic share shift framed the month’s industry news, as President Trump nominated Heidi Overton as FDA commissioner, ending three months without a permanent head following Marty Makary’s May departure, while interim commissioner Kyle Diamantas reversed several decisions including reopening the review of Regenxbio’s Hunter syndrome gene therapy; separately, Lilly extended its metabolic lead with 48% year-over-year growth on Mounjaro of $9.9bn (up 91%) and Zepbound of $4.9bn (up 46%), though in oral GLP-1s Novo’s Wegovy pill generated $497mm versus $98mm for Lilly’s Foundayo
  • In September, Karim Mikhail and Michael Davis were named permanent directors of CBER and CDER, respectively