Monte Rosa Therapeutics Inc. plans a signal-verifying phase II trial next year after making known the positive interim data from an ongoing phase I/II trial testing molecular glue degrader MRT-2359 in combination with androgen receptor (AR) inhibitor Xtandi (enzalutamide, Astellas Pharma Inc.). The investigation targeted heavily pretreated patients with metastatic castration-resistant prostate cancer bearing AR mutations.
Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months of 2025, biopharma dealmaking was robust with a collective value of $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. These three December deals helped revive the surge in dealmaking that had cooled in November.
Radiopharm Theranostics Ltd.’s radiotracer RAD-101 met the primary endpoint in 92% of patients in the phase IIb imaging trial in brain metastases, according to interim results. To date, 11 of the 12 patients treated with RAD-101 (F18-Pivalate) achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. The results showed significant and selective tumor uptake, and images confirm metabolic activity in brain metastases compared to equivocal MRI findings.
Through the first 11 months of 2025, biopharma dealmaking remained robust with collective value reaching $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. November contributed $15.62 billion, below the average of $24.55 billion per month and a notable decline from October’s unusually strong $31.91 billion, which was the single highest month of 2025.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Acadia, Amgen, Apellis, Bio-Thera, GSK, Immunitybio, Kymera, Merck, Novo Nordisk, Sobi, Stada.
Biopharma happenings, including deals and partnerships, and other news in brief: Cosette, Everest Medicines, Genmab, Geron, Hasten, Hyloris, Mayne, Merus.
Clinical updates, including data readouts and publications: AB Science, Anixa, Arcus, Ausperbio, Avenzo, Beyondspring, Cullgen, Innovent, Innoviva, Relay, Tenaya.