Deals and an M&A strengthen end-of-year numbers
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.

Deals and an M&A strengthen end-of-year numbers
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.
GSPT1 chat favorable as Monte Rosa scores in prostate phase I/II
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.
Today's news in brief
BioWorld briefs for Dec. 16, 2025.
ADEL wins $1.04B Sanofi deal for tau-targeting Alzheimer’s drug
ADEL Inc. closed a year-end licensing deal worth up to $1.04 billion with Sanofi SA for ADEL-Y01, a specific tau-targeting Alzheimer’s disease drug candidate in a U.S. phase I study.
Radiopharm Theranostics’ RAD-101 meets brain metastases endpoints
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.
Hits’ Hyperlab launches as ‘virtual AI lab’ for new drug discovery
Things once done in laboratories can now be done with computers and AI, said Kim Woo-youn, CEO and cofounder of Hits Inc. “We live in the age of ‘digital alchemy,’” Kim told BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces.

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Analysis and data insight

Biopharma retains record dealmaking value despite November cooldown
Deals and M&A
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...
China eclipses Europe for clinical trial starts: LEK report
Clinical
China’s clinical trial volume has surged to nearly U.S. scale and now tops Europe, sitting at about 80% of U.S. levels and roughly 10% above the EU in 2024.
Eight biopharmas tap markets for $3.24B in early holiday rally
Financings
Christmas came early for a number of biopharma companies this year as eight companies collectively raised $3.24 billion in public offerings. Both Structure Therapeutics Inc. and Terns Pharmaceuticals Inc. announced upsized offerings of $650 million each, and Kymera Therapeutics Inc. raised $602...
73 Chinese biotech, med-tech companies file for HK IPOs in 2025
Financings
Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in...

Financings

Disco closes €36M seed round to advance surfaceome technology
Newco news
Disco Pharmaceuticals GmbH announced the final close of its seed round at €36 million (US$42 million), as it shapes up novel targets it has discovered with its surfaceome platform technology for formal preclinical development.

Science

Research unpicks molecular mechanism of vaccine-induced cardiac inflammation
Immune
The cardiomyositis that is a rare adverse effect of mRNA-based COVID vaccines is due to immune cell activity as a result of increased levels of the chemokines CXCL10 and interferon-γ (IFN-γ). Blocking CXCL10 and IFN-γ could prevent muscle cell damage in cell culture, and cardiomyositis in animal...

Vaccine produces DIY Xolair-like antibody, protects against anaphylaxis
Immune
Researchers at the Institut Pasteur have developed a vaccine that spurred the production of autoantibodies to immunoglobulin E antibodies, protecting vaccinated mice from anaphylaxis.
New recombinant strain of mpox virus identified in the UK
Infection
The UK Health Security Agency has identified a new recombinant strain of mpox (formerly monkeypox) that contains elements of clade Ib and clade IIb of the virus, in a traveler who recently returned from Asia.

Newco news

Laigo raises €11.5M seed money for targeted protein degradation
Financings
Laigo Bio BV has raised €11.5 million (US$13.7 million) in a seed round for the further development of a new approach to inducing targeted protein degradation by E3 ubiquitin ligases.
Myrio first to develop binders with high affinity/specificity
Clinical
Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
Azalea exits stealth to develop its in vivo gene engineering technology
Financings
San Francisco Bay Area researchers from UC Berkeley, UC San Francisco and Stanford University have combined their technologies to create Azalea Therapeutics Inc., a company focused on editing cells in vivo.
Neok Bio launches with $75M to develop bispecific ADCs
Financings
Neok Bio Inc. was formed earlier this year and is already on schedule to file an IND in a few months for its two bispecific antibody-drug conjugates (ADCs) to treat various types of tumors.
Signet builds new model for gastric cancer drug discovery
Cancer
Signet Therapeutics founder Haisheng Zhang is betting on organoids and AI to outsmart diffuse gastric cancer and the limits of traditional “clean” drug design.

U.S.

Rezolute’s lone drug misses a phase III
Clinical
Rezolute Inc.’s phase III Sunrize study of its only candidate, ersodetug, a fully human monoclonal antibody that binds to allosteric site on insulin receptors, missed its primary and secondary endpoints in treating the ultra-rare disease congenital hyperinsulinism.

Europe

Ireland plots to safeguard US investment in biomanufacturing sector
U.S.
Ireland is taking stock of the implications Trump administration tariffs and drug pricing policies hold for its world-leading biomanufacturing sector, which has been largely built on the back of investment by U.S. pharma companies – and is hugely reliant on exports to the U.S.

Cosmo data positive for first new hair-loss approach in decades
Clinical
Shares of Cosmo Pharmaceuticals NV rose sharply on Dec. 3 following top-line pivotal phase III data showing a statistically significant and clinically meaningful improvement in male androgenetic alopecia patients receiving clascoterone 5%, the first topical androgen receptor inhibitor, which uses...
UK decline in commercial clinical trials continues
Clinical
Despite a raft of government policies to turn the ship around, the latest figures show a further decline in setting up and staging commercial clinical trials in the U.K., with a 25% fall in the number of patients recruited over the past two years.

Clinical

Immunome’s phase III results in desmoid tumors point to NDA
Cancer
Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral...
Arcus shifts effort, bears down on would-be ‘anchor’ in RCC
Cancer
Arcus Biosciences Inc. and partner Gilead Sciences Inc. are scrapping phase III work with anti-TIGIT antibody domvanalimab after an independent data monitoring committee said the drug will fail in gastric and esophageal cancers.
ASH 2025: Ianalumab data offer break from chronic ITP therapy
Conferences
Novartis AG’s monoclonal antibody, ianalumab (VAY-736), when added to standard-of-care eltrombopag, extended disease control of primary immune thrombocytopenia (ITP) by 45%, according to data presented Dec. 9 during a late-breaker abstract session...
ASH 2025: Tec-dara shines on ‘functional cure’ Majestec-3 MM data
Conferences
Impressive results of a potential second-line combination treatment for multiple myeloma from the Majestec-3 trial of teclistamab plus daratumumab raised eyebrows at the American Society of Hematology’s 67th annual meeting, with the combination...
Wave Life, Structure and Ascletis post wins in obesity management
Endocrine/metabolic
With new results from Wave Life Sciences Ltd., Structure Therapeutics Inc. and Ascletis Pharma Inc., obesity management drugs continue to move forward in producing weight loss and move the market.
Positive phase Ib SCD data perk Fulcrum stock
Hematologic
On the heels of mixed phase III data from Agios Pharmaceuticals Inc. with mitapivat to treat sickle cell disease (SCD), Fulcrum Therapeutics Inc. wowed investors by way of initial results from the ongoing 20-mg dose cohort in the phase Ib Pioneer...

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