Get the Daily Brief
Latest Biotech News
Regulatory approvals – hematology rare disease
Takeda and Protagonist Therapeutics received FDA approval for rusfertide, branded as Mimrylo, to treat polycythemia vera, a rare blood disorder. The approval places a new option in the PV...
Regulatory approvals – rare inflammatory disease
Priovant Therapeutics, a Roivant subsidiary, secured FDA clearance for Lisraya (brepocitinib) in dermatomyositis. The decision marks the first approval for the once-daily oral JAK1/TYK2 inhibitor,...
Clinical development – ulcerative colitis animal data
A study in mice reported that an ethanolic extract of Caulerpa peltata eased acute ulcerative colitis signs and appeared to activate the Nrf2 pathway. Researchers described reductions in disease...
Biotech financing and strategy – large growth equity
Moderna raised $2.6 billion via an upsized offering, tying the financing to momentum in its cancer work. The capital raise followed a major win in a key study, positioning Moderna to accelerate...
Biopharma partnerships – Roche taps next-gen ADC payload platform
Genentech agreed to pay DualityBio $45 million upfront for its DUPAC antibody-drug conjugate payload platform, with milestones potentially exceeding $1 billion. Under the collaboration and license...
Regulatory pathway – FDA clearance for new gene editing IND
Adicet Bio received FDA clearance for its IND application for ADI-212 in metastatic castration-resistant prostate cancer. The company’s next step is to advance the program into clinical evaluation...
Regulatory – CE mark for next-gen stroke prevention device
Abbott won a CE mark approval for the Amulet 360 left atrial appendage occluder, aimed at reducing stroke risk in patients with non-valvular atrial fibrillation. The clearance gives Abbott another...
M&A and capital allocation – biopharma deal volume signal
Biopharma deal activity accelerated in July, with total year-to-date deal value reaching $186.69 billion through the first seven months of 2026—up 13% versus the comparable 2025 period. July...
Bankruptcy and restructuring – agitation-treatment company
Bioxcel Therapeutics filed for Chapter 11 and said Teva bid on Igalmi for up to $125 million, after the company had previously signaled it was evaluating strategic options. The filing targets the...
Regulatory approvals – cardiometabolic
The FDA has approved Eli Lilly’s tirzepatide (Mounjaro) to reduce cardiovascular risk in adults with type 2 diabetes, extending the drug’s label beyond glycemic control and weight loss. The...
Regulatory approvals – rare inflammatory disease
Roivant’s Priovant Therapeutics has won FDA approval for Lisraya (brepocitinib) in dermatomyositis, marking a new regulatory win for the Roivant/Pfizer-licensed pipeline. The clearance covers...
Regulatory setbacks – personalized cancer vaccines
BioNTech and Genentech have terminated a Phase 2 trial of their personalized mRNA cancer vaccine after safety and efficacy signals failed to match the promise seen in other personalized mRNA...
Company financing and funding – expansion of oncology R&D
Moderna has raised $2.6 billion through an upsized note offering to support its cancer-focused work, according to the latest market report. The funding comes as Moderna has faced shifting investor...
Drug approvals – rare blood disorders
Takeda and Protagonist Therapeutics’ rusfertide has received FDA approval for polycythemia vera, with the drug branded as Mimrylo. The clearance enables the product to enter prescription use for...
Dealmaking – oncology ADC collaboration
Genentech and DualityBio have entered a collaboration and license agreement targeting next-generation antibody-drug conjugates built on DualityBio’s DUPAC payload platform. The deal includes $45...
M&A and litigation – single-cell genomics patents
A US jury in the District of Delaware found that Parse Biosciences, a subsidiary of Qiagen, willfully infringed three patents belonging to Scale Biosciences—acquired by 10x Genomics in 2025—while...
Clinical updates – autoimmune and immunotherapy
A first-in-human clinical trial at Charité has reported that a CD19 CAR T-cell therapy induced substantial disease activity decreases in six patients with treatment-refractory seropositive...
Biotech investing and funding – women’s health biopharma
The Gates Foundation has committed up to $35 million to Profound Therapeutics to fund development of novel solutions for preeclampsia and eclampsia. The investment includes an initial $20 million...
Clinical development – hepatology and precision risk signals
A long-term study of liver transplant recipients has linked extended survival with immune-related DNA methylation remodeling occurring between five and ten years after transplantation....
FDA approvals and trial readouts in cardiometabolic disease
The FDA has approved Eli Lilly’s tirzepatide (Mounjaro) to reduce cardiovascular risk in adults with type 2 diabetes, based on results from SURPASS-CVOT. The outcomes trial compared tirzepatide...