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SMRTS engineered mRNA switches on in tumors only – precision mRNA shows preclinical selectivity
Researchers published a Molecular Therapy paper describing SMRTS (selective modified RNA translation system), an engineered mRNA approach that activates therapeutic genes in tumor cells while...
NIH awards $40M to Vitalex/Lundquist for VXV‑01 fungal vaccine—Phase I prep under way
The NIH/NIAID awarded up to $40 million in non‑dilutive funding to Vitalex Biosciences and the Lundquist Institute to advance VXV‑01, a second‑generation dual‑antigen fungal vaccine targeting...
Adaptive licenses TCR tech and data to Pfizer – big‑ticket pact to accelerate immunology R&D
Adaptive Biotechnologies struck two non‑exclusive agreements with Pfizer: one to apply Adaptive’s T‑cell receptor (TCR) discovery platform to Pfizer clinical samples for rheumatoid arthritis...
Enhertu cleared for first-line use — Roche HER2 tests broaden access
The FDA granted a first-line label expansion for AstraZeneca and Daiichi Sankyo’s Enhertu, clearing the antibody-drug conjugate for use in adults with unresectable or metastatic HER2-positive...
Immunome’s oral desmoid therapy slashes progression risk — Phase III win
Immunome reported Phase III data showing its investigational oral therapy reduced the risk of disease worsening or death by 84% versus placebo in progressing desmoid tumors. The company described...
Kyverna’s CAR‑T for a rare autoimmune disease heads to FDA — registrational success
Kyverna Therapeutics announced pivotal-trial results in stiff person syndrome (SPS) that met the study’s primary and all secondary endpoints, prompting plans for a U.S. filing in the first half of...
Sobi pays $950M upfront for Arthrosi — bolsters gout pipeline
Sweden’s Sobi agreed to acquire Arthrosi Therapeutics for $950 million cash upfront plus up to $550 million in milestones to add pozdeutinurad (AR882), a Phase III oral URAT1 inhibitor, to its...
Chai Discovery raises $130M — AI antibody design scales up
AI-native drug developer Chai Discovery closed a $130 million Series B at a $1.3 billion valuation to accelerate its computational platform for therapeutic design. The financing, led by Oak HC/FT...
Gilead posts second Phase III win for new HIV regimen — non‑inferior to Biktarvy
Gilead announced a second positive Phase III trial showing its two‑drug regimen achieved non‑inferiority versus the established triple therapy Biktarvy. The result advances Gilead’s bid to offer...
Sanofi’s BTK hopes stumble: Phase III miss and U.S. review delay
Sanofi reported that Perseus, a Phase III study of its BTK inhibitor tolebrutinib in primary progressive multiple sclerosis, failed to meet its primary endpoint. The company also warned the U.S....
Mass General Brigham spins out generative AI startup to speed trial screening
Mass General Brigham launched a commercial spinout delivering a generative AI platform that interprets structured and unstructured clinical data to accelerate patient screening for clinical...
Adaptive inks deals with Pfizer — TCR licensing and data access for autoimmune R&D
Adaptive Biotechnologies signed two non‑exclusive agreements with Pfizer to license its T‑cell receptor discovery platform and TCR‑antigen mapping data. Under the first deal Adaptive will apply...
FDA signals wider use of real‑world data — calls for early‑phase reform
FDA Commissioner Marty Makary told a Wall Street audience the agency will consider more real‑world data (RWD) in drug and device applications, including large de‑identified datasets, and...
Kyverna’s CAR-T wins pivotal readout — FDA filing planned
Kyverna Therapeutics reported that its patient-specific CD19 CAR-T therapy achieved statistically significant benefits in a registrational trial for stiff person syndrome (SPS), meeting the...
Chai Discovery raises $130M — valuation tops $1.3B
Chai Discovery closed a $130 million Series B led by Oak HC/FT and General Catalyst, bringing the AI-native drug developer’s valuation to roughly $1.3 billion. The company said it will deploy the...
Sobi buys Arthrosi for $950M upfront — deal could reach $1.45B
Swedish drugmaker Sobi agreed to acquire Arthrosi Therapeutics for $950 million in cash with up to $550 million in clinical, regulatory, and sales milestones to add pozdeutinurad (AR882), a Phase...
Sanofi’s MS gamble falters: Phase 3 miss and regulatory delay
Sanofi disclosed setbacks for tolebrutinib, the BTK inhibitor it acquired for about $3.7 billion: a Phase 3 trial in primary progressive multiple sclerosis failed to meet its endpoints, and a...
Adaptive licenses TCR tech to Pfizer — pact could top $890M
Adaptive Biotechnologies struck two non-exclusive agreements with Pfizer to apply Adaptive’s T-cell receptor (TCR) discovery platform to rheumatoid arthritis R&D and to license TCR-antigen mapping...
Child death in brain-virus trial rattles gene therapy field
A fatality in the first patient dosed with a brain-penetrant viral vector developed by Capsida Biotherapeutics has unsettled researchers and companies working on gene therapies that cross the...
Immunome’s rare-tumor drug posts Phase 3 victory — FDA bid ahead
Immunome reported that its antibody reduced the risk of disease worsening or death by 84% in a Phase 3 trial for advanced desmoid tumors, achieving the study’s primary endpoint. The company said...