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Rare disease – Relay’s PI3Kα inhibitor clears efficacy bar in Phase 2 vascular anomalies
Relay Therapeutics reported first Phase 2 efficacy data for its PI3Kα inhibitor zovegalisib in a vascular anomalies study, saying the results cleared Wall Street expectations and expanding the...
Immuno-oncology – Regeneron’s LAG-3 program stumbles in melanoma Phase 3
Regeneron’s LAG-3 inhibitor fianlimab failed to beat pembrolizumab (Keytruda) in a Phase 3 melanoma trial in patients who had not received prior treatment. The combination did not improve...
Dealmaking – Regeneron buys into Parabilis to develop new ADC-like therapy platform
Regeneron agreed to buy a stake in Parabilis as part of a multi-target Helicon tie-up valued at up to $2.2 billion, adding an equity component and milestone-heavy economics. The collaboration uses...
Oncology – ctDNA monitoring extends treatment response insights in EXTEND Phase 2
Researchers at MD Anderson reported Phase 2 EXTEND trial data showing circulating tumor DNA (ctDNA) can enhance treatment monitoring in patients undergoing metastasis-directed therapy for early...
Diagnostics & screening – Delfi Diagnostics FirstLook Lung boosts lung cancer screening uptake
Delfi Diagnostics’ cfDNA-based FirstLook Lung assay increased lung cancer screening uptake in a cluster-randomized FIRSTLUNG trial, the company reported at the ATS International Conference. Among...
FDA regulation – Supreme Court declines IRA drug price negotiation challenges
The U.S. Supreme Court declined to hear multiple lawsuits challenging Medicare’s drug price negotiation program under the Inflation Reduction Act (IRA), dealing another procedural setback to the...
Clinical innovation – One in five pregnant individuals miss proper syphilis screening in Ontario
A population-based retrospective cohort study in CMAJ reported that one in five pregnant individuals in Ontario did not receive timely syphilis screening during pregnancy. The findings highlight...
Company pipeline/development – One in vivo CRISPR gene editing therapy heads to FDA
Intellia submitted its first in vivo CRISPR-based gene editing therapy to the FDA, marking a regulatory milestone for direct delivery approaches. The filing signals continued expansion of genome...
Oncology regulatory and late-stage pipeline milestone
Merck’s sacituzumab tirumotecan (sacituzumab tirumotecan; sac-TMT) scored a major regulatory and efficacy milestone in advanced endometrial cancer, delivering a global Phase 3 win that met both...
FDA approval for a new hypertension mechanism at AstraZeneca
The FDA approved AstraZeneca’s Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor, as a new add-on option for hypertension patients not adequately controlled on existing...
U.S. Supreme Court blocks IRA Medicare price negotiation challenges
The U.S. Supreme Court declined to take up multiple biopharma challenges to the Inflation Reduction Act’s Medicare drug price negotiation program, dealing another blow to brand manufacturers...
Oncology immunotherapy failure plus strategic dealmaking at Regeneron
Regeneron’s melanoma immunotherapy program stumbled in a late-stage test: the company said a fianlimab plus Libtayo regimen failed to improve outcomes versus Keytruda in a phase 3 setting, adding...
Cell and gene therapy trial operations in China with global data reuse
Dark Horse Consulting and KunTuo Research and Development announced a memorandum of understanding aimed at helping sponsors advance cell and gene therapy trials in China while enabling reuse of...
AI for clinical decision support in radiotherapy planning
An international trial led by University College London and the London School of Hygiene & Tropical Medicine reported that an AI system can improve radiotherapy planning for cervical and prostate...
Cancer detection and screening lift with cfDNA liquid biopsy
Delfi Diagnostics reported that its cell-free DNA liquid biopsy test, FirstLook Lung, increased lung cancer screening uptake by nearly threefold in a cluster-randomized interventional FIRSTLUNG...
Neurodevelopmental precision target discovery in Fragile X syndrome
UCLA Health researchers identified EPAC2 as a potential therapeutic target for Fragile X syndrome in preclinical work published in Neuron. The study, led by Carlos Portera-Cailliau and colleagues,...
Rare disease and neuroscience innovation via new CAR T in CD94-positive lymphomas
MD Anderson received FDA IND clearance to start a phase I trial of JV-394, a CD94-targeted CAR T therapy for patients with relapsed or refractory CD94-positive T/natural killer cell lymphomas. The...
China and dealmaking: early-stage risk shifts and licensing-driven growth
A JPMorgan analysis reported that biopharma licensing reached $82.7 billion in announced deal value in Q1 2026, while upfront cash represented only about 6% of total deal value—suggesting partners...
Clinical oncology: Merck’s TROP2 ADC posts endometrial survival win
Merck’s sacituzumab tirumotecan (sac-TMT) cleared a major late-stage hurdle in advanced endometrial cancer, becoming the first TROP2 antibody–drug conjugate to show an overall survival and...
Regulatory action: FDA approves AstraZeneca aldosterone synthase inhibitor for hypertension
The FDA approved AstraZeneca’s baxdrostat as Baxfendy, positioning it as the first drug in a new class of aldosterone synthase inhibitors for hypertension patients not adequately controlled on...