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Clinical failure: BioMarin’s ENPP1 therapy misses benefit in phase 3
BioMarin reported that its enzyme replacement therapy for ENPP1 deficiency failed to show clinical benefit in a phase 3 study, delivering a setback for the company’s rare disease pipeline. The...
Biotech financing: Degron raises for molecular glue degraders
Degron Therapeutics closed a $40 million Series A extension round to accelerate its molecular glue degraders program. The company said it will advance degraders designed to hit proteins that are...
Clinical update: Relay zovegalisib posts Phase 2 efficacy bar in vascular anomalies
Relay Therapeutics cleared an efficacy benchmark in Phase 2 for zovegalisib, its PI3Kα inhibitor, in patients with vascular anomalies tied to rare genetic disease. The first Phase 2 data readout...
Large licensing tie-up: Daewoong takes Innovo’s oral IBD candidate
Daewoong Pharmaceutical secured an exclusive license to Innovo Therapeutics’ INV-008, an oral 15-hydroxyprostaglandin dehydrogenase inhibitor for inflammatory bowel disease, in a deal valued up to...
Cell and gene therapy trial support: MD Anderson IND clearance for CD94 CAR T
UT MD Anderson received FDA IND clearance to start a Phase I trial of JV-394, a novel CD94-targeted CAR T-cell therapy for patients with relapsed or refractory CD94-positive T-cell and NK-cell...
Diagnostics commercialization: HelioLiver expands with Syneos Health
Helio Genomics partnered with Syneos Health to broaden commercialization of its blood-based HelioLiver test for early detection of hepatocellular carcinoma. Financial terms were not disclosed, but...
AI in pharma R&D: Incyte embeds Edison Scientific Kosmos
Incyte expanded its AI strategy by partnering with Edison Scientific to embed Kosmos across drug discovery and development workflows. Edison’s AI scientist Kosmos will be trained on Incyte’s...
Global health emergency: WHO declares Ebola Bundibugyo outbreak a PHEIC
WHO classified the ongoing Bundibugyo ebolavirus outbreak in the Democratic Republic of Congo as a public health emergency of international concern (PHEIC), citing intensifying threat signals...
Regulatory action – FDA hypertension approval (aldosterone synthase inhibitor)
The U.S. FDA approved AstraZeneca’s Baxfendy (baxdrostat) for hypertension in combination with other antihypertensive medications in patients not adequately controlled. The drug is a...
Oncology – Merck’s TROP2 ADC posts first global Phase 3 win in endometrial cancer
Merck’s TROP2 antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) secured its first global Phase 3 success ahead of schedule in advanced endometrial cancer, meeting both overall survival and...
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...