United Therapeutics advances SUMMIT study targeting pulmonary hypertension in COPD
United Therapeutics secures FDA clearance for its SUMMIT PH-COPD trial. Can a new treprostinil inhaler overcome earlier safety concerns?
Pharma & Biotech
Pharma & Biotech
Zipalertinib controlled brain disease in 72% of patients. Could it address a major EGFR treatment gap?
Zipalertinib achieved a 30.2% intracranial objective response rate and 72.1% intracranial disease control rate in 43 evaluable patients with EGFR-mutated lung cancer and active CNS metastases. The Phase 2 findings support further development, although the treatment remains investigational.
Pharma & Biotech
Frontier to reveal first FMC-376 clinical responses in KRAS G12C lung cancer
Frontier Medicines will present its first Phase 1 clinical findings for FMC-376 at ESMO 2026, including preliminary responses in patients previously treated with KRAS G12C inhibitors. The investigational drug targets both active and inactive KRAS G12C, but detailed response rates and patient counts remain undisclosed ahead of the presentation.
Pharma & Biotech
Faeth to present PIKTOR breast cancer data comparing multi-node cancer treatments
Faeth Therapeutics will present preclinical PIKTOR findings at ESMO 2026, including combinations with endocrine therapies and direct comparisons with gedatolisib in breast cancer models. The research supports an ongoing Phase 1b/2 trial, but human efficacy results in breast cancer are not yet available.
Pharma & Biotech
Gilead’s herpes candidate cut viral shedding by 98%. What will its latest IDWeek data reveal?
Gilead will present 28 studies at IDWeek 2026, covering Bixlenvo treatment outcomes, early real-world Yeztugo adoption and final Phase 1b findings for the investigational herpes medicine GS-1179. The programme examines how recently approved HIV treatments perform in practice while advancing a separate long-acting antiviral candidate.
Pharma & Biotech
Merck is paying a 130% premium for Silence Therapeutics. Is divesiran the main prize?
Merck KGaA has agreed to acquire Silence Therapeutics for approximately $1.3 billion in equity value, offering $20 per ADS. The transaction centers on divesiran, an RNA interference therapy that achieved an 88% response rate in Phase 2 polycythemia vera testing.
Pharma & Biotech
Sound Pharma reports Phase 3 hearing gains with SPI-1005, targeting sudden hearing loss
Sound Pharmaceuticals has presented a new Phase 3 analysis showing statistically significant low-to-mid-frequency hearing improvements with SPI-1005 in Ménière's disease. The company believes the findings support development for sudden sensorineural hearing loss, although that separate indication has not been established in a dedicated pivotal trial.
Pharma & Biotech
PharmaEssentia reports 55% two-year BESREMi persistence in polycythemia vera
PharmaEssentia will present six studies examining treatment gaps and real-world BESREMi use in essential thrombocythemia and polycythemia vera. The findings include 55% two-year treatment persistence in first-line PV users and new molecular response data from Asian patient populations.
Pharma & Biotech
Vivacta and Grit Bio advance CD19-targeting CAR-T without external cell manufacturing
Vivacta Bio and Grit Bio have secured FDA orphan drug designation for GT801 in autoimmune hemolytic anemia. Early findings from two patients showed complete responses following treatment with the investigational in vivo CAR-T therapy, which uses targeted lipid nanoparticles to generate CD19-directed immune cells inside the body.
Pharma & Biotech
Ionis TRYNGOLZA wins EU recommendation after 85% reduction in pancreatitis events
European regulators have recommended extending TRYNGOLZA to adults with fasting triglycerides of at least 880 mg/dL. The decision follows two Phase 3 trials demonstrating substantial triglyceride reductions and 85% fewer adjudicated acute pancreatitis events in a pooled analysis.