Science and Research

The vaccine met the stricter direct test for 17 of 19 serotypes shared with Capvaxive, with two meeting an older threshold.

The 125-patient single-arm study had no control group, while Medtronic says U.S. payer coverage reaches 96% of commercial and Medicare insured lives.

Among 109 treated patients, the median response lasted 12.1 months; the single-arm cohort offers no direct efficacy comparison.

The company says the agency has set no new action date, while its U.S. launch target remains conditional on approval.

Rebisufligene etisparvovec won U.S. approval on Sept. 17; Ultragenyx gave no date for a European decision.

SITC presentations will follow a three-year EVX-01 clinical update on Oct. 24; the 75% response rate was first reported in 2025.

Surrozen expects to dose DUET's first patient in Q4; clearance also meets a condition for a US$95.1M financing close around Oct. 20.

The first-line application is expected to be completed by year end; a separate monotherapy NDA has a Feb. 27, 2027 FDA target.

AstraZeneca or Daiichi Sankyo will sponsor the planned breast cancer study, with all three companies sharing trial costs and retaining drug rights.

The AUTUS pulmonary valve can later be widened by catheter; the FDA cited a 62-child study and flagged longer-term risks.

A small post hoc MRI subgroup improved after 72 weeks, while placebo comparisons came from other liver measures in the larger STEP UP dataset.

A one-year biomarker analysis could support accelerated approval while the same study runs toward possible full approval.

The monthly 200 mg dose beat placebo at Week 16; patients have already been dosed in two atopic dermatitis Phase 3 studies.

The company expects to begin first human testing of its HC74-based ADC in advanced solid tumours in the fourth quarter of 2026.

The China extension followed 240 patients, with long-term safety as its primary aim, while Sagimet prepares a U.S. Phase 3 trial.

Atlas showed 13.9 per cent complete clearance on the rival pill at week 16 as Takeda awaits an FDA action in early 2027.

A 350-patient Phase 3 study is testing PSMA PET with MRI before biopsy; Telix's Sept. 30 release gives no readout or NDA submission date.

A 37.1-minute placebo-adjusted shift in sleep onset supports Vanda's plan to seek a third U.S. HETLIOZ indication.

DBV requested priority review for VIASKIN Peanut after reporting a 31.8-point responder advantage over placebo in VITESSE.

The package includes 12 months of stability data from a new manufacturer after two manufacturing-related FDA letters.

HUTCHMED says the application covers MET-driven lung cancer after EGFR inhibitor treatment, supported by a 338-patient Phase 3 trial.

The closed SPR2015 deal carries a US$400M upfront payment; further value depends on development and commercial milestones.

The 40-patient tipelukast study missed its week-24 liver-fat and triglyceride comparisons, although secondary HDL measures improved.

The Sept. 24 verdict awards US$90 million plus interest the court will determine; post-trial proceedings and a possible appeal remain.

The application seeks dosing for smaller children with APDS, and the FDA set Jan. 30, 2027 as its target action date.

The partners cited FDA discussions over Phase 2 evidence and kept a randomized Phase 3 lung cancer trial enrolling.

The small ALTITUDE follow-up lacks a control comparison; the dose is being tested in the sham-controlled NAAVIGATE trial.

Both doses passed a vision noninferiority test against ranibizumab; higher rates of retinal complications await detail.

The new Phase 3 study shifts its primary measure to lung function after an earlier miss, but aTyr says it needs more money to run it.

The FDA will decide whether to file the application for review after PROSERA's walking-distance gain missed its preset statistical cutoff.

The first US$7 million draw needs a shareholder vote, while later tranches depend on U.S. listing steps and the first Phase 3 site.

OASIZ 301 met its systemic disease measure, but Amgen did not disclose the treatment gap; a second Phase 3 study is due to finish this year.

The adult GEP-NET radiopharmaceutical is therapeutically equivalent to Lutathera, but Lantheus has not announced its launch date or price.

The 57-patient study missed its Week 12 skin disease endpoint, leaving five other autoimmune indications on Immunovant's development calendar.