Research

The continuous-treatment cohort showed symptom gains as Alumis targets a fourth-quarter U.S. drug application.

Guardant360 CDx can identify ESR1 mutations before progression in eligible advanced breast cancer; Guardant's Oct. 8 release gave no European payer terms.

The company says its 3-MMC claims cover dyskinesia treatment alone and with PEA, but gave no publication number or grant timetable.

A European Radiology paper tested DeepHealth's MRI risk score on 787 men; simulated biopsy savings have yet to be shown in practice.

The designations cover a colorectal cancer combination and lung cancer monotherapy, both based mainly on a first-in-human study.

The 220-person ZUPREME-2 trial also showed improved HbA1c; Zealand says the first participants have begun treatment in its Phase 3a program.

The biopsy measure improved against placebo after a gluten challenge, with p=0.0176; argenx plans Phase 3 development.

The voucher came with Genglycos approval; payment awaits an antitrust waiting period and other closing conditions.

Vaxcyte expects both underwritten offerings to close Oct. 9, adding funds for adult vaccine trials and manufacturing ahead of a planned U.S. filing.

The Oct. 5 placement issued 4.84 million shares at US$1.16 each and gave the placement agent warrants for another 387,464 shares.

The primary IPI 3 to 5 cohort showed a 0.49 hazard ratio, while the partners plan regulatory talks without a stated filing date.

The study will test tablets after 21 weeks of injections in about 195 adults, with weight change tracked through week 33.

Quantum said on Oct. 6 it had entered a Study Start-Up Agreement; it gave no first-dose or readout date.

Agency feedback follows a Phase 3 miss in congenital hyperinsulinism; Rezolute will weigh its filing strategy after tumor HI data.

Seraxis notes are expected to convert into BetaNova stock if the merger closes; the first SR-02 patient dose is targeted for Q1 2027.

Stoke plans to combine four Vineland-3 subdomains for its U.S. NDA after a Phase 3 readout expected in the third quarter of 2027.

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.