Science and Research

The uncontrolled Phase 2 analysis used a September 2025 cutoff; Zentalis will present the survival data at ESMO on Oct. 23.

The hormone-free IUD remains approved for three years, with an FDA decision on a duration extension expected in the second quarter of 2027.

U.S. enrolment is expected in early 2027, with up to 80 adults testing EB06 against placebo and topline results due late that year.

Gilead gets exclusive development rights to three discovery programmes, with preclinical and later milestone payments contingent on progress.

The 145-patient MAXPIRe study missed its lung-function endpoint; safety was comparable to placebo and graft-versus-host disease trials continue.

The uncontrolled SYNCHRONICITY study reported a 3.6-letter vision gain at six months, with improvements maintained through two years.

The 60 mg dose met ALOFT-IPF's lung-function endpoint, but the topline release gives no effect size or filing date.

ICP-B161 is the company's fifth candidate to enter clinical development in 2026; the release gives no enrollment timetable.

The FDA has accepted the ADH1 application for priority review, with a May 8, 2027 target decision date.

The FDA accepted the uveitic macular edema application after MEERKAT met its primary endpoint and SANDCAT did not.

The oral drug's label covers immunocompromised adults whose lesions failed standard antivirals, with U.S. availability expected before the end of 2026.

EXCALIBER-RRMM met its second primary endpoint, with median progression-free survival estimated at 42 months versus 20 months.

The Oct. 8 label covers IV treatment from age two and Hybreza injections from age 12 for patients weighing at least 40 kilograms.

The FDA reviewed data from 12 cancer types, but Natera disclosed no performance figures or date for a marketing submission.

ICONIC-LEAD's two-year skin clearance results set a longer follow-up point for Alumis's investigational oral psoriasis drug.

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.

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.