Medical and Pharmaceutical

A recent reverse split rules out a 180-day compliance period, while Enlivex says a timely hearing request would preserve trading pending the hearing.

US$187.7M in cash supports planned operations as two fully enrolled autoimmune trials approach readouts and a third study awaits its start.

A planned 72-participant study will test four subcutaneous doses, with safety and tolerability assessed over 48 weeks.

The 523-patient study met its progression-free survival endpoint, but Pfizer withheld the comparative effect size and a filing date.

A pooled analysis of 139 treated adults showed sustained filtration gains, but long-term follow-up had no continuing placebo comparison.

Class C certification supports continued EU access beyond the 2028 transition deadline and covers the quality management system.

Four of 16 evaluable patients responded to lorigerlimab as the company enrols a lower-dose cohort after significant treatment-related toxicity.

RESOLVE will test symptom recovery and hospitalization in high-risk adults, starting with at least 200 patients in its Phase 2b portion.

The 541-patient DYNASTY-Breast02 trial met its primary endpoint, but the partners say potential patient benefit is limited.

Ivonescimab plus chemotherapy extended median survival to 14.9 months in a China-only study, with a separate U.S. trial planned.

Pumitamig plus docetaxel showed early activity after immunotherapy and chemotherapy, but the Phase 2 study had no control arm.

Severe or worse treatment-related adverse events affected 72.1 per cent across expansion cohorts; FDA talks are planned for 2027.

The single-arm analysis includes unconfirmed responses and supports two enrolling Phase 3 trials; median response duration was not disclosed.

The uncontrolled first-line analyses support continued development, with randomized SUNRAY-01 results expected in the first half of 2027.

Five of 13 patients reached immunologic remission at 12 weeks, while higher-dose cohorts and longer follow-up will guide development.

Genmab will conduct the Phase 1/2 study, while Incyte will co-fund it and supply its KRAS G12D inhibitor; a start date was not disclosed.

A 401-infant presentation compared immune responses and safety with Prevnar 20; the company has not dated its pediatric Phase 3 readout.

An independent board will review ReMEDy2 in Q1 2027 and may resize the study to as many as 728 participants or stop it for futility.

The hepatitis B developer can pursue further United States testing, but has not disclosed a new trial design or start date.

The developer will stop internal Rejuva gene-therapy work and forecasts cash into Q2 2027, ahead of a potential 2028 launch.

A 131-patient registry analysis found higher graft risk, while a separate randomized trial reported 49% fewer kidney biopsies.

A 1,859-patient pivotal trial will compare the resorbable implant with Xience, with primary completion estimated for June 2029.

The 24-week injection course targets eligible adults without cirrhosis, with boxed liver and platelet warnings.

The indication covers severe symptomatic leakage despite medical therapy, with pivotal one-year findings due at TCT.

Confirmed disability progression affected 11.7 per cent with continuous treatment versus 17.4 per cent after an initial comparator.

Patients aged 12 and older gain an alternative to capsules, while the approval release gives no launch date for the new strength.

The capsules are intended for three programs, including a Canadian Phase 3 PTSD trial of up to 100 people expected to begin in 2027.

The placebo-controlled study tests two doses of NBI-'567 over 12 weeks, with primary completion estimated for May 2028.

The 2027 rollout will connect Onclarity home collection with Quest's clinician, health-plan and consumer channels.

The non-exclusive Stevens agreement covers gel and spray formats, but Kane's announcement gives no minimum orders, pricing or revenue forecast.

The Oct. 20 announcement says the process frees capacity for other biosimilars but gives no implementation date or quantified unit-cost savings.

The 183-patient APOLLO study met both primary endpoints, with an FDA resubmission planned by the end of 2026.

The Vanderbilt development partnership will pair CT imaging with blood biomarkers, with initial performance data due Dec. 3.

Half of induction responders were in remission at one year in the uncontrolled Phase 3 study; Lilly plans global regulatory submissions.

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

The once-daily device adds a second ZILBRYSQ self-injection format for adults with anti-AChR-positive gMG, with availability expected in the first quarter of 2027.

The nonprescription apraclonidine drops are approved for people aged 12 and older, with a U.S. retail launch expected in the coming months.

Ryzumvi's expanded indication triggers a milestone payment, while U.S. commercial rights belong to Viatris.

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.