Readouts, trials and R&D strategy.
The designation covers the Phase 3 DUBLIN-4 population, while BeyondSpring completes the sale of its China-linked subsidiary to Biolin and reports cash of just $0.6 million.
The company formerly known as Quince Therapeutics says its inhaled rapamycin programme will read out first in post-lung-transplant BOS in Q1 2027, with cash expected to last through 2028.
The company formerly known as Plus Therapeutics posted $0.7M in diagnostic revenue for Q3 2026, added Aetna coverage and reported clean early safety data for REYOBIQ.
Five-year follow-up from trial VLA1553-303 shows most vaccinated adults retain neutralising antibodies above the seroresponse threshold, with older adults matching younger ones.
The clinical-stage company says it will need substantial extra funding, while a Phase 1 trial supports a single fixed dose per visit of inhaled mebufotenin.
Aardvark Therapeutics says the FDA cleared its ARD-101 IND after cardiac safety studies, allowing a 200 mg twice-daily open-label trial, with a development-plan meeting due in Q1 2027.
The US biotech reports early DA-1726 liver-fat and weight data from a very small cohort, and sets out FDA, Phase 2a and Phase 2 steps, with $8.8M in cash.
Interim Phase 1b/2a data in oculopharyngeal muscular dystrophy dysphagia showed responses in every Cohort 1 and 2 patient, with no serious adverse events, alongside Benitec's fiscal first-quarter results.
The company signed a start-up agreement with Thermo Fisher Scientific's clinical research business for a Phase 2 progressive MS trial, after FDA cleared its IND in August.
Dr Gregory George will act as interim chief operating officer while Mesoblast aligns with the FDA on a BLA in LVAD patients and awaits Phase 3 back pain data.
The US biotech says median progression-free survival has not been reached with 30 mg onvansertib plus FOLFIRI/bev in first-line RAS-mutated metastatic colorectal cancer, and it is preparing a registrational trial.
The company has sent the FDA a briefing document seeking agreement that the nafamostat study can close at the end of 2026 even if fewer than 70 patients are enrolled.
Fractyl Health says its duodenal ablation device hit the co-primary endpoint in weight maintenance after GLP-1 discontinuation, while it restructures and drops Rejuva gene therapy.
The dermatology company's U.S. YCANTH revenue rose 57.9% year over year, while enrolment in the first of two pivotal common warts trials is finished.
The US company says enrolment in its Phase 3 rilparencel trial will exceed 500 patients, while cash of $141.9 million funds operations into mid-2027.
Nektar reported Q3 2026 revenue of $9.4M, a $55.7M net loss and $952.9M in cash as its late-stage rezpegaldesleukin programme moved into full recruitment mode.
A safety review committee has recommended moving Azitra's ATR-04 Phase 1/2 trial to Cohort 2, as the company reports a $3.0 million third-quarter net loss.
The US biotech says SOLARA-2, a single-arm study in EGFR C797S-positive NSCLC, should dose its first patient in Q1 2027 and could support an accelerated approval filing.
Eledon reports Q3 2026 results, with US regulatory milestones in islet cell and kidney transplantation and $69.7 million in cash funding operations into Q2 2027.
Ensysce's Q3 report shows the psilocybin-based CY200 Phase 2a protocol is under UK review, with the MHRA and an ethics committee requesting further information.
Interim NEXICART-2 data in relapsed/refractory AL amyloidosis will go to ASH in December, as Immix confirms a mid-2027 FDA filing plan and cash into mid-2028.
The gene therapy developer says the FDA agreed the pivotal Phase 2 design for RP-A501 and that KRESLADI is commercially ready, with cash expected to last into Q3 2028.
Novartis says remibrutinib 25 mg twice daily showed early, sustained efficacy to Week 52 in three chronic inducible urticaria subtypes, with results due at ACAAI 2026.
DBV Technologies presented additional results from its 654-child VITESSE trial of the VIASKIN Peanut Patch at ACAAI in Phoenix, including severity of reactions and compliance.
The clinical-stage biotech says PRECISE-AD results are due in the first quarter of 2027, with cash expected to last through 2027.
The US biotech reports first dosing in its AURORA trial, with topline data due in the second half of 2027, after a $115M October financing.
The company acquired Advanced Vision Science from Santen to secure IOL supply for its Phase 3 glaucoma programme, and has begun implanting patients with its second candidate, BIM-DRS.
Vivani Medical says top-line Phase 1 data for its NPM-139 semaglutide implant are due this week, while the Cortigent merger still awaits final regulatory approvals.
The company says Phase 2 DMD topline data are expected in Q1 2027, with FSHD enrolment in the TRAVERSE study also due to begin that quarter.
Published preclinical data show the oral A3 adenosine receptor agonist reduced a urinary proteinuria marker by 48–80%, and an Italian Phase II study in five adults is under regulatory review.