Readouts, trials and R&D strategy.
Initial Phase 1/2 results for the allogeneic CD19-targeted CAR NK therapy support a compressed Day 0/2/4 dosing schedule, and the company plans FDA talks on a registrational path.
Laboratory data for APVO451, APVO452 and APVO711 were shown at SITC on 7 November; the company expects two molecules to enter IND-enabling studies in 2027.
Whitehawk Therapeutics said its biparatopic antibody drug conjugate for small-cell lung cancer has entered a US Phase 1 trial, as it reported Q3 2026 results with $169.7 million in cash.
Neurogene says the primary analysis of its NGN-401 Embolden trial will include every dosed participant, with topline results expected in the second half of 2027 and PPQ runs due by year-end.
Topline Part B results for VDPHL01 show hair-count gains in over 500 men, with no treatment-related serious adverse events or cardiac events of special interest.
The 600 mg dose beat placebo on ACR20 at Week 28, but 300 mg did not separate; Immunovant also says further Sjögren's development beyond Phase 2 looks unlikely.
The company reports a statistically significant efficacy gain over BCG alone in Cohort A of QUILT-2.005 and plans a supplemental BLA filing by the end of 2026.
After FDA discussions and ESMO data showing an 82% response rate in later-line disease, Tango plans a front-line trial in MTAP-deleted pancreatic cancer in the first half of 2027.
The US cell therapy developer expects eGFR-slope topline data from the PROACT 1 trial in mid-2027 and plans an accelerated approval submission the following year.
Phase 1/2 data at ACR Convergence 2026 show durable responses across myositis, lupus nephritis and systemic sclerosis, with a low rate of severe cytokine release syndrome.
Roivant's fiscal Q2 update covers early sales of FDA-approved LISRAYA, an uveitis filing plan, a positive rheumatoid arthritis readout for IMVT-1402 and a Phase 3 start for mosliciguat.
Interim results from six patients met the primary and key secondary endpoints, while the FDA and EMA granted regulatory designations for QRX003 in Peeling Skin Syndrome.
The MHRA and several EU regulators and ethics committees have authorised sites in the Phase 1/2 ASCEND study, with first dosing still expected by the end of 2026.
Elicio Therapeutics says pre-specified subgroup analyses from AMPLIFY-7P will shape Phase 3 design, despite the trial missing its primary disease-free survival endpoint in the overall population.
NeOnc Technologies posted a Q3 2026 net loss of $4.4M and flagged Phase 2a NEO100 results, FDA feedback on NEO212 and a $15M registered direct offering.
The US cell therapy developer says its cash runway extends into mid-2027 and that SC451, a hypoimmune islet therapy for type 1 diabetes, could enter the clinic as early as this year.
Two Phase 3 EMBARQ studies in chronic spontaneous urticaria met all primary and key secondary endpoints, while the company drops its Phase 2 prurigo nodularis study.
The company finished enrolling 169 evaluable patients in NANOPULSE-AF about three months early and reported Q3 2026 cash of $189.2 million.
Elutia says a GLP rabbit study of its antibiotic-coated biologic matrix met its endpoints, with no viable MRSA or E. coli recovered, and it plans a Q4 2026 FDA submission.
The US biotech says the agency has agreed the final design of a randomised trial in previously treated chronic myeloid leukaemia, with enrolment due to start before the end of 2026.
The company's third-quarter update reports continued enrolment in both studies, cash of $202.9 million into Q2 2028, and plans to discuss expanding its ALPS programme with the FDA.
Adicet Bio reports Q3 2026 results, with ADI-212 cleared for prostate cancer and prula-cel's lupus nephritis pivotal study in start-up, alongside $100.9 million in cash.
CytomX Therapeutics reported third-quarter 2026 results alongside news that its EpCAM-directed masked antibody drug conjugate holds Fast Track status, with a registrational study possible in the first half of 2027.
vTv Therapeutics says 166 participants are randomised in its Phase 3 CATT1 trial, with topline data expected mid-2027, as the FDA grants orphan designation to HPPD for sickle cell disease.
The US firm says the FDA cleared its IND for simufilam in tuberous sclerosis complex-related epilepsy in September, as it reported Q3 results and a securities settlement escrow payment.
The US biotech's November 2026 corporate presentation reports interim DA-1726 liver-fat data and lays out a timeline running into 2027.
Aptevo reports that successive changes to mipletamig's priming-dose regimen have substantially lowered infusion-related reactions in the RAINIER study, with Phase 2 planned for 2027.
The company plans to start the global Headliner study of micvotabart pelidotin in mid-2027, with FDA feedback on dose selection due in the first quarter of 2027.
Dogwood Therapeutics has enrolled 239 patients in its Phase 2b CINP trial of Halneuron, expects top-line results in November, and raised $5 million from its largest shareholder.
An investor presentation proposes pairing the investigational TLR3 agonist with Revolution Medicines' daraxonrasib, though no trial of the combination has been established.