Readouts, trials and R&D strategy.
Final results from the 92-patient study show comparable recovery times and no viral rebound to Day 28, while the company readies a tivoxavir marboxil resubmission for Q4 2026.
The US biotech reported Q3 2026 results, with enrolment continuing in the DIRECTION-GD trial of YB-101 and Phase 2a topline data due in the second half of 2027.
The US biotech says PERFORMA is progressing, with 52-week topline data due in 2029, and an FDA End-of-Phase 2 meeting on alcohol use disorder is set for December.
EyePoint will wind down wet AMD development of DURAVYU after LUGANO and LUCIA missed their primary endpoint, redirecting resources to its diabetic macular edema trials.
The company reported updated LEGEND Cohort 1 data in BCG-unresponsive high-risk NMIBC with CIS and said it agreed the efficacy-evaluable population with the FDA.
Roche will bring 16 abstracts to the CTAD Congress in Boston, spanning its brain-shuttle antibody, an oral NLRP3 inhibitor and its Elecsys blood-based Alzheimer's tests.
The company reached its 120-patient target in the placebo-controlled RESOLVE study and reported Q3 2026 results, with cash it says lasts into the second half of 2028.
The company's Q3 update puts Phase 2b PACE-1 topline data in the second half of 2027, with two Phase 3 trials planned pending FDA alignment.
The US biotech reported $503.5m in cash after its August IPO, and said FDA feedback supports a fixed-dose Phase 2b trial and a Phase 3 study in non-obstructive HCM.
Metagenomi plans to open the Phase 1/2 INTEGR8 trial in the first half of 2027, with first clinical data expected in the second half of that year.
The company says its Phase 3 IMPROVE-PAH study has approvals in 28 countries, 79 active sites and FDA orphan designation, with interim safety data due in the first half of 2027.
Updated Phase 1 data for the Claudin 6 x CD3 T cell engager show a 5.6-month median PFS, with liver enzyme elevations emerging as a dose-related safety issue.
The US biotech also reported 5% mean weight loss at 12 weeks for oral obesity candidate CRB-913 and said cash should last into 2028.
Topline Phase 2 data for PGN-EDODM1 in myotonic dystrophy type 1 show improved myotonia and a generally well-tolerated profile, with higher-dose results due in H1 2027.
Initial Phase 2 SURF302 data support a planned Phase 3 adjuvant study in 2027, while a roughly $400 million offering extends Tyra's cash runway to 2030.
Coya Therapeutics says 137 patients are enrolled in the ALSTARS study of COYA 302, above the 120 planned, as it reports a $10.6 million third-quarter net loss.
The US company says two male pattern hair loss studies of its extended-release oral minoxidil were positive, with no treatment-related serious or cardiac adverse events of special interest.
Black Diamond Therapeutics reported updated Phase 2 silevertinib data in frontline EGFR non-classical-mutation NSCLC and FDA feedback on a Phase 3 programme that could support accelerated approval.
The oncology biotech kept its Q1 2027 target for top-line OPERA-01 data, appointed a new CFO and plans an OP-3136 prostate cancer study in Q4 2026.
The company reported Q3 2026 results, saying it opted for a single-arm pivotal design despite the FDA recommending it consider randomisation, citing feasibility in a rare disease.
Lipocine has begun the BLOOM study of LPCN 1154, a 48-hour at-home oral brexanolone regimen, after an earlier Phase 3 trial missed its primary endpoint.
Week 24 data from the head-to-head psoriatic arthritis study show 54.9% of bimekizumab-bkzx patients reaching ACR50 versus 43.8% on risankizumab, with no new safety signals.
Can-Fite says a patient with advanced hepatocellular carcinoma who had a complete response in its Phase II Namodenoson study has reached ten-year survival, though the company stresses the case is anecdotal.
The randomised trial in late-line MSS colorectal cancer without liver metastases is intended to select the dose for a Phase 3 programme, with first results due in the first half of 2027.
Efgartigimod met its primary endpoint in a combined myositis population, but statistical significance was seen in IMNM and not in dermatomyositis alone, shaping argenx's filing plans.
The once-monthly antibody cut moderate-to-severe vasomotor symptom frequency by 83% versus 33% with placebo, and the company reported no serious or Grade 3+ adverse events in treated patients.
ArriVent BioPharma says firmonertinib did not meet progression-free survival goals in NSCLC, while reporting a cash position of $393.2 million that it expects to last to mid-2028.
The company also won FDA Breakthrough Therapy status for the drug in major depressive disorder and plans an NDA filing in the first half of 2027.
Trevi Therapeutics reported Q3 2026 results, citing a Phase 3 start in IPF chronic cough, a positive FDA meeting on non-IPF ILD cough and $299.4 million in cash.
Translational analysis from a Phase 1b/2 combination trial points to antigen-presenting activity and CD8 effector memory T-cell expansion, with a poster due at ASH on 12 December.