Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The cell-engineering company reported $10.2 million in third-quarter revenue and plans to buy a GMP-grade reagent supplier, partly funded by a $22 million credit facility draw.
Ocugen has granted Sydney-based Celairis exclusive regional rights to its investigational modifier gene therapy, with Phase 3 top-line data expected in the first quarter of 2027.
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.
The US company reported third-quarter TriNav revenue of $12.9 million, revised its 2026 guidance, and flagged an FDA clearance and final CMS payment changes for 2027.
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.
Phase 2 FREEDOM2-DM1 data for PGN-EDODM1 show no serious adverse events at 10 mg/kg, but the March 2026 FDA partial clinical hold is still unresolved.
Atossa Therapeutics reported lower third-quarter operating expenses and created a contingent value right linked to any sale of a priority review voucher it has yet to receive.
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 biotech reported a 46% overall response rate in 76 patients with platinum-resistant or refractory ovarian cancer and said a $50 million offering extends its cash runway into Q1 2028.
The company's CEO said in a media interview that outstanding manufacturing work continues, with resubmission planned as promptly as practicable but no assurance on timing or approval.
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.
The US biotech says its cash of $161.4 million should fund operations into 2029 as it progresses two epilepsy-focused programmes.
The company cites stronger XIAFLEX growth and Acthar Gel performance, and plans an FDA filing for XIAFLEX in plantar fibromatosis early next year.
Arbutus reported $59.1M net income for Q3 2026, as it and Genevant widened LNP patent litigation in Japan and Canada and the FDA cleared its oral PD-L1 candidate.
The company reported Q3 2026 results for iopofosine I 131 in Waldenström macroglobulinemia, citing an 87.5% response rate in patients treated directly after BTK inhibitor therapy.
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.
Humacyte reports Symvess sales of $1.0 million for the third quarter, plans a November dialysis sBLA, and has begun a Phase 2a coronary bypass study.
The company's Q3 2026 update also confirms a $205M priority review voucher sale and the start of dosing in a Phase 2 facioscapulohumeral muscular dystrophy study.
Net product sales rose 31% quarter on quarter, yet a $389.7M charge for the October settlement with United Therapeutics drove a GAAP net loss.
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.
Protalix BioTherapeutics reported nine-month revenue of $75.6M and net income of $26.1M, while enrolment continues in its Phase 2 PRX-115 gout study.
The US company also reports full enrolment in its OPGx-LCA5 Phase 3 trial and cash of $89.0 million, which it says funds operations into 2029.
The manufacturer has flagged an increased risk of false positive KPC resistance gene results on certain kit lots of three BIOFIRE panels, according to Dutch inspectorate IGJ.
IGJ says an inspection found the products were not classified as medical device accessories and were sold without correct labelling or a compliant IFU, risking use errors.
A technical investigation prompted by a customer complaint found certain lots of Remel's 2ml Neisseria meningitidis Gp C reagent do not meet instructions-for-use performance criteria.
The Dutch inspectorate has published a manufacturer field safety notice after two reports of the Audiolyser ADL Connect producing a 250 Hz tone far above the level set in Audiowin software.
The Dutch health inspectorate has published a bioMérieux field safety notice on the EMAG system, covering references 418591 and 418591U.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.