Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
CorMedix suspended 2027 DefenCath guidance after CMS reimbursement changes, while its Heron asset acquisition and a REZZAYO FDA Priority Review proceed.
PolyPid says the FDA is reviewing D-PLEX100 for preventing surgical site infections in colorectal surgery, while the EMA has validated its marketing authorisation application and European rights have reverted to the company.
The US biotech reported third-quarter results alongside the divestment, and said VIRAGE2 enrolment in metastatic pancreatic cancer should finish in the fourth quarter of 2026.
The clinical-stage biotech says PRECISE-AD results are due in the first quarter of 2027, with cash expected to last through 2027.
Coherus Oncology will supply LOQTORZI for a planned US study pairing it with Oncolytics' investigational oncolytic virus pelareorep in squamous cell anal carcinoma.
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.
MeiraGTx says its dossier for the X-linked retinitis pigmentosa gene therapy is complete, with a European filing planned for December 2026 and a US submission early next year.
Ascendis Pharma reported strong third-quarter growth led by YORVIPATH and said the CHMP and COMP have issued positive opinions for TransCon CNP in paediatric achondroplasia.
The company says Type A meeting minutes cited no clinical safety or efficacy deficiencies, and a $10M private placement extends its cash runway through 2028.
The US device maker reports a net loss of about $4.5 million and $4.0 million in cash, while advancing a PMA submission and a new Breakthrough Device Designation.
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 US biotech has finished its FDA submission for the CAR-T therapy and is seeking priority review, with a potential 2027 launch.
Monopar Therapeutics says it expects to finish its rolling FDA submission for ALXN1840 within weeks, reporting $129.4 million in cash that it says funds operations through at least March 2028.
The Rett syndrome gene therapy developer says validation batches met specifications, with an FDA CMC meeting due this quarter and BLA-pathway feedback expected in the first half of 2027.
Ascendis Pharma reported an operating profit of €125 million for Q3 2026 and a positive CHMP opinion for TransCon CNP, with an EU decision expected in Q4.
The Dutch RNA therapeutics company reports higher cash and equity in unaudited IFRS interim statements that refer to a June public offering and its Eli Lilly collaboration.
Nasdaq-listed Quantum BioPharma won approval for a share consolidation of up to 10-for-1 and a name change, and closed a C$80.86 placement of voting shares.
Ernst & Young's report on the combined 2025 and 2024 accounts of Marea Therapeutics and M2 Therapeutics cites recurring losses and a net stockholders' deficit.
Unaudited combined statements show R&D spending more than doubled in the first half of 2026, while cash and equivalents fell sharply with no new financing.
The Israeli wound-care company reports a $6.0M quarterly net loss, a clean DSMB review and successful GMP inspections, while 2026 revenue hinges on uncertain US government funding.
The Icelandic biosimilar maker reported adjusted revenue of $323.4M for the first nine months of 2026 and now expects full-year results toward the lower end of guidance.
The Nasdaq-listed botanical synthesis company reports lower cash at $12.5M and a September 2026 dual listing on the Tel Aviv Stock Exchange.
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.
Pelthos Therapeutics reports third-quarter Zelsuvmi sales of $15.2M, wider commercial coverage, an enlarged Horizon loan and an expected Q1 2027 close for its Castle Creek deal.
The company, formerly Galapagos, ended September with €2.18B in cash and investments and gave an update on its T-cell engager gamgertamig in autoimmune disease.
The US ophthalmology developer has acquired rights outside Asia to mitucapistat and has asked the FDA for a pre-IND meeting and orphan drug designation.
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.
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.
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.