Ascendis Q3 product revenue rises 89% to €366M as CHMP backs TransCon CNP
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.
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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 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.
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.
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.
The competition authority found problems only in UK vehicle refinish coatings supply, and the companies plan to offer the divestment already agreed with the European Commission.
The US CBD maker reports its smallest operating loss since 2019 and warns that a federal hemp restriction taking effect on 11 December could cover its full-spectrum products.
Lilly gains exclusive rights to develop estetrol combinations in women's health and cardiometabolic disease, plus a US co-commercialisation option on Richter's FYLREVY, and will buy about $15M of Richter shares.
Santhera has granted SteinCares exclusive rights to distribute vamorolone across 31 Latin American and Caribbean countries, with Brazil first in line and ANVISA registration to be pursued.
The Icelandic biosimilar maker reports $323.4M adjusted revenue to September, keeps its full-year guidance, but now expects to land towards the lower end of the range.
The Hungarian drugmaker reports reported pharma revenue up 2.6% to HUF 686.5bn despite a roughly 9-point currency drag, and raises its full-year outlook.
The Danish drugmaker now expects 11-12% revenue growth and 15-19% adjusted EBITDA growth at constant exchange rates, citing strong US Vyepti sales and stronger Partner Markets.
Legend Biotech posted third-quarter CARVYKTI net trade sales of about $710 million and operating income of $46.8 million, and said the FDA cleared its IND for CD19/CD20 in vivo CAR-T LB2501.
Alcon reports 10% higher third-quarter net income, while a $505m charge for discontinuing PowerVision intraocular lens programmes drives a 35% fall in nine-month operating income.
The eye-care company reported nine-month sales of $8.2bn, with dry eye products and surgical equipment launches driving growth, and highlighted its planned purchase of Neurotech Pharmaceuticals.
Eocene's subsidiary has granted Hospital Line SA exclusive rights to market the CE-marked CG-100 intraluminal bypass device in two Mediterranean markets.
The Deep TMS maker reported operating income of $2.6m and 130 systems shipped, and expects full-year 2026 results at the upper end of its guidance.
The Nasdaq- and TASE-listed neurostimulation maker reports third-quarter operating and net profit, 130 system shipments, an $85M backlog and $63.4M in cash.
BioNTech has agreed to pay $205 million in cash for a US priority review voucher, intending to speed FDA review of a future late-stage oncology filing.
The T-cell receptor therapeutics company reports higher research costs and a warrant liability charge, while holding cash and other financial assets of roughly €472M at 30 September.
The company's MD&A for the period to 30 September 2026 points to EP-104GI in eosinophilic esophagitis, with FDA-required trials ahead, and a search for funding or a partner for osteoarthritis.
The Nasdaq-listed metal 3D printing firm reports higher cash, lower debt and a revised gross margin outlook, and says it has opened its Forge 1 production campus.
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.