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ASND 資訊
ASND 事件
BioMarin Enters Binding Settlement with Ascendis on Patent Disputes
BioMarin (BMRN) announced that it has entered into binding terms with Ascendis Pharma (ASND), resolving the patent and ancillary disputes pending globally, including before the U.S. International Trade Commission, or ITC, concerning Ascendis's Yuviwel. As part of the agreement, Ascendis will pay BioMarin a royalty equal to 20% of net sales of Yuviwel in the U.S., retroactive to the first commercial sale, and 18% of net sales in the European Union, Brazil and South Korea until May 2030. The scope of the settlement includes a license for BioMarin's patents that relate to Yuviwel for all current and potential indications, including achondroplasia and hypochondroplasia. It also covers the use of Yuviwel in combination with other medicines. Under the terms of the agreement, BioMarin will dismiss the pending Section 337 investigation before the ITC and the parties will resolve all claims relating to the asserted intellectual property, including litigation pending in Brazil, Denmark, Germany, South Korea and the Northern District of California.
Ascendis Pharma Q2 Revenue $339.29M Beats Expectations
Reports Q2 revenue $339.29M, consensus $329.9M. "Our patient focus has driven achievement of important milestones and strong demand for our TransCon products as Ascendis continues to transform into a leading biopharma company," said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. "This focus on addressing unmet medical needs continues to drive a growing pipeline of innovative TransCon programs, further positioning Ascendis for durable, long-term growth in rare endocrine diseases and new therapeutic areas."
Wedbush: Vertex Acquires Crinetics for $85/Share
Wedbush notes that Vertex Pharmaceuticals (VRTX) agreed to acquire Crinetics Pharmaceuticals (CRNX) for $85/share in cash. Crinetics now trades essentially at the deal price, reflecting high confidence in closing. For Vertex, the firm views this as a sound, if modestly dilutive near-term, strategic deal. Wedbush would expect Vertex's underperformance to be temporary as the deal reinforces the durability of its M&A-driven pipeline diversification strategy following recent moves in kidney disease and other rare-disease areas. The firm tells investors to watch other commercial-stage rare/endocrine-disease names such as BioCryst Pharmaceuticals (BCRX) and Ascendis Pharma (ASND) as potential next targets, given the rich premium paid here.
Ascendis Pharma Releases Week 104 Data for TransCon CNP
Ascendis Pharma announced new radiographic data from Week 104 from the completed pivotal ApproaCH Trial of once-weekly TransCon CNP in children with achondroplasia. In the trial, TransCon CNP-treated children demonstrated continued improvements in lower extremity alignment through up to two years of treatment, including improvements in tibial-femoral angle. As previously reported, improvements in annualized growth velocity were maintained and ACH-specific height Z-score increased with TransCon CNP treatment through Week 104. Through up to two years of treatment, TransCon CNP was generally well tolerated, with a low rate of ISRs, no symptomatic hypotension, and no acceleration of bone age. Most adverse events in TransCon CNP-treated children were mild or moderate, with none leading to treatment discontinuation or withdrawal from the trial.
Ascendis Pharma Releases Week 182 Data for TransCon PTH
Ascendis Pharma announced Week 182 data from its completed Phase 3 PaTHway Trial showing that long-term treatment with TransCon PTH demonstrated sustained efficacy and safety in adults with hypoparathyroidism. Over the three-and-a-half-year duration of the trial, TransCon PTH replicated the systemic actions of endogenous PTH, with a balanced, beneficial impact on the main target organ systems - CNS, kidney, small intestine, and bone - as demonstrated by improved quality of life and normalized and stable urine calcium, serum calcium, serum phosphate, and bone mineral density. These benefits were sustained while enabling independence from conventional therapy with active vitamin D and calcium.
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