COPENHAGEN, Denmark, July 14, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from Week 156 of its Phase 3 PaTHway Trial confirming that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism regardless of its cause (post-surgical, autoimmune, genetic, or idiopathic), including improvements in biochemistries, kidney function, and quality of life. Results were shared over the weekend in an oral ...

Core Insights - Ascendis Pharma A/S announced two oral presentations at ENDO 2025, showcasing data on the safety and efficacy of its treatments for hypoparathyroidism and achondroplasia [1][2] Group 1: Hypoparathyroidism - Dr. Aliya Khan will present data from Week 156 of the Phase 3 PaTHway Trial, highlighting the long-term safety and efficacy of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism [1][2] - The presentation will cover maintenance of serum and urine biochemistries within normal levels and sustained improvement in renal function [1] Group 2: Achondroplasia - Dr. Carlos Bacino will present safety and tolerability data from Week 52 of the pivotal ApproaCH Trial of once-weekly TransCon CNP (navepegritide) in children with achondroplasia [1][2] - The data is expected to support the transformative potential of the investigational therapy for this rare genetic condition [2] Group 3: Company Overview - Ascendis Pharma is focused on applying its innovative TransCon technology platform to develop therapies that address unmet medical needs [5] - The company is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States [5]

Summary of Ascendis Pharma (ASND) Conference Call Company and Industry Overview - **Company**: Ascendis Pharma - **Industry**: Biotechnology, specifically focusing on treatments for growth disorders such as achondroplasia Key Findings from the COAST Trial - The COAST trial is a Phase II study assessing the efficacy of a combination therapy involving TransCon CNP and TransCon Growth Hormone in children with achondroplasia aged 2 to 11 years [2][3] - The trial reported a significant increase in annualized growth velocity (AGV) for treatment-naive children, achieving 9.14 cm/year, which is an increase of 4.2 cm/year compared to baseline [19][20] - For children previously treated with TransCon CNP, the AGV was 8.25 cm/year, reflecting a 3.1 cm/year increase from baseline [21][22] Efficacy and Safety Data - The combination therapy demonstrated a 0.53 increase in height Z score for treatment-naive patients and a 0.44 increase for treatment-experienced patients after 26 weeks [20][22] - The safety profile of the combination therapy was comparable to that of the individual therapies, with no serious adverse events related to the study drug reported [17][18] - The combination therapy resulted in a linear growth improvement associated with better body proportionality, which is crucial for children with achondroplasia [24][25] Future Development Plans - Ascendis Pharma plans to initiate a Phase III trial by the end of 2025, which will include both treatment-naive and experienced children [26][30] - The company aims to expand its treatment options for growth disorders and explore over 20 potential indications for its therapies [27][84] Market Position and Strategy - Ascendis Pharma is positioned as a leader in the growth disorder treatment market, with a focus on developing unique treatment combinations that unlock new therapeutic potentials [27][84] - The company is considering co-formulating TransCon CNP and TransCon Growth Hormone into a single injection for improved patient compliance [45][103] Additional Insights - The trial results indicate a potential for achieving catch-up growth in children with achondroplasia, which could normalize their height relative to parental expectations [80] - The combination therapy is expected to provide significant benefits beyond linear growth, addressing broader health concerns associated with achondroplasia [81][96] Conclusion - Ascendis Pharma's recent trial results highlight a promising advancement in the treatment of achondroplasia, with significant improvements in growth velocity and safety. The company is poised to expand its market presence and explore additional indications for its therapies, reinforcing its commitment to addressing growth disorders effectively.

Combination treatment with investigational TransCon CNP and TransCon hGH is investigational. For investor communication only. Not for use in product promotion. Not for further distribution. COACH Trial Interim Topline Week 26 Data June 9, 2025 Cautionary Note on Forward-Looking Statements 2 Combination treatment with investigational TransCon CNP and TransCon hGH is investigational. For investor communication only. Not for use in product promotion. Not for further distribution. Executive Summary This present ...

Core Insights - Ascendis Pharma announced positive interim results from the COACH Trial, demonstrating that the combination of TransCon CNP and TransCon hGH significantly improves growth and body proportionality in children with achondroplasia after 26 weeks of treatment [2][4][12] Group 1: Clinical Trial Results - For treatment-naïve children, the combination treatment resulted in a mean annualized growth velocity (AGV) of 9.14 cm/year, with a height Z-score improvement of +0.53 over 26 weeks [1][12] - For children previously treated with TransCon CNP, the mean AGV was 8.25 cm/year, with a height Z-score improvement of +0.44 over the same period [1][12] - The combination treatment led to accelerated improvement in body proportionality, aligning with increased linear growth [1][12] Group 2: Safety and Tolerability - The safety and tolerability profile of the combination treatment was consistent with that of the individual monotherapies, with generally mild treatment-emergent adverse events (TEAEs) reported [1][4][12] Group 3: Trial Design and Future Plans - The COACH Trial is a Phase 2 open-label trial investigating the efficacy, safety, and tolerability of the combination treatment in children aged 2 to 11 years with achondroplasia [5] - The interim analysis will be followed by Week 52 data, expected in Q4 2025, with plans to initiate a Phase 3 trial in the same timeframe [5][11] Group 4: Product Information - TransCon CNP is under priority review by the FDA as a monotherapy for children with achondroplasia, while TransCon hGH is already approved and marketed as SKYTROFA for pediatric growth hormone deficiency [3][10] - Both products utilize Ascendis Pharma's innovative TransCon technology platform, which aims to provide sustained release of active compounds [3][10]

Core Insights - Viavi Solutions Inc. has launched a Visual-Aided Inertial Navigation System (VINS) to enhance the navigation capabilities of aircraft and UAVs in the absence of GPS/GNSS signals, addressing the increasing incidents of GPS jamming and spoofing [1][10] Group 1: VINS Technology and Features - VINS utilizes Maxar Raptor 3D vision-based positioning software, allowing UAVs to perform long-range missions under challenging GNSS conditions, achieving horizontal positioning accuracy within 35 meters and vertical accuracy within 5 meters in GNSS-denied environments [3] - When GNSS is active, VINS significantly improves accuracy, offering horizontal positioning within 1 meter and heading accuracy of 0.1 degrees [3] - The system is designed for low-altitude operations and integrates various components, including processing and sensor modules, GNSS or CRPA antennas, and optional features like data transmission radios and M-code GNSS receivers [4][10] Group 2: Market Context and Demand - The U.S. Department of Transportation reports up to 700 GPS jamming incidents globally each day, with conflict zones like Lithuanian airspace experiencing over 800 cases in the last quarter of 2024, impacting communication networks and emergency services [2] - Viavi's recent third-quarter fiscal 2025 results exceeded expectations, driven by strong demand from service providers and network equipment manufacturers, particularly in the wireless and fiber markets [7] Group 3: Future Outlook - For the fourth quarter of fiscal 2025, Viavi anticipates revenues between $278 million and $290 million, with non-GAAP earnings per share projected between 10 cents and 13 cents, although macroeconomic challenges may pose risks [8] - The VINS will be showcased at the 2025 Joint Navigation Conference, highlighting its relevance in military operations and degraded environments [5]

Core Insights - The FDA has accepted Ascendis Pharma's New Drug Application for TransCon CNP for treating children with achondroplasia, granting it Priority Review status with a PDUFA goal date of November 30, 2025 [1][2] - TransCon CNP has shown significant annualized growth velocity and multiple benefits beyond linear growth in clinical trials compared to placebo, with a safety profile similar to that of placebo [1][2] - Achondroplasia affects over 250,000 people globally and leads to various complications, necessitating new treatment options [3] Company Overview - Ascendis Pharma is a global biopharmaceutical company focused on innovative therapies using its TransCon technology platform to address unmet medical needs [4][5] - The company is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States [5] Industry Context - Achondroplasia is a rare genetic condition caused by a variant in the FGFR3 gene, leading to serious complications beyond skeletal dysplasia, including muscular, neurological, and cardiorespiratory issues [3] - Current therapies for achondroplasia are limited, and there is a significant demand for new treatments that can improve health outcomes [2][3]

Core Viewpoint - Inertial Labs, a subsidiary of VIAVI Solutions, has launched a Visual-Aided Inertial Navigation System (VINS) that allows aircraft to maintain accurate flight paths in environments where GPS/GNSS signals are unreliable [1][2]. Group 1: Product Features and Capabilities - VINS enables Unmanned Aerial Vehicles (UAVs) to perform long-range missions in GNSS-challenged environments, utilizing advanced 3D vision-based positioning software from Maxar® Raptor™ [2][3]. - The system can maintain horizontal positioning within 35 meters, vertical positioning within 5 meters, and velocity within 0.9 m/s in GNSS-denied environments. When GNSS is enabled, it achieves a horizontal position accuracy of 1 meter and a vertical position accuracy of less than 2 meters [4]. - VINS is designed for low-altitude operations and includes a modular system with processing and sensor modules, GNSS or CRPA antennas, and additional sensors for both fixed-wing and multi-rotor UAVs [5]. Group 2: Market Context and Demand - The launch of VINS coincides with a reported increase in GPS signal jamming and spoofing incidents, with up to 700 occurrences globally each day, particularly affecting commercial and military operations [2]. - The Lithuanian airspace alone recorded over 800 cases of GPS interference in the last three months of 2024, highlighting the growing need for reliable navigation systems in contested environments [2]. Group 3: Industry Events and Demonstrations - VINS and the second-generation RSR Transcoder will be showcased at the 2025 Joint Navigation Conference from June 2-5, where VIAVI will also present on various topics related to assured Positioning, Navigation, and Timing (PNT) in GPS-denied environments [6][7][9].

Core Insights - VIAVI Solutions Inc. has launched its second-generation RSR Transcoder, designed to enhance operational capabilities in GPS/GNSS-denied environments [1][2] - The RSR Transcoder provides assured Position, Navigation, and Timing (PNT) outputs, facilitating upgrades to legacy systems [2][4] - The product addresses the increasing threat of GPS and GNSS jamming and spoofing, which are becoming common in electronic warfare [3][6] Product Features - The RSR Transcoder includes a GPS full constellation simulator and utilizes a patented algorithm for rapid conversion of assured inputs to Universal GPS signals [4] - It is ruggedized with IP68 enclosures suitable for various platforms and operates in a covert mode [5] - The device outputs at 100 Hz and offers multiple holdover oscillator options [5] Industry Context - The reliance on PNT technologies in modern military systems is growing, with adversaries increasingly capable of disrupting these systems [6] - The RSR Transcoder is positioned as a cost-effective solution for upgrading legacy systems to withstand such disruptions [6] Event Participation - The RSR Transcoder will be showcased at the 2025 Joint Navigation Conference, highlighting its capabilities in D3SOE navigation [6] - VIAVI will also present on various topics related to navigation and anti-jamming technologies during the conference [8]

Core Insights - Ascendis Pharma A/S will present new data on its hypoparathyroidism, achondroplasia, and growth hormone deficiency programs at the ESPE & ESE 2025 congress in Copenhagen from May 10-13, 2025 [1][2] Hypoparathyroidism - The company will showcase 4-year efficacy and safety data from the Phase 2 PaTH Forward Trial of TransCon PTH (palopegteriparatide) in adults with chronic hypoparathyroidism [2][4] - Presentations will include a retrospective matched cohort study using real-world data from England to estimate the risk of chronic kidney disease progression in chronic hypoparathyroidism [4][6] Achondroplasia - Ascendis will present Week 52 growth and bone morphometry data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) in children with achondroplasia [2][4] - The congress will feature discussions on assessing health-related quality of life (HRQoL) in achondroplasia across the life course [4][6] Growth Hormone Deficiency - The company will present results from the Phase 3 foresiGHt Trial supporting the efficacy and safety of once-weekly lonapegsomatropin in adults with growth hormone deficiency [2][6] - The presentations will highlight the importance of growth hormone in maintaining normal body composition and cardiometabolic health throughout adulthood [9] Company Overview - Ascendis Pharma is a global biopharmaceutical company focused on innovative therapies using its TransCon technology platform to address unmet medical needs [10] - The company is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States [10]