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GNTA, BBIO, AMRN Jump After Hours: Key Biotech Catalysts Driving Stock Gains
RTTNews· 2025-10-29 05:03
Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]
Nurix Therapeutics Posts Downbeat Q3 Results, Joins Orthopediatrics, Levi Strauss And Other Big Stocks Moving Lower In Friday's Pre-Market Session - Diginex (NASDAQ:DGNX), Inventiva (NASDAQ:IVA)
Benzinga· 2025-10-10 12:02
Summary of Key Points Core Viewpoint - U.S. stock futures showed slight gains, while several companies reported disappointing financial results leading to significant pre-market trading declines in their shares [1][4]. Company-Specific Summaries - **Nurix Therapeutics Inc (NASDAQ:NRIX)**: - Reported a quarterly loss of $1.03 per share, worse than the expected loss of $0.88 per share - Sales were $7.894 million, missing expectations of $16.736 million - Shares fell 5.8% to $10.24 in pre-market trading [1][2]. - **Venture Global, Inc. (NYSE:VG)**: - Shares dipped 18.4% to $10.27 following a resolution related to an arbitration proceeding concerning the Calcasieu Pass facility [4]. - **Orthopediatrics Corp (NASDAQ:KIDS)**: - Shares fell 15% to $15.25 after the company cut its FY25 revenue guidance [4]. - **Inventiva S.A. (NYSE:IVA)**: - Shares declined 13.6% to $4.78 in pre-market trading [4]. - **USANA Health Sciences Inc (NYSE:USNA)**: - Shares declined 13% to $22.83 after reporting preliminary results for the third quarter, with an adjusted loss of $0.15 per share and sales of $214 million [4]. - **Nanobiotix S.A. (NASDAQ:NBTX)**: - Shares declined 8.1% to $27.48 after a previous gain of 10% [4]. - **Diginex Limited (NASDAQ:DGNX)**: - Shares fell 7.6% to $29.00 in pre-market trading [4]. - **Levi Strauss & Co (NYSE:LEVI)**: - Reported quarterly earnings of $0.34 per share, beating the analyst consensus estimate of $0.31 per share - Quarterly sales were $1.543 billion, exceeding the analyst consensus estimate of $1.501 billion - Shares tumbled 7.1% to $22.81 in pre-market trading [4].
Global POISE Study Reaches Milestone of 600 Orthopedic Implants in Pediatric Patients, Advancing Research on the Safety and Efficacy of OrthoPediatrics® Products
GlobeNewswire News Room· 2025-07-16 11:00
Core Insights - OrthoPediatrics Corp. has reached a significant milestone in the Global POISE Study, with over 600 implants being observed across more than 300 pediatric patients [1][2][4] Group 1: Global POISE Study Overview - The Global POISE Study is a multi-center, post-market, prospective clinical follow-up study aimed at assessing the safety and efficacy of OrthoPediatrics' implant devices [2] - The study, launched in 2023, currently includes 13 active sites across Canada, the United States, Australia, New Zealand, and South Africa, with ongoing data collection [2][3] - The study focuses on verifying implant survival and identifying any device-related adverse events [2] Group 2: Study Impact and Future Directions - Insights from the Global POISE Study will help refine OrthoPediatrics devices to better meet the needs of children with orthopedic conditions [3] - The study aims to broaden its reach by enrolling additional patients across 17 different implant types to enhance understanding of safety and long-term effectiveness [3] Group 3: Company Background - OrthoPediatrics Corp. was founded in 2006 and focuses exclusively on pediatric orthopedics, offering over 80 products across trauma and deformity, scoliosis, and sports medicine categories [6] - The company distributes its products in the United States and over 70 countries globally, emphasizing its commitment to improving the lives of children with orthopedic conditions [6]
OrthoPediatrics Corp. to Report First Quarter Financial Results on May 7, 2025
Globenewswire· 2025-04-23 20:05
Company Overview - OrthoPediatrics Corp. is focused exclusively on advancing pediatric orthopedics, having developed a comprehensive product offering to improve the lives of children with orthopedic conditions [3] - The company markets over 80 products across three major categories: trauma and deformity, scoliosis, and sports medicine/other procedures [3] - OrthoPediatrics has a global sales organization that distributes its products in the United States and over 70 countries outside the United States [3] Upcoming Financial Results - OrthoPediatrics is scheduled to release its first quarter 2025 financial results on May 7, 2025, after the market closes [1] - A conference call will be held on the same day at 4:30 p.m. ET to discuss the financial results [1] Investor Information - Investors can access a live and archived webcast of the conference call on the company's website, which will be available for replay for at least 90 days after the event [2]
OrthoPediatrics Corp. Expands Scoliosis Portfolio with Launch of VerteGlide™ System
Globenewswire· 2025-04-08 12:05
Core Insights - OrthoPediatrics Corp. has launched the VerteGlide Spinal Growth Guidance System in the U.S. to treat Early Onset Scoliosis, marking the company's 80th system designed for pediatric musculoskeletal issues [1][4] Product Overview - The VerteGlide system is a guided growth technology aimed at children under 10 suffering from Early Onset Scoliosis, a condition that can lead to severe pulmonary and digestive dysfunction [2] - This system is designed to correct deformities and reduce the need for repeat surgeries until the child reaches skeletal maturity [2] - The device has received FDA clearance and is set for a limited launch with initial surgeries planned for summer 2025 [2] Development and Collaboration - Dr. Richard McCarthy and Dr. Scott Luhmann have played key roles in the design and development of the VerteGlide system [3] - The launch of VerteGlide reflects the company's commitment to addressing the needs of children with scoliosis, as stated by the President of the Scoliosis division, Greg Odle [3] - The system utilizes Shilla™ technology licensed from Medtronic, showcasing collaboration in advancing pediatric orthopedic solutions [3] Company Background - Founded in 2006, OrthoPediatrics focuses exclusively on pediatric orthopedics, offering a comprehensive range of products to improve the lives of children with orthopedic conditions [4] - The company markets 80 products across major categories including trauma and deformity, scoliosis, and sports medicine, distributing in the U.S. and over 70 countries [4]