Shares of Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) rose sharply in pre-market after the company announced U.S. Food and Drug Administration approval of NEREUS (tradipitant), an oral neurokinin-1 receptor antagonist, for the prevention of motion-induced vomiting in adults.Vanda Pharmaceuticals shares jumped 17.5% to $8.26 in the pre-market trading session.Here are some other stocks moving in pre-market trading.GainersAimei Health Technology Co Ltd (NASDAQ:AFJK) surged 61.6% to $133.00 in pre-market trading a ...

Group 1: RLX Technology Inc - RLX Technology Inc reported quarterly earnings of 3 cents per share on sales of $158.600 million [1] - Shares of RLX Technology rose 6% to $2.47 in pre-market trading following the earnings report [1] Group 2: Other Stocks in Pre-Market Trading - Cidara Therapeutics, Inc. surged 92% to $203.50 after a Schedule 13D Amendment revealed beneficial ownership of 3.37 million shares [4] - Binah Capital Group, Inc. gained 52.2% to $2.17 after posting stronger-than-expected third-quarter results [4] - Expion360 Inc. rose 42.4% to $1.81 following its third-quarter results [4] - Aspire Biopharma Holdings, Inc. surged 31.2% to $0.1380 in pre-market trading [4] - Invivyd, Inc. gained 28.8% to $2.28 after reporting better-than-expected third-quarter financial results [4] - Milestone Scientific Inc. surged 26.3% to $0.4801 after reporting better-than-expected third-quarter sales [4] - Lazydays Holdings, Inc. gained 23.3% to $1.85 after a previous surge [4] - Omeros Corp gained 12.5% to $7.08 following a narrower-than-expected quarterly loss [4] - Nouveau Monde Graphite Inc rose 10% to $3.25 after a decline the previous day [4] Group 3: Declining Stocks in Pre-Market Trading - TSS Inc tumbled 40.2% to $9.10 after reporting a year-over-year decrease in third-quarter results [4] - enVVeno Medical Corp declined 35.8% to $0.42 after an unfavorable FDA appeal decision [4] - Nuvve Holding Corp fell 29.3% to $0.34 after announcing third-quarter results [4] - ESS Tech Inc shares dipped 24.2% to $3.22 after reporting weak quarterly sales [4] - Direct Digital Holdings Inc fell 18.8% to $0.23 after a significant gain the previous day [4] - StubHub Holdings Inc fell 18.8% to $15.28 after worse-than-expected third-quarter EPS results [4] - Mangoceuticals Inc dipped 17.7% to $0.98 after a decline the previous day [4] - Red Cat Holdings Inc dipped 15.1% to $6.57 after worse-than-expected financial results and a lowered FY25 sales guidance [4] - WhiteFiber Inc fell 13.4% to $17.21 after reporting worse-than-expected financial results [4] - Sobr Safe Inc fell 12.4% to $2.21 after a decline the previous day [4]

Core Insights - Milestone Scientific Inc. has appointed Jason Papes as Senior Vice President, Global Head of Sales and Marketing, effective immediately [1] - Mr. Papes has over 30 years of experience in sales, marketing, and business development in the healthcare industry, with a strong background in orthopedics, neurology, pain management, and digital imaging [2] - His previous role was as Founder and Managing Partner of TEN20 Medical Distribution, where he led significant growth and earned multiple Distributor of the Year honors [3] - Mr. Papes has held executive positions at Stryker Imaging and Brainlab, contributing to substantial commercial expansions and market share growth [4] - His appointment comes at a crucial time for Milestone as it rolls out the CompuFlo® Epidural System and establishes payment pathways, including Medicare Part B rates [5] - The company is also focusing on growth in its dental segment, particularly the STA Single Tooth Anesthesia® System, where Mr. Papes will play a key role [6] - CEO Eric Hines emphasized Mr. Papes' leadership experience and market access strategies as vital for the company's growth phase [7] - Mr. Papes holds a Bachelor of Science in Biology and an International MBA, along with executive training in corporate strategy and complex sales [7] Company Overview - Milestone Scientific Inc. is a technology-focused medical research and development company that specializes in innovative injection technologies for medical and dental applications [8] - The company utilizes its proprietary DPS Dynamic Pressure Sensing Technology® to enhance the precision and safety of injections, aiming to improve patient comfort [8]

Core Insights - Milestone Scientific Inc. is focusing on expanding its CompuFlo® Epidural System in the U.S. following favorable Medicare pricing assignments, which significantly broaden the addressable market for the technology [3][4] - The company reported a decrease in total revenue for 2024, amounting to approximately $8.6 million, down from $9.8 million in 2023, while e-commerce revenue showed growth [4][6] - The company is optimistic about its future growth prospects in both the dental and medical segments, with positive initial performance in Q1 2025 [3][7] Business Update - The company has established reimbursement infrastructure for the CompuFlo® Epidural System, with Medicare Part B payment rates assigned in multiple states, enhancing market access [3] - A contract for the Federal Supply Schedule (FSS) has been awarded, allowing federal medical facilities to purchase the CompuFlo system, targeting adoption within the U.S. Department of Veterans Affairs and other federal healthcare systems [3] - Strong commercial traction is noted in the private sector, with new rollouts at various pain management clinics and ambulatory surgery centers [3] Financial Performance - Revenue for 2024 was approximately $8.6 million, a decrease of about $1.2 million from 2023 [4] - E-commerce revenue reached approximately $5.1 million in 2024, compared to $4.8 million in 2023, indicating growth in this segment [4] - The company recorded an operating loss of $6.8 million in 2024, an improvement from a loss of $7.1 million in 2023, driven by higher-margin e-commerce sales [7] Market Position - The STA Single Tooth Anesthesia System remains a leader in computer-controlled local anesthetic delivery, with over 95 million injections administered to date [3] - The company is leveraging its leadership in the dental segment through an expanded direct-to-consumer e-commerce platform, which is enhancing margins and customer engagement [3] - The clinical response to the CompuFlo system has been positive, positioning the company to capitalize on growth opportunities in the medical field [3][7]

Core Insights - Milestone Scientific Inc. is expanding the adoption of its CompuFlo® Epidural System in pain management clinics and ambulatory surgery centers following favorable Medicare pricing assignments in multiple U.S. states [1][2] - The company reported a decrease in total revenue for 2024, amounting to approximately $8.6 million, down from $9.8 million in 2023, while e-commerce revenue showed growth [3][4] - The company is optimistic about its future growth prospects in both the dental and medical segments, with positive initial performance in Q1 2025 [2][6] Business Update - The company has established a reimbursement infrastructure for the CompuFlo® Epidural System, with favorable Medicare Part B payment rates assigned by First Coast Service Options and Novitas Solutions [2] - The Medicare pricing decisions have expanded the addressable market significantly, and the company is pursuing further reimbursement approvals to enhance national expansion [2] - A contract for the Federal Supply Schedule has been awarded, allowing federal medical facilities to purchase the CompuFlo system, targeting adoption within the U.S. Department of Veterans Affairs and other federal healthcare systems [2] Financial Performance - Total revenue for 2024 was approximately $8.6 million, a decrease of about $1.2 million from 2023 [3] - E-commerce revenue reached approximately $5.1 million in 2024, compared to $4.8 million in 2023, indicating growth in this segment [3] - The company recorded an operating loss of $6.8 million in 2024, an improvement from a loss of $7.1 million in 2023, driven by higher-margin e-commerce sales [6] Market Position - The STA Single Tooth Anesthesia System remains a leader in computer-controlled local anesthetic delivery, with over 95 million injections administered to date [2] - The company is seeing strong commercial traction in the private sector, with new rollouts at various pain management clinics and ambulatory surgery centers [2] - The strategic partnership with Axial Biologics is enhancing the distribution footprint in key U.S. markets [2]

Core Insights - Milestone Scientific Inc. has announced the integration of its CompuFlo® Epidural System at InfiniSurg, LLC, a New Jersey-based ambulatory surgery center, enhancing its clinical practice with advanced technology [1][3][4] Company Overview - Milestone Scientific Inc. (NYSE: MLSS) specializes in developing computerized drug delivery instruments aimed at providing painless and precise injections, focusing on improving patient comfort and safety [5] - The company’s proprietary Dynamic Pressure Sensing Technology® is designed to enhance the precision of injections and reduce complications associated with traditional methods [5] Technology and Innovation - The CompuFlo® Epidural System utilizes objective pressure sensing technology to provide real-time feedback, which may enhance procedural confidence and reduce complications during epidural placements [3][4] - The system aims to establish a new standard of care for epidural procedures by improving procedural efficiency and patient safety through visual and audible feedback mechanisms [4] Leadership and Expertise - Dr. Roman Kosiborod, a highly experienced anesthesiologist and pain management physician, will utilize the CompuFlo® Epidural System at InfiniSurg, bringing over two decades of expertise in interventional pain management [2][3] - InfiniSurg is recognized for its patient-centric approach and commitment to innovation in outpatient surgical care, aligning with Milestone's mission to leverage advanced technologies for better patient outcomes [3]