Core Viewpoint - Milestone Pharmaceuticals is actively addressing the Chemistry, Manufacturing, and Controls (CMC) issues raised by the FDA regarding its lead product CARDAMYST for the treatment of paroxysmal supraventricular tachycardia (PSVT) and is preparing for a Type A meeting with the FDA to resolve these issues [1][2][6]. Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and short-term investments totaling $56.0 million, a decrease from $69.7 million as of December 31, 2024 [11]. - The company reported no revenue for the first quarter of 2025, consistent with the same period in 2024 [11]. - Research and development expenses increased to $5.0 million in Q1 2025 from $3.6 million in Q1 2024, primarily due to higher consulting costs [11]. - General and administrative expenses rose to $5.2 million in Q1 2025 from $4.0 million in the prior year, driven by increased outside service costs [11]. - Commercial expenses surged to $10.4 million in Q1 2025 from $2.9 million in Q1 2024, reflecting preparations for the launch of CARDAMYST [11]. - The net loss for the first quarter of 2025 was $20.8 million, compared to a net loss of $10.4 million in the same period last year [11]. Product Development and Regulatory Updates - The FDA issued a Complete Response Letter (CRL) for CARDAMYST in March 2025, citing two key CMC issues: the need for additional information on nitrosamine impurities and a new facility inspection to ensure compliance with Good Manufacturing Practices (GMP) [6]. - The Phase 3 study protocol for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) has been finalized, but enrollment is paused to focus on resolving the CRL for PSVT [4]. - A new method of use patent for etripamil nasal spray was issued, potentially extending intellectual property protection until July 2042 [6]. - CARDAMYST was recognized in an independent survey as a new drug expected to significantly impact patient health, with 40% of respondents selecting it [6]. Company Overview - Milestone Pharmaceuticals is focused on developing innovative cardiovascular solutions, with etripamil as its lead investigational product designed for self-administration in treating symptomatic episodes of PSVT and AFib-RVR [9][8].

ON TodayONONON$57.41 +6.10 (+11.89%) 52-Week Range$33.55▼$64.05P/E Ratio133.51Price Target$58.18Add to WatchlistON Holdings' NYSE: ONON stock price surged following the Q1 earnings release and 2025 update, leading its and other high-end retail stocks into technical price reversals. The results are favorable for itself, distinguishing it as a leading footwear, athletic, and apparel brand, and indicate strength in a category that includes names like Lululemon NASDAQ: LULU, a more direct competitor, and Willi ...

Contributing analyst to the iREIT+Hoya Capital investment group. The Dividend Collectuh is not a registered investment professional nor financial advisor and these articles should not be taken as financial advice. This is for educational purposes only and I encourage everyone to do their own due diligence. I'm a Navy veteran who enjoys dividend investing in quality blue-chip stocks, BDC's, and REITs. I am a buy-and-hold investor who prefers quality over quantity and plans to supplement his retirement income ...

QUEBEC CITY, Canada, May 14, 2025 (GLOBE NEWSWIRE) -- LeddarTech® Holdings Inc. (“LeddarTech”) (Nasdaq: LDTC), an AI-powered software company recognized for its innovation in advanced driver assistance systems (ADAS) and autonomous driving (AD), is pleased to announce the launch of LeddarSim™, a next-generation simulation platform purposely built to reduce the gap between virtual testing and real-world deployment. LeddarSim redefines the standards of ADAS and AD development by closing the long-standing simu ...

-- First patient expected to be dosed during Q2 2025 ---- Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas ---- Starting dose of 4mg tablet QD (once daily) ---- First trial site in Australia. Four additional sites planned for Australia, South Korea, and U.S. –-- Australian R&D Tax Incentive refund of up to 48.5% of eligible study-related costs expected -- MIAMI, May 14, 2025 (GLOBE NEWSWIRE) -- ...

PETAH-TIKVA, Israel, May 14, 2025 (GLOBE NEWSWIRE) -- Global-e Online Ltd. (Nasdaq: GLBE) the leader of global Direct-To-Consumer eCommerce enablement, and Shopify, a leading commerce technology company, today announced a new 3-year strategic partnership agreement. The new agreement renews the companies’ long-standing strategic partnership for both their 1P (i.e. Shopify Managed Markets) and 3P solutions to empower international direct to consumer e-commerce on the Shopify platform. “As the leader in this m ...

NORTH CANTON, Ohio, May 14, 2025 /PRNewswire/ -- The Timken Company (NYSE: TKR; www.timken.com), a global technology leader in engineered bearings and industrial motion, will participate in the KeyBanc Industrials & Basic Materials Conference on Wednesday, May 28, 2025 in Boston, Mass. Participating on behalf of Timken will be Philip D. Fracassa, executive vice president and chief financial officer, and Neil Frohnapple, vice president of investor relations. Materials shared during the conference will be ava ...

PayPal (NASDAQ: PYPL ) is pretty much everywhere these days; whenever you're checking out online, there always seems to be that PayPal option. What you might not know is that every time you choose that PayPalI’m a retired Wall Street PM specializing in TMT; since kickstarting my career, I’ve spent over two decades in the market navigating the technology landscape, focusing on risk mitigation through the dot com bubble, credit default of ‘08, and, more recently, with the AI boom. In one word, what I’d like m ...

The strategic acquisition will strengthen access to care, enhance outcomes and support local healthcare teamsOTTAWA, Ontario, May 14, 2025 (GLOBE NEWSWIRE) -- Calian Group Ltd. (TSX: CGY), a trusted provider of mission-critical solutions for defence, space and healthcare announced today it has acquired Advanced Medical Solutions (AMS), a leading provider of remote and emergency healthcare services in Northern Canada. The acquisition is effective immediately. About AMS Headquartered in Yellowknife, Northwest ...

PITTSBURGH, May 14, 2025 /PRNewswire/ -- CNX Resources Corporation (NYSE: CNX) today announced the release of its updated Corporate Sustainability Report featuring data for 2024. Additionally, continuing the Company's unprecedented brand of transparency and in a move further differentiating CNX's environmental performance and disclosures, the Company also announced that it will no longer issue a static annual report. Instead, CNX will update its website continuously and its ESG Performance Scorecard data on ...