BURLINGTON, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter of 2025 ended on March 31, 2025. Corporate Update On March 17, 2025, we were formally notified by Nasdaq that we had regained compliance with Nasdaq Listing Rule 5550(b)(3), and as such, will continue to be listed ...

TORONTO, May 13, 2025 (GLOBE NEWSWIRE) -- Unisync Corp. (“Unisync”) (TSX:"UNI") (OTC:“USYNF”) is pleased to report a net income before tax of $1.0 million($0.05/share) and an Adjusted EBITDA of $3.1 million($0.16/share) on revenues of $24.5 million for the three months ended March 31, 2025. Unisync operates through two business units: Unisync Group Limited (“UGL”) with operations throughout Canada and the USA and 92% owned Peerless Garments LP (“Peerless”), a domestic manufacturing operation based in Winnip ...

Reiterates Planned Submission of an NDA for Cytisinicline to FDA in June 2025 Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, May 13, 2025 SEATTLE and VANCOUVER, British Columbia, May 13, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced its financial results for first quarter 2025 ...

SCOTTSDALE, Ariz., May 13, 2025 (GLOBE NEWSWIRE) -- Caliber (NASDAQ: CWD), a real estate investor, developer, and manager, today announced the launch of Caliber Hospitality Development, LLC (“CHD”), a joint venture between Caliber and GIA Hospitality, LLC (“GIA”). CHD will serve as the exclusive development platform for Caliber’s opportunistic hospitality investments, with a focus on acquiring distressed hotel assets and developing extended stay hotels in high-demand markets. The joint venture was seeded wi ...

Updated data from ongoing Phase 1/1b trial in 1L R/M HNSCC to be presented at 2025 ASCO Annual Meeting Enrollment ongoing in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in 1L R/M HNSCC Strong financial position with approximately $462 million in cash and cash equivalents expected to fund operations into the first half of 2029 BOSTON, May 13, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunct ...

Progress continues in Phase 3 Orbit study of setrusumab in osteogenesis imperfecta (OI) Cash of $62.5 million as of March 31, 2025, expected to fund operations into 2027 LONDON, May 13, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the first quarter ended March 31, 2025, and provided recent corporate highlights. “As we close out the first quarter of 2 ...

HOUSTON, May 13, 2025 (GLOBE NEWSWIRE) -- Intuitive Machines, Inc. (Nasdaq: LUNR, “Intuitive Machines,” or the “Company”), a leading space technology and infrastructure services company, today announced its financial results for the first quarter ended March 31, 2025. Intuitive Machines CEO Steve Altemus said, “We continue to emphasize execution as we see the administration rethinking how the federal government acquires emerging technologies and services, instigates private-sector innovation, and creates lo ...

Core Viewpoint - Silicon Labs reported strong sequential and year-over-year revenue growth driven by design wins across multiple end markets, despite macroeconomic uncertainties [1][3]. Financial Highlights - Revenue for the first quarter was $178 million, a significant increase from $106.4 million year-over-year, representing a growth of approximately 67% [3][8]. - Industrial & Commercial revenue was $96 million, up 47% year-over-year, while Home & Life revenue reached $82 million, up 99% year-over-year [3]. - GAAP gross margin was 55.0%, with GAAP operating expenses at $130 million, resulting in a GAAP operating loss of $32 million [3][8]. - Non-GAAP gross margin was 55.4%, with non-GAAP operating expenses at $105 million, leading to a non-GAAP operating loss of $7 million [3][8]. Business Outlook - The company expects second-quarter revenue to be between $185 million and $200 million [3]. - The first device in the next-generation Series 3 platform is ramping into production, featuring advancements in performance and AI capabilities [3]. - New product announcements include the Series 2 BG29 family of Bluetooth Low Energy SoCs and the MG26 family of wireless SoCs, aimed at enhancing connectivity and performance in various applications [3]. Balance Sheet Overview - As of April 5, 2025, total assets were $1.229 billion, with cash and cash equivalents at $324.9 million [14][15]. - Total liabilities stood at $161.1 million, while stockholders' equity was $1.068 billion [15]. Cash Flow Summary - The net cash provided by operating activities was $48.1 million, a significant improvement compared to a net cash used of $71.8 million in the previous year [15]. - The company experienced an increase in cash and cash equivalents of $43.3 million during the quarter [15].

Core Insights - Cellectar Biosciences is seeking conditional marketing approval from the European Medicines Agency (EMA) for its product Iopofosine I 131 based on the promising results from the CLOVER WaM Phase 2 study, which showed a major response rate of 59.0% for BTKi-treated patients [1][2] - The company has a pipeline of radiotherapeutic candidates, including alpha- and Auger-emitting radioconjugates, and is exploring various funding pathways to advance its assets [2][5] Corporate Update - Cellectar plans to present the Phase 2 CLOVER WaM clinical trial data to the EMA in Q2 2025 and expects a response regarding the regulatory pathway by the end of Q3 2025 [2] - The company is evaluating strategic alternatives, including mergers, acquisitions, and partnerships, with Oppenheimer & Co. Inc. serving as the exclusive financial advisor [5] Financial Highlights - As of March 31, 2025, Cellectar had cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024 [5][14] - Research and Development (R&D) expenses for Q1 2025 were approximately $3.4 million, a decrease from $7.1 million in Q1 2024, primarily due to reduced patient follow-up activities [5][15] - General and Administrative (G&A) expenses for Q1 2025 were approximately $3.0 million, down from $4.9 million in the same period of 2024 [5][15] - The net loss for Q1 2025 was $6.6 million, or $0.14 per share, compared to a net loss of $26.6 million, or $0.91 per share, in Q1 2024 [5][16] Product Pipeline - The company's lead assets include Iopofosine I 131, CLR 121225 (an actinium-225 based program for solid tumors), and CLR 121125 (an iodine-125 Auger-emitting program) [8][9] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and two Fast Track Designations for various cancer indications [9]

Core Viewpoint - Y-mAbs Therapeutics, Inc. is set to hold a virtual Radiopharmaceutical R&D update on May 28, 2025, focusing on its ongoing clinical trials and pipeline strategy for cancer treatment [1][2]. Group 1: Upcoming Event Details - The virtual update will cover Part A clinical data from the ongoing Phase 1 GD2-SADA clinical trial, including pharmacokinetic and dosimetry data [2]. - The update will also include information on nonclinical optimization studies for the GD2-SADA asset and plans for clinical implementation [2]. - The duration of the update is expected to be 90 minutes, with a live audio webcast available on the company's Investor Relations website [3]. Group 2: Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [4]. - The company utilizes technologies such as the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies generated using the Y-BiClone platform [4]. - The product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in specific patient populations [4].