SAN DIEGO and TORONTO, June 30, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), announced that it has entered into an Interest Deferral Agreement (the “Agreement”) with Hanmi Pharmaceutical Co., Ltd. (“Hanmi”), whereby Hanmi has agreed to further defer the interest payment due un ...

Core Viewpoint - A class action lawsuit has been filed against Sarepta Therapeutics, Inc. for alleged violations of securities laws, specifically related to misleading statements about its ELEVIDYS therapy and revenue outlook [1][4]. Group 1: Lawsuit Details - The lawsuit is based on allegations that Sarepta made false and misleading statements regarding the safety and approval potential of its ELEVIDYS therapy [4]. - Investors who purchased Sarepta's securities between June 22, 2023, and June 24, 2025, are encouraged to participate in the class action before the deadline of August 25, 2025 [2]. - The class has not yet been certified, meaning that potential class members are not currently represented by an attorney [3]. Group 2: Impact on Investors - The misleading statements led investors to believe in a strong growth potential for the ELEVIDYS therapy, which ultimately resulted in financial damages when the truth was revealed [4]. - The Schall Law Firm specializes in securities class action lawsuits and aims to represent investors seeking to recover losses incurred due to the alleged misconduct [5].

As of June 30th, 16 participants have enrolled in the Phase 1b, ahead of the original goal of at least 15 total participants by 3Q 2025 Analysis of 90-day biomarker activity from cerebrospinal fluid (CSF) in all participants currently enrolled is now expected to also track earlier; available in 4Q 2025 instead of 1Q 2026 Gain will continue screening patients for enrollment through July 31st, 2025, at the request of clinical investigators and additional participants who wish to gain access to the study The i ...

- $100 million funded upfront; additional $175 million tied to milestones provides strategic flexibility through key inflection points - WALTHAM, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced it has entered into a $275 million non-dilutive senior secured term loan facility with Hercules Capital, Inc. (NYSE: HTGC), a leader i ...

NEW YORK, June 30, 2025 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) securities between May 9, 2024 and May 8, 2025, both dates inclusive (the "Class Period"), of the important July 14, 2025 lead plaintiff deadline.So What: If you purchased Iovance securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.What to do nex ...

Market Performance - U.S. stocks traded higher with the Nasdaq Composite gaining over 0.3% on Monday, the Dow up 0.45% to 44,014.63, and the S&P 500 rising 0.33% to 6,193.57 [1] - Financials shares increased by 0.8% while consumer discretionary stocks fell by 0.8% [1] Company News - Hewlett Packard Enterprise Company (HPE) and Juniper Networks, Inc. (JNPR) reached an agreement with the U.S. Department of Justice (DOJ) to resolve a lawsuit challenging HPE's acquisition of Juniper, pending court approval [2] Commodity Market - Oil prices decreased by 0.8% to $65.03, while gold prices increased by 0.5% to $3,304.40 [5] - Silver fell by 0.5% to $36.20 and copper dropped by 0.8% to $5.0820 [5] International Markets - European shares were lower, with the eurozone's STOXX 600 down 0.42% and major indices like London's FTSE 100 and Germany's DAX 40 also declining [6] - Asian markets closed mixed, with Japan's Nikkei gaining 0.84% and Hong Kong's Hang Seng Index falling 0.87% [7] Notable Stock Movements - Bitmine Immersion Technologies, Inc. (BMNR) shares surged 442% to $23.10 after announcing a $250 million private placement [9] - Artelo Biosciences, Inc. (ARTL) shares increased by 102% to $13.70 following positive data from a first-in-human study [9] - Joby Aviation, Inc. (JOBY) shares rose 15% to $10.81 after completing test flights in Dubai [9] - Fortive Corporation (FTV) shares dropped 5% to $51.03 after announcing leadership changes [9] - INmune Bio, Inc. (INMB) shares fell 59% to $2.1680 after a trial did not meet its primary endpoint [9] - Chemed Corporation (CHE) shares decreased by 15% to $475.29 after a price target cut by B of A Securities [9]

Summary of Arcturus Therapeutics KOL Presentation on ARCT-810 Phase II Interim Data for OTC Deficiency Company Overview - **Company**: Arcturus Therapeutics - **Headquarters**: San Diego - **Focus**: mRNA medicines, specifically targeting rare liver diseases like ornithine transcarbamylase (OTC) deficiency [5][6] Industry Context - **Industry**: Biotechnology, specifically in the development of mRNA therapeutics for rare diseases - **Condition**: OTC deficiency is the most common urea cycle disorder with significant unmet medical needs [6][7] Key Points from the Presentation 1. **ARCT-810 Overview**: - ARCT-810 is an mRNA therapeutic designed to replace dysfunctional OTC enzymes, improving urea cycle activity, detoxifying ammonia, and potentially eliminating the need for liver transplants [6][7][8] - It utilizes Arcturus' proprietary lunar delivery platform for effective delivery to hepatocytes [7] 2. **Regulatory Designations**: - ARCT-810 has received multiple designations: orphan drug designation, orphan medicinal product designation, fast track designation, and rare pediatric disease designation [8] 3. **Phase II Study Design**: - Two Phase II studies were conducted: one in the US and one in Europe, focusing on safety, tolerability, and biomarker assessments [11][12] - The US study enrolled patients with more severe disease, while the European study included patients with stable disease [12] 4. **Biomarker Results**: - **Plasma Glutamine**: - In the European study, mean glutamine levels decreased from high to normal during treatment and began to rise again after four weeks post-treatment [13][14] - In the US study, glutamine levels normalized after three doses and remained normal for approximately twenty days [14] - **Ureagenesis Function**: - The new N15 assay showed significant increases in relative ureagenesis function (RUF) post-treatment, with a mean increase of 14.7% [16][17] - Two subjects achieved RUF levels above 50%, indicating clinically meaningful improvements [17] - **Ammonia Levels**: - Ammonia levels remained stable and within normal ranges after treatment, supporting the favorable glutamine and ureagenesis data [18] 5. **Safety Profile**: - The safety database included 40 participants, indicating that ARCT-810 was generally safe and well-tolerated [19] - No serious infusion-related reactions were reported, and adverse events were manageable [19][20] 6. **Next Steps**: - Arcturus plans to complete the ongoing Phase II US study and engage with regulatory agencies for a multi-biomarker driven pivotal trial [68][69] Additional Insights - **Clinical Implications**: - The KOLs emphasized the importance of normalizing diet and reducing the need for ammonia scavengers as key success metrics for OTC therapies [78][80] - mRNA therapies are viewed as a potential alternative to liver transplants, especially for severe cases [100][101] - **Comparison with Other Therapies**: - ARCT-810 is positioned as a more effective solution compared to existing ammonia scavengers, which do not restore urea cycle function [87][88] Conclusion - The interim data for ARCT-810 demonstrates promising results in reducing glutamine levels and improving urea cycle function, with a favorable safety profile. The company is poised to advance its clinical development and regulatory strategy to address the significant unmet needs in OTC deficiency treatment [67][68]

ATLANTA, June 30, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) complied with federal securities laws. On June 30, 2025, Unicycive “announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.” Following this news, the price of the Company’s stock dropped.  If you pur ...

Clinical Trial Results - Moderna 的 mRNA 流感疫苗候选产品在后期试验中显示出积极结果 [1] Stock Market Performance - Moderna 的股票在试验结果公布后上涨 [1]

NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP announces that a shareholder has filed a securities class action lawsuit on behalf of investors (the “Class”) who purchased or acquired the securities of Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT) between June 22, 2023 and June 24, 2025, inclusive. For more information, submit a form at Sarepta Therapeutics, Inc. Shareholder Class Action Lawsuit, email Investor Relations Manager Peter Allocco at pallocco@bernlieb. ...