SAN DIEGO, July 18, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics for the treatment of metabolic diseases, today announced that between July 8-14, 2025, two new employees were granted inducement awards consisting of stock options to purchase an aggregate of 10,372 shares of common stock. Each option was granted pursuant to the Aardvark Therapeutics, Inc. 2025 Inducement Equit ...

Core Viewpoint - The article discusses a class action lawsuit against Sarepta Therapeutics, Inc. related to the safety of its gene therapy ELEVIDYS, alleging that the company and its executives made misleading statements regarding the therapy's risks and trial protocols [1][3]. Company Overview - Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on developing therapies for Duchenne muscular dystrophy, including the gene therapy ELEVIDYS [2]. Allegations of the Lawsuit - The lawsuit claims that Sarepta failed to disclose significant safety risks associated with ELEVIDYS, including severe side effects that were not detected during clinical trials [3]. - It is alleged that the severity of adverse events from ELEVIDYS treatment led to the halting of recruitment and dosing in clinical trials, attracting regulatory scrutiny and increasing risks around the therapy's approvals [3]. Key Events Impacting Stock Price - On March 18, 2025, Sarepta reported a patient death due to acute liver failure after ELEVIDYS treatment, causing the stock price to drop over 27% [4]. - Following an April 4, 2025 disclosure that EU authorities requested a review of the death, Sarepta's stock fell more than 7% [5]. - On June 15, 2025, a second patient death was reported, leading to a 42% decline in stock price after Sarepta suspended shipments and paused dosing in clinical studies [6]. - On June 24, 2025, the FDA announced an investigation into the risk of acute liver failure associated with ELEVIDYS, resulting in an 8% drop in stock price [7]. Legal Process - Investors who purchased Sarepta securities during the class period can seek appointment as lead plaintiff in the lawsuit, which allows them to represent the interests of all class members [8].

Core Viewpoint - Sanofi has successfully completed the acquisition of Blueprint Medicines, enhancing its portfolio with a commercialized medicine and a promising pipeline focused on systemic mastocytosis and other KIT-driven diseases [1][6]. Group 1: Acquisition Details - The acquisition includes Ayvakit/Ayvakyt (avapritinib), the only approved medicine for advanced and indolent systemic mastocytosis in the US and EU [3][10]. - Sanofi also acquired elenestinib, a next-generation investigational medicine for systemic mastocytosis, currently undergoing a phase 2/3 clinical study [4]. - Additionally, BLU-808, an investigational oral KIT inhibitor, was part of the acquisition, targeting a range of inflammatory diseases [5]. Group 2: Financial Aspects - The tender offer for Blueprint's shares was completed on July 17, 2025, with all conditions satisfied [6]. - Sanofi financed the acquisition through cash on hand and proceeds from commercial paper issuances, indicating it will not significantly impact the company's financial guidance for 2025 [7]. - The acquisition is expected to be immediately accretive to gross margin and business operating income, as well as EPS after 2026 [7]. Group 3: Market Impact - Following the acquisition, Blueprint common stock will cease trading on the NASDAQ Global Select Stock Market as of July 18, 2025 [9]. - All shares not validly tendered will convert to a cash payment of $129.00 per share, plus potential contingent payments of up to $6.00 per share based on milestone achievements [8].

Core Insights - Sapu Biosciences, in collaboration with Oncotelic Therapeutics, has published new research indicating that TGFB2 expression and promoter methylation may serve as prognostic markers in pancreatic ductal adenocarcinoma (PDAC) [1][2] Group 1: Research Findings - The study published in the International Journal of Molecular Sciences highlights that targeting TGFB2 warrants further evaluation, particularly in younger PDAC patients [1][2] - Clinical data from the OT-101 P001 PDAC study shows that in a subset of younger patients with low IL-6, the median overall survival (OS) was 12.7 months [2] - High TGFB2 expression correlates with significantly reduced OS in patients under 65, with median OS of 17.9 months for high TGFB2 expression compared to 66.9 months for low [2] Group 2: Clinical Implications - Elevated TGFB2 methylation is associated with improved survival in younger patients, with median OS of 66.9 months for high methylation versus 17.9 months for low methylation [2] - The findings suggest that TGFB2 is not merely a biomarker but a critical factor delineating a younger subset of pancreatic cancer patients who experience poorer survival outcomes [2]

SAN DIEGO, July 17, 2025 (GLOBE NEWSWIRE) -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) securities between June 22, 2023 and June 24, 2025, both dates inclusive (the “Class Period”), have until Monday, August 25, 2025 to seek appointment as lead plaintiff of the Sarepta class action lawsuit. Captioned Dolgicer v. Sarepta Therapeutics, Inc., No. 25-cv-05317 (S.D.N.Y.), the Sarepta class action lawsuit charges Sarepta as well as certain ...

SAN DIEGO, July 17, 2025 (GLOBE NEWSWIRE) -- Robbins LLP reminds stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired Biohaven Ltd. (NYSE: BHVN) securities between March 24, 2023 and May 14, 2025. Biohaven is a biopharmaceutical company that discovers, develops, and commercializes therapies for immunology, neuroscience, and oncology. The Company is developing, among other product candidates, troriluzole for the treatment of spinocerebellar ataxia (“SCA”), amo ...

CRANFORD, N.J., July 17, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), today announced the closing of its "reasonable best-efforts" public offering of 6,818,182 shares of common stock of the Company and warrants to purchase shares of common stock at a public offering price of $1.32 per share. The warrants have an exercise price of $1.32 per share, are immediately exercisable upon iss ...

Summary of Clene (CLNN) Conference Call - July 17, 2025 Company Overview - Clene Inc. (CLNN) is a late-stage clinical biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases [1] Core Industry Insights - The company is primarily involved in the development of treatments for neurodegenerative diseases, specifically Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) [1][2] - Clene's drug, CNMAU8, is being evaluated for its ability to reduce neurofilament levels in ALS patients, which serves as a biomarker for neuronal damage [3][4] Key Developments - Clene met with the FDA in June 2025 to discuss the evaluation of neurofilament as a biomarker for ALS treatment [2] - The company received $45 million in funding from the NIH to support a study involving 180 ALS patients, with data collection starting next month and continuing until September [4][5] - Clene aims to submit data to the FDA for a new drug application (NDA) by the end of 2025, with a decision expected in the first quarter of 2026 [8][6] Clinical Trial Plans - A confirmatory Phase 3 clinical trial is planned to commence later in 2025, focusing on survival as the primary endpoint [10][11] - The trial will compare the survival rates of patients taking CNMAU8 against a placebo group [10] Biomarker Insights - Neurofilament levels can indicate the onset of ALS symptoms before clinical presentation [12] - Clene is the only company in a Phase II double-blind placebo-controlled study that has shown a reduction in neurofilament levels [13] Future Directions - Clene is also exploring the potential of CNMAU8 for other neurodegenerative diseases, including MS, Parkinson's, Huntington's, and frontotemporal dementia [16][17] - The company is in discussions with the FDA regarding its MS program, which uses the same drug and dosage as in the ALS program [15][16] Additional Considerations - The company is focused on the energetic support of mitochondria, which is crucial for neuronal function [16] - Clene has presented data suggesting remyelination of damaged neurons in MS, although similar conclusions for ALS are still pending [14] This summary encapsulates the critical points discussed during the Clene conference call, highlighting the company's focus on neurodegenerative diseases, ongoing clinical trials, and future research directions.

Summary of Conference Call Records Company Overview Clean Inc. (NASDAQ: CLNN) - Clean Inc. is a late-stage clinical biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, particularly ALS [1][2]. Sono Group NV (OTCQB: SEVCF) - Sono Group NV, through its subsidiary Sono Motors GmbH, is pioneering solar technology integration into commercial vehicles, aiming to revolutionize mobility by making every commercial vehicle solar [20][22]. Key Points from Clean Inc. Conference Call Core Insights - Clean Inc. met with the FDA in June to discuss the evaluation of neurofilament as a biomarker for ALS, which is indicative of neuronal damage [2][4]. - The company is leveraging a $45 million grant from the NIH to fund a study involving 180 ALS patients, with data collection starting next month [4][5]. - Clean Inc. aims to submit a new drug application (NDA) to the FDA by the end of the year, contingent on positive data regarding neurofilament levels and survival rates [6][7]. - A confirmatory Phase 3 clinical trial is planned, focusing on survival as the primary endpoint, with the first patients expected to start treatment by the end of this year [9][10]. Additional Insights - Neurofilament levels can indicate ALS progression before clinical symptoms appear, and Clean Inc. is the only company in a Phase 2 study showing a reduction in neurofilament [12][14]. - The company is also exploring other neurodegenerative diseases, including multiple sclerosis (MS), Parkinson's, and Huntington's disease, with ongoing discussions with the FDA regarding MS [15][17]. Key Points from Sono Group NV Conference Call Core Insights - Sono Group is focused on integrating solar technology into commercial vehicles, with a patent portfolio of nine granted patents and over 30 pending patents [24][25]. - The company has received orders from six large OEMs and expects significant revenue growth in Q3 and Q4, with an average revenue per unit projected to reach €8,000 [29][30]. - Sono Group aims to uplist to a major national exchange, enhancing visibility and liquidity, which is expected to drive long-term shareholder value [32][34]. Additional Insights - The company has won a green innovation award and received national type certification for solar bus kits in Germany, simplifying the installation process across fleets [27][28]. - The solar solutions are designed to work across various vehicle types, including diesel, hybrid, and electric, providing immediate CO2 reductions and cost benefits [25][33]. - The management team emphasizes a commitment to sustainability, with employees actively participating in eco-friendly practices [31]. Conclusion Both Clean Inc. and Sono Group NV are positioned in innovative sectors with significant growth potential. Clean Inc. is advancing in the biopharmaceutical space with a focus on ALS, while Sono Group is leading in solar mobility solutions for commercial vehicles. Both companies are preparing for critical developments in the near future, including regulatory submissions and market expansions.

Core Insights - Oncotelic Therapeutics is advancing the evaluation of OT-101, an investigational antisense oligonucleotide targeting TGFB2, as a potential treatment for pancreatic ductal adenocarcinoma (PDAC) [1][5] - New research indicates that TGFB2 expression and methylation may serve as prognostic markers for overall survival in PDAC patients, particularly in younger cohorts [1][2][3] Company Overview - Oncotelic Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing RNA-targeted and small-molecule therapeutics for cancer and rare diseases [1][6] - The company has a 45% ownership interest in Sapu Biosciences, which contributed to the recent research publication [1] Research Findings - The study published in the International Journal of Molecular Sciences highlights that high TGFB2 expression correlates with reduced overall survival in patients under 65 years old, with median overall survival of 17.9 months for high TGFB2 expression compared to 66.9 months for low expression [3] - Elevated TGFB2 methylation is associated with improved survival in younger patients, with median overall survival of 66.9 months for high methylation versus 17.9 months for low methylation [3] - Clinical data from the OT-101 P001 PDAC study suggests that targeting TGFB2 is particularly beneficial for younger patients, with a median overall survival of 12.7 months in a treated subset characterized by low IL-6 [2] Market Context - The incidence of PDAC is increasing among younger adults, with approximately 4% annual growth in the 15-34 age bracket, while the five-year survival rate for all PDAC patients is only around 12% [4] - The findings underscore the need for targeted therapies like OT-101 to address the grim outcomes faced by younger PDAC patients [4]