Core Points - Hoth Therapeutics, Inc. has regained full compliance with Nasdaq's minimum bid price requirement, closing at or above $1.00 for 10 consecutive trading sessions from June 4 to June 17, 2025 [1][2] - The CEO of Hoth Therapeutics, Robb Knie, stated that regaining compliance is a significant milestone that reflects growing market confidence in the company's strategy and pipeline [3] - The company is strategically focused on delivering key milestones across multiple therapeutic areas, including inflammatory diseases, oncology, and rare diseases [3] Company Overview - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative therapies for patients with unmet medical needs, targeting rare diseases, inflammatory skin disorders, cancer, and neurological conditions [4]

Core Insights - Bioxytran, Inc. has secured a GMP quality source of camel hemoglobin, which is essential for developing a Universal Oxygen Carrier (UOC) [1][2] - The collaboration with the Heme Foundation involves a $10 million Joint Venture aimed at addressing global blood shortages through innovative oxygen transport solutions [2][5] - Camel hemoglobin is preferred due to its stability and resilience in harsh conditions, making it a superior alternative to cow hemoglobin [3][4] Company Developments - The partnership with the Heme Foundation positions Bioxytran as the primary contractor for the UOC project, potentially increasing donations to the foundation [2][5] - Bioxytran retains full intellectual property rights for the UOC development, which could lead to significant advancements in research and applications for their leading oxygen transport molecule, BXT-25 [5][6] - The CEO of Bioxytran emphasized that having a reliable supplier of camel hemoglobin could accelerate non-dilutive funding and innovation in oxygen transport technology [6] Industry Context - The Heme Foundation aims to provide alternatives for blood transfusions, reducing the complexity of supply chains and cold storage requirements [6] - The unique properties of camel hemoglobin, such as higher concentration and stability, could enhance the scalability and impact of the UOC project [4][3] - Bioxytran is focused on addressing critical unmet medical needs through its core platform technologies, including oxygen transport, which is crucial for conditions like stroke and Alzheimer's disease [7]

Core Insights - Outlook Therapeutics, Inc. is participating in a Virtual Investor Lunch Break Event on June 25, 2025, at 12:00 PM ET [1] - Key executives will discuss the company's commercial strategy, upcoming milestones, and current activities during the event [2] - A live video webcast will be available on the company's website, with a replay accessible for 90 days [3] Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) to enhance the standard of care for retinal diseases [4] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for the treatment of wet AMD [4] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK [4] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [5] - If approved, it would be the first ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [5]

NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Organon & Co. (NYSE: OGN) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Organon you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/organon-co-class-action. Investors have until July 22, 2025, to ask the Court to be appointed to lea ...

NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Sarepta Therapeutics, Inc. (NASDAQ: SRPT) for potential violations of the federal securities laws. If you invested in Sarepta, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/sarepta-therapeutics-inc-class-action. Why is Sarepta being Investigated? Sarepta is a biopharmaceutical company focused on developing treatment ...

NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Iovance you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/iovance-biotherapeutics-inc-class-action-lawsuit. Investors have until July 14, 2 ...

Core Insights - Lexicon Pharmaceuticals is set to present data on sotagliflozin's ability to reduce hypoglycemic events in type 1 diabetes patients at the 85th Scientific Sessions of the American Diabetes Association on June 22, 2025 [1][3] - The company will also present topline data from the PROGRESS Phase 2b study on pilavapadin (LX9211) for diabetic peripheral neuropathic pain during the same event [1][3] Sotagliflozin Presentation - The presentation titled "Sotagliflozin Added to Insulin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes Regardless of Kidney Function" will take place on June 22, 2025, from 4:00-4:15 p.m. CT [3] - Clinical efficacy data for sotagliflozin will be segmented by kidney function subgroups based on Estimated Glomerular Filtration Rate (eGFR) [2] PROGRESS Study Overview - The PROGRESS study began in December 2023, enrolling 496 adult patients with diabetes and moderate to severe diabetic peripheral neuropathic pain [6] - The study is placebo-controlled, focusing on changes in pain levels over an 8-week period with various dosages of pilavapadin [6][7] About Sotagliflozin - Sotagliflozin is an oral inhibitor targeting SGLT2 and SGLT1 proteins, which are involved in glucose regulation [5] - The drug has been studied in approximately 20,000 patients across various conditions, including heart failure and chronic kidney disease [5] About Diabetic Peripheral Neuropathic Pain (DPNP) - DPNP is a chronic complication of diabetes affecting around 9 million patients in the U.S., causing symptoms like burning pain and numbness [8]

Core Insights - Tevogen Bio is advancing its development of a cytotoxic T lymphocyte (CTL) therapy targeting Epstein-Barr virus (EBV)-associated lymphomas [1] - The company is utilizing its proprietary ExacTcell™ technology to manufacture EBV-specific CTLs for potential clinical trials [2] - Collaboration with Tevogen.AI aims to enhance peptide selection strategies for identifying immunologically active targets across the EBV genome [3] - The understanding of EBV-induced tumorigenesis has improved, highlighting the potential for CTLs to target EBV proteins for therapeutic breakthroughs [4] Research and Development - Computer-based selection of EBV peptides is in progress as part of preparation for clinical trials [2] - Confirmation studies are being conducted in Tevogen's R&D laboratory to validate CTL responses to selected viral peptides [2] - The collaboration with Tevogen.AI is focused on accelerating the identification of effective immunological targets [3] Scientific Insights - Recent advancements have clarified the mechanisms of EBV-induced tumorigenesis, which involve disruption of cellular pathways and promotion of malignant growth [4] - Targeting EBV proteins with specific CTLs represents a promising area for research and potential therapeutic advancements in EBV-driven cancers [4] Future Directions - Tevogen Bio plans to provide ongoing updates as its EBV research progresses through the preclinical evaluation phase [4]

Core Insights - Incannex Healthcare Inc. has achieved a significant milestone by locking the database for the RePOSA Phase 2 clinical trial of its lead drug candidate IHL-42X for obstructive sleep apnoea (OSA) as of June 16, 2025, with top-line results expected in July 2025 [1][2][3] Company Overview - Incannex is a clinical-stage biopharmaceutical company focused on developing combination drug therapies for high-impact indications, including OSA, rheumatoid arthritis, and generalized anxiety disorder [8] - The company is advancing three clinical-stage product candidates, with IHL-42X being the lead program designed to target the underlying mechanisms of OSA [8] Drug Development - IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, currently in the RePOSA Phase 2/3 clinical trial, which aims to enroll over 560 patients globally [5][6] - The drug targets two physiological pathways associated with OSA, specifically intermittent hypoxia and hypercapnia, offering a differentiated approach compared to existing treatments [7] Market Potential - OSA affects over 900 million people worldwide, with growing awareness of its impact on cardiovascular and metabolic health, positioning IHL-42X to potentially disrupt the treatment paradigm [4][6] - Approximately 67% of individuals with OSA are not classified as obese, indicating a broader patient population that could benefit from IHL-42X [7] Clinical Trial Progress - The RePOSA Phase 2 trial is evaluating IHL-42X in patients with moderate to severe OSA who are unable or unwilling to use continuous positive airway pressure (CPAP) [3][4] - Previous studies have shown that IHL-42X can reduce the Apnea-Hypopnea Index (AHI) by an average of 51% relative to baseline in all dosage strengths [6]

Core Viewpoint - Palvella Therapeutics has received a new patent for its lead product candidate QTORIN™ rapamycin, which solidifies its exclusivity in the market for treating rare genetic skin diseases [2][3]. Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare genetic skin diseases without FDA-approved treatments [5]. - The company is led by veterans in rare disease drug development and is working on a pipeline based on its patented QTORIN™ platform [5]. Product Details - QTORIN™ rapamycin is a 3.9% anhydrous gel that has been granted Breakthrough Therapy, Orphan Drug, and Fast Track Designations by the FDA for treating microcystic lymphatic malformations [4]. - The newly issued patent (No. 12,329,748) covers a wide range of claims related to QTORIN™ rapamycin and other mTOR inhibitors, emphasizing its application in treating rare dermatologic conditions [3]. Financial Support - Palvella has been awarded an FDA Orphan Products Grant, which could provide up to $2.6 million to support the ongoing SELVA Phase 3 trial of QTORIN™ rapamycin [4]. Clinical Trials - QTORIN™ rapamycin is currently being evaluated in the Phase 3 SELVA clinical trial for microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial for cutaneous venous malformations [5].