Leiden, the Netherlands, April 25, 2025: Pharming Group N.V. ("Pharming" or "the Company") (NASDAQ:PHAR) announces the following presentations by the Company or its collaborators at the 2025 Annual Meeting of the Clinical Immunology Society (CIS), taking place May 1-4, 2025 in Philadelphia, PA. These presentations include Phase III clinical data for leniolisib for pediatric patients aged 4-11 years with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) and insights into APDS and additional p ...

Core Viewpoint - Oragenics, Inc. has submitted a clinical trial protocol for its neurosteroid therapy ONP-002 to the Health and Disability Ethics Committee in New Zealand, marking a significant step in the development of treatments for mild traumatic brain injury (mTBI) or concussion [1][2][3] Company Overview - Oragenics, Inc. is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, with ONP-002 as its lead candidate for treating mTBI or concussion [4] - The company is also advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration [4] Clinical Trial Details - The Phase II clinical trial for ONP-002 aims to evaluate its efficacy in treating mTBI or concussion, with patient enrollment planned in both Australia and New Zealand [2][3] - The trial will be conducted at Christchurch Hospital, the largest tertiary, teaching, and research hospital on New Zealand's South Island, which treats over 83,000 patients annually [2][3] Treatment Significance - There are currently no pharmaceutical therapies available for treating concussion, highlighting an unmet medical need [3] - ONP-002 is designed for intranasal administration, providing a non-invasive and efficient route for drug delivery to the brain, and has shown promising results in preclinical models [3]

SARASOTA, Fla., April 07, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related disorders, today announced that Chief Medical Officer Dr. James Kelly participated in a panel discussion at the 3rd Nasal Formulation & Delivery Summit, which took place April 1-3, 2025, in Boston, MA. The conference brought together industry leaders to discuss the latest innovations in intranasal drug delivery, with a focus on CNS therape ...

SARASOTA, Fla., April 07, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related disorders, today announced that Chief Medical Officer Dr. James Kelly participated in a panel discussion at the 3rd Nasal Formulation & Delivery Summit, which took place April 1-3, 2025, in Boston, MA. The conference brought together industry leaders to discuss the latest innovations in intranasal drug delivery, with a focus on C ...

Core Insights - The company reported a total operating revenue of 1.283 billion yuan in 2024, representing a year-on-year growth of 8.74% [1] - The net profit attributable to shareholders decreased by 6.57% to 189 million yuan [1] - The company continues its dividend policy, proposing a cash dividend of 0.96 yuan per 10 shares, totaling an expected distribution of 40.52 million yuan [2] Revenue Breakdown - Revenue from raw materials reached 988 million yuan, an increase of 11.57% year-on-year [1] - Revenue from formulation products was 161 million yuan, growing by 16.77% year-on-year [1] - Antiviral product revenue decreased by 37.92% due to fluctuations in demand and pricing of oseltamivir [1] - Revenue from antifungal products surged by 60.28% due to increased commercialization demand [1] - Immunosuppressive product revenue grew by 45.72% driven by commercial demand [1] International Expansion - The company experienced a significant 45% increase in overseas revenue, attributed to expanded channels in North America and Europe [1] - The company has established multiple technology platforms to support the development of high-end generics and original new drugs [1] - Products have been registered and authorized for sale in the US, Europe, Japan, South Korea, and countries along the "Belt and Road" initiative, laying a solid foundation for future overseas revenue growth [1] R&D Investment - The company increased its R&D expenditure to 297 million yuan in 2024, a year-on-year increase of 19.65% [2] - Future R&D focus areas include treatments for NASH and dual-target drugs, with a particular emphasis on GLP-1 class drugs in the metabolic field [2] - The company aims to explore new administration methods, multi-target combination therapies, and expand indications to address unmet clinical needs [2] Dividend Policy - The company has maintained a consistent dividend policy since its listing in 2019, with cumulative cash dividends amounting to 246 million yuan over six years [2]

Core Viewpoint - Regulus Therapeutics Inc. is actively participating in the 2025 Oppenheimer Innovation on the Island Biotech Summit, highlighting its focus on innovative medicines targeting microRNAs [1]. Company Overview - Regulus Therapeutics Inc. is a biopharmaceutical company listed on Nasdaq (RGLS) that specializes in the discovery and development of medicines aimed at microRNAs [3]. - The company has developed a robust pipeline supported by a strong intellectual property portfolio in the microRNA sector [3]. - Regulus is headquartered in San Diego, California [3]. Event Participation - Jay Hagan, the CEO of Regulus, will present at the summit on April 9th, 2025, at 11:32 a.m. ET [1]. - The live event and its replay will be accessible through the investor relations section of the company's website for 90 days post-presentation [2].

Core Insights - Regulus Therapeutics announced positive topline results from the fourth cohort of its Phase 1b MAD study of farabursen for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD) [2][4] - The study demonstrated a significant halting of kidney volume growth in patients receiving a 300 mg fixed dose of farabursen over four months [1][4] - The company is on track to initiate a Phase 3 pivotal trial in Q3 2025, with a focus on a 12-month endpoint for kidney volume change [2][6] Study Details - The Phase 1b MAD study was a double-blind, placebo-controlled trial assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of farabursen in adult ADPKD patients [3] - The study included three weight-based dose levels and one fixed dose level, with primary endpoints focused on urinary PC1 and PC2 changes, and an exploratory examination of htTKV growth rate [3][4] - In the fourth cohort, 26 subjects received 300 mg of farabursen bi-weekly for three months, showing consistent mechanistic responses and halting htTKV growth [4][5] Efficacy and Safety - Patients treated with farabursen showed a mean htTKV growth rate of 0.05%, compared to 2.58% in placebo subjects, indicating a significant reduction in kidney volume growth [5] - Urinary levels of PC1 and PC2 increased significantly, correlating with the observed effects on kidney volume [5] - Farabursen demonstrated a favorable safety and tolerability profile, consistent with earlier cohorts, with no serious adverse events reported [5][9] Future Plans - The company has confirmed alignment with the FDA regarding the Phase 3 trial design, which includes a 12-month htTKV endpoint for Accelerated Approval and a 24-month eGFR endpoint for Full Approval [6][9] - Regulus aims to advance farabursen as a potential treatment option for ADPKD, addressing a significant unmet medical need [6][10] Background on ADPKD - ADPKD is a common genetic disorder characterized by the development of multiple cysts in the kidneys, leading to end-stage renal disease in approximately 50% of patients by age 60 [8] - The disease affects around 160,000 individuals in the U.S., with a global prevalence estimated between 4 to 7 million [8]

Core Viewpoint - Galmed Pharmaceuticals has secured a new patent for the combination therapy of Aramchol and Resmetirom for treating non-alcoholic steatohepatitis (NASH), extending patent protection until September 2039, which positions the company to capitalize on the commercial potential of Aramchol in the growing NASH market [1][2][5]. Company Summary - Galmed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing Aramchol for liver and fibro-inflammatory diseases, particularly NASH [12]. - The company believes that Aramchol's unique mechanism of action as a stearoyl-CoA desaturase-1 (SCD1) modulator provides a competitive advantage, making it suitable for combination therapies [6][7]. - The recent patent strengthens Galmed's intellectual property portfolio, enhancing its strategic flexibility for partnerships and commercialization [11]. Industry Summary - The global NASH treatment market is projected to grow from approximately $5.2 billion in 2022 to over $48 billion by 2035, indicating significant unmet needs and revenue opportunities [5]. - The industry is shifting towards combination therapies for NASH, as no single agent is expected to fully address the disease's complexities [4][10]. - Recent regulatory developments, including the FDA's approval of Resmetirom as the first drug for NASH patients with liver fibrosis, highlight the therapeutic potential in this area [4].

Raanana, Israel, March 14, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announced today that it has signed a non-binding Letter of Intent (LOI) with a biotech company focused on psychedelic-derived therapeutics (“the psychedelic company”), to develop a novel intranasal formulation for psychedelic-based treatment applications. This agreement aims to leverage Polyri ...

Sanuwave Health (SNWV) Q3 2024 Earnings Call November 08, 2024 08:30 AM ET Speaker0 Please note this call is being recorded and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Morgan Frank, Chairman and CEO of Sanywave. Speaker1 Thank you very much. So welcome, everyone, to Sanywave's third quarter twenty twenty four earnings call. As many of you saw, our Form 10 Q was filed with the SEC last night. Our earnings release was issued this morning, a ...