LA JOLLA, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) provides shareholders a corporate update in the following Letter to Stockholders from CEO Yuichi Iwaki, M.D., Ph.D. Dear Fellow Shareholders, The year 2025 was marked by global uncertainty, with accelerating inflation, evolving U.S. trade policies under the new administration, and persistent ...

NORCROSS, Ga., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, today announced that the U.S. Food and Drug Administration (FDA) has provided a written response, and subsequent communications, to the Company’s previously submitted Type C meeting request regarding the development program for belapectin, its investigational galectin-3 inhibitor. The FDA converted the C ...

As filed with the Securities and Exchange Commission on November 19, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ (State or other jurisdiction of incorporation or organization) Ontario, Canada 2834 98-1778211 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ide ...

Financial Data and Key Metrics Changes - Revenue net of returns for Q3 2025 totaled $146,000, an increase from $126,000 in Q3 2024, while for the nine-month period, it decreased to $302,000 from $600,000 in 2024 [12][13] - Cost of sales increased to $291,000 from $82,000 in the year-ago quarter, primarily due to a $230,000 inventory reserve recorded in Q3 2025 [13] - Gross margins, excluding the inventory reserve, were 42% for Q3 2025 compared to 35% for Q3 2024 [13] - Net loss for Q3 2025 was $2.6 million, compared to $1.4 million for Q3 2024, while the nine-month net loss was $6 million compared to $4.2 million in 2024 [14][15] - Cash and cash equivalents at September 30, 2025, totaled $3.5 million, up from $2 million at December 31, 2024 [15] Business Line Data and Key Metrics Changes - The company is transitioning from the consumer device market to biopharmaceuticals, with a focus on Entolimod and related assets [3][11] - The company recorded reserves for excess and obsolete inventory of $230,000 as part of its exit from the consumer device market [11] - The company has discontinued significant resources toward ClearUP sales, reflecting its strategic shift [12] Market Data and Key Metrics Changes - The company is focusing on building relationships with U.S. and allied governments for Entolimod as a military countermeasure [5][6] - Discussions with BARDA are anticipated to explore stockpiling opportunities for Entolimod [5] Company Strategy and Development Direction - The company has undergone a significant strategic transformation, expanding from bioelectronics to biologic pharmaceuticals with a focus on the immune system [3][4] - The primary commercial opportunity for Entolimod is as a countermeasure for acute radiation syndrome, with plans to advance clinical programs in neutropenia and lymphocyte exhaustion [6][7] - The company is also exploring alternative commercial opportunities for its non-invasive vagus nerve stimulation (VNS) program [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of the transformation and the potential of Entolimod to deliver clinical benefits across multiple organ systems [7][16] - The company aims to advance value creation activities for shareholders while bringing life-saving treatments to patients [17] Other Important Information - The company has completed the transfer of two INDs for Entolimod, enabling further clinical development [6][16] - A new corporate website has been launched to emphasize the transformed mission and expanded clinical pipeline [12] Q&A Session Summary - No specific Q&A session content was provided in the transcript, thus this section is not applicable.

Core Insights - Karolinska Development AB is approaching a period where several portfolio companies will conclude their clinical studies, which is expected to yield exciting data readouts [1] Significant Events During the Third Quarter - Organon announced the discontinuation of the clinical development of drug candidate OG-6219 following phase 2 study results [4] - Modus Therapeutics completed patient enrollment for part 1 of its ongoing phase 2a study with sevuparin for chronic kidney disease with anemia [4] - Umecrine Cognition raised SEK 24.6 million through a convertible loan for its ongoing clinical study of golexanolone in Primary biliary cholangitis [4] - Modus Therapeutics raised SEK 28.3 million in a unit issue with a subscription rate of 189% to finance the development of sevuparin [4] - Umecrine Cognition presented data supporting golexanolone's mechanism in alleviating Parkinson's disease symptoms [4] - AnaCardio completed enrollment in the phase 2a study of drug candidate AC01 for heart failure, with results expected by year-end [4] - Dilafor was granted a US patent for tafoxiparin, which will support its phase 3 clinical development [4] - PharmNovo received approval to initiate a phase 2a clinical trial of PN6047 for neuropathic pain [4] - SVF Vaccines presented positive preclinical study results for SVF-001 targeting chronic hepatitis B and D [4] - Karolinska Development participated in BOOST Pharma's financing, contributing SEK 7.5 million to support phase 3 development of BT-101 for Osteogenesis imperfecta [4] - BOOST Pharma presented new long-term data from the BOOSTB4 trial for BT-101 at an international conference [4] - Modus Therapeutics received regulatory approval to initiate the second part of its phase 2 study with sevuparin [5] Financial Update - The net profit/loss for Q3 2025 was SEK -66.8 million, compared to SEK -10.9 million in Q3 2024 [8] - Earnings per share for Q3 2025 totaled SEK -0.25, down from SEK -0.04 in Q3 2024 [8] - The total fair value of the portfolio at the end of September 2025 was SEK 1,346.7 million, a decrease of SEK 38.2 million from the previous quarter [8] - Net asset value at the end of September 2025 was SEK 1,085.4 million, or SEK 4.0 per share, down from SEK 1,224.4 million or SEK 4.5 per share at the end of September 2024 [8] - Net sales for Q3 2025 totaled SEK 0.3 million, compared to SEK 0.4 million in Q3 2024 [8] - Karolinska Development invested SEK 28.4 million in portfolio companies during Q3 2025, up from SEK 19.8 million in Q3 2024 [8] - Cash and cash equivalents decreased by SEK 26.6 million, totaling SEK 44.5 million on September 30, 2025 [8]

Core Insights - BeOne Medicines has achieved profitability for the first time in its history, marking a significant milestone for the company [1] - The company boasts one of the deepest product pipelines in the biotech industry, indicating strong future growth potential [1] Competitive Advantages - BeOne Medicines operates a fully integrated CRO-free clinical development organization, which enhances its operational efficiency [2] - The company has demonstrated exceptional discovery capabilities, having put 10 internally developed New Molecular Entities (NMEs) into the clinic in 2024 and a total of 16 since its founding [2][3] - The emphasis on clinical development is recognized as critical for realizing the value of innovation, showcasing the company's strategic focus [3]

Core Insights - Medicus Pharma Ltd. has announced a strategic collaboration with the Gorlin Syndrome Alliance to enhance access to its investigational therapy SKINJECT™ for patients with Gorlin Syndrome, a rare genetic disorder that can lead to numerous basal cell carcinomas [1][2][5] Company Overview - Medicus Pharma Ltd. is a biotech/life sciences company focused on advancing clinical development programs for novel therapeutics [1][9] - The company is currently conducting a Phase 2 clinical study (SKNJCT-003) for SKINJECT™ across nine clinical sites in the United States, which began randomizing patients in August 2024 [5][10] - Medicus has also expanded its clinical studies to Europe and is conducting another study (SKNJCT-004) in the UAE, targeting a total of 36 patients [6][10] Product Development - SKINJECT™ is an investigational localized immunogenic therapy aimed at treating non-melanoma skin diseases, particularly basal cell carcinoma [3][10] - The Phase 2 study (SKNJCT-003) has shown promising interim results, with over 60% clinical clearance reported after randomizing more than 50% of the targeted 60 patients [5][10] - The FDA has provided positive feedback regarding the development of SKINJECT™, indicating a potential 505(b)(2) regulatory pathway for its approval [5][10] Collaboration and Community Engagement - The collaboration with the Gorlin Syndrome Alliance aims to facilitate expanded access to SKINJECT™ while integrating patient community insights into the treatment's development [2][5] - The Gorlin Syndrome Alliance serves as a bridge between patients, clinicians, researchers, and industry, promoting awareness and providing support for those affected by Gorlin Syndrome [18][19] Recent Acquisitions - In August 2025, Medicus completed the acquisition of Antev, a UK-based biotech company developing Teverelix, a next-generation GnRH antagonist for advanced prostate cancer patients [7][12] - Teverelix is designed to suppress sex hormone production without an initial surge, potentially reducing cardiovascular risks for patients with existing conditions [8][13]

Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]

Group 1 - The article does not provide any specific content related to a company or industry [1]

Summary of 4D Molecular Therapeutics FY Conference Call Company and Industry Overview - **Company**: 4D Molecular Therapeutics (NasdaqGS:FDMT) - **Industry**: Ocular Gene Therapy - **Key Focus**: Development of gene therapies for ophthalmic conditions, particularly age-related macular degeneration (AMD) and diabetic macular edema (DME) Core Points and Arguments Market Landscape - The panel discussed the competitive landscape for large ophthalmic indications, including geographic atrophy (GA), wet AMD, and DME, highlighting existing approved options and the unmet needs in these areas [13][14][15] - There is a significant unmet medical need in GA, with current therapies failing to show functional benefits, leading to patient reluctance to return for treatment [20][21] Clinical Development and Differentiation - **4D-150**: 4D Molecular Therapeutics' lead program is in phase three trials for wet AMD, aiming to provide long-lasting treatment benefits compared to existing therapies [11][15] - **Durability**: The need for improved durability in treatments is emphasized, with existing therapies providing only incremental benefits [14][15] - **Gene Therapy Potential**: The promise of gene therapy is to provide long-term solutions with potentially one-time treatments that could stabilize or improve vision, representing a paradigm shift in treatment [19][20] Regulatory Challenges - The FDA and EMA are supportive of gene therapies, with a focus on safety and efficacy as critical factors for approval [52][53] - There is a need for alignment on clinical endpoints, particularly for GA, where traditional measures may not adequately reflect treatment benefits [57][59] Commercial and Access Considerations - The transition to one-time therapies poses challenges for existing business models in the U.S., where ongoing treatments generate significant revenue for practices [63][68] - The economic impact of vision loss diseases is substantial, with potential savings and productivity gains from effective one-time therapies [65][66] - The market for GA is currently under-treated, with only about 15% of patients receiving treatment, indicating significant growth potential for new therapies [64] Additional Important Insights - **Heterogeneity of Disease**: The panelists noted the complexity and variability of diseases like GA and RP, which necessitate tailored treatment approaches [61][62] - **Emerging Therapies**: There is a recognition that multiple therapies targeting different pathways may coexist in the market, allowing for a segmented approach to treatment [30][39] - **Patient-Centric Focus**: Emphasis on the importance of patient outcomes and the need for therapies that improve quality of life, rather than solely focusing on economic models [66][70] This summary encapsulates the key discussions and insights from the conference call, highlighting the current state and future potential of gene therapies in the ocular space.