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I-Mab Announces Publication of Givastomig Monotherapy Data in Clinical Cancer Research
Globenewswire· 2025-06-30 20:01
Monotherapy efficacy and safety profile provided backbone for clinical development strategy in 1L combination with nivolumab plus chemotherapy ROCKVILLE, MD, June 30, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced publication of the first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in Clinical Cancer Research ...
Vor Biopharma's RemeGen Deal Paves Way For Multi-Billion Dollar Autoimmune Market
Benzinga· 2025-06-30 18:31
Core Insights - Vor Biopharma Inc. has been upgraded by H.C. Wainwright, marking a significant turnaround for the company following the in-licensing of telitacicept [1][4] - The company has entered into a strategic licensing agreement with RemeGen Co., Ltd. for the development and commercialization of telitacicept outside Greater China [2] Financial Details - Vor Biopharma will pay $125 million upfront, which includes $45 million in cash and $80 million in stock warrants, along with potential milestone payments exceeding $4 billion and tiered royalties [3] - The stock price of Vor Biopharma has increased by 49.1%, reaching $1.58 [7] Market Opportunity - The market potential for telitacicept in generalized myasthenia gravis (gMG) is significant, with an estimated 82,700 people in the U.S. affected in 2021, and 75% of these patients receiving treatment [5] - If priced at $225,000 per patient annually and capturing 15% of the U.S. market, peak annual sales for telitacicept could reach $1.8 billion [5] - Additional sales of $2.7 billion could be generated if the drug successfully launches in the EU and Japan, achieving a 10% market share [6] Management Changes - Jean-Paul Kress has been appointed as CEO and Chairman, replacing Dr. Robert Ang, who will remain as a strategic advisor until October [3]
Tevogen CEO Contributes to Build-Out and First-Year Operations of New Headquarters
Globenewswire· 2025-06-30 18:28
Core Insights - Tevogen Bio Holdings Inc. emphasizes the significance of AI in drug discovery and has made a substantial investment in its new corporate headquarters [1][2] - The new facility will enhance collaboration among cross-functional teams and support the development of Tevogen's AI platforms [2][3] - The CEO's personal investment reflects strong leadership conviction in the company's mission and long-term vision for affordable cell therapies [3] Company Developments - The CEO, Ryan Saadi, M.D., M.P.H., contributed $500,000 for the build-out and first-year operating costs of the new headquarters in Warren, New Jersey [1] - The new facility more than doubles the previous operational footprint and centralizes various teams, including research and regulatory affairs [2] - The dedicated collaboration spaces are designed to facilitate the work of data scientists and engineers on Tevogen's proprietary AI platforms, PredicTcell™ and AdapTcell™ [2] Financial Outlook - The CFO, Kirti Desai, highlighted that the CEO's investment underscores the leadership's commitment to capital discipline while enabling efficient scaling [3]
Biotech Catalyst Alert: NKTR, CDTX & WGS Rallying With Big Gains
MarketBeat· 2025-06-30 18:21
Core Insights - The biopharmaceutical industry is characterized by volatile stock movements, with companies often experiencing rapid rallies and sell-offs due to trial data and product developments [1][2] Company Summaries Nektar Therapeutics (NKTR) - Nektar Therapeutics has seen a significant increase in share price following successful Phase 2b trial results for its immunotherapy drug candidate, Rezpeg, which targets conditions like eczema affecting approximately 10 million patients in the U.S. [4][6] - The stock price surged over 300% within five trading days, reaching just under $30 per share, although it remains significantly lower than its all-time high of over $1,500 from early 2018 [5][6] - Analysts are optimistic, with six out of seven rating the stock as a Buy and a consensus price target of $84.17, indicating a potential upside of about 227% [6] Cidara Therapeutics (CDTX) - Cidara Therapeutics experienced a nearly 150% increase in share price following positive Phase 2b trial results for CD388, a non-vaccine treatment for seasonal influenza, which demonstrated a 76% protection rate for 24 weeks [8][9] - The stock reached its highest level since spring 2021, and analysts are bullish, with all nine ratings being Buy, although the company issued $250 million in new stock, which could dilute existing shares [10] GeneDx Holdings Corp. (WGS) - GeneDx has seen a recent stock surge of nearly 40% after announcing a partnership with Galatea Bio for genetic testing and updated guidance from the American Academy of Pediatrics recommending genomic sequencing for children with developmental delays [12][14] - Despite topping analyst predictions for first-quarter sales and raising revenue guidance for FY 2025, the stock had previously plummeted by almost 50% [12][13] - Six out of eight analysts rate WGS as a Buy, but concerns remain regarding its high valuation and competition in the genomic diagnostics space [15]
RARE's GTX-102 Gets FDA's Breakthrough Status for Angelman Syndrome
ZACKS· 2025-06-30 16:41
Core Insights - Ultragenyx Pharmaceuticals (RARE) has received FDA Breakthrough Therapy designation for its investigational therapy GTX-102 (apazunersen) aimed at treating Angelman syndrome (AS) [1][5]. FDA Breakthrough Therapy Designation - The Breakthrough Therapy designation accelerates the development and review of drugs for serious conditions, granted when early clinical evidence indicates significant improvement over existing treatments [2]. - Drugs with this designation benefit from enhanced guidance and support from senior FDA officials [2]. Clinical Study Results - GTX-102 demonstrated rapid and lasting improvements in AS patients during a phase I/II study lasting up to three years, involving 74 patients aged 4 to 17 with complete maternal UBE3A gene deletion [5][6]. - Participants showed consistent developmental progress and ongoing improvements across multiple symptom areas during treatment [6]. Current and Future Studies - Ultragenyx is currently enrolling patients for a phase III Aspire study and plans to initiate a phase II/III Aurora study to evaluate GTX-102 for a broader range of AS genotypes [8]. - The Aurora study is expected to start in the second half of 2025 [8]. Market Context - AS is a rare neurogenetic disorder affecting approximately 60,000 individuals in accessible markets, leading to severe developmental challenges with no approved therapies currently available [7]. Other Clinical Programs - Ultragenyx is developing other gene therapy candidates, including UX143 for osteogenesis imperfecta, which received Breakthrough Therapy designation in October 2024 [9]. - The company is also evaluating UX701 for Wilson disease and has achieved significant results in the phase III GlucoGene study for glycogen storage disease type Ia [10]. - A regulatory application for UX111, an AAV gene therapy for Sanfilippo syndrome type A, is under Priority Review, with a decision expected on August 18, 2025 [11].
OSE Immunotherapeutics Publishes Letter to Shareholders
Globenewswire· 2025-06-30 16:00
Group 1 - OSE Immunotherapeutics has published its inaugural Letter to Shareholders, highlighting key achievements, growth strategy foundations, and future perspectives [1] - The company is focused on developing first-in-class assets in immuno-oncology and immuno-inflammation to meet unmet patient needs [2] - OSE Immunotherapeutics collaborates with leading academic institutions and biopharmaceutical companies to develop transformative medicines for serious diseases [2] Group 2 - The company is headquartered between Nantes and Paris and is listed on Euronext [2] - Additional information about the company's assets can be found on its website [3]
GCANRx Announces Uplisting to New Market Tier
Globenewswire· 2025-06-30 13:06
BALTIMORE, June 30, 2025 (GLOBE NEWSWIRE) -- Greater Cannabis Company, Inc. (“GCANRx” or the “Company”) (OTC: GCAN) a biopharmaceutical company pioneering development of next generation cannabinoid therapeutics and consumer products is pleased to announce that its application to the OTCID Basic Market has been officially approved by OTC Markets Group. The upgrade will take effect upon the market's launch on July 1, 2025 and marks a significant milestone in GCAN’s ongoing efforts to strengthen its presence i ...
Revolution Medicines and Summit Therapeutics Enter into Clinical Collaboration to Evaluate Combinations of Three RAS(ON) Inhibitors with Ivonescimab in RAS Mutant Tumors
Globenewswire· 2025-06-30 12:00
Core Insights - Revolution Medicines and Summit Therapeutics have entered a clinical collaboration to evaluate the safety and efficacy of RAS(ON) inhibitors in combination with Summit's ivonescimab across multiple solid tumor types [1][2][3] Company Overview - Revolution Medicines is a late-stage clinical oncology company focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes daraxonrasib (RMC-6236), elironrasib (RMC-6291), and zoldonrasib (RMC-9805) [4] - Summit Therapeutics is a biopharmaceutical oncology company dedicated to developing patient-friendly therapies aimed at improving quality of life and addressing unmet medical needs [5][6] Clinical Collaboration Details - The collaboration will assess combinations of RAS(ON) inhibitors with ivonescimab in three priority tumor types: RAS mutant non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC) [2] - Under the agreement, Summit will provide ivonescimab for clinical research, while Revolution Medicines will act as the study sponsor, with both companies retaining commercial rights to their respective compounds [2] Drug Development Insights - Initial evidence suggests that daraxonrasib and elironrasib can provide additive antitumor activity when combined with a PD-1 antibody in first-line treatment for RAS mutant non-small cell lung cancer [2] - The collaboration aims to explore the therapeutic potential of combining investigational drugs from Revolution's RAS(ON) inhibitor portfolio with Summit's advanced PD-1 / VEGF bispecific inhibitor [3]
Allarity Therapeutics Receives Australian Patent Acceptance Notice for Stenoparib DRP® Companion Diagnostic
Globenewswire· 2025-06-30 12:00
Core Viewpoint - Allarity Therapeutics has received formal acceptance of its patent application for the Drug Response Predictor (DRP) companion diagnostic specific to stenoparib from IP Australia, marking a significant step in its global strategy for intellectual property protection and commercialization of its proprietary technology [1][2][3]. Company Overview - Allarity Therapeutics, Inc. is a Phase 2 clinical-stage pharmaceutical company focused on developing stenoparib, a dual PARP and WNT pathway inhibitor, as a personalized cancer treatment using its proprietary DRP technology [1][6]. - The company is headquartered in the U.S. and has a research facility in Denmark, aiming to address significant unmet medical needs in cancer treatment [6]. Patent and Intellectual Property - The accepted patent covers 40 claims and is a crucial part of Allarity's strategy to protect its DRP platform internationally, with the patent expected to be granted within 20 working days if unopposed [2][3]. - Allarity has previously secured a European patent for the stenoparib DRP and holds 18 granted patents for drug-specific DRPs, including eight in the U.S. [3]. Drug and Technology Details - Stenoparib is an orally available small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, with potential applications in various cancer types, particularly ovarian cancer [4]. - The DRP technology is designed to select patients likely to benefit from specific drugs based on gene expression signatures, enhancing therapeutic benefit rates [5]. Future Prospects - The acceptance of the Australian patent is seen as a vital achievement in securing international IP protection while advancing stenoparib through Phase 2 trials towards U.S. regulatory approval [3].
Chemomab Announces Oral Presentation of Positive Nebokitug Phase 2 Clinical Data in Primary Sclerosing Cholangitis at BSG Live'25
Globenewswire· 2025-06-30 12:00
SPRING Trial Data Presented at BSG Live’25 Confirms the Clinical Potential of Nebokitug as a First-in-Class Novel Treatment for PSC and Supports Advancement to Phase 3 Treatment with Nebokitug Is Well-Tolerated and Associated with Substantial Improvements in Multiple Fibrotic and Inflammatory Biomarkers that Represent Slowing of PSC Disease Progression TEL AVIV, Israel and GLASGOW, United Kingdom, June 30, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage biotechnology c ...