Intend to announce updated clinical data from Phase 1/2 VBP301 trial of VCAR33ALLO in the first half of 2025 and updated clinical data from Phase 1/2a VBP101 trial of trem-cel in combination with Mylotarg in the second half of 2025 Extends cash runway through release of updated data from VBP101 and VBP301 trials in 2025 CAMBRIDGE, Mass., Dec. 27, 2024 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a... Read more
Northvale, New Jersey--(Newsfile Corp. - December 26, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that the company has launched Elite's generic version of Vyvanse® (Lisdexamfetamine Disylate) with strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules. The product is indicated... Read more
Coeptis Aims to Bring AI Innovation in Biotechnology and Technology WEXFORD, Pa., Dec. 26, 2024 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (Nasdaq: COEP) (the "Company" or "Coeptis"), a biopharmaceutical company specializing in innovative cell therapy platforms for cancer, autoimmune, and infectious diseases, proudly announces the completion of its acquisition of the NexGenAI Affiliates Network... Read more
Company recently signed a non-binding term sheet with Dr Glitter Pty Ltd for mutual development in ActivCrystal™ Format Vancouver, Canada, Dec. 26, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health... Read more
Vancouver, Canada, Dec. 24, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced it has received Institutional Review Board (IRB) approval for its Phase I/IIa clinical trial of CMND-100,... Read more
New Drug Application (NDA) is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+ NSCLC U.S. Food and... Read more
Blarcamesine: Potential novel oral treatment to target upstream Alzheimer’s disease pathology through autophagy enhancement Submission based on favorable ANAVEX®2-73-AD-004 trial results in patients with early Alzheimer’s disease Once daily oral administration of blarcamesine meaningfully slowed clinical decline in early Alzheimer's disease patients, demonstrating a favorable safety profile with no associated... Read more
Tonix received FDA’s Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025 TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S., who are mostly women TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for fibromyalgia and... Read more
The Company has received approval to begin enrollment of the Phase 1b clinical trial in Australia Phase 1b clinical trial will assess safety and tolerability along with biomarkers during three months of dosing with GT-02287 in people diagnosed with Parkinson’s disease Phase 1b clinical trial follows successful Phase 1 study in which GT-02287 was safe and well tolerated while demonstrating GCase target... Read more
AUSTIN, Texas / Dec 23, 2024 / Business Wire / Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid-induced toxicities (the “Company” or “Anebulo”), today announced a positive regulatory update and the close of a capital raise. In a Phase 2 proof-of-concept study, Anebulo enrolled 134 adult subjects... Read more
With the addition of these two new assay launches, Zomedica has added 8 new assays in the past 18 months to the rapidly growing TRUFORMA Platform ANN ARBOR, MI / ACCESSWIRE / December 23, 2024 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced the launch of... Read more
DENVER, Dec. 23, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that a 14th site is now activated and able to enroll subjects in the NEUTRALIZE-AKI pivotal trial. The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the... Read more
Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other... Read more
SAN DIEGO, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Singular Genomics Systems, Inc. (Nasdaq: OMIC) (“Singular Genomics” or the “Company”), a company leveraging novel next-generation sequencing (NGS) and spatial multiomics technologies to empower researchers and clinicians, today announced that it has entered into a definitive merger agreement whereby an affiliate of Deerfield Management Company, L.P. will acquire Singular... Read more
Inmagene Biopharmaceuticals is a clinical stage company focused on developing IMG-007, a non-depleting anti-OX40 monoclonal antibody with an extended half-life and a silenced ADCC function The transaction is expected to result in approximately $175 million to support further development of IMG-007, including $75 million from an oversubscribed Private Placement that will close immediately following the... Read more
THE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This... Read more
In the pre-specified per-protocol population, belapectin showed a statistically significant reduction (p-value < 0.05) in development of esophageal varices in 2mg/kg cohort compared to placebo While there was a favorable trend for incidence of varices in the primary end point intent-to-treat population, belapectin did not achieve statistical significance Belapectin was overall well tolerated with no safety... Read more
LOI Agreement is steppingstone to formal agreement, The Multinational Pharmaceutical company is ranked in the top five contrast agent suppliers in the world, signaling and solidifying Voyageur’s importance in the global contrast agent market Calgary, Alberta, Canada – TheNewswire - December 20, 2024 - Voyageur Pharmaceuticals Ltd. (TSXV:VM) (OTC Pink:VYYRF) ("Voyageur" or the "Company") a... Read more
SYMVESS is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair In clinical testing SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection Highly experienced sales team already recruited and trained in preparation for commercial launch DURHAM,... Read more
Investigational REGN7508 (catalytic domain) and REGN9933 (A2 domain) are being evaluated for their potential to control thrombosis while minimizing bleeding risk in a variety of patient populations and clinical settings Evaluated against current standards of care, single doses of REGN7508 and REGN9933 administered 12 to 24 hours after total knee replacement demonstrated robust antithrombotic effects Phase 3... Read more
All four patients treated with NXC-201 normalized their disease markers within 30 days of dosing, of which, two are already classified as complete responders (CR), and the remaining two are bone marrow MRD negative (10-6); all patients remain in response as of the data cutoff of Nov 14, 2024 Bone marrow MRD negativity predicts future CR; company believes remaining two patients could be confirmed as CRs in the... Read more
Aadi Enters into Exclusive License for Three-Asset ADC Portfolio Developed through a Collaboration between WuXi Biologics and HANGZHOU DAC Aadi Enters Agreement to Sell FYARRO® and Associated Infrastructure to KAKEN Pharmaceutical for $100M; Announces PIPE Financing of $100M Cumulative Capital Expected to Fund Operations into Late 2028, Including Anticipated Clinical Data for the ADC Portfolio Co-Founder... Read more
Registered Phase-1b 12-week study will investigate safety, diabetes control, and weight loss KELOWNA, BC / ACCESSWIRE / December 19, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has begun dosing in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Study is designed mainly to... Read more
Company aligned with FDA on CMC strategy and requirements in preparation of Phase 3 pivotal trial of IMNN-001 Vertical integration of major components assures a high-quality, commercially viable future manufacturing capability On track to initiate Phase 3 pivotal trial of IMNN-001 in first quarter of 2025 LAWRENCEVILLE, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage... Read more
GAITHERSBURG, Md., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced a sponsored research agreement with the University of California, San Francisco (UCSF) to advance pre-clinical... Read more
Establishment reflects the clinical progress of IMM-1-104 and its promise in pancreatic cancer Follows recent Orphan Drug designation in pancreatic cancer and Fast Track designations in first- and second-line pancreatic cancer for IMM-1-104 CAMBRIDGE, Mass., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and... Read more
Preliminary clinical data in post-anti-PD-1 NSCLC patients demonstrated a 27% ORR and 73% DCR in monotherapy trial Monotherapy activity with inhaled KB707 provides further evidence of successful repeat administration of HSV-1 based inhaled lung gene delivery and builds on recent clinical data update for CF and AAT deficiency respiratory disease programs PITTSBURGH, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Krystal... Read more
Approval given after Safety Review Committee (SRC) review of safety data from the three patients comprising Cohort 2 No significant safety or dose limiting toxicities reported in Cohort 2 New patients currently being evaluated for eligibility in Cohort 3 PK and PD data from Cohort 1 patients consistent with preclinical and Phase 0 trial results BOSTON, Dec. 18, 2024 /PRNewswire/ -- TransCode Therapeutics,... Read more
Initiative Includes Milestone-Based Inventory Purchase Commitments During Q1 and Q2, 2025 Toronto, Ontario--(Newsfile Corp. - December 18, 2024) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX) ("Therma" or the "Company"), a developer and investment partner specializing in advanced diagnostic and medical device technologies, is pleased to announce the Company has signed a letter of intent (LOI) for... Read more
North American drug delivery development experts added to help guide Lexaria's strategic plans KELOWNA, BC / ACCESSWIRE / December 18, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces the creation of its new Scientific Advisory Board ("SAB") to assist in guiding Lexaria's rapid drug delivery platform technology... Read more
EYLEA HD demonstrated non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks Safety data remains consistent with the known EYLEA HD and EYLEA safety profiles Supplementary biologics license application planned for submission to the U.S. Food and Drug Administration in the first quarter of 2025 TARRYTOWN, N.Y., Dec. 17, 2024 (GLOBE... Read more
FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women TNX-102 SL has the potential to be the first member of a new class of... Read more
Ginkgo Bioworks to apply its mammalian cell engineering expertise to develop new cell-based systems for treating and monitoring endocrine disorders BOSTON, Dec. 17, 2024 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced a subcontract of up to $9.4 million awarded in partnership with Carnegie Mellon University to... Read more
Icovamenib met the primary endpoint, displaying a meaningful statistically significant placebo-corrected mean reduction in HbA1c in the prespecified per protocol patient population Best response achieved in target, beta-cell deficient patients on one or more antidiabetic agents at baseline, showing a placebo-adjusted mean reduction of 1.47% in HbA1c at Week 26 with statistical significance, after only 12 weeks... Read more
TN-201 Well Tolerated at 3E13 vg/kg Dose AAV9 Capsid Demonstrated Robust Delivery of TN-201 Transgene to Heart Muscle Cells Resulting in Increasing RNA Expression and an Increase in Protein Levels Observed at One Year Circulating Biomarkers and Other Clinical Measures Mostly Remained Stable or Improved from Baseline Tenaya Management to Host a Webcast Conference Call Today at 8:00 a.m. ET SOUTH SAN... Read more
Agreement Supports Phase IIb and Future Phase III Trial Development, Addressing Critical Needs in Palliative Care Using Optimi's Natural Psilocybin Extract Vancouver, British Columbia--(Newsfile Corp. - December 17, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of GMP-certified, naturally-derived psilocybin and MDMA, has entered into... Read more
U.S. wellness clinics sold to Stella, including a data-sharing partnership to launch a technology-driven clinic management solution for mental health care providers. Numinus Wellness clinics acquired by Stella for US$3.53 million Numinus focusing on business units and product development ("Numinus Network") to facilitate clinic efficiency and care reimbursement for mental health practitioners Stella... Read more
WESTPORT, Conn., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Portage Biotech, Inc. (“Portage” or the “Company”) (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of novel multi-targeted therapies for use as monotherapy and in combination, is pleased to announce that it has entered into a Letter of Intent (“LOI”) with Immunova, LLC, (“Immunova”) a private Connecticut-based biotechnology company. Under... Read more
Dr. Gibson joining Lexaria's new scientific advisor board KELOWNA, BC / ACCESSWIRE / December 17, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces the appointment of Dr. Michael Gibson as its new Chief Medical Advisor. Dr. Gibson will collaborate directly with President John Docherty as Lexaria's patented... Read more
Carlsbad, CA, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases, today announced the appointment of Brian G. Feagan, MD, FRCPC, to its Clinical Advisory Board. Dr. Feagan is a distinguished... Read more
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