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Associated Press
2 days ago
- Business
- Associated Press
NRx Pharmaceuticals (NASDAQ: NRXP) Reports Q2 2025 Results, Highlights Progress Across Lead Programs
LOS ANGELES, CA - August 19, 2025 ( NEWMEDIAWIRE ) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended June 30, 2025, and provided a corporate update. The Company highlighted progress in all three lead programs, including expanded FDA Fast Track designation for NRX-100 in treating suicidal depression, filing of multiple regulatory documents, and advancement of the NRX-101 NDA. A strategic investor group led by B Group Capital has committed capital through a purchase of restricted common stock with a one-year lockup and no dilutive mechanisms. The capital is expected to support the Company through key regulatory milestones and help scale HOPE Therapeutics and its clinic network. To view the full press release, visit About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression; the company recently filed module 3 manufacturing data to support the New Drug Application for NRX-101. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal depression. The filing is based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and the Government of France, licensed under a data sharing agreement. Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: Forward Looking Statements Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading 'Risk Factors' discussed under the caption 'Item 1A. Risk Factors' in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption 'Item 1A. Risk Factors' in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law.
Globe and Mail
2 days ago
- Business
- Globe and Mail
NRx Pharmaceuticals (NASDAQ: NRXP) Reports Q2 2025 Results, Highlights Progress Across Lead Programs
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended June 30, 2025, and provided a corporate update. The Company highlighted progress in all three lead programs, including expanded FDA Fast Track designation for NRX-100 in treating suicidal depression, filing of multiple regulatory documents, and advancement of the NRX-101 NDA. A strategic investor group led by B Group Capital has committed capital through a purchase of restricted common stock with a one-year lockup and no dilutive mechanisms. The capital is expected to support the Company through key regulatory milestones and help scale HOPE Therapeutics and its clinic network. To view the full press release, visit About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression; the company recently filed module 3 manufacturing data to support the New Drug Application for NRX-101. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal depression. The filing is based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and the Government of France, licensed under a data sharing agreement. NOTE TO INVESTORS: IBN is a multifaceted financial news, content creation and publishing company utilized by both public and private companies to optimize investor awareness and recognition. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: Corporate Communications
Associated Press
06-02-2025
- Health
- Associated Press
Bracco Imaging Receives FDA Fast Track Designation for BR55, Ultrasound Molecular Imaging Agent for the Detection of Active Bowel Inflammation in Crohn's Disease
BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the detection of active bowel inflammation in patients with Crohn's disease. BR55 is a contrast agent for ultrasound imaging targeted at a molecule expressed in angiogenesis, i.e., the vascular endothelial growth factor receptor type 2, or VEGFR2. Phase 2 studies have provided satisfactory safety results and a high accuracy of BR55-enhanced ultrasound imaging at marking the expression of VEGFR2 in patients with breast, ovarian, and thyroid cancer, as well as in patients with Crohn's disease. The safety and efficacy of BR55 when used for the detection of areas of active bowel inflammation in patients with Crohn's disease is going to be evaluated in large-scale, multicenter, multinational adequate and well-controlled Phase 3 studies. MILAN, Feb. 6, 2025 /PRNewswire/ -- Bracco Imaging, a global leader in diagnostic imaging, announced today that the U.S. FDA has granted Fast Track designation for the development of BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection for detecting areas of active bowel inflammation in patients with Crohn's disease. BR55 is a novel molecular imaging ultrasound contrast agent designed to specifically target the vascular endothelial growth factor receptor 2 (VEGFR2), a molecule highly expressed by endothelial cells in areas of angiogenesis, thus enhancing the ultrasound signal in areas with high angiogenesis activity. The FDA designation follows the successful completion of Phase 2 studies, showing more than 95% accuracy of BR55-enhanced ultrasound imaging at detecting the expression of VEGFR2 in breast, ovarian, and thyroid cancer tissues, as well as in bowel segments showing active inflammation in patients with Crohn's disease. Crohn's disease is a chronic, relapsing inflammatory disease of the gastrointestinal tract, in which angiogenesis and chronic inflammation are codependent, i.e., inflammation promotes angiogenesis, and the growth of new vessels enhances tissue inflammation, so that disease activity correlates with the extent of neovascularization.i,ii,iii,iv,v,vi Recent clinical evidence has shown that, even in the absence of clinical symptoms, persistence of active inflammation can result in progressive bowel damage, serious complications and disability. Therefore, proactive monitoring of disease activity is of paramount importance for proper patient Detection of angiogenesis with molecular imaging, using a widely available, portable, noninvasive, radiation-free imaging modality like ultrasound, may emerge as a powerful tool to monitor the effectiveness of treatment used to control inflammation and disease activity in patients with Crohn's disease, especially now that new drugs and biologics are being developed, or have already been introduced in clinical 'The FDA Fast Track process is designed to facilitate development and expedite the review of important new therapeutics and medical imaging It is aimed at improving the management of patients with serious conditions and filling an unmet medical need, such as the accurate monitoring of disease activity in patients with Crohn's disease,' said Alberto Spinazzi, MD, Chief Medical and Regulatory Officer, Bracco Imaging Group. 'This Fast Track designation supports our goal to get BR55 to the patient earlier and more efficiently.' Bracco Imaging is now advancing to prospective, controlled, large-scale Phase 3 studies aimed at evaluating the safety and efficacy of BR55 when used not only to detect angiogenesis but also active inflammation in patients with Crohn's disease. 'Today's milestone is a result of our deep commitment to innovation that advances precision imaging technologies,' said Fulvio Renoldi Bracco, CEO, Bracco Imaging Group. 'As a leader in diagnostic imaging, Bracco will continue to invest in promising approaches, such as the science of microbubble technology, which enhances the contrast in ultrasound and shows great potential for additional targeted applications.' About BR55 BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection is an investigational ultrasound contrast agent designed to bind to VEGFR2, a protein that plays a central role in angiogenesis and inflammatory processes. By targeting VEGFR2, BR55 enables real-time, non-invasive imaging of areas of angiogenesis, offering the potential for earlier and more accurate assessment of active inflammation in conditions like Crohn's disease. This precision imaging approach may significantly enhance clinicians' ability to diagnose and monitor disease activity, guiding better treatment decisions. About Bracco Imaging Bracco Imaging is a global leader in diagnostic imaging, providing advanced imaging agents and state-of-the-art delivery systems across a wide range of modalities, including X-ray, MRI, Nuclear Medicine, and Ultrasound. With a legacy of innovation and a commitment to improving patient outcomes, Bracco continues to pioneer technologies that enhance diagnostic accuracy and transform patient care. Press Contact: Carolina Bargoni Bracco Imaging, Communications Director +39 347 5397738 i Jackson JR, Seed MP, Kircher CH, Willoughby DA, Winkler JD. The codependence of angiogenesis and chronic inflammation. FASEB J 1997; 11:457-465 ii Costa C, Incio J, Soares R. Angiogenesis, and chronic inflammation: cause or consequence? Angiogenesis 2007; 10:149-166 iii Halin C, Detmar M. Chapter 1. Inflammation, angiogenesis, and lymphangiogenesis. Methods Enzymol 2008; 445:1-25 iv Pousa ID, Maté J, Gisbert JP. Angiogenesis in inflammatory bowel disease. Eur J Clin Invest 2008; 38:73-81 v Knod JL, Crawford K, Dusing M, Collins MH, Chernoguz A, Frischer JS. Angiogenesis and Vascular Endothelial Growth Factor-A Expression Associated with Inflammation in Pediatric Crohn's Disease. J Gastrointest Surg 2016; 20:624-630 vi Scaldaferri F, Vetrano S, Sans M, Arena V, Straface G, Stigliano E, Repici A, Sturm A, Malesci A, Panes J, Yla-Herttuala S, Fiocchi C, Danese S. VEGF-A links angiogenesis and inflammation in inflammatory bowel disease pathogenesis. Gastroenterology 2009; 136:585‑95.e5 vii Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet 2024; 403:1177-1191. viii Chidlow JH Jr, Shukla D, Grisham MB, Kevil CG. Pathogenic angiogenesis in IBD and experimental colitis: new ideas and therapeutic avenues. Am J Physiol Gastrointest Liver Physiol 2007; 293:G5-G18 ix Matsuno H, Yudoh K, Uzuki M, Nakazawa F, Sawai T, Yamaguchi N, Olsen BR, Kimura T. Treatment with the angiogenesis inhibitor endostatin: a novel therapy in rheumatoid arthritis. J Rheumatol 2002; 29:890-895 x Nijhawan P, Behl T. The Role of Endostatin in Rheumatoid Arthritis. Curr Rheumatol Rev 2021; 17:68-75 xi Danese S, Sans M, de la Motte C, Graziani C, West G, Phillips MH, Pola R, Rutella S, Willis J, Gasbarrini A, Fiocchi C. Angiogenesis as a novel component of inflammatory bowel disease pathogenesis. Gastroenterology 2006; 130:2060-2073
