Remedy Pharmaceuticals, Inc.

NEW YORK, Nov. 19, 2024 /PRNewswire/ -- Remedy Pharmaceuticals, a leader in stroke drug development, announced today that a Type C meeting held with the U.S. Food and Drug Administration (FDA) on October 16, 2024, provided valuable feedback on the design of a Phase 3 trial of its investigational drug, CIRARA, for large hemispheric infarction (LHI), a severe and life-threatening form of ischemic stroke. A Type C meeting is a formal discussion between the FDA and a sponsor to review product development plans. Remedy sought feedback on the proposed Phase 3 study, and the meeting, along with meeting minutes, clarified key aspects of the trial's design. "The FDA's feedback reinforces our confidence in our planned Phase 3 trial design and CIRARA's potential to address the urgent unmet needs of patients with LHI," said Sven Jacobson, CEO of Remedy Pharmaceuticals. "We are committed to advancing CIRARA and to redefining the standard of care for this devastating condition characterized by high mortality and severe long-term disability." About Large Hemispheric Infarctions Large hemispheric infarctions (LHIs) are severe strokes affecting a significant portion of one cerebral hemisphere, typically involving the territory supplied by the middle cerebral artery (MCA). These strokes result in extensive brain damage and often lead to life-threatening complications such as severe cerebral edema, increased intracranial pressure, and brain herniation. About Remedy Pharmaceuticals: New York-based Remedy Pharmaceuticals, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing and bringing lifesaving treatments to people affected by acute central nervous system (CNS) diseases and injuries. Contact: Sven Jacobson CEO Remedy Pharmaceuticals 212.586.2226 [email protected] SOURCE Remedy Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Oct. 22, 2024 /PRNewswire/ -- Remedy Pharmaceuticals, a pioneer in stroke drug development, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Division (OOPD) has granted Orphan Drug Designation for CIRARA for the treatment of "large territory acute ischemic stroke," which includes large hemispheric infarctions (LHI). LHI is a particularly severe form of ischemic stroke caused by a blockage in the one of two large blood vessels in the brain: internal carotid artery or middle cerebral artery (MCA), which cuts off the blood supply to large areas of the brain, resulting in severe swelling, significant mortality, and high disability rates. "The Orphan Drug Designation for CIRARA underscores the uniqueness of large territory ischemic strokes in terms of mechanism and universally poor outcomes in contrast to smaller strokes," said Sven Jacobson, CEO of Remedy Pharmaceuticals. "This designation will accelerate our efforts to bring CIRARA to acute ischemic stroke patients at the highest risk of severe disability and death." The FDA's Orphan Drug Designation program provides orphan status to drugs or biologics intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Sponsors of medicines with Orphan Drug Designation may be eligible for various incentives, including tax credits for qualified clinical trials, prescription drug user fee exemptions, and seven years of marketing exclusivity upon FDA approval. About Large Hemispheric Infarction A large hemispheric infarction is a particularly severe type of ischemic stroke that affects a substantial portion of the brain. This occurs when there is a blockage in a major cerebral artery, such as the middle cerebral artery (MCA) or the internal carotid artery (ICA), both of which are responsible for supplying large regions of the brain with oxygen-rich blood. Treatment for LHI typically involves rapid revascularization strategies to restore blood flow, such as mechanical thrombectomy or intravenous thrombolysis (administering clot-dissolving drugs like tPA). However, the large scale of the infarction and the resultant edema leads to poorer outcomes compared to smaller strokes, with many patients suffering long-term disability or, in some cases, death. About Remedy Pharmaceuticals: New York-based Remedy Pharmaceuticals, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing and bringing lifesaving treatments to people affected by acute central nervous system (CNS) diseases and injuries. Contact: Sven Jacobson CEO Remedy Pharmaceuticals 212.586.2226 [email protected] SOURCE Remedy Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK , Oct. 22, 2024 /PRNewswire/ -- Remedy Pharmaceuticals, a pioneer in stroke drug development, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Division (OOPD) has granted Orphan Drug Designation for CIRARA for the treatment of “large territory acute ischemic stroke,” which includes large hemispheric infarctions (LHI). LHI is a particularly severe form of ischemic stroke caused by a blockage in the one of two large blood vessels in the brain: internal carotid artery or middle cerebral artery (MCA), which cuts off the blood supply to large areas of the brain, resulting in severe swelling, significant mortality, and high disability rates. “The Orphan Drug Designation for CIRARA underscores the uniqueness of large territory ischemic strokes in terms of mechanism and universally poor outcomes in contrast to smaller strokes,” said Sven Jacobson , CEO of Remedy Pharmaceuticals. “This designation will accelerate our efforts to bring CIRARA to acute ischemic stroke patients at the highest risk of severe disability and death.” The FDA’s Orphan Drug Designation program provides orphan status to drugs or biologics intended to treat diseases or conditions that affect fewer than 200,000 people in the United States . Sponsors of medicines with Orphan Drug Designation may be eligible for various incentives, including tax credits for qualified clinical trials, prescription drug user fee exemptions, and seven years of marketing exclusivity upon FDA approval. About Large Hemispheric Infarction A large hemispheric infarction is a particularly severe type of ischemic stroke that affects a substantial portion of the brain. This occurs when there is a blockage in a major cerebral artery, such as the middle cerebral artery (MCA) or the internal carotid artery (ICA), both of which are responsible for supplying large regions of the brain with oxygen-rich blood. Treatment for LHI typically involves rapid revascularization strategies to restore blood flow, such as mechanical thrombectomy or intravenous thrombolysis (administering clot-dissolving drugs like tPA). However, the large scale of the infarction and the resultant edema leads to poorer outcomes compared to smaller strokes, with many patients suffering long-term disability or, in some cases, death. About Remedy Pharmaceuticals: New York -based Remedy Pharmaceuticals, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing and bringing lifesaving treatments to people affected by acute central nervous system (CNS) diseases and injuries. Contact: Sven Jacobson CEO Remedy Pharmaceuticals 212.586.2226 sven@remedypharmaceuticals.com View original content to download multimedia: SOURCE Remedy Pharmaceuticals