Sun Pharmaceutical Industries and Israel-based Moebius Medical announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain. Planning for confirmatory Phase 3 clinical trials for MMII is underway. The FDA's Fast Track program is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs in order to potentially bring important new medicines to patients earlier. Among other benefits, companies whose investigational products are granted FTD are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review. 'As we enter Phase 3 development, we are very encouraged by the FDA's decision to grant Fast Track designation to MM-II and recognize its potential to fill an unmet medical need for patients suffering from Osteoarthritis,' said Marek Honczarenko, MD, PHD, Senior Vice President, Head Global Development at Sun Pharma.Powered by Capital Market - Live

MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended to reduce friction and wear on the joint and thus relieve joint pain. The company and Moebius Medical jointly developing this product, have announced plans to initiate a Phase 3 clinical program and to seek a CE Mark for the product in the European Union. The FDA's Fast Track program is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs in order to potentially bring important new medicines to patients earlier. Among other benefits, companies whose investigational products are granted FTD are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review. Marek Honczarenko, MD, PHD, senior vice president, Head Global Development, Sun Pharma, said, 'As we enter Phase 3 development, we are very encouraged by the FDA's decision to grant Fast Track designation to MM-II and recognize its potential to fill an unmet medical need for patients suffering from Osteoarthritis.' Moshe Weinstein, CEO of Moebius Medical, added, 'This Fast Track Designation, which will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II, and follows our recently released Phase 2b data, which showed MMII's potential to provide effective and durable treatment for patients with knee pain of Osteoarthritis.' Moebius Medical is a clinical stage biotechnology company that is developing novel pain relief treatments for osteoarthritis Sun Pharmaceuticals Industries is a leading global pharmaceutical company with specialty and generic presence and India's top pharma company. The company's consolidated net profit jumped 40.20% to Rs 2,835.6 crore on 5.96% rise in revenue from operations to Rs 12,652.75 crore in Q1 FY25 over Q1 FY24. The script rose 0.29% to Rs 1,825.75 on the BSE.Powered by Capital Market - Live

Sun Pharmaceutical Industries has launched Tedizolid Phosphate tablets 200 mg in India under the brand name 'STARIZO'. STARIZO (Tedizolid Phosphate) is a novel, oxazolidinone-class antibacterial, used to treat Acute Bacterial Skin and Skin Structure Infection (ABSSSI). Sun Pharma has obtained rights from Merck Sharp & Dohme Singapore Trading to develop, manufacture and commercialise Tedizolid Phosphate in India. Powered by Capital Market - Live

Sun Pharmaceuticals Industries Ltd gained for a fifth straight session today. The stock is quoting at Rs 1753.25, up 0.31% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.53% on the day, quoting at 24703.35. The Sensex is at 80851.87, up 0.53%. Sun Pharmaceuticals Industries Ltd has gained around 10.45% in last one month. Meanwhile, Nifty Pharma index of which Sun Pharmaceuticals Industries Ltd is a constituent, has gained around 7.94% in last one month and is currently quoting at 22237.85, up 0.19% on the day. The volume in the stock stood at 7.58 lakh shares today, compared to the daily average of 25.56 lakh shares in last one month. The benchmark August futures contract for the stock is quoting at Rs 1752.95, up 0.3% on the day. Sun Pharmaceuticals Industries Ltd is up 54.15% in last one year as compared to a 27.38% jump in NIFTY and a 45.31% jump in the Nifty Pharma index.The PE of the stock is 150.65 based on TTM earnings ending June 24.Powered by Capital Market - Live

Sun Pharmaceutical Industries has entered into an agreement with Pharmazz Inc. Delaware US, pursuant to which Sun Pharma has agreed to invest upto $15 Mn investment resulting in more than 5% holding in Pharmazz Inc. Pharmazz Inc (Pharmazz) is a Delaware, US corporation based in Willowbrook Illinois, US and is a biopharmaceutical company developing its two leading drug candidates, Sovateltide for treatment of acute cerebral ischemic stroke and Centhaquine for treatment of hypovolemic shock. Both products are approved in India and marketed through partners under brands, Tyvalzi (Sovateltide) and Lyfaquin (Centhaquine) and are being developed for USA and other markets. Sun Pharma shall also receive the exclusive right to license Sovateltide for marketing & distribution in certain emerging market countries. Powered by Capital Market - Live