During Wednesday’s current trade, Perrigo Company Public Limited Company (NYSE:PRGO)’s shares gained 24.80%, and is now trading at $205.55, hitting new 52-week high of $215.73, after Perrigo Company, declared that it has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application for hydromorphone HCI extended-release tablets 8 mg, 12 mg and 16 mg. The FDA concluded that Perrigo’s products are therapeutically equivalent to Mallinckrodt Inc.’s Exalgo® 8 mg, 12 mg and 16 mg and can be substituted with the full expectation that it will produce the same clinical effect and safety profile when used under the conditions specified in the labeling. Shipments to our pharmacy customers will commence within the next few weeks
Exalgo® (hydromorphone HCI extended-release tablets) is indicated for the treatment of chronic pain in opioid-tolerant patients requiring continuous around-the-clock opioid analgesia for an extended amount of time. Combined brand and generic sales were about $133 million in 2014.
Perrigo Corporation plc, through its auxiliaries, develops, manufactures, and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products, and active pharmaceutical ingredients (API). Its Consumer Healthcare segment offers OTC pharmaceutical products in the areas of analgesics, cough/cold/allergy/sinus, gastrointestinal, smoking cessation, and animal health products, in addition to in the areas of feminine hygiene, diabetes care, and dermatological care; and contract manufacturing services.
CymaBay Therapeutics Inc. (NASDAQ:CBAY)’s shares dipped 7.18% during the current trading session Wednesday, and is now trading at $6.14, after a clinical-stage biopharmaceutical corporation, declared that Harold Van Wart, Ph.D., President and Chief Executive Officer, will present a corporate update at the 14th Annual Needham Healthcare Conference on Tuesday, April 14, at 12:10 p.m. ET at the Westin Grand Central Hotel in New York City.
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical corporation developing therapies to treat metabolic diseases with high unmet medical need, counting serious rare and orphan disorders. Arhalofenate, the corporation’s lead product candidate, has shown two therapeutic actions in a single drug in multiple Phase 2 gout studies. In gout patients, arhalofenate is intended to prevent painful flares in joints while at the same time promoting excretion of uric acid by the kidney, thereby addressing both the signs and symptoms of gout and the hyperuricemia that is the root cause of the disease.
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