Shares of San Diego-based Adamis Pharmaceuticals Corp. (NASDAQ:ADMP) fell 51% to close Monday at 62 cents after the FDA issued a complete response letter regarding its high-dose naloxone injection candidate, Zimhi, for the treatment of opioid overdose. The agency raised questions about chemistry, manufacturing and controls (CMC), but not the candidate's safety or efficacy, the company said.
Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery. The pivotal top-line data will allow the Waltham, Mass.-based company to submit a de novo application to the FDA for commercialization in the first half of 2020, said CEO Stephen From. If approved, the OBG eye drop would be the first product indicated to repair corneal epithelial defects, as well as the first prescription hyaluronic acid (HA) eye drop in the U.S., creating new competition for widely used bandage contact lenses (BCL).
Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery.
Diffusion Pharmaceuticals Inc., a company developing trans sodium crocetinate (TSC) for the treatment of cancer, has reported increased survival for inoperable glioblastoma patients enrolled in the lead-in portion of its open-label phase III study testing TSC plus standard-of-care (SOC) temozolomide and radiation therapy against SOC alone.
Less than four months after accepting Alnylam Pharmaceuticals Inc.'s NDA for Givlaari (givosiran), the FDA has approved the new RNAi therapy for the treatment of adults with the rare genetic disorder acute hepatic porphyria (AHP). The condition is defined by a buildup of toxic porphyrin molecules formed during the production of heme. That buildup can cause incidents of severe pain and paralysis, respiratory failure, seizures and mental status changes, according to the agency.
Myovant Sciences Ltd. reported that its lead candidate, relugolix, met its primary efficacy endpoint and all six secondary endpoints in a phase III study of men with advanced prostate cancer, adding new strength to the asset's story, analysts said.
Adults with complicated urinary tract infections (cUTIs) and limited or no alternative treatment options could soon receive Shionogi & Co. Ltd.'s cefiderocol following FDA approval for the antibacterial. The approved indication also included kidney infections caused by susceptible gram-negative microorganisms. The new therapy, to be marketed as Fetroja, is expected to be available in early 2020.
In a bid to expand its presence in CNS to a wider range of neurodegenerative diseases following a substantial restructuring last month, Alkermes plc has moved to acquire privately held neuronal epigenetics specialist Rodin Therapeutics Inc. for $100 million up front and up to $850 million in clinical, regulatory and commercial milestones.
Adults with complicated urinary tract infections (cUTIs) and limited or no alternative treatment options could soon receive Shionogi & Co. Ltd.'s cefiderocol following FDA approval for the antibacterial. The approved indication also included kidney infections caused by susceptible gram-negative microorganisms. The new therapy, to be marketed as Fetroja, is expected to be available in early 2020.
A second phase II failure to differentiate from placebo in a test of benefits for people with depression has put AV-101, an NMDA receptor antagonist developed by Vistagen Therapeutics Inc., in uncertain territory.
