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FDA Signs Off Check-Cap's Pivotal Study For Capsule-Based Colorectal Cancer Screening Technology
Monday, March 15, 2021 - 7:34am | 222Read More...Check-Cap Ltd (NASDAQ: CHEK) stock is moving higher on heavy volume in the premarket session after the FDA approved its Investigational Device Exemption (IDE) application, permitting Check-Cap to begin a pivotal study of C-Scan in the U.S. C-Scan is the company's capsule-...
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Seres Stops Enrollment In Melanoma Study, Deprioritizes Further Development
Monday, March 8, 2021 - 9:35am | 207Read More...Seres Therapeutics Inc (NASDAQ: MCRB) and its study partners have voluntarily discontinued further enrollment in the Phase 1 study evaluating SER-401 in metastatic melanoma. The company cited challenges related to the pandemic. The study was assessing the safety and...
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Flexion To Test Higher Dose Of FX201 Gene Therapy In Early-Stage Osteoarthritis Study
Thursday, February 18, 2021 - 3:15pm | 281Read More...Flexion Therapeutics Inc (NASDAQ: FLXN) plans to advance FX201 into the high dose cohort of Phase 1 dose-escalation trial, evaluating the safety and tolerability of FX201 for the treatment of osteoarthritis (OA). The decision follows an independent Data Monitoring Committee (...
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Yumanity Therapeutics Sees Lead Candidate Interim Data From Early-Stage Parkinson's Study By Mid-2021
Wednesday, February 10, 2021 - 1:02pm | 274Read More...Yumanity Therapeutics Inc (NASDAQ: YMTX) reported results from the Phase 1 single ascending dose study in 40-healthy volunteers, evaluating its lead candidate, YTX-7739, an SCD inhibitor, for the treatment of Parkinson's disease. No safety concerns were identified, and YTX-7739...
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Opiant Pharma Advances OPNT003 PK Study With First Patient Dosing
Tuesday, February 9, 2021 - 12:30pm | 221Read More...Opiant Pharmaceuticals Inc (NASDAQ: OPNT) doses the first patient in a confirmatory pharmacokinetic (PK) study evaluating OPNT003 (nasal nalmefene) for opioid overdose treatment. Results from the study are anticipated in June 2021. The open-label, randomized, crossover study...
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Orchard Therapeutics' MPS-I Gene Therapy Shows Encouraging Action In Early Study, Shares Spike
Tuesday, February 9, 2021 - 9:19am | 317Read More...Orchard Therapeutics Plc (NASDAQ: ORTX) gains in premarket in reaction to positive interim data from a proof-of-concept study evaluating its gene therapy OTL-203 in Mucopolysaccharidosis type I (MPS-I). All eight patients treated with OTL-203 showed stable cognitive function,...
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Getting Into The Drug Business: From NDAs To PDUFA Dates
Tuesday, September 27, 2016 - 2:20pm | 665Read More...The strongest catalysts for a pharma stock are the various milestones on the road to FDA approval for new drugs. For new investors, they’ll often see a stock rise astronomically, but, when they go to make sense of the reasons for the jump, they’re greeted with unfamiliar acronyms. Let...
