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Sesen Bio Stock Crashes As FDA Shoots Down Its Bladder Cancer Pitch
Monday, August 16, 2021 - 5:44am | 371Read More...The FDA issued a Complete Response Letter (CRL) to Sesen Bio Inc's (NASDAQ: SESN) bladder cancer candidate Vicineum. The Company acquired the antibody-drug conjugate in the buyout of Viventia back in 2016. Sesen described the reason for the CRL as a combination of...
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Fusion Pharma Stock Is Trading Higher As FDA Clears Early-Stage Study For Radiopharmaceutical In Neck, Bladder Cancers
Thursday, July 29, 2021 - 7:09am | 188Read More...The FDA has signed off Fusion Pharmaceuticals Inc's (NASDAQ: FUSN) Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human...
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G1 Therapeutics Starts Mid-Stage Bladder Cancer Trial With Cosela
Monday, June 14, 2021 - 9:33am | 151Read More...G1 Therapeutics Inc (NASDAQ: GTHX) has initiated the PRESERVE 3 Phase 2 study evaluating Cosela (trilaciclib) in patients with untreated, locally advanced, or metastatic urothelial carcinoma (mUC). Cosela will be administered with first-line platinum-based chemotherapy and the...
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Oncologic Drugs Adcomm Backs Merck's Keytruda, Roche's Tecentriq Accelerated Approvals In Bladder Cancer
Thursday, April 29, 2021 - 11:47am | 309Read More...The FDA’s Oncologic Drugs Advisory Committee voted 5-3 in favor of keeping Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) accelerated approval alive as a first-line bladder cancer treatment, even after a Merck confirmatory trial failed. While the confirmatory...
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Roche Walks Away From Regular FDA Nod For Tecentriq In Pretreated Bladder Cancer
Monday, March 8, 2021 - 8:01am | 304Read More...Roche Holding AG (OTCMKT: RHHBF) has joined AstraZeneca Plc (NASDAQ: AZN) in withdrawing cancer immunotherapies from the U.S. for bladder cancer that has already been treated with platinum-based chemotherapy, as confirmatory trials not meet their primary endpoints. The company...
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Sesen Bio's Vicineum US Application For Bladder Cancer Accepted For Review; Shares Spike
Tuesday, February 16, 2021 - 10:13am | 173Read More...Under priority review status, the FDA has accepted Sesen Bio Inc's (NASDAQ: SESN) marketing application for review seeking approval for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer. Additionally, the FDA stated that it is not...
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For Eleven Biotherapeutics, Cancer Trial Outcomes Could Be 'Major Catalyst'
Tuesday, March 20, 2018 - 12:52pm | 297Read More...Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a Cambridge, Massachusetts-based developer of targeted protein therapeutics, has been showing promising clinical data for TPT-based cancer treatments. The stock could see significant upside if later-stage bladder cancer trials set for mid-2018 prove to...
