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Why Are Karyopharm Therapeutics Shares Gaining Today?
Tuesday, July 18, 2023 - 9:12am | 272Karyopharm Therapeutics Inc (NASDAQ: KPTI) shares are trading higher after the FDA granted Fast Track Designation to the development program of selinexor for myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis....
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EXCLUSIVE: FDA Grants Expedited Review Status To SAB Biotherapeutics' Influenza Antibody
Thursday, April 13, 2023 - 8:00am | 402The FDA has granted Fast Track designation for SAB Biotherapeutics' (NASDAQ: SABS) SAB-176, an investigational therapeutic for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains. What Happened: SAB-176 is produced...
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Veru's Cancer Candidate Sabizabulin Gets FDA Fast Track Tag For COVID-19
Monday, January 31, 2022 - 12:41pm | 325The FDA has granted Fast Track designation to Veru Inc's (NASDAQ: VERU) sabizabulin, oral cytoskeleton disruptor, to combat COVID-19 infection and the cytokine storm responsible for Acute Respiratory Distress Syndrome (ARDS) and death. Sabizabulin disrupts microtubule...
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Calliditas' Chronic Orphan Liver Disease Candidate Receives FDA Fast Track Tag
Monday, August 9, 2021 - 10:57am | 189The FDA has granted Fast Track Designation to Calliditas Therapeutics AB's (NASDAQ: CALT) lead NOX inhibitor candidate setanaxib for primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe. In the Phase 2...
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Moderna RSV-Targeted mRNA Vaccine Candidate Gets Fast Track Tag In US
Tuesday, August 3, 2021 - 9:52am | 260The FDA granted Fast Track designation Moderna Inc's (NASDAQ: MRNA) mRNA-1345, its investigational single-dose mRNA vaccine against the respiratory syncytial virus (RSV) in adults older than 60 years of age. The respiratory syncytial virus is a common respiratory virus that...
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Alkermes Receives FDA Fast Track Status For Mucosal Melanoma Immunotherapy
Monday, August 2, 2021 - 8:53am | 188The FDA has granted Fast Track designation to Alkermes plc's (NASDAQ: ALKS) nemvaleukin alfa (nemvaleukin) for mucosal melanoma. Nemvaleukin is an investigational engineered interleukin-2 (IL-2) variant immunotherapy. Earlier this year, the FDA also granted orphan drug...
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Catalyst Biosciences Stock Moves Higher On Additional FDA Fast Track Tag For MarzAA
Monday, June 28, 2021 - 8:45am | 195The FDA has granted Fast Track Designation to Catalyst Biosciences Inc's (NASDAQ: CBIO) Marzeptacog alfa (activated), MarzAA, the Company's subcutaneously administered next-generation engineered coagulation Factor VIIa (FVIIa) for episodic bleeding in subjects with...
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Applied Therapeutics Stock Moves Higher On FDA Fast Track Review For AT-007 In Rare Metabolic Disorder
Thursday, June 17, 2021 - 7:18am | 168The FDA has granted Fast Track designation to Applied Therapeutics Inc's (NASDAQ: APLT) AT-007 to treat Galactosemia, a rare metabolic disease. AT-007 is the Company's central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic...
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VBI Vaccines' Brain Cancer Immunotherapy Gets FDA Fast Track Review; Announces Updated Tumor Response, Overall Survival Data
Tuesday, June 8, 2021 - 10:38am | 295The FDA has granted Fast Track Designation for VBI Vaccines Inc's (NASDAQ: VBIV) VBI-1901, its cancer vaccine immunotherapeutic candidate to treat recurrent glioblastoma (GBM) patients with first tumor recurrence. The company also announced the most recent tumor response...
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Fulcrum Therapeutics, Evofem Biosciences Drug Candidates Receive FDA Fast Track Designation
Wednesday, May 12, 2021 - 4:19pm | 346The FDA has granted Fast Track designation to Fulcrum Therapeutics Inc's (NASDAQ: FULC) losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy (FSHD). Fulcrum is on track to report full data from the ReDUX4 Phase 2b trial at the virtual FSHD...
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Celsion Receives Fast Track Tag In US For Ovarian Cancer Immunotherapy
Monday, February 22, 2021 - 9:57am | 146The FDA has
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Here's Why Conatus Pharmaceuticals' Stock Surged 23%
Wednesday, February 3, 2016 - 1:26pm | 249Shares of Conatus Pharmaceuticals Inc (NASDAQ: CNAT), a nano-cap biotechnology company focused on the development and commercialization of medicines to treat liver disease, surged higher by more than 22 percent on Wednesday. Conatus Pharmaceuticals announced earlier in the day that the U.S....