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Intercept Pharma Shares Rise on FDA Acceptance of NDA for Liver Fibrosis Treatment

Shares of Intercept Pharmaceuticals rose today after the company reported that the U.S. Food and Drug Administration accepted its NDA for obeticholic acid (OCA) for the treatment of liver fibrosis due to NASH and granted priority review status. This morning biopharmac...
Streetwise Reports | November 27, 2019 |

Intra-Cellular Therapies Shares Rise 200% on FDA Approval of Adult Schizophrenia Drug

Shares of Intra-Cellular Therapies opened greater than 100% higher today after the company reported that the FDA approved its antipsychotic CAPLYTA® (lumateperone) drug for the treatment of schizophrenia in adults. This morning a biopharmaceutical company foc...
Streetwise Reports | December 27, 2019 |

NewLink Genetics Shares Shoot Higher after FDA Ebola Vaccine Approval

Shares of NewLink Genetics got a boost today after the firm reported that the FDA approved its ERVEBO V920 vaccine used in the treatment of Zaire Ebola virus. The company's shares set a new 52-week high price in mid-morning trading. This morning after the U.S. markets...
Streetwise Reports | December 23, 2019 |

Sarepta Shares Get a 35% Boost from FDA Approval of 2nd DMD Drug

Sarepta Therapeutics shares traded 35% higher after the firm reported that the FDA approved its second RNA exon-skipping treatment drug VYONDYS 53 injection for the treatment of Duchenne's Muscular Dystrophy in patients amenable to skipping Exon 53. Yesterday evening,...
Streetwise Reports | December 16, 2019 |

RedHill Biopharma Shares Rise 10% After Receiving FDA Approval for H. Pylori Treatment Drug Talicia

Shares of RedHill Biopharma Ltd. traded more than 10% higher today after the firm announced that the FDA has approved its Talicia delayed-release capsules for the treatment of H. pylori infection in adults. The firm plans to commence distribution by its U.S. sales force in Q1/...
Streetwise Reports | November 5, 2019 |

FDA Accepts NDA for Global Blood Therapeutics' Sickle Cell Drug; Shares Up 14%

Shares of Global Blood Therapeutics are trading more than 14% higher after the FDA accepted its New Drug Application filing for Voxelotor, a drug used in the treatment of sickle cell disease. Earlier today clinical-stage biopharmaceutical firm Global Blood Therapeuti...
Streetwise Reports | September 6, 2019 |

Kiniksa Pharma Awarded FDA Breakthrough Therapy Status for Pericarditis Treatment Drug

Shares of Kiniksa Pharmaceuticals opened nearly 30% higher today after the firm reported that the FDA granted Breakthrough Therapy designation for Rilonacept for the treatment of recurrent pericarditis. This morning, Hamilton, Bermuda based biopharmaceutical company ...
Streetwise Reports | November 21, 2019 |

Savara Shares Double After FDA Grants Breakthrough Therapy Status for aPAP Treatment

Shares of Savara opened nearly 140% higher today after the orphan lung disease company advised that the FDA has granted Breakthrough Therapy designation for the firm's Molgradex for treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP). This morning orphan lun...
Streetwise Reports | January 2, 2020 |

Neovasc Shares Climb 80% Upon FDA Premarket Approval Filing for Refractory Angina Device

Shares of specialty cardiovascular medical device company Neovasc Inc. opened more than 100% higher after the firm reported that it submitted a Premarket Approval application to the FDA for its Neovasc Reducer device for use in the treatment of refractory angina. This...
Streetwise Reports | January 3, 2020 |

Genprex Shares Soar 250% on FDA Fast Track Designation for Lung Cancer Drug

Genprex's shares spiked 380% higher in morning trading as the company reported that the FDA granted Fast Track Designation for its Oncoprex immunogene therapy in combination with EGFR inhibitor osimertinib. This morning, Genprex Inc. (GNPX:NASDAQ) , which "utilizes a...
Streetwise Reports | January 22, 2020 |
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