Stock price effects of breakthrough therapy designation

4 March 2019 - Since 2012, the FDA has awarded ‘breakthrough therapy designation’ to drug candidates in clinical development that ...

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U.S. FDA grants breakthrough therapy designation to Amicus’ AT-GAA in late onset Pompe disease

25 February 2019 - First breakthrough therapy for an investigational treatment in Pompe disease. ...

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When biotechs get breakthrough therapy status, Mr. Market yawns

23 February 2019 - As a biotech consultant, I’ve heard many CEO’s tell me that a “drumbeat of news” is ...

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Modis Therapeutics announces that MT1621 receives breakthrough therapy designation from FDA for the treatment of TK2 deficiency

19 February 2019 - Designation based on compelling data from initial clinical studies and high unmet need in thymidine kinase 2 ...

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CymaBay Therapeutics announces seladelpar granted breakthrough therapy designation by the FDA for the treatment of primary biliary cholangitis

15 February 2019 - CymaBay Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for seladelpar for ...

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Lynparza (olaparib) granted breakthrough therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer

28 January 2016 - AstraZeneca today announced that the US FDA has granted breakthrough therapy designation for the oral poly ...

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Finch Therapeutics’ investigational drug CP101 granted breakthrough therapy designation from FDA for recurrent C. difficile infection

8 February 2019 - Designation to accelerate Finch’s efforts to provide an effective therapy for patients fighting recurrent C. difficile infection. ...

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US FDA grants breakthrough therapy designation for potential next-generation RSV medicine MEDI8897

5 February 2019 - Designation based on positive primary analysis of the Phase IIb trial that demonstrated the safety and ...

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Merck receives breakthrough therapy designation from FDA for V114, the company’s investigational 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease, in infants, children, and adolescents

30 January 2019 - Merck today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation ...

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TG Therapeutics receives breakthrough therapy designation from the U.S. FDA for umbralisib for the treatment of marginal zone lymphoma

22 January 2019 - Breakthrough therapy designation granted based on interim data from the marginal zone lymphoma cohort of the UNITY-NHL ...

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Menlo Therapeutics’ serlopitant granted breakthrough therapy designation by FDA for the treatment of pruritus associated with prurigo nodularis

15 January 2019 - Menlo Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for serlopitant for the ...

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BeiGene receives U.S. FDA breakthrough therapy designation for zanubrutinib in mantle cell lymphoma

14 January 2019 - BeiGene today announced that the U.S. FDA has granted breakthrough therapy designation for its investigational Bruton’s tyrosine ...

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Novartis investigational therapy crizanlizumab (SEG101) receives FDA breakthrough therapy designation for the prevention of vaso-occlusive crises in sickle cell disease

8 January 2019 - FDA filing of crizanlizumab anticipated in first half of 2019. ...

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Aadi Bioscience receives breakthrough therapy designation for Tarzifyx (ABI-009) in PEComa indication

3 January 2019 - Aadi Bioscience today announced that its drug Tarzifyx (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) has received ...

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Chugai's satralizumab receives FDA breakthrough therapy designation for neuromyelitis optica and neuromyelitis optica spectrum disorders

19 December 2018 - Designation is seventh for Chugai originated drug. ...

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