Dicerna receives breakthrough therapy designation for DCR-PHXC for treatment of primary hyperoxaluria type 1

15 July 2019 - FDA recognises primary hyperoxaluria Types 2 and 3 as meeting criteria for a serious or life-threatening disease ...

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Eiger announces breakthrough therapy designation granted by FDA for avexitide for treatment of post-bariatric hypoglycemia

17 June 2019 - Third Eiger pipeline program granted breakthrough therapy designation. ...

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Novartis shows growing strength in lung cancer innovation with new capmatinib investigational data

3 June 2019 - The U.S. FDA recently granted capmatinib breakthrough therapy designation for the treatment of patients with metastatic NSCLC ...

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Bayer receives U.S. FDA breakthrough therapy designation for copanlisib for the treatment of marginal zone lymphoma

29 May 2019 - Breakthrough therapy designation for copanlisib primarily based on follow-up data from the pivotal Phase II study ...

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Iovance Biotherapeutics announces breakthrough therapy designation for LN-145 for treatment of advanced cervical cancer patients who have progressed on or after chemotherapy

22 May 2019 - Iovance Biotherapeutics today announced that the U.S. FDA has granted breakthrough therapy designation to Iovance TIL therapy ...

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Celgene Corporation announces Pomalyst granted breakthrough therapy designation from FDA for HIV positive and negative Kaposi sarcoma

13 May 2019 - Celgene plans to submit sNDA by end of 2019. ...

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Sunovion and PsychoGenics announce that SEP-363856 has received FDA breakthrough therapy designation for the treatment of people with schizophrenia

10 May 2019 - SEP-363856 offers an innovative approach to the treatment of schizophrenia including the potential to be the first ...

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La Jolla Pharmaceutical announces U.S. FDA’s grant of breakthrough therapy designation for LJPC-0118 for the treatment of severe malaria

24 April 2019 - Designation offers potential for expedited development and review, and highlights the urgent need for additional treatment options ...

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Viela Bio receives U.S. FDA breakthrough therapy designation for inebilizumab for treatment of neuromyelitis optica spectrum disorder

18 April 2019 - Designation based on positive primary analysis of pivotal study, N-MOmentum. ...

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Genfit announces FDA grant of breakthrough therapy designation to elafibranor for the treatment of PBC

18 April 2019 - FDA grants elafibranor breakthrough therapy designation, based on Phase 2 data, for treatment of primary biliary cholangitis ...

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Selumetinib granted US breakthrough therapy designation in neurofibromatosis type 1

1 April 2019 - Selumetinib is a MEK 1/2 inhibitor being co-developed by AstraZeneca and MSD. ...

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Axsome Therapeutics receives FDA breakthrough therapy designation for AXS-05 for the treatment of major depressive disorder

27 March 2019 - Designation offers potential for expedited development and review. ...

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Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukaemia with an IDH1 mutation in adult patients ineligible for intensive chemotherapy

26 March 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) in ...

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Promedior received breakthrough therapy designation from FDA for PRM-151 in idiopathic pulmonary fibrosis

26 March 2019 - Promedior today announced that PRM-151, a novel investigational anti-fibrotic immunomodulator, has been granted breakthrough therapy designation ...

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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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