NS Pharma, Inc.

30 articles about NS Pharma, Inc.

• NS-018, an Investigational Treatment for Myelofibrosis, Receives Orphan Drug Designation from the European Commission

  8/8/2023

  NS Pharma, Inc. announced today that the European Commission (EC) has granted Orphan Drug Designation to NS-018 (ilginatinib) an oral, selective JAK2 inhibitor which is being investigated for the treatment of myelofibrosis (MF).

• FDA Grants Orphan Drug Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy

  8/7/2023

  NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to NS-089/NCNP-02, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44 skipping therapy.

• FDA Grants Breakthrough Therapy Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy

  7/27/2023

  NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to NS-089/NCNP-02, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44 skipping therapy.

• FDA Grants Rare Pediatric Disease Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy

  7/7/2023

  NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has granted Rare Pediatric Disease Designation to NS-089/NCNP-02 (brogidirsen) an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44 skipping therapy.

• NS Pharma Announces FDA Clearance to Initiate a Phase I/II Study for NS-050/NCNP-03, an Exon 50 Skipping Candidate for the Treatment of Duchenne Muscular Dystrophy

  6/15/2023

  NS Pharma, Inc. announced the U.S. Food & Drug Administration has agreed to the planned Phase I/II study of NS-050/NCNP-03, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 50 skipping therapy.

• VILTEPSO® (viltolarsen) injection Four-Year Clinical Trial Data Published in the Journal of Neuromuscular Diseases

  5/9/2023

  NS Pharma is pleased to announce that previously reported long-term efficacy and safety data (final visit up to Week 216) from the open-label extension of a Phase 2 study of VILTEPSO® (viltolarsen) have been published in the May issue of the Journal of Neuromuscular Diseases.

• NS Pharma Announces FDA Clearance to Initiate Phase II Study for NS-089/NCNP-02, an Exon 44 Skipping Candidate for the Treatment of Duchenne Muscular Dystrophy

  4/14/2023

  NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has agreed to the planned Phase II study of NS-089/NCNP-02 for Duchenne muscular dystrophy. 

• VILTEPSO® (viltolarsen) injection Open Label Extension Clinical Trial Data Scheduled for Presentation at the MDA Clinical & Scientific Conference 2023

  3/19/2023

  NS Pharma is pleased to announce participation in the Muscular Dystrophy Association's Clinical & Scientific Congress 2023 being held in Dallas, Texas. The company will be presenting previously reported long-term efficacy and safety data from the open-label extension of a Phase 2 study of VILTEPSO®.

• NS Pharma Announces First Patient Enrolled in Phase 2 Study to Assess Efficacy and Safety of NS-018 Compared to Best Available Therapy (BAT) in Patients With Myelofibrosis

  2/17/2023

  NS Pharma, Inc. announced the first patient enrollment in a Phase 2 clinical study of NS-018, an investigational treatment for myelofibrosis, a rare and incurable blood cancer.

• NS Pharma opens new U.S drug discovery center in Cambridge, MA

  1/6/2023

  NS Pharma announced the opening of a new office in Cambridge, Massachusetts, to establish the NS Pharma Innovation Research Partnering division.

• NS Pharma Announces Receipt of Orphan Drug Designation from the U.S. FDA for NS-018, an Investigational Treatment for Myelofibrosis

  12/20/2022

  NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai), today announced that the U.S. FDA has granted Orphan Drug Designation to NS-018 (ilginatinib), an investigational treatment for myelofibrosis (MF), a rare and incurable blood cancer.

• NS Pharma Reports on Results of VILTEPSO® (viltolarsen) injection After Four Years of Treatment in Open-Label Extension Trial in Duchenne Muscular Dystrophy

  10/24/2022

  NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka) announced today that long-term efficacy and safety data (final analysis up to Week 216) from the open-label extension of a Phase 2 study of VILTEPSO® (viltolarsen) injection were presented at the 27th International Hybrid Annual Congress of the World Muscle Society (WMS 2022) in Halifax, Nova Scotia, Canada.

• VILTEPSO® (viltolarsen) injection Four-Year Clinical Trial Data to be Presented at the World Muscle Society 2022 Conference

  10/4/2022

  NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka ), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai ), announced today that four-year efficacy and safety data from the open-label extension of a Phase 2 study of VILTEPSO ® (viltolarsen).

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  Dyne's Exon-51 Skipping DMD Therapy Moves Forward on FDA Go Sign

  7/5/2022

  The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.

• VILTEPSO® (viltolarsen) injection: Long-Term Efficacy and Safety Data Published in the Journal of Neuromuscular Diseases

  5/31/2022

  NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai), announced the publication of long-term efficacy and safety data based on analyses at 109 weeks from the 192-week open-label extension trial of a Phase 2 study of VILTEPSO® (viltolarsen) injection in the Journal of Neuromuscular Diseases.

• VILTEPSO® (viltolarsen) injection Interim Long-Term Clinical Trial Data Scheduled for Presentation at the Child Neurology Society Annual Meeting

  9/22/2021

   NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai), announced today an electronic poster presentation on long-term efficacy and safety data (interim analysis at 109 weeks) from the open-label extension (up to 192 weeks) of a Phase 2 study of VILTEPSO® (viltolarsen) injection at the Child Neurology Society 50th Annual Meeting.

• VILTEPSO® (viltolarsen) injection Interim Long-Term Clinical Trial Data Scheduled for Presentation at the World Muscle Society 2021 Virtual Conference

  9/17/2021

  NS Pharma, Inc. announced today an electronic poster presentation on long-term efficacy and safety data (interim analysis at 109 weeks) from the open-label extension (up to 192 weeks) of a Phase 2 study of VILTEPSO® (viltolarsen) injection at the World Muscle Society 2021 Virtual Conference being held September 20–24.

• VILTEPSO® (viltolarsen) injection: Long-Term Efficacy and Safety Data Presented at the PPMD 2021 Virtual Annual Conference

  7/1/2021

  NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai), announced that new long-term efficacy and safety data based on interim analyses at 109 weeks from the open-label extension trial of a Phase 2 study of VILTEPSO® (viltolarsen) injection were presented at the PPMD 2021 Annual Conference.

• Webcast of VILTEPSO® (viltolarsen) injection: Long-Term Data Scheduled for Presentation at the PPMD 2021 Virtual Annual Conference

  6/21/2021

  NS Pharma, Inc. announces a webcast during the PPMD 2021 Virtual Annual Conference held from June 23 to 26 .

• VILTEPSO® (viltolarsen) injection Long-Term Clinical Trial Data to be Presented at the PPMD 2021 Virtual Annual Conference

  5/12/2021

  NS Pharma, Inc., a wholly owned subsidiary of Nippon Shinyaku Co., Ltd., announced that new, long-term efficacy and safety data from the open-label extension of a Phase 2 study of VILTEPSO® injection will be presented at the PPMD 2021 Annual Conference being held virtually from June 23-26.