Sodium channel blockers

DGAP-News: Newron Receives Fourth Tranche from Financing Agreement with European Investment Bank (EIB)

Retrieved on: 
Monday, September 6, 2021

The EIB loan is backed by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe.

Key Points: 
  • The EIB loan is backed by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe.
  • Tranche 4 consists of EUR 7.5 million and will primarily be used to support the Company's development programs in diseases of the central nervous system.
  • The first three tranches of the loan totaling EUR 25 million were received by Newron in 2019 and 2020.
  • Newron is developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Newron Receives Fourth Tranche from Financing Agreement with European Investment Bank (EIB)

Retrieved on: 
Monday, September 6, 2021

The EIB loan is backed by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe.

Key Points: 
  • The EIB loan is backed by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe.
  • Tranche 4 consists of EUR 7.5 million and will primarily be used to support the Companys development programs in diseases of the central nervous system.
  • The first three tranches of the loan totaling EUR 25 million were received by Newron in 2019 and 2020.
  • Newron is developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Newron Initiates First Potentially Pivotal Study with Evenamide in Patients with Schizophrenia

Retrieved on: 
Monday, September 6, 2021

Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the initiation of Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the initiation of Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia.
  • This study is part of Newrons Phase III evenamide clinical trial program that targets patients with schizophrenia experiencing worsening of psychosis on therapeutic doses of atypical antipsychotics, as well as treatment-resistant patients.
  • If successful, Newron believes the study would qualify as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics.
  • Newron is developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Poxel and Sumitomo Dainippon Pharma Announce the Approval of TWYMEEG® (Imeglimin hydrochloride) for the Treatment of Type 2 Diabetes in Japan

Retrieved on: 
Wednesday, June 23, 2021

Going forward, well continue to support Sumitomo Dainippon Pharma in establishing TWYMEEG as a key treatment for type 2 diabetes in Japan, and in other countries where Sumitomo Dainippon Pharma has the rights to the product.

Key Points: 
  • Going forward, well continue to support Sumitomo Dainippon Pharma in establishing TWYMEEG as a key treatment for type 2 diabetes in Japan, and in other countries where Sumitomo Dainippon Pharma has the rights to the product.
  • The Phase 3 TIMES program was a joint development effort between Poxel and Sumitomo Dainippon Pharma.
  • This approval of TWYMEEG allows us to provide patients with type 2 diabetes the opportunity for greater flexibility in their treatment regimens, said Koichi Kozuki, Executive Officer, Drug Development Division of Sumitomo Dainippon Pharma.
  • Poxel has a strategic partnership with Sumitomo Dainippon Pharma for TWYMEEG (Imeglimin) in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries.

Eisai to Divest Rights for Zonegran in Europe and Other Regions to Advanz Pharma

Retrieved on: 
Tuesday, June 15, 2021

Under this agreement, Eisai will divest its rights associated with Zonegran in such European countries, the Middle East, Russia, and Australia to Advanz Pharma.

Key Points: 
  • Under this agreement, Eisai will divest its rights associated with Zonegran in such European countries, the Middle East, Russia, and Australia to Advanz Pharma.
  • Eisai will continue to act as the distributor in Russia, through its local affiliate Limited Liability Company Eisai, and Australia through its local affiliate Eisai Australia Pty.
  • Eisai will retain its rights to Zonegran in Canada, Mexico and Asian countries and continue to distribute the product in certain licensed Asian countries.
  • Eisai believes that this divestiture agreement with Advanz Pharma will lead to maximization of the antiepileptic agent's product value.

Newron Announces Paragraph IV ANDA Filings for Xadago® (safinamide) in the USA

Retrieved on: 
Thursday, May 20, 2021

Supernus Pharmaceuticals holds the commercialization rights in the USA.

Key Points: 
  • Supernus Pharmaceuticals holds the commercialization rights in the USA.
  • Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
  • Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong.

Newron Announces Paragraph IV ANDA Filing for Xadago® (safinamide) in the USA

Retrieved on: 
Tuesday, May 4, 2021

Supernus Pharmaceuticals holds the commercialization rights in the USA.

Key Points: 
  • Supernus Pharmaceuticals holds the commercialization rights in the USA.
  • Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
  • Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong.

SK life science Reports Effectiveness of Long-Term Use with Cenobamate

Retrieved on: 
Thursday, April 15, 2021

The objectives of the study included the characterization of the long-term safety of cenobamate and to understand how to best add cenobamate to regimens that included phenytoin or phenobarbital.

Key Points: 
  • The objectives of the study included the characterization of the long-term safety of cenobamate and to understand how to best add cenobamate to regimens that included phenytoin or phenobarbital.
  • Further increases to 400 mg/day using bi-weekly 50 mg/day increments were allowed.\nCenobamate was discovered and developed by SK Biopharmaceuticals and SK life science.
  • For more information, visit SK Biopharmaceuticals\' website at www.skbp.com/eng and SK life science\'s website at www.SKLifeScienceInc.com .\nBoth SK Biopharmaceuticals and SK life science are part of SK Group, one of the largest conglomerates in Korea.
  • SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments witha number ofcompetitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors.

Newron Announces 2020 Financial Results and Provides Outlook For 2021

Retrieved on: 
Tuesday, March 16, 2021

Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the year ended December 31, 2020, and provided an outlook for 2021.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the year ended December 31, 2020, and provided an outlook for 2021.
  • Other current financial assets) as of December 31, 2020 is EUR 31.3 million
    The onset of the COVID-19 pandemic in 2020 presented enormous challenges for societies across the world.
  • 2020 has demonstrated that Newrons business remains resilient, and we move into 2021 and beyond confident in our strategy for the future.
  • Given Newrons extensive experience in the development of Xadago/safinamide, Newron and Zambon have agreed on Newron taking responsibility for conducting the study.

DGAP-News: Newron announces 2020 financial results and provides outlook for 2021

Retrieved on: 
Tuesday, March 16, 2021

Milan, Italy, March 16, 2021 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the year ended December 31, 2020, and provided an outlook for 2021.

Key Points: 
  • Milan, Italy, March 16, 2021 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the year ended December 31, 2020, and provided an outlook for 2021.
  • Other current financial assets) as of December 31, 2020 is EUR 31.3 million
    "The onset of the COVID-19 pandemic in 2020 presented enormous challenges for societies across the world.
  • 2020 has demonstrated that Newron's business remains resilient, and we move into 2021 and beyond confident in our strategy for the future.
  • Given Newron's extensive experience in the development of Xadago(R)/safinamide, Newron and Zambon have agreed on Newron taking responsibility for conducting the study.