International Headache Society

Fujitsu joins Japan Health & Productivity Management Alliance

Retrieved on: 
Monday, December 11, 2023
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Through its participation in the Health & Productivity Management Alliance, Fujitsu aims to contribute to the sustainability of Japanese companies by creating an environment where employees can work in good physical and mental health by sharing knowledge and know-how on health management across industries.

Key Points: 
  • Through its participation in the Health & Productivity Management Alliance, Fujitsu aims to contribute to the sustainability of Japanese companies by creating an environment where employees can work in good physical and mental health by sharing knowledge and know-how on health management across industries.
  • Fujitsu will further contribute to the creation of a platform for health management to solve societal issues including increasing medical costs.
  • To further strengthen its health management culture, Fujitsu will promote the use and exchange of information on initiatives and health management with other participating companies in the Health & Productivity Management Alliance.
  • Through the promotion of collaborative health by companies and the Japanese Health Insurance Societies, the Health & Productivity Management Alliance will identify data-driven issues, implement solutions, and evaluate various measures.

Satsuma Pharmaceuticals Announces FDA Acceptance of 505(b)(2) NDA for STS101, a Novel and Investigational Dihydroergotamine (DHE) Nasal Powder Product for the Acute Treatment of Migraine

Retrieved on: 
Thursday, May 18, 2023
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(Nasdaq: STSA), a development-stage biopharmaceutical company today announced that its 505(b)(2) new drug application (NDA) for STS101, a novel and investigational therapeutic product candidate for the acute treatment of migraine, has been accepted for review by the FDA.

Key Points: 
  • (Nasdaq: STSA), a development-stage biopharmaceutical company today announced that its 505(b)(2) new drug application (NDA) for STS101, a novel and investigational therapeutic product candidate for the acute treatment of migraine, has been accepted for review by the FDA.
  • Although not required for approval based on Satsuma’s communications with the FDA, results from the 1,600-subject STS101 SUMMIT Phase 3 double-blind, placebo-controlled efficacy trial are also included in the NDA.
  • Satsuma announced topline SUMMIT trial results in November 2022 and subsequently announced further results in December 2022 .
  • The CVR is based on cumulative proceeds received by SNBL from the Monetization Event after making certain deductions.

Satsuma Pharmaceuticals Announces Topline Results from SUMMIT Phase 3 Trial of STS101 for the Acute Treatment of Migraine

Retrieved on: 
Monday, November 14, 2022
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The only treatment-emergent adverse event reported by more than 5% of SUMMIT subjects who self-administered STS101 was nasal discomfort, reported by 8.3% of subjects.

Key Points: 
  • The only treatment-emergent adverse event reported by more than 5% of SUMMIT subjects who self-administered STS101 was nasal discomfort, reported by 8.3% of subjects.
  • However, based on our interactions to date with the FDA, we believe the results from the STS101 Phase 1 pharmacokinetic and ASCEND Phase 3 open-label, long-term safety trials will support the STS101 NDA filing and marketing approval.
  • In addition, Satsuma announced that it does not plan to invest in commercializing STS101 and will actively explore alternatives to maximize value for shareholders, while minimizing cash expenditures.
  • DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients.

Satsuma Pharmaceuticals Reports Third Quarter 2022 Financial Results and Recent Business Highlights

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Thursday, November 3, 2022
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SOUTH SAN FRANCISCO, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the third quarter of 2022 and summarized recent business highlights.

Key Points: 
  • (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the third quarter of 2022 and summarized recent business highlights.
  • In August 2022, Satsuma announced completion of subject enrollment in the SUMMIT trial.
  • Satsuma plans to report SUMMIT topline results in November 2022.
  • This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the Company), as well as the Companys plans, objectives and expectations for its business operations and financial performance and condition.

Satsuma Pharmaceuticals Announces Positive Results from the Ongoing STS101 ASCEND Phase 3 Open-label, Long-term Safety Trial

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Tuesday, September 20, 2022
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(Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced positive safety, tolerability and efficacy results from its recent analysis of the Companys ongoing STS101 ASCEND Phase 3 open-label, long-term safety trial.

Key Points: 
  • (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced positive safety, tolerability and efficacy results from its recent analysis of the Companys ongoing STS101 ASCEND Phase 3 open-label, long-term safety trial.
  • The STS101 ASCEND Phase 3 long-term safety trial is a multi-center, open-label trial in subjects with migraine that is being conducted in the United States.
  • For further information regarding the STS101 ASCEND Phase 3 long-term safety trial, see www.ClinicalTrials.gov, identifier NCT04406649: A Study to Evaluate STS101 in the Acute Treatment of Migraine (ASCEND).
  • No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

Satsuma Pharmaceuticals Reports Second Quarter 2022 Financial Results and Recent Progress in STS101 Development Program

Retrieved on: 
Tuesday, August 9, 2022
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(Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the second quarter of 2022 and summarized progress in its STS101 development program.

Key Points: 
  • (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the second quarter of 2022 and summarized progress in its STS101 development program.
  • Satsuma is on track to report topline results from the SUMMIT trial in the fourth quarter of 2022.
  • In May 2022, Satsuma completed clinical and chemistry, manufacturing and controls (CMC) pre-NDA meetings with the FDA for STS101.
  • Research and development expenses were $12.5 million for the second quarter 2022, compared to $8.4 million for the same period of 2021.

Satsuma Pharmaceuticals Announces Completion of Enrollment in SUMMIT Pivotal Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine

Retrieved on: 
Tuesday, August 2, 2022
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SOUTH SAN FRANCISCO, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced completion of subject enrollment in the Company’s ongoing STS101 SUMMIT pivotal Phase 3 efficacy trial, with more than 1,400 subjects randomized. Satsuma expects to announce topline results from the SUMMIT trial in the fourth quarter of 2022.  

Key Points: 
  • (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced completion of subject enrollment in the Companys ongoing STS101 SUMMIT pivotal Phase 3 efficacy trial, with more than 1,400 subjects randomized.
  • The STS101 SUMMIT pivotal Phase 3 efficacy trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in more than 1,400 subjects with migraine that is being conducted in the United States.
  • For further information regarding the STS101 SUMMIT Phase 3 efficacy trial, see www.ClinicalTrials.gov, identifier NCT04940390: A Randomized, Double-Blind, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (SUMMIT).
  • Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine.

Teva Announces Promising Interim Results From Its Study PEARL, About the Impact of AJOVY® (fremanezumab)

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Friday, June 24, 2022
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AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen.

Key Points: 
  • AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen.
  • AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver.
  • Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century.
  • (v0.1) - The two year Pan-European Real World (PEARL) prospective, observational study of AJOVY (fremanezumab)
    2 KPMG, prepared for the European Migraine and Headache Alliance (EMHA).

Satsuma Pharmaceuticals Reports First Quarter 2022 Financial Results and Recent Business Highlights

Retrieved on: 
Tuesday, May 10, 2022
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SOUTH SAN FRANCISCO, Calif., May 10, 2022 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the first quarter of 2022 and summarized recent business highlights.

Key Points: 
  • (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the first quarter of 2022 and summarized recent business highlights.
  • Research and development expenses were $11.6 million for the first quarter 2022, compared to $7.2 million for the same period of 2021.
  • General and administrative expenses were $4.0 million for the first quarter 2022, compared to $3.3 million for the same period of 2021.
  • This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the Company), as well as the Companys plans, objectives and expectations for its business operations and financial performance and condition.

Satsuma Pharmaceuticals Reports 2021 Full Year and Fourth Quarter Financial Results and Business Highlights

Retrieved on: 
Tuesday, March 15, 2022
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SOUTH SAN FRANCISCO, Calif., March 15, 2022 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the fourth quarter and full year ended December 31, 2021 and summarized its business highlights.

Key Points: 
  • (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the fourth quarter and full year ended December 31, 2021 and summarized its business highlights.
  • Satsuma plans to report topline results from the SUMMIT trial in Q4 2022.
  • The Company believes the SUMMIT trial, if successful, will support a planned New Drug Application (NDA) filing in Q1 2023.
  • Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine.