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| SpringWorks Therapeutics, Inc.: SpringWorks Therapeutics erhält positive CHMP-Stellungnahme für Mirdametinib zur Behandlung erwachsener und pädiatrischer Patienten mit NF1-PN | - im Falle einer Marktzulassung wäre Mirdametinib die erste und einzige Behandlung in der Europäischen Union für Erwachsene und Kinder mit NF1-PN -
- die Entscheidung der Europäischen Kommission... ► Artikel lesen |
| SpringWorks Therapeutics, Inc.: SpringWorks Therapeutics Receives Positive CHMP Opinion for Mirdametinib for the Treatment of Adult and Pediatric Patients with NF1-PN | - If approved, mirdametinib is expected to be the first and only therapy in the European Union with marketing authorization for both adults and children with NF1-PN -
- Decision from European Commission... ► Artikel lesen |
| Laufende Fusionskontrollverfahren: Merck KGaA, Darmstadt; Erwerb sämtlicher Anteile an und der alleinigen Kontrolle über SpringWorks Therapeutics, Inc., Stamford, Connecticut, USA | Datum der Anmeldung:08.05.2025Aktenzeichen:B3-54/25Unternehmen:Merck KGaA, Darmstadt; Erwerb sämtlicher Anteile an und der alleinigen Kontrolle über SpringWorks Therapeutics, Inc., Stamford, Connecticut... ► Artikel lesen |
| Avidity Biosciences, Inc.: Avidity Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) | SAN DIEGO, May 21, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics... ► Artikel lesen |
| Avidity Biosciences, Inc.: Avidity Biosciences Reports First Quarter 2025 Financial Results and Recent Highlights | On track to deliver key regulatory updates for del-brax and topline data from dose escalation cohorts in the FORTITUDE trial in the second quarter
Positive topline... ► Artikel lesen |
| Avidity Biosciences, Inc.: Avidity Biosciences Completes Enrollment in Biomarker Cohort in Phase 1/2 FORTITUDE Trial for Delpacibart Braxlosiran (del-brax) in People Living with Facioscapulohumeral Muscular Dystrophy | Del-brax FORTITUDE biomarker cohort designed for potential accelerated approval; plan to share regulatory update in Q2 2025
Regulatory alignment on global Phase... ► Artikel lesen |
| Mineralys Therapeutics, Inc.: Mineralys Therapeutics Announces Late-Breaking Presentation of Data from the Launch-HTN Pivotal Trial of Lorundrostat in Uncontrolled or Resistant Hypertension at 34th European Meeting on Hypertension ... | - Largest hypertension trial of an aldosterone synthase inhibitor to date demonstrated the efficacy of lorundrostat in over 1,000 participants with uncontrolled or resistant hypertension in a real-world... ► Artikel lesen |
| Mineralys Therapeutics, Inc.: Mineralys Therapeutics Announces Late-Breaking Data from Advance-HTN Pivotal Trial of Lorundrostat in Uncontrolled and Resistant Hypertension Presented at the American College of Cardiology's ... | - Lorundrostat 50 mg dose achieved a 15.4 mmHg absolute reduction and 7.9 mmHg placebo-adjusted reduction (p=0.001), assessed by 24hr ABPM at week 12, with favorable safety and tolerability profile... ► Artikel lesen |
| Mineralys Therapeutics, Inc.: Mineralys Therapeutics Announces Data from the Phase 2 Advance-HTN Trial of Lorundrosat for the Treatment of Hypertension Has Been Accepted as a Late-Breaking Presentation at the 2025 American ... | RADNOR, Pa., March 17, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic... ► Artikel lesen |
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