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SpringWorks Therapeutics Announces Publication of Long-Term Efficacy a...
SpringWorks Therapeutics Announces Publication of Long-Term Efficacy and Safety Data from the Phase 3 DeFi Trial of OGSIVEO® (nirogacestat) in Adults with Desmoid Tumors in the Journal of Clinical Oncology – Long-term continuous OGSIVEO treatment for up to 4 years was associated with further tumor size reductions, increase in objective response rate, sustained improvement in desmoid tumor symptoms and consistent safety profile – STAMFORD, Conn., Oct. 21, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck, announced today that long-term efficacy and sa...
SpringWorks Therapeutics Announces Publication of Long-Term Efficacy a...
SpringWorks Therapeutics Announces Publication of Long-Term Efficacy and Safety Data from the Phase 3 DeFi Trial of OGSIVEO® (nirogacestat) in Adults with Desmoid Tumors in the Journal of Clinical Oncology Long-term continuous OGSIVEO treatment for up to 4 years was associated with further tumor size reductions, increase in objective response rate, sustained improvement in desmoid tumor symptoms and consistent safety profile STAMFORD, Conn., Oct. 21, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that long...
European Commission Grants Approval of OGSIVEO® (nirogacestat) for the...
European Commission Grants Approval of OGSIVEO® (nirogacestat) for the Treatment of Adults with Desmoid Tumors OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors STAMFORD, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck, announced today that the European Commission (EC) granted marketing authorization for OGSIVEO® (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for the treatment of adults with progressing desmoid tumors who require systemic treatme...
European Commission Grants Approval of OGSIVEO® (nirogacestat) for the...
European Commission Grants Approval of OGSIVEO® (nirogacestat) for the Treatment of Adults with Desmoid Tumors OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors STAMFORD, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted marketing authorization for OGSIVEO® (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for the treatment of adults with progressing desmoid tumors who...
European Commission Grants Conditional Approval of EZMEKLY® (mirdameti...
European Commission Grants Conditional Approval of EZMEKLY® (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN – EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms – STAMFORD, Conn., July 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck, announced today that the European Commission (EC) granted conditional marketing authorization for EZMEKLY® (mirdametinib) for the treatment of symptoma...
European Commission Grants Conditional Approval of EZMEKLY® (mirdameti...
European Commission Grants Conditional Approval of EZMEKLY® (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN – EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms – STAMFORD, Conn., July 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted conditional marketing authorization for EZMEKLY® (mirdametinib) for ...
- David Nierengarten
- Dennis Pak
- Martin Fan
- Wedbush Research
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- David Nierengarten
- Dennis Pak
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- Martin Fan
- Ritika Das
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VYGR VOYAGER THERAPEUTICS INC.
RARE ULTRAGENYX PHARMACEUTICAL INC.
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BIIB BIOGEN INC.
ASND ASCENDIS PHARMA A/S SPONSORED ADR
ARDX ARDELYX INC
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ANAB ANAPTYSBIO INC.
ARGX ARGENX ADS
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APLS APELLIS PHARMACEUTICALS
DNLI DENALI THERAPEUTICS INC
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SpringWorks Therapeutics Receives Positive CHMP Opinion for Nirogacest...
SpringWorks Therapeutics Receives Positive CHMP Opinion for Nirogacestat for the Treatment of Adults with Desmoid Tumors – If approved, nirogacestat will be the first and only therapy with marketing authorization in the EU for the treatment of desmoid tumors – – Decision from European Commission expected in the third quarter of 2025 – STAMFORD, Conn., June 20, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European Medicine Agency’s (EMA) Committee f...
- Wedbush Research
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BICARA THERAPEUTICS INC.
- David Nierengarten
- Dennis Pak
- Martin Fan
- Ritika Das
- Robert Driscoll
- Wedbush Research
XNCR XENCOR INC.
XENE XENON PHARMACEUTICALS INC
VYGR VOYAGER THERAPEUTICS INC.
TTWO TAKE-TWO INTERACTIVE SOFTWARE INC.
RARE ULTRAGENYX PHARMACEUTICAL INC.
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FATE FATE THERAPEUTICS INC
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ASND ASCENDIS PHARMA A/S SPONSORED ADR
ARDX ARDELYX INC
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7974 NINTENDO CO. LTD.
BLDR BUILDERS FIRSTSOURCE INC.
EA ELECTRONIC ARTS INC.
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PINS PINTEREST INC. CLASS A
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- David Nierengarten
- Dennis Pak
- Dylan Shindler
- Laura Chico
- Martin Fan
- Ritika Das
- Robert Driscoll
- Yun Zhong
XENE XENON PHARMACEUTICALS INC
VYGR VOYAGER THERAPEUTICS INC.
RARE ULTRAGENYX PHARMACEUTICAL INC.
NVCR NOVOCURE LTD.
NBIX NEUROCRINE BIOSCIENCES INC.
KURA KURA ONCOLOGY INC.
GERN GERON CORP.
FATE FATE THERAPEUTICS INC
CTMX CYTOMX THERAPEUTICS INC.
BPMC BLUEPRINT MEDICINES CORP.
BMRN BIOMARIN PHARMACEUTICAL INC.
BIIB BIOGEN INC.
ASND ASCENDIS PHARMA A/S SPONSORED ADR
ARDX ARDELYX INC
FRX_CN FENNEC PHARMACEUTICALS
ANAB ANAPTYSBIO INC.
ARGX ARGENX ADS
MRSN MERSANA THERAPEUTICS
ISR ISORAY
APLS APELLIS PHARMACEUTICALS
DNLI DENALI THERAPEUTICS INC
RCUS ARCUS BIOSCIENCES
SURF SURFACE ONCOLOGY
SRRK SCHOLAR ROCK HOLDING CORPORATION
KNSA KINIKSA PHARMACEUTICALS
REPL REPLIMUNE GROUP
ARVN ARVINAS HOLDING
YMAB Y-MABS THERAPEUTICS
STRO SUTRO BIOPHARMA
STOK STOKE THERAPEUTICS
IGMS IGM BIOSCIENCES
SWTX SPRINGWORKS THERAPEUTICS
IDYA IDEAYA BIOSCIENCES
PASG PASSAGE BIO
BDTX BLACK DIAMOND THERAPEUTICS
ACET ADICET BIO INC
KROS KEROS THERAPEUTICS
ITOS ITEOS THERAPEUTICS
ZNTL ZENTALIS PHARMACEUTICALS
LRMR LARIMAR THERAPEUTICS INC
PRAX PRAXIS PRECISION MEDICINES
TVTX TRAVERE THERAPEUTICS INC
VRDN VIRIDIAN THERAPEUTICS INC
DAWN DAY ONE BIOPHARMACEUTICALS INC
ELEV ELEVATION ONCOLOGY
ATXS ASTRIA THERAPEUTICS INC
GMTX GEMINI THERAPEUTICS INC
VIGL VIGIL NEUROSCIENCE INC
TYRA TYRA BIOSCIENCES INC
EWTX EDGEWISE THERAPEUTICS INC
APGE APOGEE THERAPEUTICS INC
- David Nierengarten
- Dennis Pak
- Martin Fan
- Ritika Das
- Robert Driscoll
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FATE FATE THERAPEUTICS INC
ISR ISORAY
REPL REPLIMUNE GROUP
SWTX SPRINGWORKS THERAPEUTICS
APRE APREA THERAPEUTICS
RVMD REVOLUTION MEDICINES
ZNTL ZENTALIS PHARMACEUTICALS
IMNM IMMUNOME
NUVB NUVATION BIO INC (A)
DAWN DAY ONE BIOPHARMACEUTICALS INC
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SpringWorks Therapeutics erhält positive CHMP-Stellungnahme für Mirdam...
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 wird für das dritte Quartal 2025 erwartet – STAMFORD, Conn., May 25, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), ein kommerzielles Biopharmaunternehmen mit dem Schwerpunkt seltene Erkranungen und Krebserkrankungen, gab heute be...
SpringWorks Therapeutics recibe un dictamen positivo del CHMP para el ...
SpringWorks Therapeutics recibe un dictamen positivo del CHMP para el uso de mirdametinib en el tratamiento de la NF1-NP en pacientes adultos y pediátricos – Si se aprueba, se espera que el mirdametinib sea la primera y única terapia autorizada para el tratamiento de la NF1-NP en la Unión Europea, tanto para adultos como para niños – – Decisión de la Comisión Europea prevista en el tercer trimestre de 2025 – STAMFORD, Connecticut, May 25, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), una empresa biofarmacéutica en fase comercial centrada en las enfermedades...
SpringWorks Therapeutics reçoit un avis favorable du CMUH pour l’utili...
SpringWorks Therapeutics reçoit un avis favorable du CMUH pour l’utilisation du mirdamétinib pour le traitement des patients adultes et pédiatriques atteints de NF1-PN – S’il est approuvé, le mirdamétinib devrait être le premier et unique traitement dans l’Union européenne à bénéficier d’une autorisation de mise sur le marché pour les adultes et les enfants atteints de NF1-PN – – La décision de la Commission européenne est attendue pour le troisième trimestre 2025 – STAMFORD, Connecticut, 25 mai 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq : SWTX), une société biophar...
SpringWorks Therapeutics: CHMP valuta positivamente Mirdametinib per i...
SpringWorks Therapeutics: CHMP valuta positivamente Mirdametinib per il trattamento di pazienti adulti e pediatrici affetti da NF1-PN – Se approvato, mirdametinib sarà la prima e unica terapia nell'Unione europea a ottenere l'autorizzazione all'immissione in commercio sia per gli adulti che per i bambini affetti da NF1-PN – – La decisione della Commissione europea è prevista nel terzo trimestre del 2025 – STAMFORD, Connecticut, May 25, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), un'azienda biofarmaceutica in fase di sviluppo commerciale focalizzata su gravi m...
SpringWorks Therapeutics krijgt positief advies van de CHMP voor Mirda...
SpringWorks Therapeutics krijgt positief advies van de CHMP voor Mirdametinib voor de behandeling van volwassen en pediatrische patiënten met NF1-PN - Als mirdametinib wordt goedgekeurd, zal het naar verwachting de eerste en enige therapie in de Europese Unie zijn met een handelsvergunning voor zowel volwassenen als kinderen met NF1-PN - - Besluit van de Europese Commissie wordt verwacht in het derde kwartaal van 2025 - STAMFORD, Connecticut, May 25, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), een biofarmaceutisch bedrijf in de commerciële fase dat zich richt...
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