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Aprea Therapeutics Receives FDA Orphan Drug Designation for Eprenetapopt for the Treatment of Acute Myeloid Leukemia (AML)
April 08, 2021 11:15 ET | Aprea Therapeutics
BOSTON, April 08, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate...
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European Commission Grants Ocugen Orphan Medicinal Product Designation for Gene Therapy Product Candidate, OCU400, For the Treatment of Both Retinitis Pigmentosa and Leber Congenital Amaurosis
February 23, 2021 07:30 ET | Ocugen
MALVERN, Pa., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc., (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness...
Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST)
February 19, 2021 02:00 ET | Immunicum AB
Press Release 19 February 2021 Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST) Immunicum AB (publ; IMMU.ST)...
Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST)
February 19, 2021 02:00 ET | Immunicum AB
Pressmeddelande 19 februari 2021  Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST) Immunicum AB (publ;...
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Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting
September 21, 2020 07:00 ET | Axsome Therapeutics, Inc.
Single Phase 3 trial to be conducted to support an NDA filing of AXS-12 in the treatment of narcolepsy; trial initiation anticipated 1Q 2021 Extensive patient safety database, previously obtained...
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Kiniksa Announces U.S. Orphan Drug Designation for Mavrilimumab for the Treatment of Giant Cell Arteritis
September 15, 2020 08:00 ET | Kiniksa Pharmaceuticals, Ltd.
HAMILTON, Bermuda, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and...
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Merus announces FDA Orphan Drug Designation of Zenocutuzumab for the Treatment of Pancreatic Cancer
July 27, 2020 08:00 ET | Merus N.V.
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific...
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Kiniksa Announces U.S. Orphan Drug Designation for Rilonacept for the Treatment of Pericarditis
July 16, 2020 07:30 ET | Kiniksa Pharmaceuticals, Ltd.
HAMILTON, Bermuda, July 16, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and...
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Spero Therapeutics Receives FDA Orphan Drug Designation for SPR720 for the Treatment of Nontuberculous Mycobacterial (NTM) Infection
March 11, 2020 08:30 ET | Spero Therapeutics, Inc.
CAMBRIDGE, Mass., March 11, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and...
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Monopar Therapeutics Receives Orphan Drug Designation from the European Commission for Camsirubicin in the Treatment of Soft Tissue Sarcoma
February 18, 2020 09:00 ET | Monopar Therapeutics Inc.
CHICAGO, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ: MNPR) today announced it has been granted Orphan Drug Designation from the European Commission for its drug candidate...