Showing 1-10 of about 26 articles.

Ocugen

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

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...

February 23, 2021

Immunicum AB

Immunicum AB (publ) Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors (GIST)

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)...

February 19, 2021 multilang-release

Immunicum AB

Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST)

Pressmeddelande 19 februari 2021 Immunicum AB (publ) erhåller särläkemedelsstatus, ODD, från EMA för ilixadencel för behandling av gastrointestinal stromacellstumör (GIST) Immunicum AB (publ;...

February 19, 2021 multilang-release

Axsome Therapeutics, Inc.

Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting

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...

September 21, 2020

Kiniksa Pharmaceuticals, Ltd.

Kiniksa Announces U.S. Orphan Drug Designation for Mavrilimumab for the Treatment of Giant Cell Arteritis

HAMILTON, Bermuda, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and...

September 15, 2020

Merus N.V.

Merus announces FDA Orphan Drug Designation of Zenocutuzumab for the Treatment of Pancreatic Cancer

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...

July 27, 2020

Kiniksa Pharmaceuticals, Ltd.

Kiniksa Announces U.S. Orphan Drug Designation for Rilonacept for the Treatment of Pericarditis

HAMILTON, Bermuda, July 16, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and...

July 16, 2020

Spero Therapeutics, Inc.

Spero Therapeutics Receives FDA Orphan Drug Designation for SPR720 for the Treatment of Nontuberculous Mycobacterial (NTM) Infection

CAMBRIDGE, Mass., March 11, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and...

March 11, 2020

Monopar Therapeutics Inc.

Monopar Therapeutics Receives Orphan Drug Designation from the European Commission for Camsirubicin in the Treatment of Soft Tissue Sarcoma

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...

February 18, 2020

Hillstream BioPharma, Inc.

Hillstream BioPharma Granted Orphan Drug Designation for HSB-1216 (QUATRAMER Salinomycin) for Treatment of Small Cell Lung Cancer (SCLC)

Positive pre-clinical data with an emerging validated mechanism of action, Ferroptosis HSB-1216 is a novel therapeutic using the QUATRAMER formulation of a potent anti-Ferroptotic compounds,...

January 06, 2020