News
Latest press releases – plus an archive of press releases, thus recording milestones and key facts in Sunstone’s history.
F2G’s olorofim receives both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP designation for multiple fungal infections
F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, announced today that following the granting of Breakthrough Therapy designation in November (the first antifungal ever to achieve such a designation),...
Orphazyme initiates rolling submission of New Drug Application for arimoclomol with US FDA in Niemann-Pick disease Type C
Orphazyme A/S (ORPHA.CO), a biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announces it has initiated the submission of its New Drug Application (NDA) for a rolling review by the US...
Orphazyme’s arimoclomol receives US Fast Track Designation in Amyotrophic Lateral Sclerosis
Orphazyme A/S (ORPHA.CO), a biopharmaceutical company pioneering Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, announces that the Company has received Fast Track Designation from the US Food and Drug Administration (FDA) for the...
VAXIMM Announces Results from VXM01 Phase I/II Combination Trial with PD-L1 Inhibitor Avelumab to be Presented at ASCO20
14 May 2020, VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that the safety run-in results from a Phase I/II study in progressive glioblastoma with its lead product candidate, oral VXM01, in combination...
Patent for Oncoral approved in Japan
Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia”) today announced that the patent application for Oncoral has been approved in Japan. The approval in Japan adds to the already obtained patents in the US and a selected number of countries in Europe and China. The...
Susanne Rydberg utses till ny VD för Arcoma AB
Styrelsen i Arcoma har utsett Susanne Rydberg till ny Verkställande Direktör. Susanne Rydberg har lång erfarenhet från ledande positioner, senast nu som VD för Eurofins BioPharma Product Testing Sweden AB och dessförinnan som verksamhetschef för Lindes Nordeuropeiska...