BioCentury | Sep 30, 2020
Product Development

Sept. 29 Quick Takes: Ironwood reduces headcount following Phase III miss; plus Sandoz, Catalyst, Myovant, Orphazyme, Synklino, WHO, BridgeBio, Kurma, Junshi, Arcutis, Genfit-LabCorp and GSK

...Relugolix is under Priority Review by FDA for the indication with a Dec. 20 PDUFA date. Orphazyme...
BioCentury | Sep 17, 2020
Product Development

Sept. 16 Quick Takes: AAT deficiency data lift Arrowhead; plus Metacrine’s IPO, Seer spinout and PDUFA dates for Niemann-Pick, burn therapies

...for Orphazyme’s Niemann-Pick therapyFDA accepted and granted Priority Review to an NDA for arimoclomal from Orphazyme...
...the small molecule inducer of Hsp70, which has a PDUFA date of March 17, 2021. Orphazyme...
...June 29, 2021.TARGETSHsp70 – heat shock protein 70 BC Staff NexoBrid (debrase gel dressing) arimoclomol (BRX-345, OR-01) ARO-AAT Vericel Corp. MediWound Ltd. Orphazyme...
BioCentury | Nov 27, 2019
Company News

Management tracks: Ultragenyx COO to step down next year; plus Agios, MiMedx, Iveric, Ardelyx, Novo Seeds, Axcella, NervGen

...served as CEO of F-star Biotechnology Ltd. from 2012-18; and Anders Hinsby, former CEO of Orphazyme...
BioCentury | Jul 15, 2019
Company News

Management tracks: GSK, Orphazyme, Kymera and more

...of the planned split of its consumer healthcare and innovative R&D businesses. Protein misfolding company Orphazyme...
...and neurosciences at AbbVie Inc. (NYSE:ABBV). Mary Romeo, Assistant Editor Cabaletta Bio Inc. GlaxoSmithKline plc Kymera Therapeutics LLC Navitor Pharmaceuticals Inc. Orphazyme...
BioCentury | Feb 1, 2019
Clinical News

Orphazyme finds path forward for Niemann-Pick therapy in subgroup data

...for the small molecule inducer of heat shock protein 70 (Hsp70). In September, Orphazyme said arimoclomol...
...Path Forward for Arimoclomol in NPC After Phase II/III Miss" ). In the subgroup analyses, arimoclomol...
...for NPC, and Orphan Drug designation in the EU. Orphazyme A/S (CSE:ORPHA), Copenhagen, Denmark Product: Arimoclomol...
BioCentury | Jan 30, 2019
Clinical News

Orphazyme finds path forward for Niemann-Pick therapy in subgroup data

...for the small molecule inducer of heat shock protein 70 (Hsp70). In September, Orphazyme said arimoclomol...
...Path Forward for Arimoclomol in NPC After Phase II/III Miss" ). In the subgroup analyses, arimoclomol...
...designations in the U.S. for NPC, and Orphan Drug designation in the EU. Chris Lieu arimoclomol (BRX-345, OR-01) Orphazyme...
BioCentury | Jan 5, 2019
Finance

Ready to launch

...NASDAQ:ONTX) / SymBio Pharmaceuticals Ltd. (Tokyo:4582) Rigosertib MDS Phase III data 2H19 Orphazyme A/S (CSE:ORPHA) Arimoclomol...
BioCentury | Oct 19, 2018
Clinical News

Orphazyme seeking path forward for arimoclomol in NPC after Phase II/III miss

...patients to receive placebo or thrice-daily oral arimoclomol in addition to standard of care (SOC). Orphazyme...
...for NPC, and Orphan Drug designation in the EU. Orphazyme A/S (CSE:ORPHA), Copenhagen, Denmark Product: Arimoclomol...
...Phase II/III data Milestone: Final Phase II/III (4Q18); extension study data (2Q19) Jaime De Leon arimoclomol (BRX-345, OR-01) Orphazyme...
BioCentury | Oct 10, 2018
Company News

Management tracks: Hamburg joins Alnylam board

...appointed Georges Gemayel as chairman. Gemayel is also chairman of Enterome Bioscience S.A. (Paris, France), Orphazyme...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

...NYSE:NVS; SIX:NOVN) Siponimod (BAF312) Secondary progressive multiple sclerosis (SPMS) Submit MAA 3Q18 Orphazyme A/S (CSE:ORPHA) Arimoclomol...
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