BioCentury | Aug 13, 2018
Company News

Amicus prices Galafold at $315k per year

Amicus Therapeutics Inc. (NASDAQ:FOLD) said Monday that it will price Galafold migalastat at $315,000 per year and vowed to limit annual price increases of the Fabry disease drug to the rate of inflation. On Friday,...
BioCentury | Aug 10, 2018
Company News

Amicus' Galafold wins accelerated approval from FDA

FDA granted accelerated approval to Galafold migalastat from Amicus Therapeutics Inc. (NASDAQ:FOLD) to treat Fabry disease in adults who have amenable mutations. Amicus said the U.S. approval is the first for a new Fabry disease...
BioCentury | Apr 6, 2018
Targets & Mechanisms

GI Band-Aid

...Inc. is also tapping into gut leakiness to treat GI disease. Its candidate larazotide acetate (INN-202...
BioCentury | Apr 6, 2018
Finance

Fundamentally driven

...digital camera company Monster Digital Inc. and concomitant $21 million private placement. Lead asset larazotide (INN-202...
...Other), Cabometyx (Other) Darzalex, daratumumab (JNJ-54767414, humax-cd38) EBV-CTL, tabelecleucel (ata 129, ata129) Feraccru, ferric maltol (ST10) larazotide (AT-1001, INN-202, SPD550) NKTR-214 olumacostat...
BioCentury | Mar 30, 2018
Clinical News

Japan approvals include Hemlibra, Shingrix Galafold

Japan approved a basket of drugs including hemophilia drug Hemlibra emicizumab from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), shingles vaccine Shingrix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Fabry's disease drug Galafold migalastat from Amicus Therapeutics Inc....
BioCentury | Mar 23, 2018
Company News

Japan approvals include Hemlibra, Shingrix, Galafold

Japan approved a basket of drugs including hemophilia drug Hemlibra emicizumab from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), shingles vaccine Shingrix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Fabry's disease drug Galafold migalastat from Amicus Therapeutics Inc....
BioCentury | Feb 23, 2018
Financial News

Amicus raises $300M in bumped-up follow-on

Amicus Therapeutics Inc. (NASDAQ:FOLD) raised $300 million on Feb. 15 through the sale of 19.4 million shares at $15.50 in an upsized follow-on underwritten by J.P. Morgan, Goldman Sachs, Cowen, Leerink and BofA Merrill Lynch....
BioCentury | Feb 16, 2018
Financial News

Amicus raises $300M in bumped-up follow-on

Amicus Therapeutics Inc. (NASDAQ:FOLD) raised $300 million through the sale of 19.4 million shares at $15.50 in an upsized follow-on underwritten by J.P. Morgan, Goldman Sachs, Cowen, Leerink and BofA Merrill Lynch. The price is...
BioCentury | Feb 16, 2018
Clinical News

Priority Review for Amicus' migalastat

FDA accepted and granted Priority Review to an NDA from Amicus Therapeutics Inc. (NASDAQ:FOLD) for migalastat (AT1001) to treat Fabry's disease in patients 16 years and older who have amenable mutations. The PDUFA date is...
BioCentury | Feb 12, 2018
Company News

Priority Review for Amicus' migalastat

FDA accepted and granted Priority Review to an NDA from Amicus Therapeutics Inc. (NASDAQ:FOLD) for migalastat (AT1001) to treat Fabry's disease in patients 16 years and older who have amenable mutations. The PDUFA date is...
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