BioCentury | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

...Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23...
...million in milestones, plus royalties. Targets EZH2 - Enhancer of zeste homolog 2 FGF23 - Fibroblast growth factor 23...
...E7438, EPZ-6438) Plenity, Gelesis100 (attiva) Ultragenyx Pharmaceutical Inc. Epizyme Inc. Sarepta Therapeutics Inc. Selecta Biosciences Inc. Gelesis Inc. China Medical System Holdings Ltd. Fibroblast growth factor 23 (FGF23) Enhancer...
BioCentury | Feb 28, 2020
Product Development

Feb. 27 Quick Takes: FDA approves Biohaven’s migraine therapy, plus Acacia, Zogenix, Ultragenyx-Kyowa, GSK, Illumina-BGI

...said FDA accepted and granted Priority Review to an sBLA for Crysvita burosumab-twza to treat FGF23-related...
...mesenchymal tumors that can’t be resected or localized; its PDUFA date is June 18. The anti-FGF23...
...Dopamine D2 receptor DRD3 - Dopamine D3 receptor FGF23 - Recombinant human IgG1 mAb against fibroblast growth factor 23...
BioCentury | Oct 3, 2019
Product Development

Kidney is the new liver: why kidney indications are coming into sharp focus

...fibrosis and oxidation. Promising targets include the oxidation regulator NRF2, the pro-inflammatory protein APOA, and FGF23...
...she said. Targets APOA1 - Apolipoprotein A-1 CB1 (CNR1) - Cannabinoid receptor 1 FGF23 - Fibroblast growth factor 23...
BioCentury | Sep 3, 2019
Clinical News

Ardelyx gains on Phase III hyperphosphatemia combination data

...phosphorus levels <5.5 mg/dL (49.1% vs. 23.5%, p≤0.0097) as well as a 22-24% reduction in FGF23...
...AMPLIFY at American Society of Nephrology meeting in November in Washington, D.C. Targets: FGF23 - Fibroblast growth factor 23...
BioCentury | Oct 6, 2018
Finance

Seeking validation

...Ltd. received FDA approval on April 17 for Crysvita, a recombinant human IgG1 mAb against fibroblast growth factor 23 (FGF23)...
BioCentury | Aug 3, 2018
Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

...approved Crysvita burosumab-twza to treat X-linked hypophosphatemia. Crysvita is a recombinant human IgG1 mAb against fibroblast growth factor 23 (FGF23)...
BioCentury | Jul 31, 2018
Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

...approved Crysvita burosumab-twza to treat X-linked hypophosphatemia. Crysvita is a recombinant human IgG1 mAb against fibroblast growth factor 23 (FGF23)...
BioCentury | Jun 29, 2018
Clinical News

Ultragenyx's Crysvita meets in Phase III for pediatric XLH

...therapy (72% vs. 6%, p<0.0001). In April, FDA approved the recombinant human IgG1 mAb against fibroblast growth factor 23 (FGF23)...
...Crysvita burosumab-twza (KRN23, UX023) Business: Musculoskeletal Molecular target: Fibroblast growth factor 23 (FGF23) Description: Recombinant human IgG1 mAb against FGF23...
...III data Milestone: NA Jaime De Leon Crysvita (burosumab , KRN23, UX023) Kyowa Hakko Kirin Co. Ltd. Ultragenyx Pharmaceutical Inc. Fibroblast growth factor 23 (FGF23)...
BioCentury | Apr 20, 2018
Clinical News

Ultragenyx gains rare disease approval, voucher

...growing skeletons (see BioCentury, March 2) . Crysvita is a recombinant human IgG1 mAb against fibroblast growth factor 23 (FGF23)...
...burosumab-twza (KRN23, UX023) Business: Musculoskeletal Chris Lieu Crysvita (burosumab , KRN23, UX023) Kyowa Hakko Kirin Co. Ltd. Ultragenyx Pharmaceutical Inc. Fibroblast growth factor 23 (FGF23) Musculoskeletal...
BioCentury | Apr 17, 2018
Company News

Ultragenyx gains rare disease approval, voucher

...skeletons (see BioCentury Extra, Feb. 23) . Crysvita is a recombinant human IgG1 mAb against fibroblast growth factor 23 (FGF23)...
...$0.86 to $54.68 on Tuesday. Chris Lieu Crysvita (burosumab , KRN23, UX023) Kyowa Hakko Kirin Co. Ltd. Ultragenyx Pharmaceutical Inc. Fibroblast growth factor 23 (FGF23) Musculoskeletal...
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