BioCentury | Jun 23, 2020
Product Development

June 22 Quick Takes: Invitae acquiring ArcherDX; plus lymphoma approval for Karyopharm, Merck, Nabriva, Myovant, Assembly-AbbVie, Genentech and more

...that it received a complete response letter from FDA regarding an NDA resubmission for Contepo fosfomycin...
...MMAC1; TEP1) - Phosphatase and tensin homolog deleted on chromosome ten BioCentury Staff PCV-15 (V114) Contepo, fosfomycin (Zolyd, ZTI-01) Relumina...
BioCentury | Aug 19, 2019
Company News

Nabriva gets first approval in novel antibiotic class

...Antibiotic Treatments Focus of Reintroduced Senate Bill" ). The company hopes FDA approval for Contepo fosfomycin...
BioCentury | Aug 16, 2019
Company News

Ahead of FDA decisions on one antibiotic, Nabriva plans resubmission of another

...risk. On Friday, the company said it will again seek approval of broad-spectrum antibiotic Contepo fosfomycin...
...52-week highs, respectively. Nabriva added $0.12 to $2.28 on Friday. Sandi Wong, Staff Writer Contepo, fosfomycin (Zolyd, ZTI-01) Nabriva...
BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

...lateral sclerosis (ALS) Nabriva Therapeutics plc (NASDAQ:NBRV) FDA issues a complete response letter for Contepo fosfomycin...
BioCentury | May 1, 2019
Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

...Wednesday after FDA issued a complete response letter for its NDA for broad-spectrum antibiotic Contepo fosfomycin...
...Percent changes are at constant exchange rates. Consensus figures provided by FactSet. BioCentury Staff Contepo, fosfomycin (Zolyd, ZTI-01) HTX-011 Onpattro...
BioCentury | Apr 6, 2019
Finance

Big caps under pressure

...pegol Treat wet age-related macular degeneration (AMD) Submit BLA 2Q19 Nabriva Therapeutics plc (NASDAQ:NBRV) Contepo fosfomycin...
BioCentury | Jan 18, 2019
Clinical News

FDA moves up PDUFA for Nabriva's Contepo by two months

...Nabriva Therapeutics plc (NASDAQ:NBRV) said FDA accelerated its review timeline for Nabriva's broad-spectrum antibiotic Contepo fosfomycin...
...antibiotic. Nabriva Therapeutics plc (NASDAQ:NBRV), Dublin, Ireland Product: Contepo fosfomycin Business: Infectious Jennie Walters Contepo, fosfomycin (Zolyd, ZTI-01) Nabriva...
BioCentury | Oct 6, 2018
Finance

Seeking validation

...formation in patients with severe homozygous cystinuria Submit NDA 4Q18 Nabriva Therapeutics plc (NASDAQ:NBRV) Contepo fosfomycin...
BioCentury | Jul 27, 2018
Company News

Nabriva acquires Zavante

...for $97.5 million in milestones. Nabriva declined to provide details. Nabriva gained Contepo fosfomycin (formerly Zolyd...
...Track designations in the U.S. Contepo is also being evaluated in a pediatric trial (see “Zolyd...
...Inc., San Diego, Calif. Nabriva Therapeutics plc (NASDAQ:NBRV), Dublin, Ireland Business: Infectious Jaime De Leon Zolyd, fosfomycin (ZTI-01) Nabriva...
BioCentury | Apr 7, 2017
Clinical News

Zolyd: Ph II/III ZEUS data

...double-blind, international Phase II/III ZEUS trial in 465 patients showed that thrice-daily 6 g IV Zolyd...
...Diego, Calif. Product: Zolyd fosfomycin ( ZTI-01 ) Business: Infectious Molecular target: NA Description: IV fosfomycin...
...eradication rates and pharmacokinetics Status: Phase II/III data Milestone: Submit NDA (early 2018) Meghan Sullivan fosfomycin ZTI-01 Zavante Therapeutics Inc. Zolyd...
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