Keyword: Paratek Pharmaceuticals
Paratek’s omadacycline sailed through phase 3 before winning an FDA green light for two types of infection: community-acquired bacterial pneumoni and acute bacterial skin and skin structure infections.
Seysara is an oral, once-daily, narrow-spectrum antibiotic derived from tetracycline for people over 9 years old with acne vulgaris.
An FDA advisory committee voted in favor of Paratek’s new antibiotic for acute bacterial skin infections and community-acquired bacterial pneumonia.
Paratek’s first in a new class of antibiotics showed noninferiority to current drugs, FDA reviewers wrote ahead of an AdComm meeting.
Shares in Paratek were up almost a third in premarket trading this morning after Bloomberg said the company, gearing up to file a new antibiotic, is considering a sale.
The biotech plans to use the cash to hustle cancer drugs licensed from Bristol-Myers and Tesaro through late-phase trials in its home nation of China.
The third late-phase success sets Paratek up to file for approval, although incidence of vomiting and nausea cast a shadow over the data.
Shares in Paratek Pharmaceuticals jumped 35% in premarket trading on the back of data from a phase 3 trial of its antibiotic candidate omadacycline.
Allergan and partner Paratek Pharmaceuticals have hit their primary endpoints in two key phase 3 acne trials for their investigational med sarecycline.
Paratek Pharmaceuticals saw its shares jump by more than 23% in afterhours trading as it posted new Phase III data for its antibiotic omadacycline--with just one more trial to go before it can file with regulators.