Robinhood shares gain on Q2 beat, as user and crypto growth accelerate
WALTHAM, Mass. & GENEVA, Switzerland - Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in partnership with the Global Antibiotic Research & Development Partnership (GARDP), has announced the U.S. Food and Drug Administration’s acceptance of a New Drug Application for zoliflodacin. This novel oral antibiotic is intended for the treatment of uncomplicated gonorrhea in adults and adolescents aged 12 and older.
Gonorrhea, a prevalent bacterial sexually transmitted infection, has seen a rise in drug-resistant strains, posing significant public health challenges. The World Health Organization has classified antimicrobial resistance as one of the top global threats to health. Zoliflodacin, if approved, would be the first new treatment option for gonorrhea in many years.
The FDA’s decision is informed by data from multiple clinical trials, including a pivotal Phase 3 trial that showed zoliflodacin’s effectiveness in achieving microbiological cure at the urogenital site, comparable to the current regimen of ceftriaxone and azithromycin. Zoliflodacin was generally well-received in trials, with no serious adverse events or deaths reported.
Dr. David Altarac, Chief Medical Officer at Innoviva Specialty Therapeutics, expressed optimism about providing a new treatment option for gonorrhea, particularly for infections caused by drug-resistant strains. Dr. Manica Balasegaram of GARDP highlighted the importance of public-private partnerships in addressing antimicrobial resistance and the potential global impact of zoliflodacin’s approval.
Zoliflodacin works by inhibiting a bacterial enzyme critical for reproduction, showing activity against multidrug-resistant Neisseria gonorrhoeae strains. The convenience of a single oral dose could simplify treatment for patients and help combat the spread of resistant gonorrhea.
The FDA has granted zoliflodacin a Qualified Infectious Disease Product designation, which entails benefits like Priority Review and Extended Market Exclusivity. Innoviva anticipates a standard review process for zoliflodacin, with Entasis Therapeutics, Inc., holding the commercial rights in key markets and GARDP focused on ensuring access in low and middle-income countries. According to InvestingPro analysis, Innoviva maintains a strong financial position with a current ratio of 2.48 and operates with moderate debt levels, suggesting solid backing for its drug development initiatives. InvestingPro subscribers have access to 12 additional key insights about Innoviva’s financial health and market position.
This article is based on a press release statement. With an overall financial health score rated as "GREAT" by InvestingPro, Innoviva appears well-positioned to execute its development strategy. The company has demonstrated strong revenue growth of 18.7% over the last twelve months, reflecting its expanding market presence in specialty therapeutics.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.