GSK Announces FDA Acceptance of New Meningococcal Jab BLA [Yahoo! Finance]
ANI Pharmaceuticals, Inc. (ANIP)
Last ani pharmaceuticals, inc. earnings: 2/27 08:30 am
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Source: Yahoo! Finance
The FDA has granted a standard review to the BLA and is expected to give its decision on Feb 14, 2025. The MenABCWY vaccine candidate combines the antigenic components of GSK's two popular licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). The MenABCWY combination targets the five serogroups of the bacteria Neisseria meningitides (A, B, C, W, and Y), which is primarily responsible for most invasive meningococcal disease cases globally. Per GSK, a potential approval of this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and lead to a simplified immunization schedule. The 5-in-1 meningitis vaccine candidate has the potential to reduce the number of injections compared to current FDA-approved meningitis vaccines, as it has been designed to protect against all five vaccine-preventable serogroups with one combined product. The BLA was based on data from a pivotal phase III study. The study met all its primary endpoints, includi
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ANIP
Earnings
- 2/29/24 - Beat
ANIP
Sec Filings
- 4/22/24 - Form 4
- 4/19/24 - Form 144
- 4/18/24 - Form 144
- ANIP's page on the SEC website