CAMBRIDGE, Mass., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and...
Phase 3 PIVOT-PO trial is expected to begin with First Patient, First Visit in 4Q 2023 Spero to receive $30 million development milestone payment from GSK CAMBRIDGE, Mass., July 31, 2023 ...
CAMBRIDGE, Mass., April 06, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced publication in The New England Journal of Medicine (NEJM) of the results from the Phase 3...
Spero Therapeutics, Inc. (Nasdaq:SPRO) (Spero), a multi-asset clinical-stage biopharmaceutical company focused on developing and commercializing novel antibiotics to treat multi-drug resistant bacterial infections, today announced that it was awarded funding of $15.7 million, with the potential for up to an additional $28.5 million over 5 years, from the Biomedical Advanced Research and Development Authority (BARDA). The funding will support the further clinical development of Spero’s oral carbapenem product candidate, SPR994, for the treatment of complicated urinary tract infections (cUTIs) caused by antibiotic resistant Gram-negative bacteria.
Spero Therapeutics, Inc. (Nasdaq:SPRO) (Spero), a multi-asset clinical-stage biopharmaceutical company focused on developing and commercializing novel antibiotics to treat multi-drug resistant bacterial infections, today reported positive results from an interim analysis of its ongoing single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical trial of SPR994, its investigational oral carbapenem product candidate designed for the treatment of Gram-negative infections, in healthy volunteers. The data demonstrate that SPR994 has a favorable safety, pharmacokinetic and pharmacodynamic profile that supports the advancement of SPR994 to a pivotal Phase 3 clinical trial at a 300 mg dose administered three times per day (TID).
Asymchem, a leading custom manufacturer of Intermediates and API's for the life sciences industry, today announced that its Fuxin 1 site, a dedicated carbapenem manufacturing facility, successfully passed the U.S. Food and Drug Administration (USFDA) general GMP reinspection conducted between March 12-15, 2018. No Form 483 was issued.