Infectious disease-focused biopharma companies continued their rebound into year-end, with the BioWorld Infectious Disease Index finishing 2025 up 68.55% after standing at a collective 28.98% at the end of October. The rally underscores a sharp reversal from earlier in the year, when the index had declined 17.83% by the end of April before recovering to a 4.34% gain by July.
Two former Spero Therapeutics Inc. executives are on the hook for a total of $187,500 in civil penalties in a settlement resolving U.S. SEC allegations of issuing misleading statements centered on the FDA’s evaluation of Spero’s lead drug candidate that resulted in a 64% stock drop in May 2022.
Infectious disease biopharma stocks bounced back in June and July, with the BioWorld Infectious Disease Index (BIDI) closing July up 4.34%. This marked a sharp reversal from earlier in the year, as the BIDI had dropped 17.83% by the end of April and 21.04% by the end of May.
GSK plc knew a good thing when it swooped in nearly three years ago to rescue Spero Therapeutics Inc.’s oral antibiotic from a complete response letter (CRL). New pivotal phase III study data showed tebipenem pivoxil hydrobromide (HBr) for complicated urinary tract infections (cUTI), including pyelonephritis, hit its primary endpoint.
Insider trading isn’t always about profits. Sometimes it’s avoiding losses. That’s the basis of the U.S. SEC’s complaint against Matthew Groom, an information technology consultant to Spero Therapeutics Inc. Groom agreed Sept. 15 to a $28,000 settlement to resolve the complaint stemming from a trade of Spero shares that enabled him to avoid $13,000 in losses when news of the company’s downsizing and issues with its lead product became public two years ago.
AN2 Therapeutics Inc.’s decision to pause enrollment in the phase III portion of its phase II/III testing epetraborole in treatment-refractory Mycobacterium avium complex lung disease, citing potentially lower-than-expected efficacy from a blinded aggregate analysis of the phase II portion, left analysts and investors with little to do but speculate on the program’s viability going forward.
GSK plc has announced it has stopped early two pivotal phase III trials of its urinary tract infection drug, gepotidacin, for efficacy and is preparing regulatory filings for what could be the first new oral antibiotic for the disease in more than 20 years.
Spero Therapeutics Inc. has come out swinging after a U.S. FDA rejection for its oral antibiotic, tebipenem Hbr, picking up a potential $600 million licensing deal with pharma giant GSK plc after agreeing on a plan with the regulator to revive the drug.
Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application.
