Latest news with #tebipenemHBr
Yahoo
4 days ago
- Business
- Yahoo
SPRO Stock Soars 245% on GSK-Partnered UTI Drug Meeting Study Goal
Shares of Spero Therapeutics SPRO more than tripled in market value yesterday after a phase III study evaluating its investigational oral antibiotic for complicated urinary tract infections (cUTIs) was stopped early due to efficacy. The drug, called tebipenem HBr, is being developed in partnership with GSK plc GSK. This late-stage study, called PIVOT-PO, enrolled hospitalized adult patients with cUTIs, including pyelonephritis (a type of kidney infection). The decision to stop the study early was made following a recommendation from an independent committee, which found that the study met its primary endpoint of non-inferiority. In other words, treatment with tebipenem was as effective as intravenously (IV) administered antibiotic imipenem-cilastatin, a commonly prescribed treatment for cUTIs. These findings are based on an interim analysis of data from 1,690 patients enrolled in the study. Based on the positive results, Spero's partner, GSK, plans to submit a regulatory filing seeking approval for the drug with the FDA later this year. Full data from the PIVOT-PO study will be presented at a future medical meeting. Per Spero, around 2.9 million cases of cUTIs are treated annually in the United States alone. The current standard of care for cUTIs typically involves IV antibiotics, which require hospital administration. If approved, tebipenem HBr will be the first oral carbapenem antibiotic for cUTIs. An effective oral alternative would represent a major shift in the treatment paradigm, potentially reducing hospital stays, lowering costs and improving patient convenience. Year to date, shares of Spero have skyrocketed 128% against the industry's 5% decline. Image Source: Zacks Investment Research Tebipenem is being developed as part of a licensing agreement between Spero Therapeutics and GSK, signed in 2022. Per the terms, Spero is responsible for certain development work, including the PIVOT-PO study, while GSK holds exclusive rights to market the drug globally, except in certain Asian territories. The drug has also been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA, which are intended to expedite development and review. QIDP status provides priority review and five additional years of market exclusivity upon approval, whereas Fast Track allows for more frequent FDA interaction and rolling submissions. Notably, this is the second anti-infective program stopped early by GSK due to efficacy. Like tebipenem, GSK had also stopped the late-stage EAGLE 2 and 3 studies, which evaluated Blujepa (gepotidacin), an oral antibiotic for treating uncomplicated urinary tract infections (uUTIs). This drug was recently approved by the FDA for uUTIs. Spero currently carries a Zacks Rank #4 (Sell). Spero Therapeutics, Inc. price | Spero Therapeutics, Inc. Quote A couple of better-ranked stocks from the industry are Adaptive Biotechnologies ADPT and Agenus AGEN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Adaptive Biotechnologies' 2025 loss per share have improved from 92 to 87 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 69 to 65 cents. Adaptive Biotechnologies' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.38%. Shares of ADPT have surged 53% year to date. Agenus' loss per share estimate for 2025 has narrowed from $6.43 to $2.78 over the past 60 days, and the same for 2026 has improved from $6.57 to $5.26 during the same period. Agenus' earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%. Year to date, its shares have gained 10%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Agenus Inc. (AGEN) : Free Stock Analysis Report Adaptive Biotechnologies Corporation (ADPT) : Free Stock Analysis Report Spero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Globe and Mail
5 days ago
- Business
- Globe and Mail
Biotech Finds Mid-Week Success After Meeting Primary Endpoint
A biotech company based out of Massachusetts found a tremendous amount of success mid-week after the company announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), met its primary end point and will stop early for efficacy, according to a recent press release. Traders wasted no time snatching up shares of Spero Therapeutics Inc. (Nasdaq:SPRO), pushing the small cap to close the session up at $2.35/share (+244.57%). This move was a massive breakout from the multi-month downtrend this stock was stuck in since last year. Spero Therapeutics Inc is a clinical-stage biopharmaceutical firm. It focuses on identifying, developing and commercializing novel treatments for MDR (Multi-drug-resistant) bacterial infections and rare diseases. The company's product candidate, tebipenem pivoxil hydrobromide or tebipenem HBr, is designed to be an oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections. It is also developing SPR720, a novel oral antibiotic designed for the treatment of a rare, orphan disease caused by pulmonary non-tuberculous mycobacterial infections, or NTM disease. Besides, it is also focused on SPR206, a next-generation polymyxin investigational product candidate, being developed as an IV-administered medicine to treat MDR Gram-negative infections in the hospital. Copyright © 2025 All rights reserved. Republication or redistribution of content is expressly prohibited without the prior written consent of shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. View more of this article on About Media, Inc.: Founded in 1999, is one of North America's leading platforms for micro-cap insights. Catering to both Canadian and U.S. markets, we provide a wealth of resources and expert content designed for everyone—from beginner investors to seasoned traders. is rapidly gaining recognition as a leading authority in the micro-cap space, with our insightful content prominently featured across numerous top-tier financial platforms, reaching a broad audience of investors and industry professionals. Want to showcase your company's story to a powerful network of investors? We can help you elevate your message and make a lasting impact. Contact us today. Contact: Media, Inc.
Medscape
5 days ago
- Business
- Medscape
GSK, Spero Stop UTI Drug Trial After Early Success
(Reuters) -Spero Therapeutics and partner GSK are stopping a late-stage trial of an experimental oral drug for complicated urinary tract infections early as the study met its main goal, the companies said on Wednesday. Shares of Spero more than tripled to $2.24 in premarket trading. The decision comes after a recommendation from an independent committee that completed an interim analysis of data from 1,690 patients enrolled in the trial. The companies were studying the oral drug, tebipenem HBr, as a treatment for complicated urinary tract infections (cUTIs), including a type of kidney infection called pyelonephritis. An estimated 2.9 million cases of cUTIs are treated annually in the U.S. alone. The current standard of care includes antibiotics called carbapenem, but those are only available for intravenous administration. In the trial, the drug showed it was at least as good as an intravenous imipenem-cilastatin, a type of antibiotic, in hospitalized adult patients. If approved, the drug could be the first oral carbapenem antibiotic for patients with cUTIs. The review by the committee did not identify any new safety concerns beyond what had been reported in other studies, with diarrhea and headache as the two most reported side effects. The companies had entered into a licensing agreement for the development of tebipenem HBr in 2022. The U.S. FDA had previously declined to approve the drug saying a late-stage study testing it was insufficient and an additional study would be required. The British drugmaker plans to work with U.S. regulatory authorities to include the data as part of a filing in the second half of the year. Full results will be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed journal, the companies said. (Reporting by Sriparna Roy and Yadarisa Shabong in Bengaluru; Editing by Devika Syamnath)
Reuters
6 days ago
- Business
- Reuters
GSK, Spero to stop urinary tract infection drug trial due to early success
May 28 (Reuters) - Spero Therapeutics (SPRO.O), opens new tab and partner GSK (GSK.L), opens new tab said on Wednesday an experimental drug for complicated urinary tract infections met the main goal of a late-stage trial and the companies will be stopping the trial early for efficacy. Spero shares nearly tripled to $2 in premarket trading. The decision comes after a recommendation from an independent committee that completed a pre-specified interim analysis of data from 1,690 patients enrolled in the trial. The companies were studying the oral drug, tebipenem HBr, as a treatment for complicated urinary tract infections, including pyelonephritis, in which kidneys become infected. In the trial, the drug showed it was at least as good as an existing intravenous treatment in hospitalized adult patients. GSK plans to work with U.S. regulatory authorities to include the data as part of a filing in the second half of the year.
