Welcome to our dedicated page for Spero Therapeuti news (Ticker: SPRO), a resource for investors and traders seeking the latest updates and insights on Spero Therapeuti stock.
Spero Therapeutics, Inc. (SPRO) is a clinical-stage biopharmaceutical company pioneering novel therapies for multidrug-resistant bacterial infections and rare diseases. This page serves as the definitive source for verified news and official updates on SPRO's research advancements, regulatory milestones, and strategic initiatives.
Investors and healthcare professionals will find timely updates on key programs including tebipenem HBr (oral carbapenem antibiotic), SPR206 (IV polymyxin), and other pipeline developments. The curated news collection covers clinical trial results, FDA communications, partnership announcements, and financial disclosures.
All content is rigorously verified to ensure accuracy and relevance for stakeholders monitoring antibiotic innovation. Bookmark this page for direct access to SPRO's latest developments in addressing critical unmet medical needs through advanced therapeutic candidates.
Spero Therapeutics (NASDAQ: SPRO) announced the immediate cessation of commercialization activities for tebibenen HBr due to FDA feedback indicating insufficient data for approval. The company will reduce its workforce by about 75% and shift focus to the development of new drugs SPR720 and SPR206. While anticipating cost savings to fund operations through late 2023, Spero remains committed to engaging with the FDA for the potential approval of tebipenem HBr. The company ended the previous year with approximately $146.4 million in cash.
Spero Therapeutics, Inc. (Nasdaq: SPRO) announced its participation in the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) from April 23-26, 2022, in Lisbon, Portugal. The company will present two oral presentations and four posters focused on its investigational antibiotic candidate, tebipenem HBr. Notably, one of the posters has been recognized as a top-rated presentation. Tebipenem HBr is currently under FDA review and aims to treat complicated urinary tract infections.
Spero Therapeutics (Nasdaq: SPRO) announced the publication of the Phase 3 ADAPT-PO clinical trial results for tebipenem pivoxil hydrobromide in The New England Journal of Medicine. This trial is the first head-to-head comparison of oral versus intravenous treatments for complicated urinary tract infections. The NDA for tebipenem HBr is currently under FDA review with a PDUFA target date of June 27, 2022. The drug aims to provide an oral treatment option for adult patients with limited options.
Spero Therapeutics (Nasdaq: SPRO) provided updates on its clinical programs and financial performance for Q4 and full-year 2021. The FDA identified deficiencies in the NDA review for tebipenem HBr, impacting labeling discussions, but a meeting is scheduled to address these issues. Spero expects a commercial launch of tebipenem HBr in 2H 2022, pending approval. The company reported a net loss of $89.8 million for 2021, with total revenue rising to $18.3 million. Ongoing trials for SPR720 and SPR206 show potential for future development and value creation.
Spero Therapeutics (Nasdaq: SPRO) will hold a conference call on March 31, 2022, at 4:30 p.m. ET to discuss its fourth quarter and full-year 2021 financial results and provide a business update. The call can be accessed via phone or a live audio webcast available on Spero's website. Spero focuses on creating novel treatments for multi-drug-resistant bacterial infections, with its lead candidate, tebipenem HBr, recently receiving FDA NDA acceptance. This investigational drug aims to address complicated urinary tract infections but is not yet approved.
Spero Therapeutics announced positive results from its Phase 1 bronchoalveolar lavage (BAL) clinical trial for SPR206, its next-generation polymyxin candidate, which targets drug-resistant gram-negative infections. With a well-tolerated profile, the drug showed a lung epithelial lining fluid to plasma concentration ratio of 0.264, ensuring effective dosing against targeted pathogens. The findings support advancement into further clinical trials for hospital-acquired and ventilator-associated pneumonia. SPR206 has the potential to address critical treatment gaps for patients with serious bacterial lung infections.
Spero Therapeutics has expanded its partnership with the Biomedical Advanced Research and Development Authority (BARDA) to develop tebipenem for treating complicated urinary tract infections (cUTI) in pediatric patients. The contract extension increases potential funding to $59.7 million, with an additional $12.9 million allocated for a clinical trial. Spero's New Drug Application for tebipenem HBr is currently under review by the FDA. This collaboration addresses treatment options for multi-drug resistant infections, enhancing Spero's clinical pipeline.
Spero Therapeutics (Nasdaq: SPRO) announced the FDA lifted the clinical hold on its Phase 2 trial for SPR720, aimed at treating nontuberculous mycobacterial (NTM) disease. This decision allows Spero to resume clinical development, with plans to initiate the trial in the second half of 2022. SPR720 is designed as a once-daily oral treatment, addressing a significant unmet need for patients suffering from NTM-PD. The program has received FDA's Qualified Infectious Disease Product and orphan drug designations, indicating its potential significance in the market.
Spero Therapeutics (Nasdaq: SPRO) announced that the FDA has granted Priority Review for its New Drug Application (NDA) for tebipenem HBr, an oral antibiotic aimed at treating complicated urinary tract infections (cUTI). The target action date for the NDA is June 27, 2022. Tebipenem HBr has received multiple designations, including Qualified Infectious Disease Product and Fast Track. Positive data from the Phase 3 ADAPT-PO trial support this application, indicating non-inferiority to existing IV treatments. The company anticipates launching the product in the second half of 2022.
Spero Therapeutics, Inc. (Nasdaq: SPRO) announced that CEO Ankit Mahadevia will present at two upcoming virtual healthcare conferences: the Piper Sandler 33rd Annual Conference from November 29 to December 2, 2021, and the Evercore ISI HealthCONx Conference from November 30 to December 2, 2021. The Piper Sandler presentation will be available on-demand starting November 24 at 2:00 PM ET, while the Evercore presentation is scheduled for December 1 at 3:05 PM ET. Webcasts can be accessed via Spero's website, where replays will also be available.
