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. (Nasdaq: SPRO) is a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections. News about Spero often centers on its lead investigational product, tebipenem pivoxil hydrobromide (tebipenem HBr), an oral carbapenem antibiotic candidate for complicated urinary tract infections (cUTI), including pyelonephritis.
Readers following SPRO news can expect updates on clinical trial milestones, such as the pivotal Phase 3 PIVOT-PO trial, which Spero and its partner GSK reported met its primary endpoint and was stopped early for efficacy. Coverage also includes presentations of clinical data at major infectious disease conferences like IDWeek, where late-breaking results and detailed efficacy and safety analyses for tebipenem HBr have been shared.
Spero’s news flow also features regulatory and partnership developments. This includes announcements that GSK plans to, and has, submitted or resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for tebipenem HBr in cUTI, including pyelonephritis, as well as disclosures about milestone payments to Spero triggered by these filings under the exclusive license agreement between the companies.
In addition, Spero regularly reports its quarterly operating results and business updates, detailing collaboration revenue, grant funding, research and development spending, and cash runway expectations. Corporate governance and capital markets news, such as inducement equity grants under Nasdaq Listing Rule 5635(c)(4), amendments to stock incentive plans, and outcomes of annual stockholder meetings, also appear in the company’s announcements.
For investors, clinicians, and observers interested in antibiotic development, MDR infections, and rare disease therapeutics, the SPRO news page provides a consolidated view of Spero’s clinical progress, regulatory interactions, financial updates, and key collaborations over time.
Spero Therapeutics (Nasdaq: SPRO) announced the acceptance of 7 abstracts at IDWeek™ 2022, from October 19-23 in Washington, DC. The presentations will include data on tebipenem HBr and SPR206, focusing on their effectiveness against complicated urinary tract infections (cUTI) and pulmonary infections. Notable studies include clinical outcomes from the Phase 3 ADAPT-PO study and pharmacokinetics of SPR206. Tebipenem HBr is a late-stage oral antibiotic candidate with potential FDA approval for treating cUTI. Spero also highlights collaborations with various health organizations.
Spero Therapeutics, Inc. (Nasdaq: SPRO) is hosting a virtual R&D event on October 6, 2022, at 11:30 a.m. ET. Key opinion leader Kevin L. Winthrop, MD, MPH, will discuss the treatment landscape for non-tuberculous mycobacteria (NTM) pulmonary disease, alongside presentations from Spero's management about SPR720, a potential novel oral therapy for NTM infections. A live Q&A session will follow the presentations. Interested participants can register for the event here.
Spero Therapeutics and GSK have entered an exclusive license agreement for the late-stage antibiotic tebipenem HBr, aimed at treating complicated urinary tract infections (cUTI). Spero will receive an upfront payment of $66 million and potential milestone payments totaling up to $225 million, along with tiered royalties. GSK will invest $9 million in Spero's common stock and is set to develop and commercialize tebipenem HBr globally, except in Japan. The partnership is expected to enhance Spero's financial position and facilitate a new Phase 3 clinical trial in 2023.
Spero Therapeutics has appointed Kamal Hamed as Chief Medical Officer, bringing over 20 years of expertise in anti-infective development. Previously, Dr. Hamed held senior roles at Lysovant Sciences and Basilea Pharmaceutica, where he led the successful global approval of various anti-infective products. Dr. Hamed aims to advance Spero’s pipeline, including the promising SPR720 for nontuberculous mycobacterial infection and SPR206 for resistant Gram-negative infections. His leadership is expected to strengthen Spero’s position in the biopharmaceutical sector focused on urgent healthcare needs.
Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company, announced that Ankit Mahadevia, M.D., will present at the 24th Annual H.C. Wainwright Global Investment Conference from September 12-14, 2022. The presentation is scheduled for September 12 at 3:30 PM ET at Lotte New York Palace Hotel. Spero focuses on treatments for rare diseases and multi-drug resistant infections, with key products including SPR720 for rare pulmonary disease and SPR206 for Gram-negative infections. Webcasts of the presentation will be available on their website after the event.
Spero Therapeutics (Nasdaq: SPRO) announced alignment with the FDA regarding the regulatory path for tebipenem HBr, targeting complicated urinary tract infections (cUTI). A recent Type A meeting revealed that positive results from an additional Phase 3 trial could support its NDA resubmission. This pivotal trial is designed to demonstrate tebipenem HBr as a viable oral alternative to intravenous therapies. If approved, it would be the first oral carbapenem antibiotic in the U.S. The company aims to advance development through external partnerships.
Spero Therapeutics (Nasdaq: SPRO) reported Q2 2022 results, highlighting a net loss of $28.7 million, down from $18.6 million a year earlier. Total revenues decreased to $2.0 million, reflecting reduced BARDA and DoD funding. The company plans to initiate a Phase 2 trial for SPR720 in Nontuberculous Mycobacterial Pulmonary Disease in Q4 2022, with interim results expected in mid-2023. Additionally, a Phase 2 trial for SPR206 is set for Q3 2023. Despite setbacks with tebipenem HBr's NDA and restructuring costs of $11.8 million, Spero maintains sufficient cash reserves of $45.4 million until late 2023.
Spero Therapeutics (Nasdaq: SPRO) has announced a conference call on August 10, 2022, at 4:30 p.m. ET to discuss its Q2 2022 financial results and update its business operations and pipeline. Investors can access the call via phone or through a live audio webcast available on Spero's website. The archived webcast will be available for 30 days post-call. Spero is focused on developing treatments for bacterial infections, including multi-drug resistant strains, with pipeline candidates including SPR720, SPR206, and investigational drug Tebipenem HBr.
Spero Therapeutics (Nasdaq: SPRO) has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for tebipenem HBr oral tablets, intended for treating complicated urinary tract infections (cUTI). The FDA's action, announced on June 27, 2022, indicates that the NDA cannot be approved in its current form, citing insufficient data from Spero's Phase 3 clinical trial. The company plans to request a Type A meeting with the FDA to discuss next steps and address the agency's concerns, aiming for a clearer pathway to regulatory approval.
Spero Therapeutics (Nasdaq: SPRO) reported its Q1 2022 financial results, revealing a net loss of $32.8 million, up from $19.4 million in Q1 2021. Total revenues plummeted to $2.1 million from $7.3 million due to decreased funding under previous contracts. The company announced plans to initiate a Phase 2 trial for SPR720 in Nontuberculous Mycobacterial-Pulmonary Disease in H2 2022, while SPR206 shows promise for treating multi-drug resistant infections. With a cash position of $122 million, Spero aims to sustain its operations through late 2023 amid a strategic focus on clinical milestones.
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