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, Inc. (Nasdaq: SPRO) announced a conference call on November 5, 2020, at 4:30 p.m. EST to discuss its third quarter 2020 financial results and business updates. The company is focused on developing treatments for multi-drug resistant bacterial infections and rare diseases. Spero's lead candidate, tebipenem HBr, showed positive results in its Phase 3 ADAPT-PO trial for complicated urinary tract infections. Additionally, Spero is advancing SPR720 for rare pulmonary diseases and SPR206 for multi-drug resistant infections in hospitals.
Spero Therapeutics (Nasdaq: SPRO) announced 15 data presentations at IDWeek™ 2020, taking place virtually from October 21-25, 2020. Key topics include a late breaker oral presentation on the Phase 3 ADAPT-PO clinical trial for tebipenem HBr, which showed non-inferiority to IV ertapenem for treating complicated urinary tract infections (cUTI). Other presentations cover Spero's pipeline products, including SPR720 and SPR206. The company aims to advance antibacterials targeting multi-drug resistant infections and plans to submit a New Drug Application for tebipenem HBr in Q2 2021.
Spero Therapeutics (Nasdaq: SPRO) announced a key opinion leader call on September 30, 2020, to discuss oral tebipenem HBr for complicated urinary tract infections (cUTI). Dr. Keith Kaye will present on the treatment landscape and unmet needs. The call follows positive top-line results from Spero’s ADAPT-PO Phase 3 trial, where tebipenem HBr was shown to be statistically non-inferior to intravenous ertapenem. If approved, tebipenem HBr would be the first oral carbapenem approved in the U.S., with an NDA submission expected in Q2 2021.
Spero Therapeutics, Inc. (Nasdaq: SPRO) announced key investor presentations for September 2020, led by CEO Ankit Mahadevia. The company focuses on developing treatments for multi-drug resistant infections and rare diseases. Spero will present at the Cantor Virtual Global Healthcare Conference on September 17 and the Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit on September 23. Webcasts will be available on their website. Notably, Spero reported positive Phase 3 ADAPT-PO trial results for its lead product, tebipenem HBr, aimed at treating complicated urinary tract infections.
Spero Therapeutics, Inc. (Nasdaq: SPRO) has priced its public offering of 4,785,000 shares of common stock and 3,215,000 shares of non-voting Series D Convertible Preferred Stock at $10.00 each, aiming for gross proceeds of $80.0 million. The offering, closing around September 15, 2020, includes a 30-day option for underwriters to purchase an additional 1,200,000 shares. Proceeds will fund the development of tebipenem HBr and support general corporate purposes. The offering complies with an SEC Form S-3 registration statement.
Spero Therapeutics (Nasdaq: SPRO) announced a public offering of 8,000,000 shares of common stock, including shares of non-voting Series D Convertible Preferred Stock convertible into 1,000 shares of common stock. The net proceeds will fund the advancement of its product tebipenem HBr, aimed at filing a New Drug Application with the FDA, ongoing pipeline development, and general corporate purposes. The offering is subject to market conditions, with underwriters granted a 30-day option to purchase an additional 15% of shares at the public offering price.
Spero Therapeutics announced positive topline results from its pivotal Phase 3 trial of oral tebipenem HBr, indicating statistical non-inferiority to intravenous ertapenem for treating complicated urinary tract infections (cUTI) and acute pyelonephritis. The trial included 1,372 patients and demonstrated overall response rates of 58.8% for tebipenem HBr compared to 61.6% for ertapenem. Tebipenem HBr had a comparable safety profile, with treatment-emergent adverse events reported in about 26% of patients. Spero plans to submit a NDA to the FDA in Q2 2021.
Spero Therapeutics (Nasdaq: SPRO) announced the FDA's acceptance of its Investigational New Drug application for SPR720, an oral antimicrobial targeting nontuberculous mycobacterial (NTM) pulmonary disease. This acceptance allows Spero to initiate a Phase 2a trial by the end of 2020, involving around 90 patients. SPR720 aims to fulfill a critical unmet need for NTM infections, as it is the first oral antibiotic being developed specifically for this condition. It also has QIDP and orphan drug designations from the FDA, enhancing its development prospects.
Spero Therapeutics, Inc. (Nasdaq: SPRO) announced on July 31, 2020, that its Compensation Committee granted non-qualified stock options to purchase 22,000 shares to two new employees, as part of the 2019 Inducement Equity Incentive Plan. The options have an exercise price of $11.70 per share, equal to the closing stock price on that date, vesting over four years. This plan is designed to attract talent by offering inducements for new hires who have not previously been employed by Spero.
Spero Therapeutics, Inc. (Nasdaq: SPRO) announced on June 30, 2020, the granting of non-qualified stock options for 40,000 shares to five new employees under its 2019 Inducement Equity Incentive Plan. The options, with an exercise price of $13.53 per share, will vest over four years, with 25% vesting after the first year. This incentive is in accordance with Nasdaq Listing Rule 5635(c)(4) and is aimed at attracting talent in the biopharmaceutical sector focused on treating multi-drug resistant bacterial infections and rare diseases.
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