Welcome to our dedicated page for Spero Therapeutics news (Ticker: SPRO), a resource for investors and traders seeking the latest updates and insights on Spero Therapeutics stock.
Spero Therapeutics, Inc. (symbol: SPRO) is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies to combat multi-drug-resistant (MDR) bacterial infections and rare diseases. The company's mission is to bring novel treatments to patients who are in dire need of effective options against these challenging infections.
Core Business and Product Pipeline
Spero's lead product candidate is tebipenem pivoxil hydrobromide (tebipenem HBr), an oral carbapenem-class antibiotic designed to treat MDR Gram-negative infections in adults. This groundbreaking product addresses a critical need for effective oral therapies in the fight against resistant bacterial infections.
In addition to tebipenem HBr, Spero is also developing SPR720, a novel oral antibiotic aimed at treating pulmonary non-tuberculous mycobacterial (NTM) infections, a rare and often difficult-to-treat orphan disease. Furthermore, the company's pipeline includes SPR206, an investigational next-generation polymyxin product intended for intravenous administration in hospital settings to combat severe MDR Gram-negative infections.
Recent Achievements and Partnerships
Spero Therapeutics has made significant strides in its development programs. The company has secured a $95 million development milestone payable over two years as part of a licensing agreement with GSK, highlighting its potential and industry recognition. These funds are instrumental in advancing its clinical trials and bringing its innovative therapies closer to market.
Company Culture and Team
Spero Therapeutics prides itself on a culture of respect, action, collaboration, and transparency. The team comprises leaders in the field who are passionate about making a difference. This collaborative ethos ensures that every team member is not only contributing their expertise but also feeling like an integral part of the company's innovative journey.
In summary, Spero Therapeutics, Inc. is at the forefront of developing novel treatments for some of the most challenging and resistant bacterial infections. With its promising product pipeline and strong industry partnerships, the company is well-positioned to make a significant impact in the biopharmaceutical landscape.
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.
Spero Therapeutics, Inc. (Nasdaq: SPRO) submitted an NDA to the U.S. FDA for its oral antibiotic, tebipenem HBr, targeting complicated urinary tract infections (cUTI), with a potential launch in H2 2022. Additionally, the company entered a non-dilutive revenue financing agreement with HealthCare Royalty Partners for up to $125 million, enhancing its financial position. The third-quarter report shows a net loss of $22.5 million, down from $18.9 million the prior year, with total revenues at $3.1 million. Despite these challenges, Spero's cash reserves of $123.4 million should sustain operations into Q4 2022.
Spero Therapeutics, Inc. (Nasdaq: SPRO) will host a conference call on November 10, 2021, at 4:30 p.m. ET to discuss its Q3 2021 financial results and provide updates on its business and pipeline. The company focuses on developing treatments for multi-drug resistant bacterial infections and rare diseases. Spero's lead candidate, tebipenem HBr, is under review with a new drug application filed after positive Phase 3 trial results. Other developments include an oral therapy for NTM infections and an IV-administered polymyxin product for treating MDR infections.
Spero Therapeutics, Inc. (Nasdaq: SPRO) announced the submission of a New Drug Application (NDA) to the FDA for tebipenem HBr tablets, aimed at treating complicated urinary tract infections (cUTI). This marks a significant advancement as tebipenem HBr would be the first oral carbapenem antibiotic for cUTI if approved. Data from the Phase 3 ADAPT-PO trial confirmed its effectiveness, showing non-inferiority to IV ertapenem. The anticipated launch is set for the second half of 2022, which could reduce healthcare resource utilization by shifting from IV to oral treatments.
Spero Therapeutics (Nasdaq: SPRO) has appointed Kathleen Tregoning to its Board of Directors, effective October 12, 2021. Tregoning, a seasoned biotechnology executive, replaces Jean-François Formela, who resigned as part of a planned transition. Currently the Chief Corporate Affairs Officer at Cerevel Therapeutics, Tregoning's extensive experience in public policy and corporate affairs is expected to greatly benefit Spero, especially as it prepares for the anticipated launch of tebipenem HBr and other clinical programs. Spero focuses on developing treatments for multi-drug resistant infections and rare diseases.
Spero Therapeutics, Inc. (Nasdaq: SPRO) announced the grant of non-qualified stock options for 12,900 shares to three new employees under the 2019 Inducement Equity Incentive Plan. This move, made on September 30, 2021, is intended to attract new talent as per Nasdaq rules. Each option has an exercise price of $18.41 and will vest over four years, contingent upon the employees' continued employment. Spero is focused on developing treatments for multi-drug resistant bacterial infections and rare diseases, with notable products like tebipenem HBr and SPR720.
FAQ
What is the current stock price of Spero Therapeutics (SPRO)?
What is the market cap of Spero Therapeutics (SPRO)?
What is the primary focus of Spero Therapeutics?
What are the main product candidates of Spero Therapeutics?
What is tebipenem HBr?
What is SPR720?
What is SPR206?
What recent achievement has Spero Therapeutics made?
How does Spero Therapeutics foster its company culture?
Who can I contact for investor relations at Spero Therapeutics?
Who should media inquiries be directed to at Spero Therapeutics?
What sets Spero Therapeutics apart in the biopharmaceutical industry?
