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 (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.
Spero Therapeutics (Nasdaq: SPRO) will have Ankit Mahadevia, M.D., its CEO, presenting at two upcoming conferences: the 2022 RBC Capital Markets Global Healthcare Conference on May 18, 2022, and the H.C. Wainwright Global Investment Conference on May 25, 2022. The RBC presentation will feature a fireside chat format at 3:35 PM ET, while the H.C. Wainwright presentation will occur at 12:30 PM ET. Webcasts can be accessed via Spero Therapeutics' website, where replays will also be available.
Spero focuses on treating multi-drug resistant bacterial infections and rare diseases.
Spero Therapeutics (Nasdaq: SPRO) will host a conference call on May 16, 2022, at 4:30 p.m. ET to discuss its Q1 2022 financial results and update on its business and pipeline. The conference call is accessible at 1-877-704-4453 (domestic) or 1-201-389-0920 (international) using conference ID 13729221. Additionally, an audio webcast will be available on its website, which will be archived for 30 days. Spero focuses on developing treatments for complicated bacterial infections, with the FDA reviewing its New Drug Application for tebipenem HBr.
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.
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?
