Spero Therapeutics Inc. (SPRO) shares popup 4.70% in after-hours on Friday, January 14, 2022, and closed the weekly trading at $13.82. Even in the regular trading session of Friday, SPRO’s stock gained 10.65%. SPRO shares have fallen 19.76% over the last 12 months, and they have moved up 0.76% in the past week. Over the past three months, the stock has lost 22.44%, while over the past six months, it has declined 5.85%.
Let’s briefly discuss its recent news and developments.
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FDA lifted the clinical trial hold on SPR720
On January 04, 2022, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the Phase 2 trial of SPR720. Spero Therapeutics, Inc. (SPRO) is developing SPR720 for nontuberculous mycobacterial (NTM) disease which is an investigational oral product candidate.
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FDA put a hold on clinical trial after reviewing data from a non-human primate toxicology study in which mortalities with inconclusive causality to treatment were observed. Spero recently submitted a comprehensive study report with detailed analyses from the NHP toxicology study after the FDA lifted the clinical trial ban. The company will resume the SPR720 Phase 2 trial for NTM-pulmonary disease (NTM-PD) patients, with an expected study start date commencing in the second half of 2022.
FDA accepted NDA for SPRO Tebipenem HBr
On January 03, 2022, the U.S. Food and Drug Administration (FDA) granted Priority Review designation and confirmed the acceptance for substantive review of the New Drug Application (NDA) for tebipenem HBr oral tablets.
tebipenem HBr SPRO drug candidate which is used to treat adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible microorganisms.
FDA also granted Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations for these cUTI indications and set a target action date of June 27, 2022.
Spero Therapeutics submitted NDA after positive data from the Phase 3 ADAPT-PO trial in which ADAPT-PO met its primary endpoint by demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with acute pyelonephritis (AP).
The Company expects a commercial launch for tebipenem HBr in the second half of 2022, subject to its approval by the FDA.
SPRO latest financial results
On November 10, 2021, Spero Therapeutics, Inc. (SPRO), reported financial results for the third quarter ended September 30, 2021.
Q3 2021 financial highlights
- SPRO reported total revenue of $3.1 million in the third quarter of 2021, compared with revenues of $4.0 million in the third quarter of 2020.
- Total operating expenses were $25.6 million compared to $23.01 million in Q3 2020.
- It suffered a net loss of $22.5 million or $0.70 per common share in Q3 2021, compared to a net loss of $18.9 million or $0.86 per common share reported for the same period in 2020.
- As of September 30, 2021, Spero had cash, cash equivalents, and marketable securities of $123.4 million.
Well, there is no latest news but we can assume that the recent positive news from FDA could be the reason behind its positivity on Friday. we hope that it will continue to perform well on Tuesday as well.