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Spero (SPRO) Up Following Positive FDA Update for UTI Drug
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Shares of Spero Therapeutics (SPRO - Free Report) jumped 55.50% after the company provided a positive update following the receipt of minutes from a recent Type A meeting with the FDA on its experimental candidate, tebipenem HBr. Investors were encouraged by Spero achieving common ground with the FDA on the regulatory path forward for tebipenem HBr.
Tebipenem HBr is being developed for the treatment of complicated urinary tract infection (cUTI), including pyelonephritis, caused by certain microorganisms in adult patients with limited treatment options.
The meeting was conducted to discuss the steps required for resubmission of the new drug application (NDA) for tebipenem HBr for the treatment of cUTI, including pyelonephritis.
Please note that Spero received a complete response letter (CRL) from the FDA in June 2022 for a prior NDA seeking approval for tebipenem HBr for the treatment of adult patients with certain bacterial microorganisms that cause cUTI, including pyelonephritis. In the CRL, the regulatory body concluded that the data from the phase III ADAPT-PO study was insufficient to support approval during the prior review cycle.
During the above-mentioned type A meeting, the FDA indicated that positive results from a single additional phase III study supported by confirmatory nonclinical evidence of efficacy could be sufficient to back the approval of tebipenem HBr for the treatment of cUTI, including pyelonephritis for a limited use indication.
SPRO also reached alignment with the FDA on key components of the proposed pivotal phase III study design, which may be the subject of a Special Protocol Assessment request, to be confirmed once the clinical protocol is finalized.
Spero plans to advance tebipenem HBr’s clinical development and potential commercialization through external partnerships. A potential approval will make tebipenem HBr the first oral carbapenem antibiotic to receive marketing approval in the United States.
Shares of the company have lost 93% in the past year compared with the industry’s decline of 25.8%.
Image Source: Zacks Investment Research
The successful development of the candidate will be a significant boost for this clinical-stage biopharmaceutical company.
Spero is also developing SPR720 as a novel oral therapy product candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
The company also has an IV-administered next-generation polymyxin product candidate, SPR206, in its pipeline being developed to treat multi-drug resistant Gram-negative infections in the hospital setting.
The development of SPR206 is supported by funding from the National Institute of Allergy and Infectious Diseases. Spero also has a license agreement with Pfizer Inc. (PFE - Free Report) for the same.
Pfizer’s previously announced a $40 million equity investment in Spero. Per the terms, Pfizer has the right to develop, manufacture and commercialize SPR206 in ex-U.S. and ex-Asia territories. In lieu, Spero is eligible to receive up to $80 million in development and sales milestone payments and high single-digit to low double-digit royalties on net sales of SPR206 in these territories.
In July 2022, SPRO achieved a regulatory milestone under its license agreement with Pfizer, which will earn it a $5 million milestone payment expected in the third quarter of 2022.
Loss estimates for BOLT have narrowed to $2.54 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.
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Spero (SPRO) Up Following Positive FDA Update for UTI Drug
Shares of Spero Therapeutics (SPRO - Free Report) jumped 55.50% after the company provided a positive update following the receipt of minutes from a recent Type A meeting with the FDA on its experimental candidate, tebipenem HBr. Investors were encouraged by Spero achieving common ground with the FDA on the regulatory path forward for tebipenem HBr.
Tebipenem HBr is being developed for the treatment of complicated urinary tract infection (cUTI), including pyelonephritis, caused by certain microorganisms in adult patients with limited treatment options.
The meeting was conducted to discuss the steps required for resubmission of the new drug application (NDA) for tebipenem HBr for the treatment of cUTI, including pyelonephritis.
Please note that Spero received a complete response letter (CRL) from the FDA in June 2022 for a prior NDA seeking approval for tebipenem HBr for the treatment of adult patients with certain bacterial microorganisms that cause cUTI, including pyelonephritis. In the CRL, the regulatory body concluded that the data from the phase III ADAPT-PO study was insufficient to support approval during the prior review cycle.
During the above-mentioned type A meeting, the FDA indicated that positive results from a single additional phase III study supported by confirmatory nonclinical evidence of efficacy could be sufficient to back the approval of tebipenem HBr for the treatment of cUTI, including pyelonephritis for a limited use indication.
SPRO also reached alignment with the FDA on key components of the proposed pivotal phase III study design, which may be the subject of a Special Protocol Assessment request, to be confirmed once the clinical protocol is finalized.
Spero plans to advance tebipenem HBr’s clinical development and potential commercialization through external partnerships. A potential approval will make tebipenem HBr the first oral carbapenem antibiotic to receive marketing approval in the United States.
Shares of the company have lost 93% in the past year compared with the industry’s decline of 25.8%.
Image Source: Zacks Investment Research
The successful development of the candidate will be a significant boost for this clinical-stage biopharmaceutical company.
Spero is also developing SPR720 as a novel oral therapy product candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
The company also has an IV-administered next-generation polymyxin product candidate, SPR206, in its pipeline being developed to treat multi-drug resistant Gram-negative infections in the hospital setting.
The development of SPR206 is supported by funding from the National Institute of Allergy and Infectious Diseases. Spero also has a license agreement with Pfizer Inc. (PFE - Free Report) for the same.
Pfizer’s previously announced a $40 million equity investment in Spero. Per the terms, Pfizer has the right to develop, manufacture and commercialize SPR206 in ex-U.S. and ex-Asia territories. In lieu, Spero is eligible to receive up to $80 million in development and sales milestone payments and high single-digit to low double-digit royalties on net sales of SPR206 in these territories.
In July 2022, SPRO achieved a regulatory milestone under its license agreement with Pfizer, which will earn it a $5 million milestone payment expected in the third quarter of 2022.
It currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) , both carrying a Zacks Rank #2 (Buy), at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.54 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.