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Iterum (ITRM) Plans Early Submission of UTI Drug NDA, Stock Up
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Iterum Therapeutics (ITRM - Free Report) jumped 17.8% on Mar 6, 2024, and continued to gain another 3.4% in the after-market hours as it announced plans to resubmit a new drug application (NDA) for oral sulopenem to the FDA in the first half of the second quarter of 2024, ahead of schedule.
The NDA will seek approval for the candidate to treat adult women with uncomplicated urinary tract infections (uUTIs) in the United States.
Sulopenem, a thiopenem antibiotic, is being developed to treat urinary tract and intra-abdominal infections. An intravenous formulation of the candidate is also currently under development.
We remind the investors that in 2021, Iterum received a complete response letter (CRL) from the FDA against its initial NDA for oral sulopenem for the uUTIs indication. Per the CRL, the NDA could not be approved in its present form and additional data was required to support the approval of oral sulopenem for the treatment of adult women with uUTIs.
The FDA recommended Iterum to conduct an additional clinical study of the candidate, potentially using a different comparator drug. Following the FDA’s recommendation, the company initiated the phase III non-inferiority REASSURE study of oral sulopenem for the treatment of uUTIs compared with Augmentin (amoxicillin/clavulanate) in the Augmentin susceptible population.
In the past year, shares of Iterum have gained 29.6% against the industry’s 3.5% decline.
Image Source: Zacks Investment Research
The company plans to resubmit the oral sulopenem NDA for the uUTIs indication based on positive top-line results from the late-stage REASSURE study, which was announced earlier this year. The study met its primary endpoint of overall response, demonstrating non-inferiority of oral sulopenem to Augmentin.
Furthermore, treatment with oral sulopenem resulted in the overall success of combined clinical cure plus microbiologic eradication in 61.7% of patients compared with 55% for Augmentin, demonstrating statistically significant superiority over the comparator drug. Consistent results were observed for all key secondary efficacy endpoints in the uUTIs population as well.
Management believes that the encouraging results from prior phase III studies of oral sulopenem also support the candidate’s potential in other indications, such as complicated urinary tract infections.
Oral sulopenem was generally well-tolerated in the REASSURE study, observing a safety profile, consistent with previously conducted phase III studies. Detailed results are expected to be presented at an upcoming medical conference.
Iterum has also completed additional non-clinical pharmacokinetics and pharmacodynamics studies which it believes to support the dosing regimen selected for oral sulopenem to treat adult women with uUTIs.
The company expects the FDA’s review timeline to be six months from the date the FDA accepts the resubmitted NDA. Based on ITRM’s expectations, a final decision from the FDA is expected during the first half of the fourth quarter of 2024.
However, the company’s expectation of the regulatory approval for oral sulopenem to treat uUTIs hinges upon whether the resubmitted NDA addresses all the deficiencies identified in the CRL.
Iterum also announced that with the positive REASSURE study results in hand, it will focus on a strategic process to sell, license, or otherwise dispose of its rights to sulopenem to maximize value for its stakeholders.
Per current operating plans, the company expects its existing cash balance as of Dec 31, 2023, together with the net proceeds from the sale of ordinary shares under its at-the-market offering agreementthrough Feb 29, 2024, to fund its operating expenses into 2025.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, shares of ADMA have surged 79.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. Over the past year, shares of the FGEN have plunged 91.1%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $1.97 to $1.81. In the past year, shares of ACET have plunged 68.5%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.
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Iterum (ITRM) Plans Early Submission of UTI Drug NDA, Stock Up
Iterum Therapeutics (ITRM - Free Report) jumped 17.8% on Mar 6, 2024, and continued to gain another 3.4% in the after-market hours as it announced plans to resubmit a new drug application (NDA) for oral sulopenem to the FDA in the first half of the second quarter of 2024, ahead of schedule.
The NDA will seek approval for the candidate to treat adult women with uncomplicated urinary tract infections (uUTIs) in the United States.
Sulopenem, a thiopenem antibiotic, is being developed to treat urinary tract and intra-abdominal infections. An intravenous formulation of the candidate is also currently under development.
We remind the investors that in 2021, Iterum received a complete response letter (CRL) from the FDA against its initial NDA for oral sulopenem for the uUTIs indication. Per the CRL, the NDA could not be approved in its present form and additional data was required to support the approval of oral sulopenem for the treatment of adult women with uUTIs.
The FDA recommended Iterum to conduct an additional clinical study of the candidate, potentially using a different comparator drug. Following the FDA’s recommendation, the company initiated the phase III non-inferiority REASSURE study of oral sulopenem for the treatment of uUTIs compared with Augmentin (amoxicillin/clavulanate) in the Augmentin susceptible population.
In the past year, shares of Iterum have gained 29.6% against the industry’s 3.5% decline.
Image Source: Zacks Investment Research
The company plans to resubmit the oral sulopenem NDA for the uUTIs indication based on positive top-line results from the late-stage REASSURE study, which was announced earlier this year. The study met its primary endpoint of overall response, demonstrating non-inferiority of oral sulopenem to Augmentin.
Furthermore, treatment with oral sulopenem resulted in the overall success of combined clinical cure plus microbiologic eradication in 61.7% of patients compared with 55% for Augmentin, demonstrating statistically significant superiority over the comparator drug. Consistent results were observed for all key secondary efficacy endpoints in the uUTIs population as well.
Management believes that the encouraging results from prior phase III studies of oral sulopenem also support the candidate’s potential in other indications, such as complicated urinary tract infections.
Oral sulopenem was generally well-tolerated in the REASSURE study, observing a safety profile, consistent with previously conducted phase III studies. Detailed results are expected to be presented at an upcoming medical conference.
Iterum has also completed additional non-clinical pharmacokinetics and pharmacodynamics studies which it believes to support the dosing regimen selected for oral sulopenem to treat adult women with uUTIs.
The company expects the FDA’s review timeline to be six months from the date the FDA accepts the resubmitted NDA. Based on ITRM’s expectations, a final decision from the FDA is expected during the first half of the fourth quarter of 2024.
However, the company’s expectation of the regulatory approval for oral sulopenem to treat uUTIs hinges upon whether the resubmitted NDA addresses all the deficiencies identified in the CRL.
Iterum also announced that with the positive REASSURE study results in hand, it will focus on a strategic process to sell, license, or otherwise dispose of its rights to sulopenem to maximize value for its stakeholders.
Per current operating plans, the company expects its existing cash balance as of Dec 31, 2023, together with the net proceeds from the sale of ordinary shares under its at-the-market offering agreementthrough Feb 29, 2024, to fund its operating expenses into 2025.
Iterum Therapeutics PLC Price and Consensus
Iterum Therapeutics PLC price-consensus-chart | Iterum Therapeutics PLC Quote
Zacks Rank and Other Stocks to Consider
Iterum currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the drug/biotech industry worth mentioning are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ACET carry a Zacks Rank #2 each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, shares of ADMA have surged 79.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. Over the past year, shares of the FGEN have plunged 91.1%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $1.97 to $1.81. In the past year, shares of ACET have plunged 68.5%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.