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Reneo (RPHM) Plummets 83% on Failure of Metabolic Disorder Study
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Reneo Pharmaceuticals (RPHM - Free Report) , a clinical-stage company, announced the failure of the mid-stage pivotal STRIDE study of its investigational candidate, mavodelpar (REN001), to treat primary mitochondrial myopathies (PMM) in adult patients.
Per the data readout from the phase IIb STRIDE study, treatment with mavodelpar did not meet primary or secondary efficacy endpoints.
Based on this undesirable outcome, Reneo has decided to implement immediate cost-saving initiatives, which include the abandonment of all mavodelpar development activities. The company will also be slashing its workforce by approximately 70% under its cost-saving initiative.
Reneo reported having more than $100 million in cash, cash equivalents, and short-term investments in its balance sheet, which indicates that the company might fall short of cash to continue its operations in the absence of any additional funding.
Reneo’s stock nose-dived 82.7% on Dec 14, 2023, in response to the discouraging news. Year to date, shares of RPHM have plunged 42.5% compared with the industry’s 16.2% decline.
Image Source: Zacks Investment Research
Reneo’s mavodelpar is a potent and selective PPARδ agonist that is being studied to treat rare genetic mitochondrial diseases.
The pivotal phase IIb STRIDE study evaluated the safety and efficacy of 100 mg mavodelpar administered once daily in adult patients with PMM due to mitochondrial DNA (mDNA) defects over 24 weeks. The primary efficacy endpoint of the study was the change from baseline in the distance walked during the 12-minute walk test at week 24.
The secondary efficacy endpoint of the STRIDE study was the change from baseline in the PROMIS Short Form Fatigue 13a score, along with several other exploratory endpoints.
Reneo was also evaluating mavodelpar in an open-label extension (OLE) STRIDE AHEAD study to evaluate the long-term safety and tolerability of 100 mg mavodelpar administered once daily in adult patients with PMM due to both mitochondrial and nuclear DNA (nDNA) defects over 24 months. The OLE study has now been discontinued as part of the company’s cost-saving initiatives.
PMM is a group of rare genetic metabolic disorders caused by mutations or deletions in the mtDNA or nDNA. PMM takes a serious toll on the quality of life of the patients and ranges in severity from progressive weakness to death.
Reneo was also evaluating mavodelpar for an additional indication to treat patients with long-chain fatty acid oxidation disorders caused by deletions or mutations in nDNA. This program also stands abandoned, per the company’s press release.
The discontinuation of the entire mavodelpar development program and the absence of any other investigational candidates in its pipeline paves the way for Reneo Pharma to go belly-up shortly.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 7.8%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have gained 3.6%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 68.3%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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Reneo (RPHM) Plummets 83% on Failure of Metabolic Disorder Study
Reneo Pharmaceuticals (RPHM - Free Report) , a clinical-stage company, announced the failure of the mid-stage pivotal STRIDE study of its investigational candidate, mavodelpar (REN001), to treat primary mitochondrial myopathies (PMM) in adult patients.
Per the data readout from the phase IIb STRIDE study, treatment with mavodelpar did not meet primary or secondary efficacy endpoints.
Based on this undesirable outcome, Reneo has decided to implement immediate cost-saving initiatives, which include the abandonment of all mavodelpar development activities. The company will also be slashing its workforce by approximately 70% under its cost-saving initiative.
Reneo reported having more than $100 million in cash, cash equivalents, and short-term investments in its balance sheet, which indicates that the company might fall short of cash to continue its operations in the absence of any additional funding.
Reneo’s stock nose-dived 82.7% on Dec 14, 2023, in response to the discouraging news. Year to date, shares of RPHM have plunged 42.5% compared with the industry’s 16.2% decline.
Image Source: Zacks Investment Research
Reneo’s mavodelpar is a potent and selective PPARδ agonist that is being studied to treat rare genetic mitochondrial diseases.
The pivotal phase IIb STRIDE study evaluated the safety and efficacy of 100 mg mavodelpar administered once daily in adult patients with PMM due to mitochondrial DNA (mDNA) defects over 24 weeks. The primary efficacy endpoint of the study was the change from baseline in the distance walked during the 12-minute walk test at week 24.
The secondary efficacy endpoint of the STRIDE study was the change from baseline in the PROMIS Short Form Fatigue 13a score, along with several other exploratory endpoints.
Reneo was also evaluating mavodelpar in an open-label extension (OLE) STRIDE AHEAD study to evaluate the long-term safety and tolerability of 100 mg mavodelpar administered once daily in adult patients with PMM due to both mitochondrial and nuclear DNA (nDNA) defects over 24 months. The OLE study has now been discontinued as part of the company’s cost-saving initiatives.
PMM is a group of rare genetic metabolic disorders caused by mutations or deletions in the mtDNA or nDNA. PMM takes a serious toll on the quality of life of the patients and ranges in severity from progressive weakness to death.
Reneo was also evaluating mavodelpar for an additional indication to treat patients with long-chain fatty acid oxidation disorders caused by deletions or mutations in nDNA. This program also stands abandoned, per the company’s press release.
The discontinuation of the entire mavodelpar development program and the absence of any other investigational candidates in its pipeline paves the way for Reneo Pharma to go belly-up shortly.
Reneo Pharmaceuticals, Inc. Price and Consensus
Reneo Pharmaceuticals, Inc. price-consensus-chart | Reneo Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Reneo currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 (Buy) 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 Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 7.8%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have gained 3.6%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 68.3%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.