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Vertex (VRTX) Kidney Disease Drug to Enter Clinical Development
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Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the FDA has cleared its investigational new drug application to begin clinical development of its pipeline candidate, VX-407, for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Vertex plans to begin a phase I study on VX-407 in ADPKD later this month.
VX-407 is a first-in-class small molecule corrector that targets the underlying cause of this common inherited kidney disease, which leads to growth of several kidney-enlarging cysts that hurt kidney function. This can eventually lead to kidney failure or premature death. ADPKD affects 250,000 people in the United States and Europe. However, at present, no drugs are approved to address the underlying cause of ADPKD.
Vertex’s stock has risen 36.4% in the past year against a decline of 7.6% for the industry.
Image Source: Zacks Investment Research
While cystic fibrosis (CF) remains the main area of focus for Vertex, the company is seeing rapid success in its non-CF pipeline candidates’ development. Vertex and partner CRISPR Therapeutics’ (CRSP - Free Report) one-shot gene therapy, Casgevy, was approved for two blood disorders, sickle cell disease and transfusion-dependent beta thalassemia, in multiple regions in 2023. These approvals have diversified its commercial opportunity.
Vertex is also developing treatments for acute and neuropathic pain, APOL1-mediated kidney disease, type I diabetes and alpha-1 antitrypsin deficiency. It has earlier-stage programs in diseases such as muscular dystrophy. ADPKD is Vertex’s 10th disease area in its clinical pipeline.
Many of its non-CF candidates represent multibillion-dollar opportunities. Among these, investors are paying a lot of attention to pain asset VX-548, which, they believe, has blockbuster potential.
Vertex has completed three pivotal phase III acute pain studies on VX-548, a novel first-in-class, non-opioid NaV1.8 inhibitor. Data from the studies, announced in January 2024, showed that treatment with VX-548 led to a significant reduction in pain intensity across a range of conditions, both surgical and non-surgical, and across a range of settings. Based on the above data, Vertex plans to submit a new drug application with the FDA for VX-548 across a broad label in moderate-to-severe acute pain by mid-2024.
Zacks Rank and Stocks to Consider
Vertex currently has a Zacks Rank #3 (Hold).
Vertex Pharmaceuticals Incorporated Price and Consensus
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 99.3%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.
In the past 60 days, estimates for MorphoSys’ 2024 loss per share have improved from $2.26 to $2.08. Estimates for 2025 have narrowed from a loss of $1.09 per share to a loss of 89 cents per share. In the past year, shares of MOR have risen 357.3%.
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Vertex (VRTX) Kidney Disease Drug to Enter Clinical Development
Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the FDA has cleared its investigational new drug application to begin clinical development of its pipeline candidate, VX-407, for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Vertex plans to begin a phase I study on VX-407 in ADPKD later this month.
VX-407 is a first-in-class small molecule corrector that targets the underlying cause of this common inherited kidney disease, which leads to growth of several kidney-enlarging cysts that hurt kidney function. This can eventually lead to kidney failure or premature death. ADPKD affects 250,000 people in the United States and Europe. However, at present, no drugs are approved to address the underlying cause of ADPKD.
Vertex’s stock has risen 36.4% in the past year against a decline of 7.6% for the industry.
Image Source: Zacks Investment Research
While cystic fibrosis (CF) remains the main area of focus for Vertex, the company is seeing rapid success in its non-CF pipeline candidates’ development. Vertex and partner CRISPR Therapeutics’ (CRSP - Free Report) one-shot gene therapy, Casgevy, was approved for two blood disorders, sickle cell disease and transfusion-dependent beta thalassemia, in multiple regions in 2023. These approvals have diversified its commercial opportunity.
Vertex is also developing treatments for acute and neuropathic pain, APOL1-mediated kidney disease, type I diabetes and alpha-1 antitrypsin deficiency. It has earlier-stage programs in diseases such as muscular dystrophy. ADPKD is Vertex’s 10th disease area in its clinical pipeline.
Many of its non-CF candidates represent multibillion-dollar opportunities. Among these, investors are paying a lot of attention to pain asset VX-548, which, they believe, has blockbuster potential.
Vertex has completed three pivotal phase III acute pain studies on VX-548, a novel first-in-class, non-opioid NaV1.8 inhibitor. Data from the studies, announced in January 2024, showed that treatment with VX-548 led to a significant reduction in pain intensity across a range of conditions, both surgical and non-surgical, and across a range of settings. Based on the above data, Vertex plans to submit a new drug application with the FDA for VX-548 across a broad label in moderate-to-severe acute pain by mid-2024.
Zacks Rank and Stocks to Consider
Vertex currently has a Zacks Rank #3 (Hold).
Vertex Pharmaceuticals Incorporated Price and Consensus
Vertex Pharmaceuticals Incorporated price-consensus-chart | Vertex Pharmaceuticals Incorporated Quote
Some better-ranked stocks in the healthcare sector are ADMA Biologics (ADMA - Free Report) and MorphoSys , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 99.3%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.
In the past 60 days, estimates for MorphoSys’ 2024 loss per share have improved from $2.26 to $2.08. Estimates for 2025 have narrowed from a loss of $1.09 per share to a loss of 89 cents per share. In the past year, shares of MOR have risen 357.3%.