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Vertex (VRTX) Non-Cystic Fibrosis Pipeline Boosts Stock This Year
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Vertex Pharmaceuticals Incorporated (VRTX - Free Report) enjoys a dominant position in the cystic fibrosis (CF) market. Vertex’s CF sales continue to grow, driven by its triple therapy, Trikafta (marketed as Kaftrio in Europe). In the United States, Trikafta sales are being fueled by label expansions to younger age groups (two to five years old). In the ex-U.S. markets, the drug continues to witness strong uptake with recently achieved reimbursements and expanded use in young age groups.
While CF remains the main area of focus, Vertex is also developing treatments for sickle cell disease (SCD), beta thalassemia (TDT), 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.
So far this year, the stock has risen 23.6% against the industry’s 23.1% decline.
Image Source: Zacks Investment Research
In the CF franchise, all eyes are on the triple combination of vanzacaftor, a CFTR potentiator, deutivacaftor, a CFTR corrector and tezacaftor. Vertex is developing the triple combination CF regimen for patients 12 years of age and older. The company has completed enrollment in two pivotal phase III on the triple combination regimen. This new once-a-day combination medicine has the potential to offer enhanced patient benefits than Trikafta. It can potentially treat CF patients who have discontinued Trikafta or other Vertex CF medicines. It can also improve dosing (once daily) and lower the royalty burden.
The studies are expected to be completed by the end of 2023. Vertex also expects the pivotal studies of vanzacaftor/tezacaftor/deutivacaftor in patients six to 11 years old to be completed by the end of 2023. Data from all three studies are expected in early 2024.
Additionally, Vertex is developing a mRNA therapeutic, VX-522, in partnership with Moderna (MRNA - Free Report) for approximately 5,000 people with CF who cannot benefit from its CFTR modulators. Vertex and Moderna are conducting a single ascending dose (SAD) clinical study on VX-522, after the FDA cleared the investigational new drug application in December 2022. Vertex expects to complete SAD and initiate the multiple ascending dose (MAD) study by the end of 2023.
Many of its non-CF candidates represent multibillion-dollar opportunities. Seven of the programs are past the proof-of-concept stage.
Vertex has co-developed a gene-editing treatment, Casgevy (exa-cel), in partnership with CRISPR Therapeutics (CRSP - Free Report) , for two devastating diseases — SCD and TDT. Casgevy was approved for both indications in the United Kingdom in November 2023.
Vertex and CRISPR Therapeutics have submitted a regulatory application to the FDA for exa-cel in SCD and TDT indications, with a final decision expected by Dec 8, 2023 (priority review) and Mar 30, 2024, respectively. Vertex and CRISPR Therapeutics’ submissions on exa-cel in the European Union are under review. Vertex expects exa-cel to be its next commercial launch. Vertex believes exa-cel has the potential to be a one-time functional cure for SCD and TDT patients, with an estimated patient population of approximately 32,000.
Investors are paying a lot of attention to pain asset VX-548, which, they believe, has blockbuster potential.
VX-548, a novel first-in-class, non-opioid NaV1.8 inhibitor, is being evaluated in two pivotal phase III acute pain studies, one following bunionectomy surgery and the other following abdominoplasty surgery. The pivotal program is expected to be completed in late 2023, with data readout expected in 2024.
Vertex has completed a phase II study of VX-548 in diabetic peripheral neuropathy, a form of peripheral neuropathic pain, with data readout expected in late 2023. Vertex plans to begin another mid-stage study of VX-548 in patients with lumbosacral radiculopathy, another form of peripheral neuropathic pain, in late 2023.
A better-ranked biotech stock is Dynavax Technologies Corporation (DVAX - Free Report) , with a Zacks Rank of 2 (Buy).
In the past 30 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 22 cents to 12 cents. During the same period, earnings per share estimates for 2024 have improved from 8 cents to 18 cents. Year to date, shares of DVAX have rallied 28.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 293.21%.
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Vertex (VRTX) Non-Cystic Fibrosis Pipeline Boosts Stock This Year
Vertex Pharmaceuticals Incorporated (VRTX - Free Report) enjoys a dominant position in the cystic fibrosis (CF) market. Vertex’s CF sales continue to grow, driven by its triple therapy, Trikafta (marketed as Kaftrio in Europe). In the United States, Trikafta sales are being fueled by label expansions to younger age groups (two to five years old). In the ex-U.S. markets, the drug continues to witness strong uptake with recently achieved reimbursements and expanded use in young age groups.
While CF remains the main area of focus, Vertex is also developing treatments for sickle cell disease (SCD), beta thalassemia (TDT), 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.
So far this year, the stock has risen 23.6% against the industry’s 23.1% decline.
Image Source: Zacks Investment Research
In the CF franchise, all eyes are on the triple combination of vanzacaftor, a CFTR potentiator, deutivacaftor, a CFTR corrector and tezacaftor. Vertex is developing the triple combination CF regimen for patients 12 years of age and older. The company has completed enrollment in two pivotal phase III on the triple combination regimen. This new once-a-day combination medicine has the potential to offer enhanced patient benefits than Trikafta. It can potentially treat CF patients who have discontinued Trikafta or other Vertex CF medicines. It can also improve dosing (once daily) and lower the royalty burden.
The studies are expected to be completed by the end of 2023. Vertex also expects the pivotal studies of vanzacaftor/tezacaftor/deutivacaftor in patients six to 11 years old to be completed by the end of 2023. Data from all three studies are expected in early 2024.
Additionally, Vertex is developing a mRNA therapeutic, VX-522, in partnership with Moderna (MRNA - Free Report) for approximately 5,000 people with CF who cannot benefit from its CFTR modulators. Vertex and Moderna are conducting a single ascending dose (SAD) clinical study on VX-522, after the FDA cleared the investigational new drug application in December 2022. Vertex expects to complete SAD and initiate the multiple ascending dose (MAD) study by the end of 2023.
Many of its non-CF candidates represent multibillion-dollar opportunities. Seven of the programs are past the proof-of-concept stage.
Vertex has co-developed a gene-editing treatment, Casgevy (exa-cel), in partnership with CRISPR Therapeutics (CRSP - Free Report) , for two devastating diseases — SCD and TDT. Casgevy was approved for both indications in the United Kingdom in November 2023.
Vertex and CRISPR Therapeutics have submitted a regulatory application to the FDA for exa-cel in SCD and TDT indications, with a final decision expected by Dec 8, 2023 (priority review) and Mar 30, 2024, respectively. Vertex and CRISPR Therapeutics’ submissions on exa-cel in the European Union are under review. Vertex expects exa-cel to be its next commercial launch. Vertex believes exa-cel has the potential to be a one-time functional cure for SCD and TDT patients, with an estimated patient population of approximately 32,000.
Investors are paying a lot of attention to pain asset VX-548, which, they believe, has blockbuster potential.
VX-548, a novel first-in-class, non-opioid NaV1.8 inhibitor, is being evaluated in two pivotal phase III acute pain studies, one following bunionectomy surgery and the other following abdominoplasty surgery. The pivotal program is expected to be completed in late 2023, with data readout expected in 2024.
Vertex has completed a phase II study of VX-548 in diabetic peripheral neuropathy, a form of peripheral neuropathic pain, with data readout expected in late 2023. Vertex plans to begin another mid-stage study of VX-548 in patients with lumbosacral radiculopathy, another form of peripheral neuropathic pain, in late 2023.
Zacks Rank and A Stock to Consider
Vertex currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Pharmaceuticals Incorporated Price and Consensus
Vertex Pharmaceuticals Incorporated price-consensus-chart | Vertex Pharmaceuticals Incorporated Quote
A better-ranked biotech stock is Dynavax Technologies Corporation (DVAX - Free Report) , with a Zacks Rank of 2 (Buy).
In the past 30 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 22 cents to 12 cents. During the same period, earnings per share estimates for 2024 have improved from 8 cents to 18 cents. Year to date, shares of DVAX have rallied 28.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 293.21%.