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Vertex (VRTX) Hits Record High on Non-Opioid Pain Drug Data
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Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced encouraging data from a phase II study that demonstrated a promising safety and efficacy profile of its investigational non-opioid pain medicine, VX-548, for treating painful diabetic peripheralneuropathy (DPN) across all doses. DPN is a type of neuropathic pain (damage to nerves) caused by diabetes.
The data from the phase II dose-ranging study showed that VX-548, a novel first-in-class NaV1.8 inhibitor, led to a statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the Numeric Pain Rating Scale (NPRS), a measure of pain intensity in adults.
The mean change in NPRS at Week 12 was -2.26, -2.11 and -2.18 at the 69 mg, 46 mg and 23 mg doses, respectively. In the active reference arm of pregabalin (neuropathic pain relief tablets), the mean change from baseline in NPRS at Week 12 was -2.09. In all the dose arms, sustained mean reductions in pain were observed from baseline starting at Week 1. The pain intensity continued to decrease until Week 5 and was then maintained throughout the treatment period of 12 weeks. More than 30% of patients treated with VX-548 achieved more than 50% reduction in pain in all dose groups, while more than 20% of patients reported a 70% decline in pain in 69 mg and 46 mg dose arms. VX-548 was generally well tolerated in the study, with no serious adverse events.
Based on the positive data from the phase II study, Vertex plans to move VX-548 to pivotal development for DPN.
Vertex also initiated the second phase study of VX-548 in patients with painful lumbosacral radiculopathy, another form of peripheral neuropathic pain (caused by damage to nerves).
Investors are paying a lot of attention to VX-548, which, they believe, has blockbuster potential. It can change the standard of care for neuropathic pain, an area with limited treatment options, mostly highly addictive opioid-based medications. Following the positive data, shares of Vertex were up 13.2% on Wednesday, hitting a 52-week high price of $405.36.
So far this year, the stock has risen 40.7% against the industry’s 19.2% decline.
Image Source: Zacks Investment Research
VX-548 is also being evaluated in two pivotal phase III acute pain studies, one following bunionectomy surgery and the other following abdominoplasty surgery. Data from the pivotal studies are expected in first-quarter 2024.
Though Vertex enjoys a dominant position in the cystic fibrosis (CF) market, it has seen success in its non-CF pipeline candidates’ development lately.
Last week, the FDA approved Vertex and partner CRISPR Therapeutics’ (CRSP - Free Report) Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease (SCD) for patients aged 12 years and older with recurrent vaso-occlusive crises. Casgevy became the first CRISPR-based gene-editing therapy to be approved in the United States.
CRISPR and Vertex have also developed Cagevy for the treatment of transfusion-dependent beta thalassemia (TDT) in the United States. A regulatory filing for the use of Casgevy for this indication is currently under review. A decision from the FDA is expected on Mar 30, 2024. Last month, Casgevy was approved in the United Kingdom for treating both SCD and TDT indications.
This week, Vertex also struck a non-exclusive licensing deal with Editas Medicine (EDIT - Free Report) for using the latter’s Cas9 gene-editing technology for developing Casgevy. Editas’Cas9 gene editing tool uses an enzyme called Cas9 to target genetic defects that cause specific diseases, thus providing a precise and targeted approach to gene editing medicines.
A better-ranked biotech stock is Dynavax Technologies Corporation (DVAX - Free Report) , carrying a Zacks Rank of 2 (Buy).
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 23 cents to 12 cents. During the same period, earnings per share estimates for 2024 have improved from 3 cents to 18 cents. Year to date, shares of DVAX have rallied 26.4%.
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) Hits Record High on Non-Opioid Pain Drug Data
Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced encouraging data from a phase II study that demonstrated a promising safety and efficacy profile of its investigational non-opioid pain medicine, VX-548, for treating painful diabetic peripheralneuropathy (DPN) across all doses. DPN is a type of neuropathic pain (damage to nerves) caused by diabetes.
The data from the phase II dose-ranging study showed that VX-548, a novel first-in-class NaV1.8 inhibitor, led to a statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the Numeric Pain Rating Scale (NPRS), a measure of pain intensity in adults.
The mean change in NPRS at Week 12 was -2.26, -2.11 and -2.18 at the 69 mg, 46 mg and 23 mg doses, respectively. In the active reference arm of pregabalin (neuropathic pain relief tablets), the mean change from baseline in NPRS at Week 12 was -2.09. In all the dose arms, sustained mean reductions in pain were observed from baseline starting at Week 1. The pain intensity continued to decrease until Week 5 and was then maintained throughout the treatment period of 12 weeks. More than 30% of patients treated with VX-548 achieved more than 50% reduction in pain in all dose groups, while more than 20% of patients reported a 70% decline in pain in 69 mg and 46 mg dose arms. VX-548 was generally well tolerated in the study, with no serious adverse events.
Based on the positive data from the phase II study, Vertex plans to move VX-548 to pivotal development for DPN.
Vertex also initiated the second phase study of VX-548 in patients with painful lumbosacral radiculopathy, another form of peripheral neuropathic pain (caused by damage to nerves).
Investors are paying a lot of attention to VX-548, which, they believe, has blockbuster potential. It can change the standard of care for neuropathic pain, an area with limited treatment options, mostly highly addictive opioid-based medications. Following the positive data, shares of Vertex were up 13.2% on Wednesday, hitting a 52-week high price of $405.36.
So far this year, the stock has risen 40.7% against the industry’s 19.2% decline.
Image Source: Zacks Investment Research
VX-548 is also being evaluated in two pivotal phase III acute pain studies, one following bunionectomy surgery and the other following abdominoplasty surgery. Data from the pivotal studies are expected in first-quarter 2024.
Though Vertex enjoys a dominant position in the cystic fibrosis (CF) market, it has seen success in its non-CF pipeline candidates’ development lately.
Last week, the FDA approved Vertex and partner CRISPR Therapeutics’ (CRSP - Free Report) Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease (SCD) for patients aged 12 years and older with recurrent vaso-occlusive crises. Casgevy became the first CRISPR-based gene-editing therapy to be approved in the United States.
CRISPR and Vertex have also developed Cagevy for the treatment of transfusion-dependent beta thalassemia (TDT) in the United States. A regulatory filing for the use of Casgevy for this indication is currently under review. A decision from the FDA is expected on Mar 30, 2024. Last month, Casgevy was approved in the United Kingdom for treating both SCD and TDT indications.
This week, Vertex also struck a non-exclusive licensing deal with Editas Medicine (EDIT - Free Report) for using the latter’s Cas9 gene-editing technology for developing Casgevy. Editas’Cas9 gene editing tool uses an enzyme called Cas9 to target genetic defects that cause specific diseases, thus providing a precise and targeted approach to gene editing medicines.
Zacks Rank and 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) , carrying a Zacks Rank of 2 (Buy).
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 23 cents to 12 cents. During the same period, earnings per share estimates for 2024 have improved from 3 cents to 18 cents. Year to date, shares of DVAX have rallied 26.4%.
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%.