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Pharvaris (PHVS) Stock Up 18% on HAE Drug Meeting Study Goal
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Shares of Pharvaris (PHVS - Free Report) soared 18.1% on Wednesday after management announced that encouraging topline data from the phase II CHAPTER-1 study evaluating deucrictibant for the prophylactic treatment of hereditary angioedema (“HAE”) attacks.
The CHAPTER-1 study evaluated two doses of an immediate-release capsule version of deucrictibant (20mg and 40mg) against a placebo over a 12-week treatment period.
The study achieved its primary endpoint of the time-normalized number of investigator-confirmed HAE attacks during the treatment period. Data from the study showed an 84.5% reduction in monthly attack rate in patients who received a 40mg dose of deucrictibant compared to those receiving a placebo.
Treatment with deucrictibant also led to a reduction in the severity of attacks. It reduced the number of attacks that had to be treated with on-demand medication, which were the study’s secondary endpoints. Both doses of the drug were well-tolerated in study participants.
A rare genetic disease, HAE is marked by severe and potentially fatal swelling of the arms, legs, face and throat.
Year to date, shares of Pharvaris have surged 120% against the industry’s 20.9% decline.
Pharvaris is developing two formulations of deucrictibant — an immediate-release capsule formulation to enable rapid onset of activity for acute treatment — and an extended-release tablet to enable sustained absorption and efficacy in prophylactic treatment. The extended-release formulation of the drug is being evaluated in a phase I study for the prophylaxis treatment of HAE.
This encouraging clinical progress comes almost half a year after the FDA lifted its clinical hold on the use of deucrictibant as an on-demand treatment in the United States. Though the clinical hold on the use of deucrictibant as a long-term prophylaxis still remains active in the United States, the study was unaffected in ex-U.S. countries.
The remaining clinical hold will be removed provided Pharvaris completes a 26-week rodent toxicology study. Management completed this study and claims that the study objective has been met. The company intends to submit these results to the FDA by this month’s end.
Like Pharvaris, Ionis Pharmaceuticals (IONS - Free Report) is evaluating its pipeline candidate to reduce HAE attacks.
Last month, Ionis reported positive data from the two-year analysis of a phase II open-label expansion study on its investigational prophylactic medicine, donidalorsen, in patients with HAE. The analysis of the data from the study showed that continued treatment with the Ionis drug over two years demonstrated a sustained reduction in HAE attacks and improved quality of life. Ionis is currently evaluating donidalorsen in a phase III study in HAE patients. The top-line data from this study is expected in first-half 2024.
Following the announcement of Pharvaris’ results, shares of BioCryst Pharmaceuticals (BCRX - Free Report) fell 10% on Dec 6. BioCryst markets Orladeyo, which was approved by the FDA in 2020 as the first oral treatment for HAE attacks in individuals aged 12 years and older. Some Wall analysts pointed out that the results posted by Pharvaris put deucrictibant in a favorable position over the BioCryst drug.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.63. During the same period, the earnings estimates for 2024 have risen from $2.95 to $3.12. Shares of NVO have surged 44.2% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
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Pharvaris (PHVS) Stock Up 18% on HAE Drug Meeting Study Goal
Shares of Pharvaris (PHVS - Free Report) soared 18.1% on Wednesday after management announced that encouraging topline data from the phase II CHAPTER-1 study evaluating deucrictibant for the prophylactic treatment of hereditary angioedema (“HAE”) attacks.
The CHAPTER-1 study evaluated two doses of an immediate-release capsule version of deucrictibant (20mg and 40mg) against a placebo over a 12-week treatment period.
The study achieved its primary endpoint of the time-normalized number of investigator-confirmed HAE attacks during the treatment period. Data from the study showed an 84.5% reduction in monthly attack rate in patients who received a 40mg dose of deucrictibant compared to those receiving a placebo.
Treatment with deucrictibant also led to a reduction in the severity of attacks. It reduced the number of attacks that had to be treated with on-demand medication, which were the study’s secondary endpoints. Both doses of the drug were well-tolerated in study participants.
A rare genetic disease, HAE is marked by severe and potentially fatal swelling of the arms, legs, face and throat.
Year to date, shares of Pharvaris have surged 120% against the industry’s 20.9% decline.
Pharvaris is developing two formulations of deucrictibant — an immediate-release capsule formulation to enable rapid onset of activity for acute treatment — and an extended-release tablet to enable sustained absorption and efficacy in prophylactic treatment. The extended-release formulation of the drug is being evaluated in a phase I study for the prophylaxis treatment of HAE.
This encouraging clinical progress comes almost half a year after the FDA lifted its clinical hold on the use of deucrictibant as an on-demand treatment in the United States. Though the clinical hold on the use of deucrictibant as a long-term prophylaxis still remains active in the United States, the study was unaffected in ex-U.S. countries.
The remaining clinical hold will be removed provided Pharvaris completes a 26-week rodent toxicology study. Management completed this study and claims that the study objective has been met. The company intends to submit these results to the FDA by this month’s end.
Like Pharvaris, Ionis Pharmaceuticals (IONS - Free Report) is evaluating its pipeline candidate to reduce HAE attacks.
Last month, Ionis reported positive data from the two-year analysis of a phase II open-label expansion study on its investigational prophylactic medicine, donidalorsen, in patients with HAE. The analysis of the data from the study showed that continued treatment with the Ionis drug over two years demonstrated a sustained reduction in HAE attacks and improved quality of life. Ionis is currently evaluating donidalorsen in a phase III study in HAE patients. The top-line data from this study is expected in first-half 2024.
Following the announcement of Pharvaris’ results, shares of BioCryst Pharmaceuticals (BCRX - Free Report) fell 10% on Dec 6. BioCryst markets Orladeyo, which was approved by the FDA in 2020 as the first oral treatment for HAE attacks in individuals aged 12 years and older. Some Wall analysts pointed out that the results posted by Pharvaris put deucrictibant in a favorable position over the BioCryst drug.
Zacks Rank & Key Pick
Pharvaris currently carries a Zacks Rank #3 (Hold).A better-ranked stock in the overall healthcare sector is Novo Nordisk (NVO - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.63. During the same period, the earnings estimates for 2024 have risen from $2.95 to $3.12. Shares of NVO have surged 44.2% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.