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KALV Stock Moves More Than 30% in a Week: What Is Driving This Rally?
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Key Takeaways
KALV surged 36% after FDA approval of Ekterly for treating acute hereditary angioedema attacks.
Ekterly is the first oral on-demand HAE drug, offering a more convenient alternative to injectables.
FDA approval was backed by strong data from the KONFIDENT study showing faster symptom relief vs. placebo.
Shares of KalVista Pharmaceuticals (KALV - Free Report) have soared 36% in the past week, all thanks to the FDA’s approval of its lead pipeline drug for the hereditary angioedema (HAE) indication.
Earlier this week, the FDA approved the company’s novel plasma kallikrein inhibitor, sebetralstat, for the treatment of acute (sudden) HAE attacks in individuals aged 12 years and older. The drug will be marketed under the brand name Ekterly.
This latest approval makes Ekterly the first and only oral on-demand therapy for HAE, a rare genetic disease marked by severe and potentially fatal swelling of the arms, legs, face and throat.
The approval also marks a milestone for KalVista, which until now has been devoid of marketed drugs. With Ekterly now ready for immediate commercial launch in the United States, KalVista transitions into a commercial-stage biotech, unlocking a potential recurring revenue stream in a niche but lucrative market.
KALV Stock Performance
Year to date, KalVista’s shares have surged 89% compared with the industry’s 5% growth. While commercial execution remains key, the current momentum reflects optimism around its product profile, launch readiness and growth prospects.
Image Source: Zacks Investment Research
How Does KALV’s Ekterly Change the HAE Treatment Paradigm?
Since HAE attacks can arise unpredictably and escalate quickly, timely administration of effective therapy is essential. While there are current on-demand treatments like Firazyr and Kalbitor — both marketed by Takeda (TAK - Free Report) — they are administered via injections, which can be inconvenient and challenging for patients in a crisis. While preventive therapies are available, HAE attacks can still occur, making on-demand solutions a necessary part of long-term disease management.
This makes Ekterly’s oral formulation a potentially game-changing advancement. The convenience of a tablet that can be taken at the first signs of an attack could drive broader adoption and enhance patient compliance.
KalVista’s Ekterly also holds an edge over Takeda’s Kalbitor, which carries a boxed warning for a life-threatening allergic reaction called anaphylaxis — a label precaution not required for Ekterly, despite its similar mechanism of action as a kallikrein inhibitor. That safety distinction could play a role in prescribing decisions.
The FDA approval is based on data from the late-stage KONFIDENT study, which showed that treatment with Ekterly achieved significantly faster symptom relief, reduced attack severity and led to quicker attack resolution compared to placebo. The safety profile of the drug was also similar to that of patients treated with placebo.
KalVista is also evaluating Ekterly in the phase III KONFIDENT-KID study in pediatric patients aged 2-11 years with HAE. The company plans to share results from this study later this year.
KALV’s Zacks Rank
KalVista currently carries a Zacks Rank #3 (Hold).
In the past 60 days, loss per share estimates for Amarin’s 2025 have improved from $3.85 to $2.30. Loss per share estimates for 2026 have narrowed from $3.59 to $1.50 during the same period. AMRN stock has surged 79% year to date.
Amarin’s earnings beat estimates in two of the trailing four quarters, met the mark once and missed in the other, delivering an average surprise of 29.11%.
In the past 60 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $3.46 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $3.91 to $1.99. AGEN stock has soared 89% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.
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KALV Stock Moves More Than 30% in a Week: What Is Driving This Rally?
Key Takeaways
Shares of KalVista Pharmaceuticals (KALV - Free Report) have soared 36% in the past week, all thanks to the FDA’s approval of its lead pipeline drug for the hereditary angioedema (HAE) indication.
Earlier this week, the FDA approved the company’s novel plasma kallikrein inhibitor, sebetralstat, for the treatment of acute (sudden) HAE attacks in individuals aged 12 years and older. The drug will be marketed under the brand name Ekterly.
This latest approval makes Ekterly the first and only oral on-demand therapy for HAE, a rare genetic disease marked by severe and potentially fatal swelling of the arms, legs, face and throat.
The approval also marks a milestone for KalVista, which until now has been devoid of marketed drugs. With Ekterly now ready for immediate commercial launch in the United States, KalVista transitions into a commercial-stage biotech, unlocking a potential recurring revenue stream in a niche but lucrative market.
KALV Stock Performance
Year to date, KalVista’s shares have surged 89% compared with the industry’s 5% growth. While commercial execution remains key, the current momentum reflects optimism around its product profile, launch readiness and growth prospects.
Image Source: Zacks Investment Research
How Does KALV’s Ekterly Change the HAE Treatment Paradigm?
Since HAE attacks can arise unpredictably and escalate quickly, timely administration of effective therapy is essential. While there are current on-demand treatments like Firazyr and Kalbitor — both marketed by Takeda (TAK - Free Report) — they are administered via injections, which can be inconvenient and challenging for patients in a crisis. While preventive therapies are available, HAE attacks can still occur, making on-demand solutions a necessary part of long-term disease management.
This makes Ekterly’s oral formulation a potentially game-changing advancement. The convenience of a tablet that can be taken at the first signs of an attack could drive broader adoption and enhance patient compliance.
KalVista’s Ekterly also holds an edge over Takeda’s Kalbitor, which carries a boxed warning for a life-threatening allergic reaction called anaphylaxis — a label precaution not required for Ekterly, despite its similar mechanism of action as a kallikrein inhibitor. That safety distinction could play a role in prescribing decisions.
The FDA approval is based on data from the late-stage KONFIDENT study, which showed that treatment with Ekterly achieved significantly faster symptom relief, reduced attack severity and led to quicker attack resolution compared to placebo. The safety profile of the drug was also similar to that of patients treated with placebo.
KalVista is also evaluating Ekterly in the phase III KONFIDENT-KID study in pediatric patients aged 2-11 years with HAE. The company plans to share results from this study later this year.
KALV’s Zacks Rank
KalVista currently carries a Zacks Rank #3 (Hold).
KalVista Pharmaceuticals, Inc. Price
KalVista Pharmaceuticals, Inc. price | KalVista Pharmaceuticals, Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Amarin Corporation (AMRN - Free Report) and Agenus (AGEN - Free Report) . While AMRN sports a Zacks Rank #1 (Strong Buy) at present, Agenus carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, loss per share estimates for Amarin’s 2025 have improved from $3.85 to $2.30. Loss per share estimates for 2026 have narrowed from $3.59 to $1.50 during the same period. AMRN stock has surged 79% year to date.
Amarin’s earnings beat estimates in two of the trailing four quarters, met the mark once and missed in the other, delivering an average surprise of 29.11%.
In the past 60 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $3.46 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $3.91 to $1.99. AGEN stock has soared 89% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.