KalVista Pharmaceuticals Receives Approval for EKTERLY (sebetralstat) in Japan
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 22 2025
0mins
Source: SeekingAlpha
Approval Announcement: Japan has granted marketing and manufacturing approval for EKTERLY (sebetralstat), a novel treatment for acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 and older.
Unique Treatment: EKTERLY is the first and only oral on-demand treatment for HAE approved in Japan, highlighting its significance in the market.
Commercialization Partner: KalVista Pharmaceuticals will partner with Kaken Pharmaceutical to commercialize EKTERLY in Japan.
Launch Timeline: Kaken Pharmaceutical plans to launch EKTERLY shortly after it is listed on the Japanese National Health Insurance System.
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Analyst Views on KALV
Wall Street analysts forecast KALV stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for KALV is 34.38 USD with a low forecast of 29.00 USD and a high forecast of 39.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
9 Analyst Rating
9 Buy
0 Hold
0 Sell
Strong Buy
Current: 15.140
Low
29.00
Averages
34.38
High
39.00
Current: 15.140
Low
29.00
Averages
34.38
High
39.00
About KALV
KalVista Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company. The Company is focused on the discovery, development and commercialization of drug therapies for diseases with significant unmet need. Its product candidate is sebetralstat, an inhibitor of plasma kallikrein being developed for hereditary angioedema (HAE). Sebetralstat is designed to offer people living with HAE a medication that can be taken as a discreet oral dose to readily treat HAE attacks on-demand, including at the earliest signs before the attack fully develops. Sebetralstat works by targeting the kallikrein-kinin system (KKS) cascade, selectively inhibiting plasma kallikrein and its uncontrolled activity that drives HAE attacks. The Company is also designing an oral Factor XIIa inhibitor for HAE prophylaxis, positioning KalVista to address the full spectrum of HAE disease management. Factor XIIa inhibitor program is developed to address other therapeutic areas, including inflammation and thrombosis.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Market Performance: Kalvista shares closed at $15.82 on Thursday, indicating that despite the target price increase, the current stock price remains significantly below the new target, suggesting a potential undervaluation by the market.
- Competitive Analysis: In the biopharmaceutical sector, Kalvista's advancements in innovative drug development may attract increased investor interest, especially in light of the target price increase, which could stimulate stock price appreciation.
- Investor Confidence: The positive rating and target price increase from analysts may bolster investor confidence in Kalvista, potentially facilitating its future financing and market expansion plans.
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KalVista Launches EKTERLY, Achieves $35M in First-Year Revenue
- Positive Market Response: KalVista Pharmaceuticals reported approximately $35 million in net product revenue for its hereditary angioedema treatment EKTERLY in Q4 2025, indicating strong market demand through growing prescriber adoption and repeat prescriptions.
- Breakthrough Treatment: EKTERLY is the first and only oral on-demand treatment approved by the FDA in July 2025 for acute attacks in patients aged 12 and older, representing a significant advancement in the treatment landscape.
- Global Expansion Plans: KalVista granted Multicare Pharmaceuticals exclusive rights to commercialize sebetralstat in Latin America, covering Brazil, Argentina, Colombia, and Mexico, thereby enhancing its global market reach.
- Rapid Clinical Progress: The company completed enrollment in the Phase 3 KONFIDENT-KID trial evaluating sebetralstat in children aged 2 to 11 a full year ahead of schedule, with plans to submit a new drug application in Q3 2026 and a potential U.S. launch in 2027.
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