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Kalvista Pharm - KALV STOCK NEWS

Welcome to our dedicated page for Kalvista Pharm news (Ticker: KALV), a resource for investors and traders seeking the latest updates and insights on Kalvista Pharm stock.

KalVista Pharmaceuticals Inc (KALV) is a clinical-stage biopharmaceutical company advancing novel protease inhibitors for rare diseases. This dedicated news hub provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic initiatives.

Our curated collection offers immediate access to KALV's latest press releases, including progress on oral plasma kallikrein inhibitors for hereditary angioedema and diabetic macular edema therapies. Track updates across all development phases – from preclinical research to late-stage trials – while staying informed about partnership announcements and financial disclosures.

Key coverage areas include clinical trial results, FDA communications, intellectual property developments, and scientific presentations. The resource is particularly valuable for monitoring KALV's Factor XIIa inhibitor program and comparative effectiveness data against existing therapies.

Bookmark this page for real-time updates on KalVista's innovative pipeline and regulatory progress. For comprehensive tracking of this clinical-stage innovator's journey in protease inhibition therapeutics, we recommend checking back regularly.

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KalVista Pharmaceuticals (Nasdaq: KALV) has entered into a licensing agreement with Kaken Pharmaceutical for commercialization rights of sebetralstat in Japan. The deal includes an $11 million upfront payment, potential additional payment of up to $11 million upon achieving regulatory milestone expected in early 2026, plus commercial milestone payments and royalties approximately in the mid-twenties percentage of sales.

Sebetralstat is an investigational, oral on-demand treatment for hereditary angioedema (HAE). The drug has received Orphan Drug Designation from Japan's Ministry of Health, Labour and Welfare, and KalVista has submitted a New Drug Application in Japan. If approved, sebetralstat would become the first oral on-demand treatment for HAE in Japan.

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KalVista Pharmaceuticals (NASDAQ: KALV) has granted inducement stock options to ten newly-hired employees. The aggregate grant consists of 87,000 shares of KalVista common stock, issued on April 1, 2025.

The options' exercise price matches KalVista's common stock closing price on the grant date. The vesting schedule includes 25% after one year, with the remaining vesting monthly over three years, contingent on continued employment. The options have a 10-year term and fall under KalVista's Inducement Equity Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4).

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KalVista Pharmaceuticals (NASDAQ: KALV) has announced its upcoming participation in the 24th Annual Needham Virtual Healthcare Conference. The company will engage in a fireside chat scheduled for Monday, April 7, 2025, at 1:30 p.m. ET.

The presentation will be accessible through a live webcast on KalVista's official website. Additionally, an audio recording of the presentation will remain available on the company's website for 30 days following the event.

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KalVista Pharmaceuticals (KALV) has completed enrollment for its KONFIDENT-KID clinical trial of sebetralstat, an oral plasma kallikrein inhibitor for pediatric hereditary angioedema (HAE) patients aged 2-11. Due to high demand, the trial expanded from 24 to approximately 36 patients across seven countries in North America, Europe, and Asia.

The enrollment was completed a full year ahead of schedule. The trial will collect safety, pharmacokinetic, and efficacy data for up to one year using a proprietary pediatric oral disintegrating tablet formulation. Initial results are expected before year-end, with an sNDA submission planned by mid-2026.

If approved, sebetralstat would become the first oral on-demand therapy for pediatric HAE patients aged 2-11 years and only the second FDA-approved on-demand treatment in this population. Currently, the only available on-demand treatment for this age group in the U.S. requires intravenous administration.

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KalVista Pharmaceuticals (KALV) reported its Q3 fiscal 2025 results and operational updates, highlighting significant progress for sebetralstat, its oral treatment for hereditary angioedema (HAE). The company secured its seventh regulatory submission and orphan drug designation in Japan, with FDA PDUFA date set for June 17, 2025.

New clinical data demonstrated sebetralstat's effectiveness in treating laryngeal attacks, with median symptom relief time of 1 hour 16 minutes. The drug showed promise for adolescents and patients on long-term prophylaxis, who experienced 1.7 HAE attacks per month with symptom relief in 1.3 hours median time.

Financially, KalVista reported no revenue for Q3. R&D expenses decreased to $12.6M from $22.5M year-over-year, while G&A expenses increased to $30.3M from $10.6M due to pre-commercial activities. The company secured $160M through royalty financing and equity offerings, maintaining a strong cash position of $253.2M as of January 31, 2025.

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KalVista Pharmaceuticals (NASDAQ: KALV) has announced a virtual investor event focused on the commercialization strategy for sebetralstat, their investigational treatment for hereditary angioedema (HAE).

The webcast is scheduled for Tuesday, March 25, 2025, from 8:00 AM to 10:00 AM ET. The event will feature presentations from KalVista's management team and leading HAE experts who will discuss:

  • Current HAE treatment guidelines
  • Unmet needs for HAE patients
  • Potential of sebetralstat as a new treatment option

The event will include a live Q&A session and can be accessed through the Investors section at ir.kalvista.com. A replay will be available after the event.

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KalVista Pharmaceuticals (NASDAQ: KALV) announced the granting of inducement stock options to two newly-hired employees. The compensation committee approved options to purchase a total of 14,000 shares of KalVista common stock on March 3, 2025.

The options' exercise price equals the closing price of KalVista stock on the grant date. The vesting schedule includes 25% after one year, with the remaining vesting monthly over three years, contingent on continued employment. The options have a 10-year term and fall under KalVista's Inducement Equity Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4).

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KalVista Pharmaceuticals (KALV) presented new data for sebetralstat in treating hereditary angioedema (HAE) attacks at the AAAAI/WAO 2025 Joint Congress. The KONFIDENT-S study showed promising results for laryngeal HAE attacks, with patients achieving:

- Median treatment time of 11.5 minutes after attack onset
- Median symptom relief time of 1.27 hours
- 96% effectiveness with single dose
- No difficulty swallowing tablets reported

For adolescent patients, pooled analysis from KONFIDENT/KONFIDENT-S studies (149 attacks) demonstrated:
- Median treatment time of 4 minutes vs. traditional 3+ hours
- Safety and efficacy comparable to adults
- No serious adverse events

If approved, sebetralstat would become the first oral on-demand treatment for HAE attacks, potentially transforming HAE management, particularly for vulnerable populations like adolescents and those experiencing laryngeal attacks.

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KalVista Pharmaceuticals (NASDAQ: KALV) has announced its participation in two major upcoming investor conferences. The company will engage in fireside chat presentations at the TD Cowen 45th Annual Health Care Conference in Boston on March 4, 2025, at 1:10 p.m. ET, and at the Leerink Partners 2025 Global Healthcare Conference in Miami on March 10, 2025, at 8:00 a.m. ET.

Both presentations will be accessible through live webcasts on KalVista's website (www.kalvista.com). The company will maintain audio archives of the presentations on their website for a 30-day period following the events.

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KalVista Pharmaceuticals (Nasdaq: KALV) has announced the acceptance of six abstracts for presentation at the AAAAI/WAO 2025 Joint Congress in San Diego from February 28–March 3, 2025. The presentations focus on sebetralstat and hereditary angioedema (HAE) treatment research.

Three poster presentations on February 28 will address barriers to HAE treatment in Italian patients, burden of injectable treatments in adolescents, and delays in on-demand treatment across healthcare systems. Two late-breaking posters on March 1 will present findings on HAE with normal C1INH diagnoses and sebetralstat's effectiveness for laryngeal HAE attacks from the KONFIDENT-S study.

An oral presentation on March 1 will discuss sebetralstat's use for on-demand HAE attack treatment in adolescents, analyzing pooled data from KONFIDENT and KONFIDENT-S studies. All presentation materials will be available on KalVista's website under Publications.

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Kalvista Pharm

Nasdaq:KALV

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571.23M
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1.36%
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11.21%
Biotechnology
Pharmaceutical Preparations
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United States
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