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. (NASDAQ: KALV) generates frequent news flow around its work in hereditary angioedema (HAE) and the commercialization of EKTERLY (sebetralstat). Company press releases highlight regulatory approvals, commercial launches, clinical data presentations and financial updates tied to this first and only oral on-demand treatment for acute HAE attacks in people 12 years of age and older.
News items cover major milestones such as FDA approval of EKTERLY in the United States, subsequent approvals in the European Union, United Kingdom, Switzerland, Australia, Singapore and Japan, and the initiation of commercial launches in the U.S. and Germany. KalVista also reports on licensing and commercialization agreements with partners like Kaken Pharmaceutical in Japan, Pendopharm in Canada and Multicare Pharmaceuticals in Latin America, which expand EKTERLY’s reach into additional markets.
Investors and clinicians following KALV can track updates on net product revenue from EKTERLY, patient start forms, prescriber activation and refill trends, as well as financing events such as the issuance of convertible senior notes. The company regularly announces new clinical and real‑world data from the KONFIDENT, KONFIDENT‑S and KONFIDENT‑KID studies, including patient satisfaction, pediatric interim results and European experience with sebetralstat, often presented at meetings such as the American College of Allergy, Asthma & Immunology Annual Scientific Meeting and the German Allergy Congress.
Additional KalVista news includes corporate governance developments, board and executive appointments, inducement equity grants and participation in healthcare investor conferences. This news page allows readers to follow how KalVista advances EKTERLY globally, engages with the HAE community and reports on its operational and financial progress over time.
KalVista Pharmaceuticals (KALV) reported significant operational progress, achieving over 50% enrollment in the pivotal phase 3 KONFIDENT trial for sebetralstat. The company completed a $58 million financing, ensuring funding into 2025, while publishing phase 2 trial results in The Lancet. Q3 financial results showed no revenue and a net loss of $21.3 million, an improvement from $22.5 million year-over-year. R&D expenses increased to $20.1 million, reflecting ongoing clinical trials. KalVista remains focused on addressing hereditary angioedema treatment needs and plans to utilize new funding for trials and general corporate purposes.
KalVista Pharmaceuticals presented five posters at the 2023 AAAAI Annual Meeting in San Antonio, Texas, showcasing key findings related to sebetralstat, an oral treatment for Hereditary Angioedema (HAE). The research indicates that orally disintegrating tablets display similar pharmacokinetics to existing film-coated tablets, which supports potential lifecycle extensions in the US and EU. Data also illustrate the treatment burden of injectable therapies, with an emphasis on the advantages of sebetralstat. Notably, Phase 2 trial results show that early treatment can significantly lower attack severity and cumulative symptom burden compared to placebo.
KalVista Pharmaceuticals (NASDAQ: KALV) announced the acceptance of multiple abstracts for the 2023 Annual Scientific Meeting of the American Academy of Allergy, Asthma & Immunology in San Antonio, Texas, from February 24-27. Results from studies will be presented on February 26 from 9:45-10:45 a.m. CST. Key presentations include:
- Treatment with Sebetralstat for hereditary angioedema.
- Comparative bioavailability of Sebetralstat.
- Anxiety related to on-demand treatment for hereditary angioedema.
- Patient perspectives on early treatment for hereditary angioedema.
- Adverse drug reactions from parenteral treatments for hereditary angioedema.
KalVista focuses on oral protease inhibitors for unmet medical needs.
KalVista Pharmaceuticals has announced significant progress in its Phase 3 KONFIDENT clinical trial for sebetralstat, an oral therapy for hereditary angioedema (HAE) attacks. The trial has surpassed 50% enrollment of the 114 targeted patients, with expected topline data in the second half of 2023. The trial is active in 17 countries with more than 50 locations. Additionally, the FDA has provided guidance that no efficacy trials are required for a supplemental NDA for the oral disintegrating tablet formulation of sebetralstat. The company is also moving forward with regulatory pathways in Japan, targeting patient enrollment in both KONFIDENT and a follow-up study.
KalVista Pharmaceuticals (NASDAQ: KALV) announced the publication of phase 2 trial results for its oral treatment, sebetralstat, in treating hereditary angioedema (HAE) attacks, featured in The Lancet. The trial included 68 patients, demonstrating that sebetralstat was well tolerated, offering rapid relief from attacks compared to placebo. Key findings included a significantly longer time to conventional treatment use and a faster onset of symptom relief. The promising results suggest sebetralstat could become the first oral, on-demand treatment for HAE patients. The company anticipates phase 3 KONFIDENT trial results in late 2023.
KalVista Pharmaceuticals (NASDAQ: KALV) announced the expansion of its KONFIDENT trial for sebetralstat, an oral plasma kallikrein inhibitor, into Japan following positive phase 1 data indicating its efficacy and safety for short-term prophylaxis (STP) in Japanese adults. The KONFIDENT-S trial aims to evaluate the treatment's effectiveness. Additionally, a post hoc analysis from a phase 2 trial presented at the 60th Annual Scientific Session of the Western Society of Allergy, Asthma & Immunology demonstrated sebetralstat's consistent symptom relief across attack locations.
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) announced its participation at the virtual SVB Securities Global Biopharma Conference on February 16, 2023, at 8:40 a.m. ET. A live webcast of the presentation will be available on the company's website, with an audio archive for 30 days post-event. KalVista focuses on developing oral, small molecule protease inhibitors for conditions such as hereditary angioedema (HAE) and diabetic macular edema (DME). The company is actively conducting the Phase 3 KONFIDENT trial for its oral therapy, sebetralstat, targeting HAE attacks and has a pipeline that includes a novel plasma kallikrein inhibitor for DME.
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) announced the granting of inducement stock options to two new employees, allowing them to purchase a total of 14,000 shares of common stock at an exercise price of $7.64 each, equal to the stock's closing price on the grant date, February 1, 2023. The options will vest over a four-year period, with one-fourth vesting on the one-year anniversary and the remainder in monthly installments, contingent on continued employment. This move follows Nasdaq Listing Rule 5635(c)(4) and aligns with KalVista's commitment to attracting talent in the pharmaceutical sector, particularly in developing therapies for hereditary angioedema and diabetic macular edema.
KalVista Pharmaceuticals has promoted Ben Palleiko to President, expanding his role to lead business and commercial growth following a
KalVista Pharmaceuticals has announced a registered direct offering of 9.484 million shares at $6.00 per share and 182,470 prefunded warrants at $5.999, totaling approximately $58 million in gross proceeds. The offering is set to close on December 28, 2022, pending customary conditions. Proceeds will fund clinical trials, commercial sales development, research, and working capital, enabling operations funding into 2025. The shares are offered under an effective shelf registration statement with the SEC, enhancing liquidity for future projects and developments.
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