KalVista Pharmaceuticals, Inc. - KALV STOCK NEWS

KalVista Pharmaceuticals (NASDAQ: KALV) announced that the European Medicines Agency (EMA) has validated the submission of a Marketing Authorization Application (MAA) for sebetralstat, an oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE). If approved, sebetralstat would be the first oral, on-demand treatment for HAE in Europe. The MAA is supported by results from the KONFIDENT phase 3 clinical trial and ongoing KONFIDENT-S open label extension trial.

Key findings include:

• Sebetralstat met the primary endpoint in phase 3 trials
• Both 300 mg and 600 mg formulations achieved faster symptom relief than placebo
• Median time to beginning of symptom relief for laryngeal attacks was 1.3 hours
• KalVista submitted a New Drug Application (NDA) to the U.S. FDA in June 2024
• KONFIDENT-KID clinical trial initiated to evaluate sebetralstat in pediatric patients aged 2-11 years

KalVista Pharmaceuticals (NASDAQ: KALV) has granted inducement options to eleven newly-hired employees to purchase a total of 90,000 shares of KalVista common stock. The options, issued on August 1, 2024, have an exercise price of $13.83 per share, matching the closing price on the grant date. The vesting schedule includes 25% after one year, with the remainder vesting in equal monthly installments over three years, subject to continued employment. Each option has a 10-year term and falls under KalVista's Inducement Equity Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4).

KalVista Pharmaceuticals has submitted a New Drug Application (NDA) for sebetralstat, an oral treatment for hereditary angioedema (HAE) attacks, potentially launching in the first half of 2025. The phase 3 KONFIDENT trial data, published in The New England Journal of Medicine, supports the drug's efficacy. The company began a pediatric trial and plans additional regulatory submissions across Europe and Japan this year. Financially, KalVista reported no revenue for the fiscal year ending April 30, 2024. R&D expenses rose to $86.2 million, while G&A expenses increased to $54.3 million. The net loss widened to $126.6 million, or $(3.44) per share. Cash reserves grew to $210.4 million, primarily due to a stock offering in February 2024.

KalVista Pharmaceuticals (NASDAQ: KALV) announced the granting of inducement options to twelve newly-hired employees, allowing them to purchase a total of 84,000 shares of common stock as of July 1, 2024. The options were granted under Nasdaq Listing Rule 5635(c)(4) and have an exercise price of $11.89 per share, matching the closing price on the grant date. These options vest over four years, with one-fourth vesting after one year and the remainder vesting monthly over the next three years, contingent on continued employment. Each option has a 10-year term and is governed by KalVista's Inducement Equity Incentive Plan and relevant option agreements.

KalVista Pharmaceuticals (NASDAQ: KALV) has launched the KONFIDENT-KID trial to evaluate sebetralstat, an oral plasma kallikrein inhibitor, for treating hereditary angioedema (HAE) attacks in children aged 2 to 11. The open-label trial will enroll 24 children across seven countries in North America, Europe, and Asia. Over one year, it will gather safety, pharmacokinetic, and efficacy data using a pediatric oral disintegrating tablet formulation of sebetralstat. If successful, sebetralstat could become the first oral on-demand therapy for this age group, addressing a significant unmet need, as the current option is an intravenous treatment.

KalVista Pharmaceuticals (NASDAQ: KALV) has submitted a New Drug Application (NDA) to the FDA for sebetralstat, an oral plasma kallikrein inhibitor intended for the on-demand treatment of hereditary angioedema (HAE) in patients aged 12 and older. The NDA is based on successful phase 3 trial results showing rapid symptom relief, with sebetralstat significantly outperforming placebo. If approved, sebetralstat would be the first oral on-demand HAE treatment. The FDA's review decision is expected in September 2024. KalVista also plans to submit marketing applications globally and initiate a pediatric trial in Q3 2024.

KalVista Pharmaceuticals presented data from the US subgroup of the phase 3 KONFIDENT trial and real-world claims at the Eastern Allergy Conference 2024, and the Japanese subgroup at the Japanese Dermatological Association 2024. The US subgroup showed a median time to treatment of 38 minutes and symptom relief beginning at 1.3 hours, comparing favorably with overall trial results. Despite increased long-term prophylaxis use in the US, on-demand treatment prescriptions remain steady, with significant non-prescription healthcare costs. Japanese trial results were consistent with overall data, and sebetralstat was well tolerated with no serious adverse events. Real-world data also highlighted that HAE attacks impact quality of life and work productivity similarly for both prophylaxis and on-demand treatment patients.

KalVista Pharmaceuticals (NASDAQ: KALV) announced the issuance of inducement stock options to a newly-hired employee on June 3, 2024. The compensation committee of the board of directors granted options to purchase 7,000 shares of KalVista common stock. These options are part of the company's Inducement Equity Incentive Plan, granted under Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $12.11 per share, which matched the closing price on the grant date. One-fourth of the options vest after one year, with the remaining shares vesting monthly over the next three years, contingent on the employee's continued service. Each option has a 10-year term.

KalVista Pharmaceuticals presented new data on hereditary angioedema (HAE) at the EAACI Congress 2024, spotlighting significant unmet needs despite current treatments.

Key findings include the challenges of injectable on-demand therapies, with 50% of US patients experiencing untreated HAE attacks worsening in severity. Common reasons for not treating include saving medication for severe attacks and avoiding needle pain.

UK data shows 63% of patients perceive their treatment as 'early,' yet only 14% treat within one hour. Anxiety about using injectable therapies is also a major concern.

Patients who treat early recover faster and feel less anxious. There's strong patient preference for oral treatments, anticipating higher usage and less anxiety.

Physicians report significant issues with non-androgen long-term prophylaxis, including moderate to very severe attacks and high treatment burdens. KalVista highlighted the potential of oral sebetralstat to address these challenges based on positive Phase 3 KONFIDENT results.