KalVista Pharmaceuticals

KalVista Pharmaceuticals announces five abstracts accepted for e-Poster presentation at the 2024 ACAAI Annual Scientific Meeting, focusing on sebetralstat's impact on hereditary angioedema.

KalVista Pharmaceuticals submitted MAAs for sebetralstat, an oral HAE treatment, to UK, Switzerland, Australia, and Singapore. Sebetralstat could be the first oral on-demand HAE treatment for adults and adolescents, with a PDUFA date of June 17, 2025. The MAAs are supported by KONFIDENT phase 3 trial data, showing significant symptom relief acceleration. A pediatric trial for sebetralstat commenced in June 2024, potentially making it the first oral on-demand therapy for children aged 2-11. KalVista's stock has seen a 26.18% return over the past week, despite operating at a loss.

KalVista Pharmaceuticals to participate in a fireside chat at the 2024 Cantor Global Healthcare Conference on September 19th. The company announced positive phase 3 data for its oral therapy, sebetralstat, in February 2024, with an FDA PDUFA goal date of June 17, 2025. KalVista received EMA MAA validation in August 2024 and plans to file for approval in the UK, Japan, and other countries later in 2024.

KalVista Pharmaceuticals presented sebetralstat data at Bradykinin Symposium 2024, showing consistent efficacy and safety profiles across phase 2 and 3 trials, with rapid symptom relief and a safety profile comparable to placebo. Median time to treatment was 9 minutes for all attacks and 8 minutes for laryngeal attacks, with median time to symptom relief at 1.8 hours for all attacks and 1.3 hours for laryngeal attacks. Oral sebetralstat may address challenges of current injectable treatments for HAE.

KalVista Pharmaceuticals provided an operational update and released financial results for the first fiscal quarter ended July 31, 2024. Highlights include the FDA's acceptance of the NDA for sebetralstat, an oral plasma kallikrein inhibitor for HAE, and the EMA's validation of the MAA. KalVista anticipates filing for approval in the UK, Japan, and other countries later in 2024, aiming for a June 2025 commercial launch. Financial results showed a net loss of $40.4 million, with R&D and G&A expenses increasing to $26.6 million and $17.6 million, respectively.

KalVista Pharmaceuticals announced the FDA accepted its New Drug Application for sebetralstat, an oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE) attacks in patients aged 12 and older, with a PDUFA goal date of June 17, 2025. Sebetralstat, if approved, would be the first oral on-demand treatment for HAE. The NDA was supported by data from the KONFIDENT phase 3 trial and ongoing KONFIDENT-S extension trial, showing significant symptom relief and good tolerability. KalVista also initiated the KONFIDENT-KID trial for pediatric patients aged 2-11 and expects to file for approval in the UK, Japan, and other countries in 2024.

KalVista submits NDA to FDA for sebetralstat, an oral on-demand treatment for HAE, based on phase 3 trial results showing faster symptom relief than placebo. The drug is well-tolerated with no treatment-related SAEs. FDA has a 60-day review period, with potential approval leading to the first oral on-demand HAE therapy.