KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) announced its participation in the 2024 Cantor Global Healthcare Conference, coupled with an update on the regulatory progress of its lead drug candidate, sebetralstat. The company's management is scheduled for a fireside chat on Thursday, September 19th, 2024, at 10:20 a.m. ET in New York, N.Y., where they will discuss the company’s clinical programs and strategic direction.
The presentation will be webcast live on the KalVista website, with an audio archive available for 30 days. This event occurs as KalVista advances toward potential regulatory approvals for sebetralstat, an oral, on-demand therapy for hereditary angioedema (HAE).
Regulatory Milestones for Sebetralstat
KalVista has achieved significant regulatory milestones for sebetralstat. The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for sebetralstat, setting a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025. This acceptance indicates the FDA's agreement that the application is sufficiently complete to permit a substantive review.
In Europe, the European Medicines Agency (EMA) validated KalVista's Marketing Authorization Application (MAA) in August 2024. Validation confirms that the submission is complete and triggers the formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Expansion of Regulatory Filings
Building on these regulatory advancements, KalVista plans to extend its filings to other key markets. The company intends to submit applications for approval in the United Kingdom, Japan, and additional countries later in 2024. These submissions aim to broaden the availability of sebetralstat to patients with HAE globally.
About Sebetralstat and the KONFIDENT Trial
Sebetralstat is an oral, on-demand therapy designed to treat HAE attacks. The NDA and MAA submissions were supported by positive Phase 3 data from the KONFIDENT trial, which demonstrated statistically significant and clinically meaningful reductions in the time to symptom relief compared to placebo. The KONFIDENT trial showcased the potential of sebetralstat as a convenient and effective treatment option for HAE patients.
Hereditary Angioedema (HAE) Context
Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of severe swelling (angioedema) in various parts of the body, including the face, throat, limbs, and abdomen. These attacks can be debilitating and, in some cases, life-threatening if the airway is compromised. Current treatment options include prophylactic therapies to prevent attacks and on-demand treatments to manage acute episodes. Sebetralstat, if approved, would offer patients a novel oral on-demand option, addressing a significant unmet need in HAE management.
