KALV - KalVista stock rises on regulatory guidance for hereditary angioedema therapy

KalVista Pharmaceuticals ( NASDAQ: KALV ) reported clinical trial and regulatory updates for its lead drug sebetralstat, a potential oral on-demand therapy for hereditary angioedema (HAE) attacks.

The company recently received additional FDA regulatory guidance for the oral disintegrating tablet (ODT) formulation of sebetralstat which confirmed the requirements to support a supplemental NDA (sNDA) filing.

The FDA noted that no efficacy trials with the ODT formulation will be required before filing the sNDA submission, according to the company.

KalVista expects that the ODT formulation will follow the expected initial launch formulation in the U.S. and EU, however it may become the initial launch formulation in other geographies.

KalVista added that it has enrolled more than 50% of the 114 targeted number of patients in the phase 3 trial called KONFIDENT. Topline data is expected in H2 2023.

The company noted that it will now be enrolling Japanese patients in both KONFIDENT and KONFIDENT-S studies to support a regulatory filing in Japan after receiving guidance from the Japanese drug regulator.

"We have already exceeded our recruitment target goals for KONFIDENT in the US, and recruitment outside the US continues to accelerate as new sites come online," said

HAE attacks is a disorder characterized by recurrent episodes (attacks) of severe swelling of the skin and mucous membranes.

KALV +3.93% to $8.47 premarket Feb. 14

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