Two Biotech/pharma stocks to watch – STTK, KALV
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Despite positive tidings, shares of Shattuck Labs (NASDAQ:STTK) and KalVista Pharmaceuticals (NASDAQ:KALV) closed lower Tuesday. Is this a buy-the-dip opportunity, considering both stocks have rallied >80% in the past year.
Shattuck Labs Strikes Deal with Japan’s Ono Pharma
Clinical-stage biotech Shattuck Labs (STTK) announced a worldwide drug discovery collaboration with Japanese R&D company Ono Pharmaceutical, by which it will receive an up-front payment and the eligibility for milestone payments (subject to success) of up to $227 million, as well as tiered royalties based on global net sales.
Shattuck develops bifunctional fusion proteins as a new class of biologic medicine for the treatment of cancer and autoimmune disease. The agreement with Ono requires Shattuck to generate novel bifunctional fusion proteins targeting certain pathways in autoimmune and inflammatory diseases. The associated research and development expenses will be covered by Ono, which in turn has received an exclusive option to develop and commercialize multiple products resulting from the collaboration agreement.
KalVista Pharma’s positive findings in Phase 3 HAE study
KalVista Pharmaceuticals (KALV) reported positive findings from a phase 3 study of its oral on-demand therapy sebetralstat, for Hereditary Angioedema (“HAE”), a rare genetic disease causing rapid swelling in different body locations. The pharma company said sebetralstat achieved beginning of symptom relief significantly faster than placebo. The median time to beginning of symptom relief was 1.61 hours with sebetralstat 300 mg dose vs. 6.72 hours with placebo, while the safety profile of sebetralstat was comparable to placebo. The trial enrolled a total of 136 adult and adolescent HAE patients.
The company said it is on track to file a new drug application (“NDA”) to the FDA in H1-24, and plans for regulatory submissions in Europe and Japan later this year. If approved by the FDA, sebetralstat will be the first oral on-demand therapy for HAE, as currently approved treatment options require either intravenous or subcutaneous administration. The company will present the phase 3 data on February 25, 2024, at the annual meeting of the American Academy of Allergy Asthma and Immunology (“AAAAI”).
