SAB Biotherapeutics Shares Soar on FDA's Breakthrough Designation

By Dean Seal

Shares of SAB Biotherapeutics Inc. shot up 88% to a high of $1.45 in early trading after the company said regulators have designated its investigational flu treatment as a breakthrough therapy.

The Sioux Falls, S.D.-based clinical-stage biopharmaceutical company said Tuesday that the U.S. Food and Drug Administration granted the designation for SAB-176, its investigational therapeutic for Type A and Type B influenza.

The designation is designed to expedite the development and evaluation of treatments for serious or life-threatening conditions that show, from preliminary clinical evidence, substantial improvement at certain endpoints over currently available therapies.

Last week, the FDA granted SAB-176 its fast-track designation and said it would guide SAB Biotherapeutics in advancing the treatment to its next phase of development with a Phase 2b dose-finding trial for influenza patient populations at high risk of developing severe disease.

The requirements for the breakthrough therapy designation are higher than those for fast-track designation, said Chief Executive Eddie Sullivan. To have both designations is rare, he added.

"These designations further assure us that SAB-176 has a clear regulatory and clinical development path to progress this important therapeutic," Mr. Sullivan said.

Shares have more than doubled since the start of the year.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

April 18, 2023 10:35 ET (14:35 GMT)

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