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Will VK2735 receive FDA Fast Track designation by 2025?
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Resolution / Starting Odds
Granted in 2024 • 25%
Granted in 2025 • 25%
Not granted by 2025 • 25%
Other designation received • 25%
FDA announcements or Viking Therapeutics press releases
Story
Viking's VK2735 Shows 8.2% Weight Loss with Placebo-Like Safety at ObesityWeek 2024
Nov 4, 2024, 10:57 AM
Viking Therapeutics reported positive early-stage clinical trial data for its oral obesity drug VK2735 at the ObesityWeek 2024 conference, exceeding expectations. The drug demonstrated a weight loss of up to 8.2% from baseline (6.8% placebo-adjusted) after 28 days of dosing with the 100 mg daily dose. VK2735 was well-tolerated, showing a safety profile similar to placebo, with no moderate or severe nausea reported even at the highest doses. Patients maintained weight loss long after the last dose. The company plans to initiate a Phase 2 study of the oral tablet formulation by the end of the year and discuss the clinical path forward with the FDA for the injectable formulation later in the quarter.
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Approved • 25%
Conditionally approved • 25%
Not approved • 25%
Approval pending • 25%
Positive efficacy and safety • 25%
Positive efficacy, negative safety • 25%
Negative efficacy • 25%
Inconclusive • 25%
Yes • 50%
No • 50%
Yes • 50%
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