Shares of Inhibikase Therapeutics, Inc. (IKT) are up 12% at $1.72 in pre-market trading, after the company announced progress on its lead program alongside a major financing deal.
Inhibikase reported that it is advancing IKT-001, a novel prodrug of imatinib mesylate, into a global phase 3 study called IMPROVE-PAH for the treatment of Pulmonary Arterial Hypertension (PAH).
The FDA has cleared the company to proceed with this pivotal program, which is designed to evaluate the safety and efficacy of IKT-001 in patients with life-threatening conditions, building on earlier data that demonstrated improved tolerability and pharmacokinetics compared to standard imatinib.
The IMPROVE-PAH trial will feature two parts. Part A will be a double-blind, placebo-controlled study in 140 patients, with pulmonary vascular resistance (PVR) at week 24 as the primary endpoint. Part B will adopt an identical format to Part A, except the primary endpoint will be six-minute walk distance at week 24 in 346 patients.
The adaptive design offers important advantages, including a 12-week dose-titration phase to reach the highest tolerable dose of IKT-001, uninterrupted enrolment between Part A and Part B, and the ability to re-estimate sample size for Part B based on Part A findings.
To support the Phase 3 program and broader pipeline development, Inhibikase also announced an underwritten public offering of 46.1 million shares of common stock and 22.9 million pre-funded warrants at $1.45 per share.
The offering is slated to close on November 24, 2025, subject to customary closing conditions, and is anticipated to generate gross proceeds of roughly $100 million.
The company also granted underwriters a 30-day option to purchase up to an additional 10.3 million shares at the offering price, less underwriting discounts and commissions.
The financing is expected to provide resources to advance IKT-001 through late-stage development and strengthen the company's balance sheet as it prepares for pivotal milestones.
The Phase 3 study is expected to initiate in the first quarter of 2026, and by adopting a single pivotal study format, the company believes it can accelerate the potential FDA approval timeline by approximately three years.
IKT has traded in the range of $1.22 to $4.20 over the past year. The stock closed yesterday's trading at $1.53, down 1.92%.
For comments and feedback contact: editorial@rttnews.com
Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.