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On Monday, H.C. Wainwright reaffirmed a Neutral rating on shares of Inhibikase Therapeutics Inc (NASDAQ:IKT), which currently trades at $2.29 and has seen a significant 76% surge over the past six months. According to InvestingPro data, the company’s stock is currently trading at its Fair Value. The decision follows the company’s progress with its lead drug candidate, IkT-001Pro, which aims to treat pulmonary arterial hypertension (PAH).
Inhibikase Therapeutics received IND-clearance from the FDA for the Phase 2b 702 trial of IkT-001Pro on September 9, 2024. The company, with a market capitalization of $159 million, maintains strong liquidity with a current ratio of 26.37 and holds more cash than debt on its balance sheet. IkT-001Pro is a prodrug of imatinib, also known as Gleevec, which has been granted FDA Orphan Drug Designation for the treatment of stable-phase chronic myelogenous leukemia.
The company is in discussions with the FDA to secure Orphan Drug Designation for the delivery of imatinib via IkT-001Pro for PAH. Inhibikase plans to apply for this designation after completing the necessary pre-clinical studies. The company believes that IkT-001Pro may offer a better safety and tolerability profile compared to imatinib for patients with PAH.
In preparation for the trial, Inhibikase has identified selected study sites for the Phase 2b 702 trial. The company has also improved its manufacturing process for IkT-001Pro to support advanced clinical development stages. These enhancements include the development of new dosage forms, a more efficient production process, and a high throughput tableting process, which are expected to differentiate from generic imatinib mesylate based on the feedback from the FDA.
During a pre-IND meeting, the FDA confirmed that IkT-001Pro would be considered a new molecular entity. Inhibikase intends to pursue the 505(b)(2) regulatory pathway for IkT-001Pro, which allows for a potentially faster development process by enabling companies to rely partially on existing clinical data for approval. Despite these developments, H.C. Wainwright has chosen to maintain a Neutral rating on Inhibikase Therapeutics stock. With analyst price targets reaching $8.00 per share and the next earnings report due on May 15, 2025, investors seeking deeper insights can access comprehensive analysis and additional ProTips through InvestingPro’s detailed research reports, which cover over 1,400 US stocks including IKT.
In other recent news, Inhibikase Therapeutics, Inc. has announced a strategic shift by halting the development of its Parkinson’s disease drug, risvodetinib, following a Phase 2 clinical trial. Although the trial met its primary endpoint of safety and tolerability, it did not show significant efficacy improvement compared to placebo. The company will now focus its resources on advancing its lead program, IkT-001Pro, for treating pulmonary arterial hypertension (PAH). This decision aligns with recent leadership changes, where Dr. Chris Cabell and Dr. John Adams have joined Inhibikase to strengthen its research and development efforts in PAH.
Additionally, Inhibikase has expanded its authorized shares from 100 million to 500 million, a move that provides flexibility for future corporate needs. Shareholders also approved amendments to the company’s 2020 Equity Incentive Plan, adding over 27 million shares for issuance. Other governance changes include the removal of a supermajority voting requirement, simplifying future amendments to the company’s articles of incorporation. These developments underscore Inhibikase’s strategic focus on PAH and its efforts to adjust its capital structure and governance practices.
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