Inhibikase Therapeutics Inc Stock Price, News & Analysis

On January 25, 2023, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced definitive agreements for a concurrent registered direct offering and private placement to sell approximately 6.74 million shares at $0.86 per share, alongside warrants to purchase up to 11.63 million shares. The offerings aim to raise about $10 million to fund clinical trials, product development, and general corporate needs. The closing is expected on January 27, 2023. The transactions were priced at a premium to market price, adhering to Nasdaq rules. H.C. Wainwright & Co. serves as the exclusive placement agent for the offerings.

Inhibikase Therapeutics, Inc. (NASDAQ: IKT) announced studies highlighting the potential of IkT-148009, a c-Abl inhibitor, as a disease-modifying treatment for Parkinson's disease. Published on January 18, 2023, in Science Translational Medicine, the findings indicate that IkT-148009 can halt disease progression, promote functional recovery, and reduce alpha-synuclein pathology in animal models. The oral doses tested are consistent with those evaluated in the ongoing Phase 2a '201' clinical trial. These results provide substantial support for the continued clinical development of IkT-148009 in treating Parkinson's and related disorders.

Inhibikase Therapeutics (IKT) announced that the FDA has lifted the clinical hold on its IkT-148009 treatment for Parkinson's disease. The Phase 2a '201' trial will resume immediately at dosages of 50 mg and 100 mg, with additional safety data to be collected at a 200 mg dose in healthy subjects beforehand.

The FDA's decision follows the Company's response to concerns raised in December 2022 and January 2023 regarding safety protocols. Enhanced ocular monitoring will also be integrated into the trial. Inhibikase plans to further pursue lifting clinical holds on programs targeting Multiple System Atrophy.

Inhibikase Therapeutics (Nasdaq: IKT) announced the initiation of its '501' bioequivalence study for IkT-001Pro, a prodrug formulation of imatinib mesylate, on December 12, 2022. The study will enroll 56 healthy volunteers to assess the safety and pharmacokinetics of IkT-001Pro compared to standard imatinib for Chronic Myelogenous Leukemia (CML). Previous preclinical studies indicated IkT-001Pro could enhance treatment adherence and reduce gastrointestinal side effects. The study's results will be pivotal for future clinical trials aimed at demonstrating superiority over existing treatments.

Inhibikase Therapeutics (Nasdaq: IKT) announced a clinical hold by the FDA regarding its IkT-148009 programs aimed at treating Parkinson's disease and Multiple System Atrophy. The FDA's letter highlighted concerns over safety and pharmacokinetic data, including the need for justification of the 200 mg dose used in the Phase 2a trial. Additionally, the FDA requested improvements in monitoring potential adverse events affecting vision. In response, the company plans to provide further data to address these issues and aims to lift the hold as soon as possible.

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced that CEO Milton Werner, Ph.D., will present at the Piper Sandler 34th Annual Healthcare Conference from November 29 to December 1, 2022, in New York. The presentation is scheduled for November 29 at 9:10 am ET. A live webcast of the presentation will be available on Inhibikase's website, with a replay accessible for 90 days post-event. Inhibikase is focused on developing therapeutics for Parkinson's disease and related disorders, primarily through its lead program, IkT-148009.

Inhibikase Therapeutics (IKT) reported a net loss of $4.49 million, or $0.18 per share, for Q3 2022, compared to a loss of $4.47 million in Q3 2021. The company faces an FDA clinical hold on its IkT-148009 programs for Parkinson's and Multiple System Atrophy but reports no serious adverse events in its Phase 2a trial. R&D expenses decreased to $2.98 million from $3.15 million year-over-year. Inhibikase plans to initiate a bioequivalence study for IkT-001Pro in Q4 2022 and continues to present its findings at industry conferences.

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced it will report its financial results for Q3 2022 after market close on November 14, 2022. A conference call will follow on November 15, 2022, at 8:00 a.m. ET, to discuss the results and provide corporate updates. The company focuses on developing therapeutics for Parkinson's disease and related disorders, with its lead program, IkT-148009, targeting neurodegeneration.

Inhibikase Therapeutics (Nasdaq: IKT) announced a clinical hold from the FDA on its IkT-148009 programs targeting Multiple Systems Atrophy (MSA) and Parkinson's disease (PD). The FDA's hold was communicated via email, with an official letter expected within 30 days. CEO Milton H. Werner stated there have been no serious adverse events in the ongoing trials and emphasized the company's commitment to addressing the FDA's concerns. Inhibikase focuses on developing treatments for neurodegenerative diseases, particularly those related to Parkinson's.