Inhibikase Therapeutics Inc Stock Price, News & Analysis

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced progress in its '501' bioequivalence study for IkT-001Pro, a prodrug of imatinib mesylate, crucial for treating Chronic Myelogenous Leukemia (CML). As of March 15, 2023, the company completed dosing of three out of four planned cohorts. The study involves 59 healthy volunteers to evaluate safety and pharmacokinetics. IkT-001Pro displayed a favorable safety profile with only four mild adverse events. The company aims to complete the trial in Q2 2023 and engage the FDA about potential approval under the 505(b)(2) statute.

Inhibikase Therapeutics (Nasdaq: IKT) announced that the FDA has lifted the clinical hold on IkT-148009, enabling the commencement of a Phase 2 clinical trial in Multiple System Atrophy (MSA). Early studies indicate significant neuroprotective benefits from IkT-148009 through c-Abl inhibition. The planned Phase 2a '202' trial will assess the safety and efficacy of IkT-148009 in MSA patients over six months. MSA, affecting about 3 in 100,000 individuals, is characterized by rapid progression and no existing disease-modifying treatments. The Company is eager to initiate further studies to validate IkT-148009's therapeutic potential.

Inhibikase Therapeutics, a clinical-stage pharmaceutical company focused on Parkinson's disease, announced that CEO Milton Werner will present at the 11th Annual Alzheimer's & Parkinson's Drug Development Summit in San Francisco from February 21-23, 2023. The presentation will spotlight IkT-148009, a small molecule c-Abl kinase inhibitor, as a potential therapy for Parkinson's disease. Scheduled for February 23 at 10:45 AM PT, it will cover the drug's efficacy in animal models and the company’s ongoing Phase 2a trial strategy. Inhibikase aims to address neurodegeneration and related disorders through its innovative pipeline.

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced the closure of a registered direct offering and private placement, raising approximately $10 million. The company sold 6,744,187 shares at $0.86 per share and an additional 4,883,721 shares in a private placement. Unregistered warrants for 11,627,908 shares were also issued at an exercise price of $0.75. Proceeds will support corporate purposes, including clinical trials and product development. The offerings were priced at a premium to market, and the company plans to file a resale registration statement for the private placement securities.

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.