Inhibikase Therapeutics Announces Preliminary Outcomes of its Pre-NDA Meeting with the FDA on the Pathway for Approval for IkT-001Pro in Blood and Gastrointestinal Cancers
Inhibikase Therapeutics, Inc. (IKT)
Company Research
Source: GlobeNewswire
BOSTON and ATLANTA, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced preliminary outcomes of the Company’s discussion with the U.S. Food and Drug Administration (FDA) on the path to approval of IkT-001Pro in blood cancers, the Company’s prodrug of the anticancer agent imatinib mesylate. “We were pleased with the discussion we had with the FDA as we begin the process of building our first NDA package needed for approval,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase. “Our bioequivalence studies were presented to the FDA and we were given specific guidance on the manufacturing requirements necessary to complete the NDA. The FDA acknowledged that the appropriate appro
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News
- Inhibikase Therapeutics Issues Letter to Shareholders and Provides Update on Development Programs [Yahoo! Finance]Yahoo! Finance
- Inhibikase Therapeutics Issues Letter to Shareholders and Provides Update on Development ProgramsGlobeNewswire
- Inhibikase Therapeutics Announces Pre-IND Meeting with the FDA for IkT-001Pro in Pulmonary Arterial Hypertension [Yahoo! Finance]Yahoo! Finance
- Inhibikase Therapeutics Announces Pre-IND Meeting with the FDA for IkT-001Pro in Pulmonary Arterial HypertensionGlobeNewswire
- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
IKT
Earnings
- 11/14/23 - Beat
IKT
Analyst Actions
- 3/5/24 - HC Wainwright
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Sec Filings
- 4/30/24 - Form 8-K
- 4/29/24 - Form S-1/A
- 4/26/24 - Form DEFA14A
- IKT's page on the SEC website