Imatinib

Inhibikase Therapeutics Announces Pre-IND Meeting with the FDA for IkT-001Pro in Pulmonary Arterial Hypertension

Retrieved on: 
Wednesday, April 3, 2024
Ventricular septal defect, DCN, Disease, HIV, Patient, CTD, Connective tissue disease, Death, Parkinson's disease, Imatinib, IND, Pulmonary hypertension, Woman, Therapy, Heart, Safety, Division, WHO, HIV/AIDS, Stomach, PAH, FDA, Blood, Food, Pharmaceutical industry

The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes.

Key Points: 
  • The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes.
  • “Following our pre-NDA discussion with the FDA related to the path to approval for IkT-001Pro in up to 11 blood and stomach cancers in January, we requested an additional FDA meeting with the Division of Cardiology and Nephrology to discuss Pro as a treatment for Pulmonary Arterial Hypertension,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase.
  • “PAH is a rare condition that primarily afflicts women between the ages of 30 and 60 and can lead to premature heart failure and death.
  • We believe that Pro may be a be a safer and better tolerated therapeutic option for imatinib treatment in PAH.

Inhibikase Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Activity

Retrieved on: 
Wednesday, March 27, 2024
Research, Malignancy, Absorption, PD, CSF, Imatinib, Central nervous system, International, Patient, Gastrointestinal tract, Journal, CML, NDA, Pharmacist, Traffic barrier, Cerebrospinal fluid, Insurance, D&O, Dark Ages, Therapy, Division, Blood, Bone marrow, FDA, SAD, Physician, Approximation error, Pharmaceutical industry

The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro.

Key Points: 
  • The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro.
  • Inhibikase will host a conference call and webcast to discuss its full-year 2023 financial results and business highlights tomorrow, March 28, 2024, at 8:00am ET.
  • The conference call can be accessed by dialing 1-877-407-0789 (United States) or 1-201-689-8562 (International) and referencing Inhibikase Therapeutics.
  • After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

Orphan designation: imatinib Treatment of pulmonary arterial hypertension, 21/06/2021 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Diagnosis, Civil service commission, Enzyme, Prevalence, Cell, Disease, Patient, Committee, Cancer, EMA, IRIS, Imatinib, Orthostatic hypertension, Agency, European, COMP, European Commission, MDC, PAH, Marketing, FGK, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of pulmonary arterial hypertension (PAH) in the European Union on 21 June 2021.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Inhibikase Therapeutics Announces Full Outcomes of its Pre-NDA Meeting with the FDA for IkT-001Pro

Retrieved on: 
Wednesday, February 28, 2024
Therapy, Division, Blood, Mesylate, FDA, Physician, Bone marrow, Food, Approximation error, Risk, Imatinib, Parkinson's disease, Patient, Trial of the century, NDA

“With the full meeting minutes from the FDA Review Team in hand, we are confident in our approach as we develop the NDA for IkT-001Pro,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase.

Key Points: 
  • “With the full meeting minutes from the FDA Review Team in hand, we are confident in our approach as we develop the NDA for IkT-001Pro,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase.
  • Further, we are not restricted from use in children nor restricted to just blood cancer-related approved indications.
  • This opens-up the opportunity to seek all 11 approved indications for IkT-001Pro that were previously approved for imatinib mesylate.
  • All other elements of the pre-NDA meeting remain unchanged from those reported on February 7, 2024.

J.P. Morgan Life Sciences Private Capital Team Adds Healthcare Veteran and Past Seagen CEO David Epstein to Advisory Board

Retrieved on: 
Tuesday, February 27, 2024
Rubius, Odyssey, Senior, Inborn errors of metabolism, Investment, Drug development, Growth, Sale, IPO, University, Intuitive Surgical, Neurodegenerative disease, Analog Devices, National academy, J. P. Morgan, MIT, Genetic distance, American Philosophical Society, Business development, Journal, Therapy, Imatinib, SRL Diagnostics, MidOcean Partners, Distinction, Laboratory, Cornell University, Drug discovery, Weill Cornell Medicine, Provost, Panasonic Executive Partner, Abbott Laboratories, Flagship, Novartis, Medtronic, MACP, Harvard Medical School, Nilotinib, American Academy, Yale School of Medicine, JPMorgan Chase, AI, MD, Flagship Pioneering, Harvard University, MassMutual, Executive, Cancer, Management

NEW YORK, Feb. 27, 2024 /PRNewswire/ -- J.P. Morgan Life Sciences Private Capital today announced the addition of David Epstein to its Healthcare Advisory Board.

Key Points: 
  • NEW YORK, Feb. 27, 2024 /PRNewswire/ -- J.P. Morgan Life Sciences Private Capital today announced the addition of David Epstein to its Healthcare Advisory Board.
  • Mr. Epstein will now advise the J.P. Morgan Life Sciences Private Capital team.
  • The J.P. Morgan Life Sciences Private Capital team leverages JPMorgan Chase's scale, resources, data assets and healthcare expertise and sits within J.P. Morgan Private Capital, a venture and growth equity investment platform that is part of J.P. Morgan Asset Management.
  • The platform finances the continued growth of private companies and taps into significant pre-IPO value creation opportunities in the consumer and technology, and life sciences sectors.

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

Retrieved on: 
Wednesday, February 7, 2024
Division, Absorption, Therapy, Mesylate, Patient, Safety, Bone marrow, Imatinib, FDA, Parkinson's disease, Food, Pharmacy, Blood, Oncology, NDA, Pharmaceutical industry

“Our bioequivalence studies were presented to the FDA and we were given specific guidance on the manufacturing requirements necessary to complete the NDA.

Key Points: 
  • “Our bioequivalence studies were presented to the FDA and we were given specific guidance on the manufacturing requirements necessary to complete the NDA.
  • During the meeting Inhibikase inquired whether additional clinical studies may be needed to seek approval and discussed manufacturing and quality control requirements for approval.
  • These preliminary outcomes from the meeting are subject to formal review of the NDA package.
  • Nine mild and one moderate treatment-related adverse events have been reported across all enrolled participants taking risvodetinib.

Mark Cuban Cost Plus Drug Company and Sidecar Health team up to tackle rising healthcare costs

Retrieved on: 
Tuesday, January 9, 2024
Insurance, Specialty, Professional Services, Health Insurance, Health, Pharmaceutical, General Health, Retail, Online Retail, Sidecar Health, Leukemia, PBC, Cost Plus Drugs, Prescription, Pharmacy, Imatinib, Tablet, World Market (store), Gallup, Pharmaceutical industry

Sidecar Health, a transformative health insurance company giving its members control over costs and choice, announced today that it is teaming up with Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs) to help bring high-quality, lower-cost prescription drugs to Sidecar Health members.

Key Points: 
  • Sidecar Health, a transformative health insurance company giving its members control over costs and choice, announced today that it is teaming up with Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs) to help bring high-quality, lower-cost prescription drugs to Sidecar Health members.
  • Both Sidecar Health and Cost Plus Drugs were founded to address the issue of rising healthcare costs, which are often driven by lack of transparency and inefficient middlemen that inflate the overall cost of healthcare services.
  • Together, Sidecar Health and Cost Plus Drugs are fostering a healthcare landscape that is transparent, consumer-friendly, and genuinely cost-effective.
  • “Cost Plus Drugs and Sidecar Health are working together to change that.” By eliminating administrative complexities and offering transparency, Sidecar Health and Cost Plus Drugs are making prescription drugs more affordable and taking a significant step toward accessible healthcare for all.

Inhibikase Therapeutics Granted Pre-NDA Meeting with the FDA for IkT-001Pro

Retrieved on: 
Monday, December 4, 2023
Food, Syndrome, Chronic myelogenous leukemia, Acute lymphoblastic leukemia, Tmax, FDA, Plasma, Imatinib, Blood, NDA, Therapy, PDGFR, Parkinson's disease, Pancreatic serous cystadenoma, Patient, Mastocytosis

BOSTON and ATLANTA, Dec. 04, 2023 (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 the U.S. Food and Drug Administration has granted a pre-New Drug Application (pre-NDA) meeting to be held in January 2024 to discuss the requirements for approval of IkT-001Pro and to review the data establishing doses of IkT-001Pro bioequivalent to 400 mg and 600 mg imatinib mesylate. The Company expects to provide an update following the meeting.

Key Points: 
  • The Company expects to provide an update following the meeting.
  • “We are pleased that the FDA has granted a pre-NDA meeting to discuss the parameters for approval of IkT-001Pro,” stated Dr. Milton Werner, President and Chief Executive Officer of Inhibikase Therapeutics.
  • Across all doses, there were only mild adverse events observed, including just two adverse events for IkT-001Pro at the highest dose comparison.
  • Pharmacokinetic profiles for imatinib delivered by IkT-001Pro and imatinib mesylate were similar at equivalent doses.

Inhibikase Therapeutics Reports Third Quarter Financial Results and Highlights Recent Period Activity

Retrieved on: 
Tuesday, November 14, 2023
Imatinib, Safety, D, Parkinson's disease, Therapy, International, IND, PD, Clinical trial, Patient, Research, European, Multiple system atrophy, MSA, FDA, Tyrosine kinase inhibitor, Federal, Orphan, ABL, Pharmaceutical industry

“We are very pleased with the progress of the last quarter,” noted Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase.

Key Points: 
  • “We are very pleased with the progress of the last quarter,” noted Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase.
  • Twenty-four participants have been enrolled, 7 prospective participants are in screening and 15 potential participants are going through informed consents.
  • The 201 Trial patient portal ( www.the201trial.com ) has been visited by more than 20,000 unique people since launch in September, 2023.
  • The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

Ascentage Pharma Hosts Ceremony Marking the Launch of Olverembatinib in Newly Approved Indication and the Dispatch of First Batch for the New Indication

Retrieved on: 
Friday, November 24, 2023
NDA, Bone marrow, Priority review, Safety, National Medical Products Administration, BAT, Leukemia, EFS, New Drug Application, NMPA, TKI, CDE, Patient, BTD, Imatinib, Trust, Nilotinib, Therapy, BCR-ABL, CML, Death, Survival, NRDL, Government, Mutation, HIV disease progression rates, Pharmaceutical industry

Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).

Key Points: 
  • Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China.
  • Ascentage Pharma and Innovent are mutually committed to the commercialization of olverembatinib in the China market.
  • Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up.