This section highlights FDA-related milestones and regulatory updates for drugs developed by CNS Pharmaceuticals (CNSP).
Over the past two years, CNS Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Berubicin and TPI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Berubicin - FDA Regulatory Timeline and Events
Berubicin is a drug developed by CNS Pharmaceuticals for the following indication: Designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Berubicin
- Announced Date:
- July 25, 2024
- Indication:
- Designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells
Announcement
CNS Pharmaceuticals, Inc. announced that its abstract has been selected for poster presentation at the 2024 SNO/ASCO CNS Cancer Conference being held August 8-10, 2024 in Denver, CO.
AI Summary
CNS Pharmaceuticals, Inc. announced that its abstract has been selected for a poster presentation at the 2024 SNO/ASCO CNS Cancer Conference in Denver, Colorado. This event is set to take place from August 8 to 10, 2024.
The selected poster presentation is titled "Use of a Brain-Penetrating Anthracycline in Anthracycline-Sensitive Brain Metastases: The Promise of Berubicin." It will be presented by Dr. Sandra Silberman, the company’s Chief Medical Officer, and is scheduled on August 8, 2024 from 7:15 to 9:00 PM MT at the Plaza Exhibit Hall of the Sheraton Denver Downtown Hotel. The study highlights promising research methods and trial design considerations that may advance treatments for brain metastases, showing the company’s dedication to developing novel therapies for brain and central nervous system cancers.
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TPI 287 - FDA Regulatory Timeline and Events
TPI 287 is a drug developed by CNS Pharmaceuticals for the following indication: in treating gliomas, pediatric neuroblastoma, and progressive supranuclear palsy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TPI 287
- Announced Date:
- May 13, 2025
- Indication:
- in treating gliomas, pediatric neuroblastoma, and progressive supranuclear palsy.
Announcement
CNS Pharmaceuticals, Inc. announced the successful transfer from Cortice Biosciences, Inc. of Orphan Drug Designation for TPI 287.
AI Summary
CNS Pharmaceuticals, Inc. announced that it has successfully completed the transfer of the FDA’s Orphan Drug Designation for its drug candidate TPI 287 from Cortice Biosciences, Inc. This key milestone supports the company’s ongoing work to develop TPI 287, an innovative abeotaxane that may cross the blood-brain barrier and treat central nervous system tumors such as glioblastoma multiforme (GBM). The orphan designation not only recognizes the potential of TPI 287 in treating rare diseases but also offers benefits like market exclusivity for seven years following approval. By securing this designation, CNS Pharmaceuticals demonstrates its commitment to advancing new treatment options for severe brain cancers. The company plans to begin enrolling patients in a Phase 2 study later in 2025 while continuing to build on promising clinical and radiologic data supporting TPI 287’s efficacy and safety.
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