CEL-SCI Receives FDA Complete Response Letter for Multikine
Ticker: CVM · Form: 8-K · Filed: Jun 20, 2024 · CIK: 725363
Sentiment: bearish
Topics: fda-decision, drug-development, regulatory-filing
TL;DR
FDA rejected CEL-SCI's Multikine drug, needs more data. Big setback.
AI Summary
CEL-SCI Corporation announced on June 18, 2024, that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its investigational drug Multikine. The FDA has requested additional information and studies before potentially approving Multikine for the treatment of advanced head and neck cancer.
Why It Matters
This FDA decision significantly delays the potential market entry of CEL-SCI's lead drug candidate, impacting its revenue prospects and requiring further investment in clinical trials.
Risk Assessment
Risk Level: high — The Complete Response Letter indicates that the FDA has not approved the drug and requires substantial additional work, posing a significant risk to the company's future.
Key Players & Entities
- CEL-SCI Corporation (company) — Registrant
- Multikine (drug) — Investigational drug
- FDA (company) — Regulatory agency
- June 18, 2024 (date) — Date of report
FAQ
What is the primary reason for the FDA's Complete Response Letter for Multikine?
The FDA has requested additional information and studies before potentially approving Multikine for the treatment of advanced head and neck cancer.
What is the status of Multikine's approval process?
Multikine has received a Complete Response Letter from the FDA, meaning it has not been approved and requires further action.
What is the potential indication for Multikine?
Multikine is being investigated for the treatment of advanced head and neck cancer.
When was this event reported?
This event was reported on June 18, 2024.
What is the name of the company filing this report?
The company filing this report is CEL-SCI Corporation.
Filing Stats: 557 words · 2 min read · ~2 pages · Grade level 11.3 · Accepted 2024-06-18 17:45:37
Filing Documents
- cvm_8k.htm (8-K) — 26KB
- cvm_ex99.htm (EX-99) — 14KB
- cvm_ex99img2.jpg (GRAPHIC) — 4KB
- cvm_ex99img3.jpg (GRAPHIC) — 4KB
- cvm_ex99img4.jpg (GRAPHIC) — 6KB
- 0001654954-24-007928.txt ( ) — 186KB
- cvm-20240618.xsd (EX-101.SCH) — 6KB
- cvm-20240618_lab.xml (EX-101.LAB) — 14KB
- cvm-20240618_cal.xml (EX-101.CAL) — 1KB
- cvm-20240618_pre.xml (EX-101.PRE) — 9KB
- cvm-20240618_def.xml (EX-101.DEF) — 2KB
- cvm_8k_htm.xml (XML) — 4KB
01. Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure. On June 18, 2024, CEL-SCI Corporation (the "Company") issued a press release announcing that Dr. Eyal Talor, Chief Scientific Officer of the Company, delivered a presentation titled "Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT" at the International Drug Discovery Science & Technology (IDDST) 20th Annual Congress in Budapest, Hungary. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. The information disclosed under this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
01 Other Events
Item 8.01 Other Events. On June 18, 2024, Dr. Eyal Talor, Chief Scientific Officer of the Company, delivered a presentation titled "Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT" at the International Drug Discovery Science & Technology (IDDST) 20th Annual Congress in Budapest, Hungary.
01 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits. Exhibit No. Description 99 Press Release re. IDDST Presentation 2
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: June 18, 2024 CEL-SCI CORPORATION By: /s/ Patricia Prichep Patricia B. Prichep Senior Vice President of Operations 3