UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
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Emerging growth company
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| Item 7.01. | Regulation FD Disclosure. |
As Delcath Systems, Inc. (the “Company”) has previously announced, the Prescription Drug User Fee Act (“PDUFA”) target date for Hepzato is August 14, 2023. In anticipation of that date, the Company prepared a staging site to reflect the possibility that the U.S. Food and Drug Administration (“FDA”) might approve Hepzato. On August 4, 2023, a vendor inadvertently published that staging site. To date, the Company has not received a decision by the FDA as to its approval of Hepzato and the target PDUFA date remains August 14, 2023.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| DELCATH SYSTEMS, INC. | ||||||
| Date: August 4, 2023 | By: | /s/ David Hoffman | ||||
| Name: | David Hoffman | |||||
| Title: | General Counsel, Chief Compliance Officer and Secretary | |||||
Document and Entity Information |
Aug. 04, 2023 |
|---|---|
| Cover [Abstract] | |
| Security Exchange Name | NASDAQ |
| Amendment Flag | false |
| Entity Central Index Key | 0000872912 |
| Document Type | 8-K |
| Document Period End Date | Aug. 04, 2023 |
| Entity Registrant Name | DELCATH SYSTEMS, INC. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-16133 |
| Entity Tax Identification Number | 06-1245881 |
| Entity Address, Address Line One | 1633 Broadway |
| Entity Address, Address Line Two | Suite 22C |
| Entity Address, City or Town | New York |
| Entity Address, State or Province | NY |
| Entity Address, Postal Zip Code | 10019 |
| City Area Code | (212) |
| Local Phone Number | 489-2100 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, $0.01 par value |
| Trading Symbol | DCTH |
| Entity Emerging Growth Company | false |