UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
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| Item 7.01 | Regulation FD Disclosure. |
On March 14, 2023, Apellis Pharmaceuticals, Inc. (the “Company”) received notification from the U.S. Food and Drug Administration (the “FDA”) that the FDA is extending the Prescription Drug User Fee Act (“PDUFA”) goal date for the supplemental New Drug Application (the “sNDA”) for the EMPAVELI Injector. The FDA stated in writing that “the labeling is still under review at this time and [the FDA] will miss the goal date of March 15, 2023.” The timing of the new PDUFA goal date is still being determined.
The EMPAVELI Injector is an on-body device designed to enhance self-administration of EMPAVELI® (pegcetacoplan), which is approved for adults with paroxysmal nocturnal hemoglobinuria (“PNH”).
The information in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
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.
| Apellis Pharmaceuticals, Inc. | ||||||
| Date: March 15, 2023 | By: | /s/ Timothy Sullivan | ||||
| Timothy Sullivan | ||||||
| Chief Financial Officer | ||||||
Document and Entity Information |
Mar. 15, 2023 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001492422 |
| Document Type | 8-K |
| Document Period End Date | Mar. 15, 2023 |
| Entity Registrant Name | Apellis Pharmaceuticals, Inc. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-38276 |
| Entity Tax Identification Number | 27-1537290 |
| Entity Address, Address Line One | 100 Fifth Avenue |
| Entity Address, City or Town | Waltham |
| Entity Address, State or Province | MA |
| Entity Address, Postal Zip Code | 02451 |
| City Area Code | (617) |
| Local Phone Number | 977-5700 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock |
| Trading Symbol | APLS |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |