UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 8.01 | Other Information. |
On August 24, 2023, Collegium Pharmaceutical, Inc. issued a press release announcing that the U.S. Food and Drug Administration has granted New Patient Population exclusivity for Nucynta®, an immediate release formulation of tapentadol. This grant extends the period of U.S. exclusivity for Nucynta from June 27, 2025 to July 3, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
| Item 9.01 | Financial Statements and Exhibits. |
| 99.1 | Press Release, dated August 24, 2023 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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.
| Dated: August 24, 2023 | Collegium Pharmaceutical, Inc. | |
| By: | /s/ Colleen Tupper | |
| Name: Colleen Tupper | ||
| Title: Executive Vice President and Chief Financial Officer | ||