Company: CRNX
Filing Date: 2025-09-26
Form Type: 8-K
Source: 0001658247-25-000008
Chunk: 0

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-09-26
Form: 8-K
Item: Item 7.01
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Item 7.01 Regulation FD Disclosure.

On September 25, 2025, Crinetics Pharmaceuticals, Inc. (the “ Company,” “ Crinetics,” “we,” “us,” or “our”) issued a press release announcing that the U. S. Food and Drug Administration (“ FDA”) approved PALSONIFYTM(paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY, a selectively-targeted somatostatin receptor type 2 nonpeptide (“ SST2”) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly.

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Company intends to hold an investor conference call on September 25, 2025 at 6:00 pm Eastern Time to discuss the FDA approval of PALSONIFY. The press release, as well as a replay of the investor conference call, will also be available under the “ Investors” section of the Company’s website.

The information contained in this Item 7.01 of this Current Report on Form 8-K, including in Exhibit 99.1 hereto, is being “furnished” and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “ Exchange Act”), is not subject to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “ Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.