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FDA clears PALSONIFY for acromegaly in adults at Crinetics (NASDAQ: CRNX)

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Crinetics Pharmaceuticals announced that the U.S. Food and Drug Administration approved PALSONIFY™ (paltusotine) on September 25, 2025 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 is described as a selectively-targeted somatostatin receptor type 2 nonpeptide agonist and is now the first once-daily, oral treatment approved for adults with acromegaly. Crinetics is also holding an investor conference call on September 25, 2025 to discuss the approval, and a press release and call replay will be available in the investors section of its website.

Positive

  • FDA approval of PALSONIFY as the first once-daily, oral treatment for adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option represents a major regulatory milestone for Crinetics.

Negative

  • None.

Insights

FDA approval of PALSONIFY marks a major milestone for Crinetics.

The approval of PALSONIFY (paltusotine) by the U.S. Food and Drug Administration for first-line treatment of adults with acromegaly is a significant regulatory milestone. The product is described as the first once-daily, oral treatment approved for adult acromegaly, which differentiates it from existing options that often rely on injectable therapies.

The label focuses on adults who had an inadequate response to surgery and those for whom surgery is not an option, anchoring PALSONIFY squarely in the chronic management setting. As a selectively-targeted somatostatin receptor type 2 nonpeptide agonist, it is positioned as a mechanism-based therapy aligned with current treatment paradigms.

The company is highlighting the event through an investor conference call on September 25, 2025, which underscores its importance. Future company disclosures may provide details on launch strategy, market uptake, and any post-approval commitments linked to this indication.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Understanding 8-K Material Events →
0001658247false00016582472025-09-252025-09-25

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________________________________________________
FORM 8-K
_________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 25, 2025
_________________________________________________________
Crinetics Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
_________________________________________________________
Delaware001-3858326-3744114
(State or Other Jurisdiction
of Incorporation)		(Commission File Number)(IRS Employer
Identification No.)
6055 Lusk Boulevard
San Diego, California
92121
(Address of Principal Executive Offices)(Zip Code)
Registrant’s Telephone Number, Including Area Code: (858) 450-6464
(Former Name or Former Address, if Changed Since Last Report)
_________________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading
Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per shareCRNXNasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
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. o


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.
On September 25, 2025, the FDA approved PALSONIFY 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.
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. All statements other than statements of historical facts contained in this Current Report on Form 8-K are forward-looking statements. These forward-looking statements speak only as of the date of this Current Report on Form 8-K and are subject to a number of known and unknown risks, uncertainties and assumptions, including, without limitation, the risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (“SEC”). The events and circumstances reflected in the Company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
Exhibit No.Description
99.1
Press Release dated September 25, 2025.
104Cover 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.
Crinetics Pharmaceuticals, Inc.
Date:
September 25, 2025
By:/s/ R. Scott Struthers, Ph.D.
R. Scott Struthers, Ph.D.
President and Chief Executive Officer
(Principal Executive Officer)

Source: View Original Filing on SEC EDGAR

FAQ

What did Crinetics Pharmaceuticals (CRNX) announce in this 8-K filing?

Crinetics Pharmaceuticals reported that the U.S. Food and Drug Administration approved PALSONIFY™ (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.

What is PALSONIFY (paltusotine) and how is it described in the filing for CRNX?

PALSONIFY (paltusotine) is described as a selectively-targeted somatostatin receptor type 2 nonpeptide agonist and is now the first once-daily, oral treatment approved for adults with acromegaly.

For which patients is PALSONIFY approved according to the Crinetics 8-K?

PALSONIFY is approved 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.

When did the FDA approve PALSONIFY for Crinetics Pharmaceuticals?

The filing states that on September 25, 2025, the U.S. Food and Drug Administration approved PALSONIFY for the indicated adult acromegaly population.

Is Crinetics hosting an investor call about the PALSONIFY approval?

Yes. Crinetics intends to hold an investor conference call on September 25, 2025 at 6:00 pm Eastern Time to discuss the FDA approval of PALSONIFY, with the press release and replay available on the company’s investor website section.

Does the Crinetics 8-K include forward-looking statements about PALSONIFY?

Yes. The document notes that it contains forward-looking statements subject to risks and uncertainties described in Crinetics’ periodic SEC filings, including its annual report on Form 10-K for the year ended December 31, 2024.