Catherine Novack

Cory Jubinville

Andy Chen

Brian Skorney

David Lebowitz

Douglas Tsao

Jessica Fye

Joseph Schwartz

Yasmeen Rahimi

Gavin Clark-Gartner

Maxwell Skor

Alexander Thompson

Alex Thompson

Anthea Li

Catherine Okoukoni

Charles Moore

Frances Dovell

Francis DiGiovanna

Gavin Kluck

Jessica Fife

John Walden

John Wobel

Josh Schimmer

Katherine Xu

Lee Hung

Leland Gershell

Richard Law

Rohan Mata

Rohan Mathur

Tyler Van Buren

Will Scheibler

Yasim Rahimi

Yuchen Ding

- Crinetics Pharmaceuticals, Inc. announced the **FDA approval of PALSONIFY (paltusotine)** for the treatment of adults with acromegaly.  **[1658247_0001658247-25-000008_crnx-2025925ex991.htm:0]** **[1658247_0001658247-25-000008_crnx-20250925.htm:1]** **[1658247_0001658247-25-000008_crnx-2025925ex991.htm:1]** **[1658247_0001658247-25-000008_crnx-20250925.htm:2]** 
- PALSONIFY is notable as the **first once-daily, oral therapy** approved by the FDA for this condition.  **[1658247_0001658247-25-000008_crnx-2025925ex991.htm:0]** **[1658247_0001658247-25-000008_crnx-20250925.htm:1]** **[1658247_0001658247-25-000008_crnx-2025925ex991.htm:1]** **[1658247_0001658247-25-000008_crnx-20250925.htm:2]** **[1658247_0001658247-25-000008_crnx-2025925ex991.htm:4]** 
- The approval was based on positive data from the **PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials**.  **[1658247_0001658247-25-000008_crnx-2025925ex991.htm:1]** 
- The company expects PALSONIFY to be available in the U.S. in **early October**.  **[1658247_0001658247-25-000008_crnx-2025925ex991.htm:1]** 
- A Marketing Authorization Application for paltusotine is currently under review in the European Union, with a Committee for Medicinal Products and Human Use (CHMP) opinion anticipated in the **first half of 2026**.  **[1658247_0001658247-25-000008_crnx-2025925ex991.htm:2]**

Crinetics Pharmaceuticals Announces FDA Approval of PALSONIFY for Acromegaly

- **PALSONIFY (paltusotine) tablets** received initial U.S. Approval in **2025** from the FDA.  **[1658247_2158344:6]** 
- It is indicated for the treatment of **adults with acromegaly** who had an inadequate response to surgery and/or for whom surgery is not an option.  **[1658247_2158344:6]** 
- The recommended initial dosage is **40 mg once daily**, which can be titrated to **60 mg once daily** after 2 to 4 weeks based on IGF-1 levels.  **[1658247_2158344:6]** 
- Clinical data from Phase 3 studies demonstrated that PALSONIFY achieved **rapid, reliable, and consistent biochemical control**, with **83%** of switch patients and **56%** of naive patients maintaining or achieving IGF-1 ≤ 1.0xULN.  **[1658247_2158344:8]**

Crinetics Pharmaceuticals Receives FDA Approval for PALSONIFY

- Crinetics Pharmaceuticals announced that **PALSONIFI** has been approved by the FDA for the treatment of adults living with acromegaly.  **[1658247_2158219_1]** 
- The broad label reflects extensive clinical data, allowing **PALSONIFI** to be a **first-line treatment** for adult patients who have had an inadequate response to surgery or for whom surgery is not an option, and notably includes data showing improvement in symptoms.  **[1658247_2158219_3]** 
- The addressable market in the U.S. for acromegaly patients is approximately **11,500**, with an estimated **1,500** newly diagnosed patients each year.  **[1658247_2158219_6]** 
- The annual wholesale acquisition cost (WAC) for **PALSONIFI** is set at approximately **$290,000**, which is comparable to other approved acromegaly products.  **[1658247_2158219_7]** 
- To ensure broad patient access, Crinetics has implemented programs such as a Quick Start program for **48-hour delivery** of the prescription and co-pay assistance, with expectations for formulary placement within **six to nine months** after launch.  **[1658247_2158219_7]**

Crinetics Pharmaceuticals announces FDA approval and launch of PALSONIFI for acromegaly

Crinetics Pharmaceuticals (CRNX)