Michael DiFiore

Ananda Ghosh

Basma Radwan Ibrahim

Joel Beatty

Marc Goodman

Chen Yang

Corinne Johnson

Dan Akshit

Graig Suvannavejh

Jarwei Fang

Joseph Thome

Samuel Lee

Seamus Fernandez

Susan

Susan Chor

Tim Anderson

- Amylyx Pharmaceuticals is advancing **avexitide** for post-bariatric hypoglycemia (PBH), a condition affecting an estimated **160,000 people** in the U.S. with no current treatments.  **[1658551_tx_379729_0]** **[1658551_tx_379729_4]** 
- The Phase III trial for avexitide, which received **FDA breakthrough therapy designation**, began dosing on **April 30th** and is anticipated to yield data in the **first half of 2026**.  **[1658551_tx_379729_2]** **[1658551_tx_379729_4]** **[1658551_tx_379729_7]** 
- Prior Phase IIb data demonstrated avexitide's efficacy, showing a **64% reduction** in severe hypoglycemic events, with the median patient experiencing **zero events**.  **[1658551_tx_379729_1]** 
- The company plans for **premium orphan pricing** for avexitide, viewing PBH as an orphan market, and expects to leverage its commercial capabilities, having achieved **$400 million** in first full year sales for its initial product launch.  **[1658551_tx_379729_6]**

Amylyx Pharmaceuticals Provides Update on Avexitide Phase III Trial for Post-Bariatric Hypoglycemia

- Amylyx Pharmaceuticals has **discontinued the ORION program of AMX0035** for Progressive Supranuclear Palsy (PSP) as the drug **did not show differences compared to placebo** in primary or secondary outcomes at Week 24.  **[1658551_e3b31b8840704e19b50ec6f4deb9647b_0]** 
- Consequently, the company will **not initiate the Phase 3 portion** of the AMX0035 program for PSP.  **[1658551_e3b31b8840704e19b50ec6f4deb9647b_0]** 
- Amylyx's primary focus is now on the **Phase 3 LUCIDITY trial of avexitide**, with enrollment expected to complete in **2025** and topline data anticipated in the **first half of 2026**.  **[1658551_e3b31b8840704e19b50ec6f4deb9647b_0]** 
- The company continues to expect its **cash runway to extend through the end of 2026**.  **[1658551_e3b31b8840704e19b50ec6f4deb9647b_0]**

Amylyx Pharmaceuticals Discontinues ORION Program for AMX0035 in PSP

Amylyx Pharmaceuticals (AMLX)