Massachusetts-based Amylyx Pharmaceuticals (Nasdaq: AMLX) announced a proposed USD 350 million underwritten public offering of common stock, with proceeds set to be directed primarily toward pre-commercial preparations for avexitide, its first-in-class GLP-1 receptor antagonist for post-bariatric hypoglycemia (PBH). The raise comes one day after the company reported that avexitide met its FDA-agreed primary endpoint in the Phase III LUCIDITY trial, demonstrating a 55% reduction in composite Level 2 and Level 3 hypoglycemic events versus placebo (p=0.000003), with all secondary endpoints also met.

The offering includes a 30-day underwriter option to purchase up to an additional USD 52.5 million in shares. Amylyx said it intends to use net proceeds, together with existing cash, for avexitide pre-commercial activities including securing additional manufacturing capacity, research and development, and working capital. This offering is materially larger than Amylyx's two prior raises: a USD 60 million offering priced in January 2025 at USD 3.50 per share and a USD 175 million offering priced in September 2025 at USD 10.00 per share, reflecting the company's improved clinical position following the LUCIDITY readout.

The proposed USD 350 million raise is twice the size of Amylyx's September 2025 offering and ten times the USD 35.1 million the company paid to acquire avexitide from Eiger BioPharmaceuticals in a bankruptcy auction in 2024. Avexitide carries FDA Breakthrough Therapy Designation for PBH in patients following Roux-en-Y gastric bypass surgery. The company said it plans to pursue regulatory submission following the positive Phase III data and has announced an expanded access program for eligible US adults. Beyond avexitide, Amylyx is advancing AMX0035 (sodium phenylbutyrate/taurursodiol) in Wolfram syndrome, where Phase II data published in The Journal of Clinical Investigation demonstrated sustained stabilization across multiple disease endpoints, with a pivotal Phase III trial targeted for initiation in the second half of 2026. AMX0114, an antisense oligonucleotide targeting calpain-2 for ALS, is in Phase I dose escalation with FDA Fast Track Designation.

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