H.C. Wainwright Reiterates Buy Rating on Amylyx Pharmaceuticals inc. (AMLX)

H.C. Wainwright analyst Andrew Fein reiterated a Buy rating and $8.00 price target on Amylyx Pharmaceuticals inc. (NASDAQ: AMLX).

The analyst commented: "Consistent C-peptide and HbA1c data shows improvement in pancreatic function. Yesterday, Amylyx announced the data from the HELIOS trial, which demonstrated consistent improvement in terms of the C-peptide levels (the primary endpoint of the trial), and in terms of HbA1c levels (which showed positive changes despite being a slower moving biomarker compared to the C-peptide), indicating slowing down of disease progression in the Wolfram syndrome (WS) patients. Both the biomarkers showed improvement in the extended 36 and 48 weeks. In contrast, the natural history data shows a constant decline of C peptide which unlike Type 1 Diabetes do not plateau (Ray et al., Pediatr Diabetes, 2023). However, we think a propensity matched natural history cohort data might be helpful to convince FDA for the final approval, which given Amylyx’s experience with the CENTAUR and PHOENIX might not be a challenging aspect of the program, that is if at all the program needs one. Importantly, Amylyx showed improvement in visual acuity, an unmet need among the WS patients, signifying that AMX0035’s MOA might stabilize and slow down optic nerve degeneration. As for the next step, Amylyx plans to negotiate with the FDA the final path for the Phase 3 design. Given the rarity of the disease, we expect that the pivotal trial might be a smaller trial, and depending on the urgency might allow for an open-label trial with objective end points like C-peptide, which is why we think the C-peptide data is so crucial for the program. Based on the preclinical and clinical data we think Phase 3 inclusion criteria might be broad and similar to the current study and might tend to include younger patients who might for obvious reasons respond better than the older patients. Reiterate Buy rating and $8 PT."

For an analyst ratings summary and ratings history on Amylyx Pharmaceuticals inc. click here. For more ratings news on Amylyx Pharmaceuticals inc. click here.

Shares of Amylyx Pharmaceuticals inc. closed at $3.92 yesterday.

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