Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) soared to a new three-year high on Tuesday after its treatment candidate for post-bariatric hypoglycemia (PBH) reported strong results in phase 3 clinical studies, paving the way for its looming commercialization.
In intra-day trading, the stock surged to a record of $35.39 before trimming a few cents to end the session up by 63.84 percent at $35.11 apiece.
For illustration purposes only. Photo by MA Arkhipov on Shutterstock
55% Improvement
In the clinical study, drug candidate Avexitide successfully reduced moderate-to-severe low-blood-sugar episodes by 55 percent in 78 enrolled participants, as compared with the placebo.
In addition, it met all secondary endpoints, demonstrating consistent, highly significant, and clinically meaningful reductions in level 2 hypoglycemic events, either by self-monitoring of blood glucose or continuous glucose monitoring, as well as level 3 hypoglycemic events.
So far, the only minor side effects recorded include diarrhea, as well as erythema and bruising at the injection site.
“Today’s results are a major milestone that demonstrate avexitide’s potential to address a critical treatment gap for the PBH community and represent a meaningful step forward for people living with this condition,” Chief Medical Officer Camille Bedrosian said.
NDA by Year-End
In line with the results, Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) is “moving with urgency” to submit a new drug application for Avexitide with the Food and Drug Administration (FDA) by the end of the year, in line with its targets to commercialize the drug candidate in 2027.
It is also planning to present the data from the clinical trial at an upcoming medical meeting.
The FDA previously granted a Breakthrough Therapy Designation for Avexitide in patients with PBH.
Price Target Upgrades
Three investment firms raised their price targets and kept positive ratings for Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) following the results.
HC Wainwright was the most bullish among the three, upgrading its price target to $55 from $34, while keeping a buy recommendation.
Stifel followed with a price target hike to $45 versus $21 previously, while reaffirming its buy recommendation.
Mizuho, on the other hand, increased its price target to $42 from $30, while maintaining its outperform rating, saying that the trial outcome came as a huge company milestone after the weak phase 3 study of its former ALS asset, Relyvrio.
Mizuho also reaffirmed Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) as a top pick for 2026.
Hedge Fund Sentiment
The third quarter of the year will become a crucial determining factor in hedge fund sentiment for Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) following the strong results of Avexitide.
In the first quarter alone, data from Insider Monkey showed that 34 hedge funds held positions in the stock, down from the 40 in the previous quarter.
However, their combined holdings jumped by 16.45 percent to $567 million from $486.9 million quarter-on-quarter, signaling growing confidence among existing investors.
What More to Expect
The question now lies in whether the stock still offers enough upside after the market largely priced in the successful clinical trial.
According to the company, PBH is a chronic metabolic condition that is estimated to affect approximately 8 percent of people in the US.
Despite the substantial burden, there are currently no FDA-approved therapies for PBH, giving Avexitide a huge opportunity to build a commercial franchise around a relatively underserved patient population, if and when approved.
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