GLP
Global Partners LP
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Ya cuz no way China is flooding NA with cheap GLP'3 right now.

GLP 1 S WILL MAKE YOUR PANCREAS SHRINK NOT WORK ANYMORE SO YOU PROLLY BE DEAD IN ABOUT 5 YEARS AFTER STOPPING

**The full article can be read on my** [Substack](https://bayescio.substack.com/p/amylyx-pharmaceuticals-inc-amlx-a?r=79ml6h&utm_campaign=post-expanded-share&utm_medium=web) **account; just click on the link.**
**Event Summary**
Amylyx Pharmaceuticals ($AMLX) is approaching one of the most important catalysts in its history, with topline Phase 3 LUCIDITY data for Avexitide expected in late August or early September 2026.
Avexitide is a first-in-class GLP-1 receptor antagonist being developed for postbariatric hypoglycemia (PBH), a rare but severe complication that can occur after bariatric surgery. Unlike the GLP-1 agonists used for obesity and diabetes, Avexitide works by blocking GLP-1 signalling at pancreatic beta cells, reducing inappropriate insulin release and helping prevent dangerous post-meal drops in blood glucose.
What makes AMLX particularly interesting to me is that the drug already has a fairly strong mechanistic and clinical foundation. The Phase 1 studies demonstrated that GLP-1 blockade directly affects the physiology responsible for PBH, while the Phase 2 PREVENT study showed substantial reductions in hypoglycemia across multiple measures, including blinded continuous glucose monitoring.
The company also has approximately $250.8M in cash and expects its runway to extend into 2028, suggesting the upcoming catalyst is not accompanied by immediate financing pressure.
I currently rate AMLX a **STRONG BUY**, with approximately a **75% probability of a positive Phase 3 readout**, based primarily on the consistency of prior clinical data.
**The Bull Case**
The bull case is relatively straightforward.
Avexitide targets a biologically well-defined mechanism. PBH is associated with excessive GLP-1 signalling after bariatric surgery, which contributes to exaggerated insulin secretion and subsequent hypoglycemia. Avexitide blocks the GLP-1 receptor and reduces the inappropriate insulin response.
The clinical data so far have consistently demonstrated exactly what the mechanism would predict.
Phase 1 demonstrated prevention of hypoglycemia during mixed-meal testing. PREVENT subsequently demonstrated meaningful reductions in hypoglycemia across multiple severity levels, while blinded CGM showed reductions in both the frequency and duration of hypoglycemic episodes. At the same time, PBH remains an underserved indication with no approved therapy specifically targeting its underlying mechanism.
If LUCIDITY reproduces the Phase 2 results, Amylyx could potentially become the first company to bring a targeted pharmacological treatment to this market.
**The Bear Case**
The main risk is that the Phase 2 results may not fully replicate in Phase 3.
PREVENT involved only 16 evaluable patients and used a crossover design. That makes the results encouraging, but it also means the magnitude of the observed treatment effect should be interpreted with caution.
PBH is not a perfectly uniform disease. Glucose levels can fluctuate significantly among patients, dietary behaviour can change during a study, and differences in baseline disease severity can meaningfully impact the results.
A larger Phase 3 study could therefore produce a smaller treatment effect than PREVENT.
The placebo group could also perform better than expected if patients modify their diet or become more attentive to glucose monitoring during the trial.
So, while I believe the existing evidence gives AMLX a better-than-average probability of success, this remains a binary biotech event.
**My Thesis (Strong Buy, \~75% Chance of a Positive LUCIDITY Readout)**
My thesis is primarily based on the fact that this isn't a drug we are trying to reverse-engineer to explain why the clinical data might have worked. The mechanism makes sense. The Phase 1 studies demonstrated that blocking GLP-1 signalling changes the relevant physiology.
The Phase 2 PREVENT study then demonstrated that this pharmacodynamic effect translates into fewer and shorter hypoglycemic episodes. The effect was also observed across multiple measures of hypoglycemia and across different surgical backgrounds. That combination gives me more confidence heading into Phase 3 than I would typically have for a small biotech approaching a binary readout.
The main question now is not whether Avexitide can affect PBH physiology. The question is whether the magnitude of that effect is sufficiently large and reproducible in the Phase 3 population to support approval.
**A Short Biomedical Analysis of Postbariatric Hypoglycemia**
PBH generally occurs after bariatric surgery and is characterised by an exaggerated post-meal insulin response, causing blood glucose to fall excessively.
The underlying physiology is particularly interesting because GLP-1 plays a key role in this process.
After food intake, GLP-1 signalling contributes to insulin secretion. In patients with PBH, this response can become exaggerated following gastrointestinal surgery, resulting in an excessive insulin response relative to the amount of glucose entering the bloodstream.
**Where Avexitide Fits Into PBH Biology**
Avexitide is a peptide GLP-1 receptor antagonist. Rather than stimulating the GLP-1 receptor, as drugs such as semaglutide or tirzepatide do, Avexitide blocks the receptor. The drug binds to GLP-1 receptors on pancreatic beta cells and reduces GLP-1-mediated insulin secretion. The intended result is a reduction in the inappropriate post-meal insulin spike, thereby raising the glucose nadir and making post-meal glucose excursions more stable.
This makes Avexitide fundamentally different from the GLP 1 agonist class that dominates the metabolic drug market. It essentially uses the same biological pathway in the opposite direction. That is important because the mechanism is directly linked to the pathology Amylyx is trying to treat.
**PREVENT: The Phase 2 Study**
This is the most important piece of clinical evidence supporting my current thesis. PREVENT was a randomised, placebo-controlled crossover study evaluating subcutaneous Avexitide in adults with PBH. The evaluable population consisted of 16 patients with severe hyperinsulinemic hypoglycemia following procedures including Roux-en-Y gastric bypass, vertical sleeve gastrectomy, gastrectomy and Nissen fundoplication.
The first important observation is the consistency of the treatment effect. Across the analysed dosing regimens, Avexitide produced substantial reductions in hypoglycemic events. The reductions were broadly in the 50%-70% range across the different levels of hypoglycemia, with statistically significant results despite the very small sample size. That consistency is encouraging because it suggests that the pharmacodynamic effect is not dependent on one particular dosing schedule.
**Hypoglycemia Severity**
PREVENT also looked at different levels of hypoglycemia.
Level 1 represents glucose below 70 mg/dL.
Level 2 represents glucose below 54 mg/dL.
Level 3 represents severe hypoglycemia associated with altered mental or physical function requiring assistance.
The reduction was approximately 53% to 56% for Level 1 and Level 2 events, while Level 3 events were reduced by approximately 67%.
The clinical value of treating PBH isn't simply about improving mildly abnormal glucose readings. The more important objective is preventing the severe episodes that can result in neuroglycopenic symptoms and require assistance. The fact that the largest reduction appeared in Level 3 events, therefore, strengthens the clinical argument for Avexitide.
**Safety and Tolerability**
The safety profile across the clinical studies has so far been relatively clean. There were no serious adverse events in PREVENT, and no participants withdrew because of treatment. The more common adverse events included diarrhoea, headache, bloating and injection site reactions or bruising. These events were generally mild to moderate. For a chronic treatment intended for patients who may already have substantial morbidity from recurrent hypoglycemia, tolerability will obviously remain important. So far, however, there is no obvious safety signal that would materially undermine the thesis.
**Why PREVENT Could Still Be Misleading**
The biggest weakness in the clinical dataset is the sample size. Sixteen evaluable patients are too few to draw definitive conclusions about efficacy. The crossover design can also make the treatment effect look more pronounced if there are differences in patient behaviour, disease severity or glucose variability between treatment periods.
PBH itself can be unpredictable. Patients can alter their diet, meal timing, and glucose-monitoring behaviour during clinical studies. Those factors can introduce noise into the data and make replication more difficult. The Phase 3 trial may therefore produce a smaller effect size even if Avexitide is genuinely effective. This is the primary reason I don't assign a probability of success of 90% or greater. The drug has strong preliminary evidence, but the evidence is still preliminary.
**Market and Competitive Landscape (more numerical valuations and models can be read in the full article on Substack)**
PBH is a small market (160,000 patients per year, as estimated by Amylyx), but that is not necessarily a weakness. It is also an extremely underserved market. There are currently no approved therapies specifically targeting the underlying mechanism of PBH. Existing management is largely based around dietary intervention, glucose monitoring and, in severe cases, revisional surgery. This gives Avexitide a potentially attractive commercial position if approved. Amylyx would not need to compete against another late-stage drug with the same mechanism.
Instead, the company would essentially be attempting to replace symptomatic management and, for some patients, more invasive interventions. That creates a very different competitive landscape from that of large metabolic markets, where multiple companies are racing toward the same indication. Avexitide is currently the only mechanistically targeted late-stage programme I identify as directly aiming to establish an approved pharmacological treatment for PBH.
**Patents and Regulatory Position**
Avexitide is covered by a global patent family filed in 2019 covering its composition and use in hyperinsulinemic hypoglycemia, including PBH and congenital hyperinsulinism. The intellectual property is expected to extend well into the late 2030s. If LUCIDITY is positive and the subsequent regulatory process is successful, Amylyx is targeting a potential commercial launch in 2027. The company also has relevant regulatory designations that support development in this rare-disease setting.
**Financial Position**
Amylyx currently has a market capitalisation of approximately $2.5B. As of June 30, 2026, the company had approximately $250.8M in cash and expects its runway to extend into 2028. Q2 R&D expenses were $23.8M, down from $27.2M in Q2 2025, reflecting lower spending on AMX0035 in progressive supranuclear palsy, partially offset by increased investment in Avexitide. SG&A was $21.9M, up from $15.6M a year earlier, driven primarily by higher legal expenses and pre-commercial preparation ahead of a potential Avexitide launch. Total operating expenses were $45.7M, and the company recorded a quarterly net loss of $43.4M, or $0.39 per share.
The key point for the upcoming catalyst is that Amylyx appears adequately funded to reach the Phase 3 readout and continue preparing for a potential launch without an immediate financing requirement. That is important for the risk-reward because a positive readout would not necessarily be followed immediately by dilutive financing.
**Bottom Line**
I'm bullish on AMLX with a **STRONG BUY rating and approximately a 75% probability of a positive Phase 3 readout.**
The bull case rests on:
The mechanism is unusually well defined.
Phase 1 demonstrated that GLP-1 blockade directly affects the physiology responsible for PBH.
PREVENT subsequently demonstrated meaningful reductions in hypoglycemia across multiple severity levels.
Blinded CGM independently supported reductions in both the frequency and duration of hypoglycemia.
The safety profile has been relatively clean.
PBH remains an extremely underserved indication with no approved targeted treatment.
Amylyx has approximately $250.8M in cash and expects its runway to extend into 2028.
The bear case remains meaningful:
PREVENT only had 16 evaluable patients.
The crossover design introduces potential statistical and behavioural limitations.
PBH is heterogeneous and inherently noisy.
The magnitude of the Phase 2 effect may not fully replicate in Phase 3.
A stronger-than-expected placebo response could narrow the treatment difference.
So while I think the probability of success is meaningfully above 50%, I would not treat AMLX as a low-risk investment.
This is still a binary biotech catalyst.
If LUCIDITY confirms the PREVENT data, I believe the market will begin to value Amylyx as a commercial-stage rare-disease company rather than a clinical-stage biotech, with a potential 2027 launch and substantial upside from current levels.
If LUCIDITY fails, however, a large portion of the investment thesis disappears almost immediately.
That asymmetry is ultimately why I find AMLX interesting at this point in the development cycle.
**Full analysis, including my detailed revenue assumptions, valuation model, patient penetration assumptions, clinical data and additional research, is available on my** [Substack](https://bayescio.substack.com/p/amylyx-pharmaceuticals-inc-amlx-a?r=79ml6h&utm_campaign=post-expanded-share&utm_medium=web)**.**
**Disclaimer**
*This post reflects my personal views and is provided for informational and educational purposes only. It should not be interpreted as financial advice, investment guidance, or a recommendation to buy or sell any security. I am not a licensed financial advisor, broker, or investment professional. Readers should conduct their own research and consult a qualified financial professional before making investment decisions.*
*I currently do not hold any shares in Amylyx Pharmaceuticals, Inc. All opinions are based on publicly available information and my own analysis at the time of writing. Nothing in this post should be interpreted as a guarantee of future performance.*