u/Stonkstronaut

Source link: https://www.streetinsider.com/dr/news.php?id=26901281&gfv=1

JonesResearch believes ABCL635 is now positioned as a potential leader in the “largely untapped” multibillion-dollar menopausal hot flashes market for women contraindicated for hormonal replacement therapy, projecting $2.5B in peak worldwide sales

Source Link: https://www.tipranks.com/news/the-fly/abcellera-price-target-raised-to-25-from-13-at-jonesresearch-thefly-news#google_vignette

Hi Everyone.

Before starting this community, I had a thesis. That thesis was that AbCellera would evolve to become the core infrastructure for drug discovery. It's been a grueling few years, but the patience is starting to pay off. When fundamentals are improving while the stock price is declining, you are set up for an asymmetrical opportunity. Today marks the inflection point in that thesis.

I just wanted to say thank you to everyone who has joined and contributed to this community. I never expected it to grow this large, and grateful that I get to share this journey with all of you. You should all be proud.

Long and strong.

-Stonkstronaut

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Here are the most notable remarks from the Q2 2026 Quarterly Update.

TLDR - I am bullish on the Phase 2 read out later this month

*Not Financial Advice. Always do your own DD

"ABCL635 top-line data readout from the Phase 2 trial expected in August 2026"

"Recruitment in this study [ABCL635] accelerated through H1, and we completed enrollment and initial dosing of patients in June, well ahead of schedule."

"As noted in our last call, we have been preparing for next steps, which would include late-stage clinical development in moderate-to-severe VMs associated with menopause and clinical studies to evaluate ABCL635 in treating VMs associated with cancer treatments"

"We do think that in addition to the convenience of once-monthly dosing, improved safety for a product like this [ABCL635] is paramount, and we are so far very encouraged by the data we've seen"

"Historically, if you look at efficacy data [for ABCL635], there has been a very good follow-through between 4-week data and 12-week data. We're feeling confident that we are in a great spot."

"There's nothing that we've seen that has given us pause or damaged our thesis [on ABCL635]...Things are on track"

"We're feeling very good that we have great target engagement in the neurons that are the main drivers of this [blocking of NK3R in the preoptic nucleus]"

"AbCellera is moving into a very exciting time, and we look forward to updating your shortly on our pipeline and our portfolio"

With Benchmark upgrading from HOLD to BUY, we now have 100% alignment across analysts

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Menopausal hot flashes are driven by overactive KNDy neurons in the hypothalamus. When estrogen drops, these neurons go into overdrive and disrupt the brain’s temperature regulation center (the MnPO), triggering hot flashes. Small-molecule drugs like fezolinetant work by blocking the NK3R receptor. Because they are small, they easily cross the blood-brain barrier and can hit both the KNDy neurons (upstream) and the MnPO directly (downstream). This dual action has been proven to reduce hot flashes effectively. AbCellera’s ABCL635 is a monoclonal antibody. Antibodies are much larger, so they have limited ability to cross into certain parts of the brain. This means ABCL635 primarily blocks NK3R on the KNDy neurons upstream, with much less direct effect on the MnPO.

Why This Can Still Work Well

A landmark study (Mittelman-Smith et al., PNAS 2012) tested exactly this idea. In ovariectomized rats (a menopause model), researchers used a targeted toxin to completely ablate (destroy) the KNDy neurons, an upstream-only intervention. The result was a clear reduction in hot flash-like symptoms (reduced tail skin vasodilation) and lower MnPO activation. This experiment is crucial: it shows that strongly suppressing KNDy neuron activity upstream alone is sufficient to calm the downstream pathway and reduce hot flashes — even without direct pharmacological action on the MnPO.

Phase 1 Data Strengthens the Case

AbCellera’s Phase 1 study showed that a single dose of ABCL635 produced strong and sustained suppression of testosterone, LH, and FSH for several weeks (far longer than the transient daily effect of small molecules). This is a validated biomarker confirming robust target engagement on KNDy neurons. In other words:

• The animal study (Panel C) proves upstream KNDy suppression works
• Panel C also proves that with the absence of the KNDy neurons, MnPO is activated, reducing hot flashes. This ultimately shows that engagement on KNDy neurons have strong activation on MnPO downstream and that having direct activation on MnPO is not necessary to get reduction in hot flashes
• Phase 1 proves ABCL635 is achieving strong, long-lasting upstream KNDy suppression in humans

TLDR

When you combine the strong mechanistic evidence from the ablation study with the impressive Phase 1 biomarker data, the probability that ABCL635 will show meaningful efficacy in Phase 2 looks reasonably high (I’d estimate 75-80%+). The antibody’s sustained pharmacology could even offer an advantage over daily pills. Of course, clinical results are never guaranteed, and Phase 2 (expected Q3 2026) will be the real test. But the science lines up well for this program.

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