JLS Fund
767 posts
JLS Fund
@FundJls
Investments at the Intersection of Neuroscience, Psychedelics & Technology
Katılım Ocak 2021
60 Takip Edilen305 Takipçiler
Newly-Filed Federal Bill Would Require the VA to Study and Provide Psychedelic Treatments psychedelicamericas.org/p/newly-filed-…
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No surprise - given the excellent data set that @ataibeckley's lead program, BPL-003, delivered in its Phase 2b study last year, and the recent FDA Breakthrough Therapy designation for treatment-resistant depression - but nevertheless a major milestone:
$ATAI has announced a successful End-of-Phase 2b meeting with the FDA regarding the development of BPL-003 for treatment-resistant depression.
This represents an important regulatory validation of both the data package and the planned path forward.
Now BPL-003 is rapidly advancing toward Phase 3 initiation in Q2 2026.
Don’t miss our Virtual Investor Day on March 6, 2026, where we will provide further insights into the Phase 3 design, as well as updates on our two other lead programs, VLS-01 and EMP-01.
Exciting days ahead 🚀
AtaiBeckley Inc@ataibeckley
We’re pleased to share that we had a successful End‑of‑Phase 2 meeting with the FDA regarding the development of BPL‑003 for treatment‑resistant depression. Phase 3 initiation remains on track for Q2 2026. Read more: ir.ataibeckley.com/news-releases/… #ClinicalTrials #AtaiBeckley #BreakthroughsInMentalHealth #TRD
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And just like that… @ataibeckley has its 3rd lead drug / EMP-01 with positive topline results for Social Anxiety Disorder (SAD)
This morning’s Phase 2a data of EMP-01 (R-MDMA) demonstrated:
· A favorable safety and tolerability profile (with minimal side effects, primarily limited to nausea)
· A clinically meaningful effect in enrolled adult patients with Social Anxiety Disorder (SAD)
You can read the full announcement here: ir.ataibeckley.com/news-releases/…
This milestone is highly significant for both patients and investors. There are very few innovative medicines on the horizon that meaningfully address SAD - a vast and underserved market.
Estimates suggest that approximately 5–10% of people worldwide will experience social anxiety disorder at some point in their lives. Let that sink in.
The current standard of care largely relies on benzodiazepines. However, benzos do not make people more social - they simply numb fear and anxiety. They are not a solution, and they come with well-known dependency risks and other serious side effects. The unmet need remains enormous.
Beyond Social Anxiety Disorder, the exploratory trial suggests that EMP-01 may possess a differentiated and clinically compelling pharmacodynamic profile. In simplified terms, its observed effects appear to combine prosocial, affect-enhancing properties of MDMA with the perceptual and insight-oriented qualities associated with psilocybin.
If confirmed, this potentially hybrid profile could be highly relevant across a broader range of neuropsychiatric indications characterized by maladaptive emotional processing and impaired social cognition, including PTSD, adjustment disorder, and related stress- and trauma-related conditions.
With today’s achievement, $ATAI now has three lead programs advancing:
· BPL-003 (intranasal 5-MeO-DMT) - going into Phase 3 – with end of P2b FDA meeting notes expected to be published in Q1
· VLS-01 (buccal DMT) – Phase 2 readout expected in the second half of the year
· EMP-01 (R-MDMA)
This further cements AtaiBeckley’s leadership position in the psychedelic medicine space. In my view, AtaiBeckley is not only leading in terms of pipeline breadth and depth, but also is uniquely positioned in the sector to execute against a clearly defined and scalable commercial strategy.
If you haven’t yet, please read my blog post from last week outlining why I believe Atai Beckley stands apart:
x.com/C_Angermayer/s…
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After 9 years in the gym, here's every fitness tip I could come up with:
1. Stop drinking alcohol.
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Helus’ Experimental Drug Cuts Depression Symptoms in Days: jlsfund.substack.com/p/helus-experi… #depression @HelusPharma
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Lundbeck’s Resilience Pays Off in Migraine Study: jlsfund.substack.com/p/lundbecks-re… @LundbeckUS #migraine
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