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MindMed MM-120 (LSD) in GAD: Recent Research, Regulatory Developments, and Market Impact

A Primer for the Uninitiated and a Review for the Accustomed
Recent LSD Research in Mental Health and GAD

Growing Evidence of LSD’s Therapeutic Potential: In the past two months, several studies have highlighted LSD’s promise for treating anxiety and other mental health disorders. Notably, a 2023 clinical trial using two guided LSD sessions (200 µg each) reported lasting reductions in anxiety and depression, with 33% of participants in anxiety remission one year post-treatment?

psychiatryinstitute.com. This suggests that LSD, when combined with therapy, can produce sustained relief from anxiety symptoms. More recently, MindMed’s own Phase 2b trial in generalized anxiety disorder (GAD) demonstrated robust efficacy from a single 100 µg dose of LSD (MM-120) without any psychotherapy?psychiatryinstitute.com. In that trial, patients receiving MM-120 showed rapid, statistically significant improvements in anxiety (Hamilton Anxiety Rating Scale) versus placebo, with 65% achieving a clinical response and 48% reaching remission by 12 weeks?psychiatryinstitute.com. These findings – achieved with pharmacotherapy alone – underscore LSD’s potential as a novel anxiolytic.

Comparisons to Microdosing and Other Indications: While microdosing LSD has been popularized anecdotally, rigorous studies have so far failed to show clear benefits. For example, controlled trials of repeated low-dose LSD found no significant improvements in mood or cognition compared to placebo?

psypost.org. This contrasts with the marked improvements seen with full psychedelic doses in therapeutic settings. Beyond anxiety, researchers are also exploring LSD for other conditions: MindMed itself is planning a Phase 3 trial (“Emerge”) of MM-120 in major depressive disorder, and other startups like MindBio are testing LSD microdoses in depression?greenmarketreport.com?biospace.com. Overall, recent research signals that LSD – at carefully controlled, therapeutically relevant doses – can produce meaningful mental health benefits, especially in hard-to-treat conditions like GAD, whereas microdosing alone remains unproven.
FDA’s Evolving Stance on Psychedelic Drug Approvals

Cautious Openness and New Guidance: The U.S. Food and Drug Administration (FDA) has in the last couple of years shown a cautious but growing openness toward psychedelic therapies. In June 2023, the FDA released its first draft guidance for clinical trials with psychedelics, acknowledging the “therapeutic potential” of drugs like psilocybin, LSD, and MDMA and expressing willingness to work with developers?

foley.com. This guidance highlights unique trial design challenges (e.g. blinding, expectancy effects) and stresses the need for rigorous methodologies, but its issuance was itself a signal that the FDA is preparing for psychedelic drug development. The agency has also granted Breakthrough Therapy Designations – an expedited development status – to several psychedelic-based treatments, including psilocybin for depression, MDMA for PTSD, and most recently MindMed’s LSD-derived MM-120 for GAD?psychiatryinstitute.com. Such designations indicate that early evidence is very promising and that the FDA will prioritize guidance on these programs. As one commentator noted, having LSD join MDMA and psilocybin as a Breakthrough therapy shows regulators see these as “hopeful treatment[s] for mental health conditions”?psychiatryinstitute.com.

Regulatory Rigor and Recent Policy Signals: Despite this optimism, the FDA’s stance remains appropriately rigorous. No psychedelic has yet been fully approved, and the FDA has made clear that Breakthrough status does not mean automatic approval?

psychiatryinstitute.com. A recent high-profile case underscored the FDA’s insistence on solid evidence: In 2024 the FDA rejected an NDA for MDMA-assisted therapy in PTSD, issuing a Complete Response Letter that requested an additional Phase 3 trial?hklaw.com. The agency agreed with advisors that the prior trials had not definitively proven efficacy, partly due to issues like patients correctly guessing they were on the drug (unblinding) and concerns about adverse events?hklaw.com. This decision, coming despite MDMA’s Breakthrough designation and strong Phase 3 results, illustrates the FDA’s commitment to traditional approval standards (statistically robust, well-controlled trials) for psychedelics. In short, recent FDA actions and policies signal guarded support: the door is open for psychedelic therapies, but sponsors must meet the same high bar for safety and efficacy as any new drug. This balanced stance directly influences how MindMed and peers design their trials and interact with regulators.
MindMed’s MM-120 Clinical Progress with the FDA

Phase 2 Success and FDA Alignment: MindMed’s lead candidate MM-120 (a pharmaceutically optimized form of LSD) has progressed rapidly, buoyed by positive clinical data and constructive FDA engagement. In late 2023, MindMed announced that its Phase 2b trial in GAD met its primary endpoint, with a single dose of MM-120 (100 µg) producing a 7.6-point greater reduction in anxiety scores (HAM-A) at 4 weeks compared to placebo (p

You'll get another chance. :)

Should've sold the 10's

Buy the dip

Rah!

Onward and upward.

MNMD announced that it will host a live webcast at 8:00 a.m. ET on Thursday, March 6, 2025 to report financial results for the fourth quarter and year ended December 31, 2024, and discuss recent business updates.

Agreed but not overly concerned - we have a heck of a year coming

Earnings have been estimated to happen around February 26. Hopefully, they'll provide an update that will be a catalyst for another move up.

Higher highs and higher lows. Keep doing your thing.

Mind Medicine Getting An 'RFK Bump'? Retail Gets More Bullish As Stock Heads For Best Day In Over 10 Months

https://www.msn.com/en-in/entertainment/oscars/mind-medicine-getting-an-rfk-bump-retail-gets-more-bullish-as-stock-heads-for-best-day-in-over-10-months/ar-AA1z4Uop

Yeah, being that we're a company that's in phase 3 with an absolutely stellar management team that has the background to get this done. I do see us hitting new all-time highs even before a buyout might occur although that might only be during an intro day trading session I do see this really peeking for a minute.

We have never had premarket activity like this in the past it's bringing in eyes

Great article!  A lot of momentum the next couple of years.... this could be $80 a share by the end of 2025

$MNMD After the rejection of Lykos Therapeutics’ MDMA-based PTSD treatment tempered excitement for psychedelic therapeutics, a recent approval and positive data are generating new momentum, which experts expect to continue throughout 2025 and 2026.

https://www.biospace.com/drug-development/psychedelics-space-regroups-as-rfk-jr-signals-support

Wait until the media starts giving this attention now that this stuff is in phase 3 trials. It will be like the Nasdaq listing but bigger. Going to be one wild ride.

Got a chance, for sure.  200 million in volume could move this exponentially 

Been a long day....

Still 45 minutes left in power hour

Hope the guy that had 50k in Calls for 11.00 gets them. Would suck to miss out on that be to only have this hit 11+ next week

For starters.

Tiger this might hit the 40s in 2 months...

Market Cap is at 758,978,969. We want this to get to 2-4B

lol... I read that first part and thought you were going to say that you were going to sh!t when you say the action but couldn't due to the scope. LOL

Literally just got out of my colonoscopy and I'm happy to see this puppy is cleaned out and ready for a massive run!

Up and up from here boys! Shroom Boom 2.0 incoming!

I'm jacked! I'm jacked to the tits!!!

Like the volume, love the price movement 

Greatness 

We will soon see multi year highs here and through the sector.

I sold my 9 and 10 strikes two days ago, of course but still have a ton of shares 

Yes, it is :)

Well, I'm gonna take a bath and say that we get close to 11 today… Well for someone else's sake, we should hit 11 because there were some odd options played for today. They have a strike price of $11

Agreed.  We can hit $70 intraday and close at$55 so he can be right too!

It's looking good premarket 

Highest Price Target from an analyst is 55.00, which is HC Wainwright. However, I think the next big wave is coming just like back in 2021. Next hype train will push these hard ahead of policy change, more news, approvals, media coverage.

Big money will flow in now.

Very nice.  At $70, I'm looking at $300k gain!  I think we are in for a nice ride here for sure!

That's what I'm talking about!

It's bubbling jack...

I'd get a $250,000 gain at $70

Phase 3, Breakthrough Therapy Designation ... and now RFK, Jr. I smell the perfect storm brewing.

25.00 would be a nice start. 70.00 would be end game. 😁

Zoom out to a 3 year chart... this next pop is going to be nice.

I'm seeing upper $70's, and thats not even a 10X, 
Probably join you at $25 with taking back my principal and leaving the free shares in the market. My average is $5, on 5K shares.

I hope they don't get bought out before that price target. 25.00 is fair.

I'm locked and loaded with my first sell order in at $25

This will no organically grow through the year. Should get interesting.

Very nice!

rfk in

RFK about to get in...

get ready for next big leg up!