Mind Medicine MindMed Inc (MNMD) Share Price

MindMed Announces Constructive End-of-Phase 2 Meeting with U.S. FDA for MM120 in Generalized Anxiety Disorder (GAD)

-Aligned on requirements for Phase 3 clinical development of MM120 for the treatment of GAD-

-Initiation of Phase 3 program remains on schedule to begin in second half of 2024-

https://www.businesswire.com/news/home/20240620626324/en/

June 20, 2024 07:00 AM Eastern Daylight Time

NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced the completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of MM120 (lysergic acid diethylamide [LSD] D-tartrate) into pivotal trials for the treatment of adults with GAD.

“On behalf of the 20 million people in the U.S. – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on the data from the previously completed Phase 2b MMED008 trial”
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“Following a constructive End-of-Phase 2 meeting with the FDA, we are pleased to have reached alignment on our Phase 3 development strategy for MM120 in GAD,” said Rob Barrow, Chief Executive Officer of MindMed. “This marks a significant milestone for MindMed and for the millions of individuals affected by GAD. We are on schedule to initiate our Phase 3 clinical program for MM120 oral dissolving tablet (ODT) in GAD in the second half of this year and look forward to sharing additional details on the design of our pivotal program in the coming months.”

The EOP2 meeting was supported by results from MindMed’s completed Phase 2b clinical trial, MMED008. The multi-center, randomized, double-blind, parallel-group, dose-finding study was designed to assess the effect of four doses of MM120 for the treatment of anxiety symptoms in participants diagnosed with GAD. In the trial, MM120 met its primary and key secondary endpoints and demonstrated a rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort. MM120 was generally well-tolerated in this trial, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day and being consistent with the expected acute effects of the trial drug.

“On behalf of the 20 million people in the U.S. – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on the data from the previously completed Phase 2b MMED008 trial,” said Daniel R. Karlin, MD, MA, Chief Medical Officer of MindMed. “Few treatment options have shown robust activity in GAD, with the last new FDA approval occurring in 2007. We are committed to bringing MM120 to people living with GAD and are excited to move into the next phase of our development program.”

About MM120

LSD (lysergide) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120, the tartrate salt form of lysergide, for GAD and is exploring its potential applications in other serious brain health disorders.

About Generalized Anxiety Disorder (GAD)

GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, persistent anxiety, and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD. This underdiagnosed and underserved indication is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007.

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD.

So right. FDA is disaster and they are supposed to be looking out for the human race. What a joke

Thank You

What a ridiculous article
A small handful of people have adverse effects from mushroom chocolates and the FDA issues a warning??? Meanwhile, as I’m typing this a dozen people died of fentanyl overdoses, 100 people just died from boozing and 3000 people croaked from cigs. Oh yeah, and scores of people also got seriously ill from contaminated meat, poultry and produce from CAFO or Monsanto mega farms.

Vomiting is not uncommon with higher doses of psilocybin, mescaline and even LSD. Vomiting is also extremely common with alcohol.

Abnormal heart rates are not only common with ALL drugs, one of the very means of classifying something as a drug is the substance’s effect on heart rates. Unlike cocaine or heroin I have never heard of a user experiencing cardiac arrest as the result of taking mushrooms or LSD.

Depression and/or seizures would be cause by underlying issues and not a direct result of drug use with the slightest possible exception of profound, extended use but even then underlying factors would be the main contributor.

The FDA is a joke with this bipolar nonsense. One minute they fast track MNMD’s LSD medicine, the next minute they warn about dangers of psychedelic meds…….pure comedy

To anyone with experience with psilocybin it is evident this report it totally blown out of context. Yes, temporary nausea is common for some at higher doses - no big deal and it can be managed. Seizures and depression are very uncommon and are likely a result of dosage abuse and state of mind of the user pre usage. Abnormal heart rates also uncommon at concerning levels for psilocybin, but are frequently a side effect from chocolate for those sensitive to caffeine. My wife can only eat a small amount of dark chocolate and never in the evening or she gets heat racing/anxiety feeling.

Sounds very similar to the poorly and or uninformed. That's me.
Please pardon my ignorance ,What is the difference?
TIA

Again, another reason why I'm invested in mind mode they are actually a medical company and not screwing around with things that they shouldn't be. Extremely bullish on them.

FOOD & DRINK
Microdosing chocolate bars leads to seizures, heart issues, vomiting and hospitalizations, FDA warns
By Social Links forAlex Mitchell
Published June 10, 2024, 7:22 p.m. ET

21 Comments
The Food and Drug Administration is warning that a chocolate bar laced with mushrooms is causing a bevy of serious health problems with users.

Diamond Shruumz-brand Microdosing Chocolate Bars are designed for consumers to engage with mushrooms in tiny increments.

However, multiple people nationwide who ate the chocolate — the brand’s website calls them “a subtle, sumptuous experience and a more creative state of mind” — experienced seizures, depression, vomiting and “abnormal heart rates.”

Others reportedly passed out after taking the $25 bars along with becoming confused or agitated, according to the FDA.

A brand of mushroom infused chocolate can be dangerous to eat, warns the FDA.
3
A brand of mushroom infused chocolate can be dangerous to eat, warns the FDA.
Getty Images/iStockphoto
A brand of mushroom candy bars is causing severe health issues.
3
A brand of mushroom candy bars is causing severe health issues.
FDA
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So far, there have been eight cases reported: four in Arizona, two in Indiana, one in Nevada and another in Pennsylvania.

Of the confirmed cases, six people have been hospitalized.

“Consumers should not eat, sell, or serve any flavor of Diamond Shruumz-brand Microdosing Chocolate Bars, and should discard them,” the FDA warned consumers while also instructing retailers “not to sell or distribute” the product and to instead hold it “in a secure location until additional instructions can be provided on how to return or safely dispose of the product.”

The government agency also warned that the full list of retailers selling the brand “is currently unknown,” but it is specifically marketed as candy to young people.

The FDA warns to not buy the product.

excellent recovery today

Totally not concerned - I have quite the sizable holding in MNMD. Over the next few years we are going to see some interesting shifts happen. MindMed will be one of the ones on top. I have no doubts.

Bought 500 shares today

Bees don’t waste time
Telling flies
That honey tastes better
Than shit

MNMD is gonna be a millionaire maker regardless of the crooked by the FDA, DEA, pharma and other adversarial groups.

I think Kevin O'Leary may be right in that the smaller companies in the psychedelic space may merge to maximize the effect of their resources and these smaller companies may rally around MindMed! The news about Lykos is nothing! Remember Karuna....$$$$

Oh this company will be one of the leaders. Lycos messed up. Rick Doblin is having a bad day. Rob Barrow is not. Shareholders here are fine.

I hated to do what I did but I sold my MNMD shares for a considerable gain last month and invested in RONN. I am still very very bullish on MNMD and this recent pull back shouldn't alarm anybody as I believe the company is still vastly undervalued according to the research I've done. If all goes according to plan with RONN, I wish to buy back an even bigger position with MNMD as I still feel confident on MindMed's molecules being successful in FDA clinical trials. Best wishes and keep fighting for the company, I'm hoping to come back!!!

This does not affect us. Good recovery so far. We will be fine. Bad trial design on Lycos part.

Great buying opportunity perhaps as they still have their mushroom drug that is in phase 3

This selloff of psychedelic drugs across the board is due to the FDA rejection of private company Lykos Therapeutics’ MDMA drug for PTSD. This is certainly a knee jerk, overdone reaction in relation to MNMD.

https://www.npr.org/sections/shots-health-news/2024/06/04/nx-s1-4991112/mdma-therapy-ptsd-fda-advisors

Should be buying now

Yes it was

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

Nice after hour spike!

This stock may need a little of its own medicine:)

This stock is resilient. Tells me the institutional longs have no desire to sell until we are significantly higher. $50-100 range. The market for their product is almost Infiniti

Agreed

MNMD recovering!
Bullish!!!!!!!!!!!!!!!!!!!!!

Multi-billion dollar valuations are approaching.
https://www.businesswire.com/news/home/20240508064415/en/MindMed-Reports-First-Quarter-2024-Financial-Results-and-Business-Updates

Not a lie. Completely different drugs. Do you have Google Marc?

And I quote:

Savannah-Marc
04/14/24 2:40 PM
Post #9,370
Keep your eye on the prize my fellow MindMed shareholders. A company with a similar profile was bought out for $14 billion while still in FDA Phase 3 clinical trials and WITHOUT FDA Breakthrough designation! Know what you own! Stay well my people!
https://www.biopharmadive.com/news/bristol-myers-karuna-acquire-schizophrenia-kar-xt/703313/

You say things and spin lies like they matter. Your opinions are worthless on whatever board you try and yuck it up on. Stick to giving "stock tips" from the drive thru window and don't forget the ketchup packets, that's the most important part!

How are they similar? Because they're both in phase 3? You could say that about hundreds of drugs. KarXT is NOT a psychedelic while MindMed's drugs are all pcychedelics, so not similar.

Typical response 🤣

AWESOME!!!!!

MindMed Presents Phase 2b Study of MM120 for Generalized Anxiety Disorder (GAD) at American Psychiatric Association (APA) Annual Meeting in New York

https://finance.yahoo.com/news/mindmed-presents-phase-2b-study-120000301.html

I have never seen a PR on a Saturday.

MNMD 10 day hourly

I think so

Maybe back to $12 next week

MindMed will be the vanguard of the shroom boom, only a matter of time before this trades in the BILLIONS!!!!!

Agreed

Primed to go sky high. This along with ATAI will be big players in this market. Also, while not related but will be a catalyst is the fact they are going to deschedule Cannabis. This is huge for this sector because of optics.

Supposed “Special Meeting” on June 9
As seen on Reddit/WeBull

I believe MindMed's FDA Breakthrough designation is going to increase value at breakneck speeds.
https://www.fool.com/investing/2024/04/25/this-small-cap-stock-is-up-150-this-year-and-heres/

Another recent bullish article.
https://investorplace.com/2024/04/the-top-3-small-cap-stocks-to-buy-in-april-2024/

Shroom boom is coming, only a matter of time!
https://www.nationalgeographic.com/premium/article/psychedelic-medicine-veterans-ptsd-anxiety-depression

Stop making shittz up! This stock is EASY $30 per share by measuring it to other companies that were in similiar circumstances such as ENTERING FDA PHASE 3 and ACHIEVING FDA BREAKTHROUGH DESIGNATION! MindMed is wayyyyyyy UNDERVALUED!!!!!

Only if Re/De-Scheduled or Major News
This was overbought after the FDA breakthrough announcement, and rightfully so because barring the dilution MNMD would probably be on the moon by now at 25-50pps

I think MNMD drifts a bit and worst case closes the big gap at 6-7pps. This is only short term as I full expected a moonshot here once Phase 3 news starts to materialize and eventually more info on MM-120 getting to market.

In the meantime, this volatility is excellent for generating cash. I’m not usually a day trader but it’s pretty easy to scalp a couple hundred $ and sometimes a few thousand per day by selling covered calls. I would never short the equity or sell naked calls on a biopharma but sell covered calls, close the intraday or next day, rinse and repeat.

Good times!

Oversold, ready for a bounce back to $11

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?orderBy=percentChange&orderDir=desc

Watch this.... https://www.hcplive.com/view/daniel-karlin-md-fda-grants-breakthrough-designation-to-mm120-for-anxiety