MNMD - MindMed Inc.

Discussion in 'Stock Message Boards NYSE, NASDAQ, AMEX' started by Twiggs462, Apr 24, 2021.

  1. Twiggs462

    Twiggs462 Member

    Joined:
    Dec 6, 2020
    Messages:
    291
    Likes Received:
    12
    Mind Medicine (MindMed) (MNMD) Stock Analysis: 94% Surge, FDA Breakthrough & Phase III Progress

     
  2. Twiggs462

    Twiggs462 Member

    Joined:
    Dec 6, 2020
    Messages:
    291
    Likes Received:
    12
    Potential Acquisition of MindMed by J&J or Similar Pharma Companies:

    Given Johnson & Johnson’s (J&J) recent acquisition of Intra-Cellular Therapies (ITCI) and its Phase 2 asset for Generalized Anxiety Disorder (GAD), the possibility of J&J or another major pharmaceutical company acquiring MindMed is a realistic scenario.
    Why MindMed is an Attractive Acquisition Target

    Psychedelic-Based Innovation – MindMed’s MM-120 (LSD-derived treatment) represents a novel approach to GAD that could complement or even disrupt traditional pharmacological treatments. Major pharma companies, including J&J, have been exploring psychedelic-based treatments, evidenced by their previous work with Spravato (esketamine) for depression.

    Regulatory Progress and Phase 3 Trials – MM-120 is already in Phase 3 clinical trials and has received Breakthrough Therapy Designation from the FDA. A successful Phase 3 outcome would make MindMed a highly attractive buyout target, as acquiring a late-stage asset could be more efficient than developing a new one in-house.

    Market Differentiation – J&J’s acquisition of ITCI suggests they are seeking broader control over the GAD treatment market. However, ITI-1284 operates through a traditional neuropsychiatric mechanism, whereas MM-120 offers a radically different approach via serotonergic psychedelics. This divergence could make MM-120 a highly valuable asset for any pharma company looking to hedge their neuroscience portfolio with a potentially revolutionary treatment.

    Big Pharma’s Need for Pipeline Expansion – Large pharmaceutical companies, including J&J, Pfizer, and Merck, are continuously searching for promising late-stage clinical assets to maintain revenue streams as existing drug patents expire. The psychedelic medicine space is emerging as a major area of interest, especially as more clinical data supports the long-term efficacy and safety of these compounds.

    Challenges and Considerations

    Regulatory Uncertainty – Despite promising trial results, psychedelic-based therapies still face regulatory hurdles and stigma. J&J or another major pharma company may wait until MM-120 secures full FDA approval before making a move.

    Cultural Fit and Integration – MindMed is structured as a high-risk, high-reward biotech firm focusing on psychedelic medicine. A large pharmaceutical company might hesitate to fully integrate this approach into a more traditional CNS pipeline.

    Competition from Other Pharma Companies – While J&J could be a strong contender to acquire MindMed, other companies with neuroscience portfolios (e.g., AbbVie, Novartis, or Biogen) could also see MM-120 as an opportunity to expand into the psychedelic treatment space.

    Conclusion: Likelihood of Acquisition

    A J&J acquisition of MindMed is not out of the question, especially given J&J’s ongoing commitment to CNS treatments and GAD. However, whether J&J makes a move could depend on:

    The success of MM-120’s Phase 3 trials
    Market receptiveness to psychedelic-based treatments
    Competitive interest from other pharmaceutical giants

    If MM-120 demonstrates clear clinical efficacy and FDA approval seems likely, MindMed will almost certainly become a prime acquisition target in the next 12–24 months. J&J, given its recent neuroscience expansion, could be a logical suitor, but other pharma companies in the CNS space could also enter the fray, making a competitive bidding scenario plausible.
     
  3. Twiggs462

    Twiggs462 Member

    Joined:
    Dec 6, 2020
    Messages:
    291
    Likes Received:
    12
    FDA Breakthrough Therapy Designation and the Future of MM120

    https://www.psychiatrictimes.com/view/fda-breakthrough-therapy-designation-and-the-future-of-mm120

    VIDEO In Link

    MindMed’s Chief Medical Officer, Dan Carlin, MD, MA, spoke with Psychiatric Times about the second phase 3 trial, Panorama (MM-120-301), for MM-120 in generalized anxiety disorder (GAD). This follows the ongoing first phase 3 trial, Voyage (MM-120-300), marking a significant milestone in the study of MM-120, a novel LSD-based treatment for GAD.

    Voyage, initiated in late 2024, is a 2-arm, double-blind, placebo-controlled study conducted across nearly 30 sites in the US. It evaluates a 100-microgram dose of MM-120 against placebo, measuring changes in Hamilton Anxiety Rating Scale scores over 12 weeks. Panorama, launched in early 2025, expands the study internationally, involving 35 sites with approximately 66% in the EU and 33% in the U.S. Unlike Voyage, Panorama includes an additional 50-microgram dose group to assess the role of functional blinding and expectancy effects.

    The introduction of the 50-microgram arm aims to address concerns surrounding participant awareness of dosing groups, ensuring that the observed effects are drug-related rather than influenced by placebo responses. This methodological approach strengthens the reliability of MindMed’s research findings.

    MindMed has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA), recognizing MM-120’s potential to significantly improve treatment options for GAD. This designation facilitates enhanced collaboration with the FDA, expediting regulatory review and development timelines.

    Looking ahead, MindMed plans to launch a Phase 3 trial for major depressive disorder in the first half of 2025, with additional studies expected. Readouts for Voyage and Panorama are anticipated in 2026, with findings poised to shape the future of psychiatric treatment. As MM-120 progresses towards FDA approval, MindMed encourages clinicians and researchers to engage with the evolving treatment landscape.

    Dr Karlin is the chief medical officer of MindMed and a fellow of the APA.
     
  4. Twiggs462

    Twiggs462 Member

    Joined:
    Dec 6, 2020
    Messages:
    291
    Likes Received:
    12
    Sector going to get white hot now. Knew it was going to come back. Was only a matter of time.
     
  5. Twiggs462

    Twiggs462 Member

    Joined:
    Dec 6, 2020
    Messages:
    291
    Likes Received:
    12
  6. Twiggs462

    Twiggs462 Member

    Joined:
    Dec 6, 2020
    Messages:
    291
    Likes Received:
    12
  7. Twiggs462

    Twiggs462 Member

    Joined:
    Dec 6, 2020
    Messages:
    291
    Likes Received:
    12
    MindMed MM-120 (LSD) in GAD: Recent Research, Regulatory Developments, and Market Impact

    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 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<0.0004)

    ir.mindmed.co
    . Importantly, this improvement was rapid (onset by Day 2) and sustained through at least 12 weeks in follow-up analyses
    ir.mindmed.co
    . Safety was also favorable, with mostly mild, transient side effects (e.g. acute psychedelic effects on dosing day)
    ir.mindmed.co
    . These data set the stage for an End-of-Phase 2 meeting with the FDA in mid-2024, after which MindMed reported “alignment” with the agency on Phase 3 requirements and trial design
    ir.mindmed.co
    . Notably, the FDA granted Breakthrough Therapy Designation to MM-120 for GAD around this time, reflecting the significant unmet need in GAD and the promising efficacy signals seen in Phase 2
    ir.mindmed.co
    . Breakthrough status gives MindMed added access to FDA guidance, the ability to do a rolling submission, and a potential for priority review, all of which could streamline the path to approval
    med.uth.edu
    .


    Phase 3 Trials and Design Innovations: With FDA guidance in hand, MindMed launched its Phase 3 program for MM-120 in late 2024. The first Phase 3 trial, dubbed “Voyage,” dosed its first patient in December 2024, making it the first-ever Phase 3 trial of LSD for an anxiety disorder

    psychiatrictimes.com
    . Voyage is a 52-week study in ~200 GAD patients (US only), with a 12-week double-blind, placebo-controlled period followed by a 40-week open-label extension
    psychiatrictimes.com
    . A second Phase 3 trial called “Panorama” began in early 2025 and will enroll ~250 patients across the US and Europe
    ir.mindmed.co
    . Both trials share a primary endpoint of anxiety reduction (HAM-A change at 12 weeks) comparing MM-120 (100 µg ODT) to placebo
    psychiatrictimes.com
    . Importantly, MindMed incorporated trial design elements specifically to address FDA’s concerns about bias and blinding in psychedelic studies. Panorama includes a 50 µg low-dose MM-120 arm intended to act as an active control – producing mild psychoactive effects but likely minimal therapeutic impact – in order to reduce unblinding bias and improve the reliability of the results
    psychiatrictimes.com
    . Additionally, MindMed is using independent, centralized raters who are blinded to treatment and even visit number, and is not combining the drug with any psychotherapy during dosing
    ir.mindmed.co
    . These measures follow best practices outlined by experts and the FDA’s guidance for psychedelic trials, aiming to isolate the drug’s true effect from expectancy or ancillary therapeutic influences
    ir.mindmed.co
    .


    Ongoing Challenges and Timeline: While MindMed’s relationship with the FDA appears positive so far, challenges remain. LSD’s profound psychoactive effects make trial blinding difficult by nature, and regulators will scrutinize whether MindMed’s methods truly mitigate bias. The novelty of approving an LSD-based medication means “heightened regulatory scrutiny” is expected

    ir.mindmed.co
    , and the company must demonstrate reproducible safety and efficacy across its pivotal studies. MindMed’s development timeline also means investors and patients must be patient: the Phase 3 trials will take time to fully enroll and complete. The company projects the first 12-week readout from the Phase 3 program in late 2025 or early 2026 for the first trial
    greenmarketreport.com
    , and top-line results from the second trial by the second half of 2026
    ir.mindmed.co
    . If all goes well, an NDA submission could follow, but any regulatory requests for additional data (as seen with MDMA) could extend the timeline. In summary, MindMed has navigated FDA interactions successfully thus far – securing Breakthrough status and trial design concurrence – and is now executing two Phase 3 trials with careful attention to regulatory expectations and scientific rigor.


    UK ILAP Designation for MM-120 ODT vs. FDA Pathways
    UK ILAP and Innovation Passport: In parallel to its U.S. efforts, MindMed has engaged with regulators in the United Kingdom to expedite MM-120’s development. In December 2024, the company announced that MM-120 ODT received an “Innovation Passport” from the UK’s Innovative Licensing and Access Pathway (ILAP)

    ir.mindmed.co
    . The Innovation Passport is the entry point into ILAP, a relatively new UK framework designed to accelerate development and approval of innovative medicines post-Brexit. This designation aims to speed time-to-market and facilitate patient access in the UK for MM-120, especially given GAD is a critical unmet need
    ir.mindmed.co
    . MindMed’s CEO noted that following the U.S. Breakthrough Therapy Designation, securing the UK Innovation Passport further validates MM-120’s potential and demonstrates the company’s commitment to working with regulators globally
    ir.mindmed.co
    .


    ILAP Benefits Compared to FDA Expedited Programs: The ILAP offers a suite of tools somewhat analogous to FDA’s expedited pathways like Breakthrough and Fast Track, though with some differences. With the Innovation Passport in hand, MindMed will receive enhanced regulatory support from the Medicines and Healthcare products Regulatory Agency (MHRA) and its partner agencies, along with access to a “Toolkit” to optimize development

    ir.mindmed.co
    . Concrete benefits of ILAP include the possibility of a rolling review and a faster 150-day assessment of the marketing application, as well as coordinated input from health technology assessment bodies (for example, the UK’s NICE) early in the process
    ir.mindmed.co
    . By comparison, in the U.S., Breakthrough designation also confers rolling review eligibility and a commitment to faster review timelines, but the FDA’s standard priority review is a 6-month target (roughly 180 days) for the NDA decision. In practice, ILAP’s accelerated 150-day review in the UK is similar in speed to FDA’s priority review, and both frameworks encourage iterative dialogue with regulators. One key difference is that ILAP, through its multi-agency collaboration, also considers post-approval access and reimbursement issues as part of the pathway
    ir.mindmed.co
    – potentially smoothing the route from approval to patient uptake in the UK.


    Strategic Value of Dual Designations: For MindMed, having regulatory acceleration in both the U.S. and UK is strategically significant. The U.S. Breakthrough designation and the UK ILAP Innovation Passport each underscore that regulators see MM-120 as a potentially transformative therapy. They also provide parallel avenues to approval: success in the Phase 3 program could, in theory, lead to near-simultaneous new drug application filings in the U.S. and UK with expedited review in both. MindMed is not alone in leveraging these pathways; for instance, Compass Pathways’ psilocybin therapy for depression was also awarded an Innovation Passport by the MHRA, complementing its FDA Breakthrough status

    sec.gov
    . These designations do not guarantee approval, but they do signal regulatory buy-in and offer a smoother ride through the review process. In summary, the ILAP designation for MM-120 ODT provides a UK parallel to the FDA’s Breakthrough program – both are helping MindMed clear regulatory hurdles faster and with greater support, potentially allowing patients in need (whether in the US, UK, or eventually elsewhere) to access this psychedelic-derived treatment sooner if efficacy and safety are confirmed.


    Precedents from Other Psychedelic-Based Drug Developers
    Compass Pathways (Psilocybin for Depression): MindMed’s journey is part of a broader landscape of companies advancing psychedelics through clinical trials. One of the leading comparators is Compass Pathways, which is developing a synthetic psilocybin (COMP360) for treatment-resistant depression. Compass received FDA Breakthrough Therapy Designation for psilocybin in 2018, after early trials suggested substantial improvements in depressive symptoms. They completed a large Phase 2b study and have launched Phase 3 trials, making Compass another front-runner in psychedelic drug development. Notably, Compass also engaged with UK’s ILAP – securing an Innovation Passport for psilocybin – indicating a similar strategy of pursuing multi-regional regulatory support

    sec.gov
    . While psilocybin and LSD are different molecules, both are “classic” psychedelics acting on 5-HT2A receptors, and regulators appear to be evaluating them on similar criteria: evidence of durable clinical benefit, manageable safety profile, and the ability to conduct trials without bias. Compass’s progress thus far (and challenges, such as carefully managing psychotherapy variables and patient expectations in trials) likely provides a roadmap that MindMed can learn from. Both companies aim to legitimize a schedule I psychedelic as an approved medicine, a path that until recently was unprecedented.


    MAPS (MDMA for PTSD): Another key precedent comes from the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), which through its public benefit corporation (now Lykos Therapeutics) has been developing MDMA-assisted therapy for post-traumatic stress disorder. MAPS achieved Breakthrough designation for MDMA/PTSD in 2017 and completed two Phase 3 trials that showed MDMA, combined with therapy, can dramatically reduce PTSD symptoms. However, as discussed, the FDA’s review of this program in 2024 revealed lingering concerns. An FDA advisory committee and the agency itself felt that bias and “functional unblinding” in the trials may have inflated efficacy results, and that more safety data were needed, leading the FDA to request an additional Phase 3 study before approval

    hklaw.com
    hklaw.com
    . This example is highly pertinent for MindMed: it demonstrates that even strong clinical outcomes in the psychedelic space must overcome skepticism about trial design. MindMed appears to be addressing these issues proactively (e.g. using a low-dose control), partly in response to the hurdles MAPS faced. The MDMA case also shows that regulators will treat psychedelic-assisted therapies with the same rigor as any drug, requiring multiple confirmatory trials. On the positive side, it’s a precedent that the FDA will seriously consider approving a psychedelic therapy if supported by solid evidence – the door was not closed, just deferred until more data are gathered.


    Other Players (e.g. Atai and Small Biotechs): Beyond these leaders, a number of other companies are in earlier stages with psychedelic-inspired treatments. Atai Life Sciences (a platform company with stakes in multiple programs) and its affiliates are exploring compounds like DMT analogs, ibogaine analogs, and novel formulations of psilocybin/MDMA, though most are in Phase 1 or 2. Smaller biotech firms are even investigating LSD analogs or derivatives for niche indications – for example, a company called Eleusis had researched microdoses of LSD for inflammation, and MindBio is studying microdosed LSD for depression in a take-home setting

    biospace.com
    biospace.com
    . While these are not directly comparable to MindMed’s Phase 3 program, they contribute to the overall regulatory context. Each successful step by any company (be it a published positive trial, a safety milestone, or a regulatory designation) helps normalize the idea of psychedelics as medicines. Likewise, any setbacks (such as a clinical hold or a trial showing no benefit) can influence regulators’ caution. At present, no psychedelic drug has completed the journey to FDA approval, but the collective progress of MAPS, Compass, MindMed and others suggests that the late 2020s could see the first approvals. MindMed stands to benefit from the trail blazed by those before it – and conversely, if MM-120 succeeds, it will set a valuable precedent for any future LSD-based therapies.


    Investor Sentiment and Market Reactions
    Market Enthusiasm for Regulatory Progress: MindMed’s advances with MM-120 have not only drawn scientific interest but also caught the attention of investors. The company’s Nasdaq-listed stock (ticker MNMD) has seen significant volatility tied to regulatory news. Notably, when MindMed announced the FDA’s Breakthrough Therapy Designation in early March 2024, the stock price jumped over 50% in a single day

    biospace.com
    . This surge reflected investor optimism that Breakthrough status would speed development and increase the likelihood of eventual approval (given that the FDA only grants this designation to especially promising drugs). The following day, the stock climbed further in pre-market trading
    biospace.com
    , indicating strong momentum from the news. Similarly, updates such as positive Phase 2 results (late 2023) and the initiation of Phase 3 trials have generally been well-received, reinforcing the sense that MindMed is leading the pack in psychedelic medicine. The UK ILAP announcement in Dec 2024 and the first patient dosed in Phase 3 were incremental positives that signaled the program’s international scope, potentially broadening the future market for MM-120 – factors that investors weigh in valuation.


    Analyst Views and Financial Outlook: Analysts covering MindMed have largely echoed this optimism. As of early 2025, the consensus recommendation on the stock is “Buy,” with price targets significantly above the current trading price. For example, a group of 13 analysts have an average 12-month price target of around $25 (USD) for MindMed, with the most bullish analyst (HC Wainwright & Co.) issuing a recent target of $55

    benzinga.com
    . Even the lower end of current analyst targets (around $14–$16) implies substantial upside from the stock’s price in the first quarter of 2025. These targets are underpinned by the large potential GAD patient population and the lack of novel competitors in that space – in other words, Wall Street anticipates that if MM-120 passes Phase 3 and earns approval, MindMed could capture a blockbuster-scale market addressing millions of anxiety sufferers. Analysts have also noted MindMed’s strengthened financial position: the company raised capital in 2024 (about $250 million in equity) and ended Q3 2024 with nearly $300 million in cash, enough runway to fund operations into 2027 (beyond the expected Phase 3 readouts)
    greenmarketreport.com
    . This reduces the risk of near-term dilution and enables MindMed to execute its trials and even prepare for commercialization. Inclusion in the Nasdaq Biotechnology Index in late 2024 further reflects the company’s maturation and has brought its stock onto the radar of biotech index funds
    greenmarketreport.com
    .


    Tempered Sentiment and Risks: Despite the generally positive sentiment, investors remain mindful of the risks. Psychedelic drug development is a nascent field, and setbacks can swiftly change market sentiment (as seen with other companies in the space). MindMed’s stock, after the initial euphoria of the Breakthrough news, has traded in a range as the company moves through the costly and lengthy Phase 3 process. Some observers note that regulatory uncertainties (e.g. the FDA potentially requiring more data or a stricter review) and the execution risk of two large trials still loom. There is also the broader question of how a psychedelic therapy will be received if approved – for instance, how administration will be managed (in-clinic dosing sessions could limit scalability) and whether insurance will reimburse it. These unknowns introduce volatility; on any given development, sentiment can swing. Overall, however, MindMed’s steady progress through late-stage trials and its engagement with regulators have instilled a level of credibility that is reflected in its stock performance and coverage. The market’s reaction thus far – sharp rallies on regulatory milestones and bullish long-term targets from analysts – suggests that investors see MindMed as one of the leaders in a potentially paradigm-shifting new sector of psychiatry

    biospace.com
    benzinga.com
    .


    Conclusion
    In summary, the landscape around MindMed’s MM-120 (LSD) program for generalized anxiety disorder is rapidly evolving and largely encouraging. Recent research has strengthened the scientific case for LSD in mental health treatment, with both academic studies and MindMed’s own trials showing meaningful, lasting anxiety reductions from controlled LSD therapy

    psychiatryinstitute.com
    psychiatryinstitute.com
    . These findings arrive at a time when the FDA and other regulators are increasingly open to psychedelic medicines, yet still demand high standards of evidence
    foley.com
    hklaw.com
    . MindMed has so far navigated this balance adeptly: achieving FDA Breakthrough designation and aligning its Phase 3 trials with regulatory expectations by innovating in study design (e.g. adding a low-dose arm to ensure blinding integrity)
    psychiatrictimes.com
    . The UK ILAP designation further positions MM-120 for accelerated approval and access, mirroring the support it has in the U.S.
    ir.mindmed.co
    ir.mindmed.co
    . Lessons from peers – whether Compass Pathways’ parallel efforts with psilocybin or MAPS’ experience with MDMA – suggest that while challenges remain, a pathway to approval for psychedelic-based therapies is forming, and MindMed is at the forefront of this movement
    hklaw.com
    sec.gov
    . Investors have taken note of these developments, with generally positive sentiment and significant stock price appreciation tied to MindMed’s regulatory progress
    biospace.com
    . Of course, the true test will be the upcoming Phase 3 trial outcomes: if MM-120 can reproduce its earlier success in larger populations, it could become the first FDA-approved LSD-derived medication, offering a groundbreaking new option for patients with GAD. Such an outcome would not only validate MindMed’s strategy but also mark a historic shift in psychiatric treatment – one that transforms a once-stigmatized psychedelic into a mainstream, FDA-sanctioned therapy for anxiety.


    Sources:

     
  8. Twiggs462

    Twiggs462 Member

    Joined:
    Dec 6, 2020
    Messages:
    291
    Likes Received:
    12
    Not sure why the strike through happened. Copy and pasted. Lot's of links to research.
     

Share This Page