Psychedelic medicines: which startup is ahead?
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SUMMARY
Compass Pathways is the psychedelic medicine startup ahead today, but Definium Therapeutics is now close enough to make the lead vulnerable.
The race splits into two different contests. Compass leads on regulatory progress and launch preparation, while several rivals may have treatments that are easier and cheaper for clinics to deliver.
Compass has the strongest total evidence because it has produced similar results in two Phase 3 studies. Definium has the best single pivotal result, but its unusually large effect still needs to be replicated.
Clinic time may decide more than investors expect. COMP360 can occupy a room for most of a working day, while GH Research and AtaiBeckley are developing treatments that may allow several patients to use the same room.
Big Pharma is already voting with its wallet. Lilly, AbbVie and Otsuka have all paid for shorter-duration approaches, suggesting that treatment practicality may be nearly as valuable as being first to approval.
Definium’s financing has changed the competitive balance. With roughly $1.1 billion available after its latest offering, it can fund several pivotal studies and absorb delays without immediately returning to investors.
None of these startups has product revenue yet, so commercial readiness still has to be judged through clinic partnerships, provider training, trial design and balance-sheet strength. Compass has done the most work here, although its treatment model is also the hardest to scale.
Lykos is the warning hanging over the whole category. Reaching the FDA first did not protect it from concerns about study conduct, safety oversight, blinding and the therapy component.
Helus owns the next readout most likely to reorder the middle of the ranking. A strong APPROACH result could move it past GH Research and AtaiBeckley on approval readiness very quickly.
The practical watchlist is simple: Compass must complete its filing and prove the economics of a full-day treatment, Definium must repeat Emerge, and the short-duration companies must show that their operational advantage survives Phase 3. Today Compass is first, but this is no longer a one-company race.
Psychedelic medicines: which startup is ahead?
Which psychedelic medicine startups are really in the race?
Seven psychedelic medicine startups belong in the comparison today, and five form the real leading group.
We include companies with a psychedelic or closely related psychoactive drug at the center of their strategy, meaningful human efficacy data and a credible route into or through Phase 3. Compass Pathways, Definium Therapeutics, AtaiBeckley, GH Research and Helus Pharma meet all three tests. Reunion Neuroscience makes the cut because its postpartum depression program has FDA Breakthrough Therapy status and a planned pivotal study. Lykos Therapeutics stays in the comparison because it reached the FDA first and continues to develop its MDMA program.
The category has changed quickly. Transcend Therapeutics has been bought by Otsuka, and AbbVie has acquired Gilgamesh's bretisilocin program. We remove acquired assets from the independent-startup ranking once a transaction closes. We also exclude nonprofit research groups, treatment clinics, ketamine chains and discovery platforms with no advanced clinical asset.
Funding figures are messy. Public companies have used IPOs, follow-on offerings, warrants and predecessor entities, and private companies disclose far less. The numbers below are conservative minimums from identifiable financings, so they should not be read as perfectly comparable lifetime totals.
| Startup | Main medicine and target | Current position | Minimum identifiable capital raised |
|---|---|---|---|
| Compass Pathways | COMP360 psilocybin for treatment-resistant depression | Phase 3 program completed | More than $1.0 billion |
| Definium Therapeutics | DT120 orally disintegrating LSD for depression and anxiety | One positive Phase 3 study; more pivotal trials running | At least $1.31 billion since 2024 |
| AtaiBeckley | Short-duration 5-MeO-DMT, DMT and related medicines | Lead program entering Phase 3; Lilly acquisition pending | At least $560 million across the predecessor companies |
| GH Research | Inhaled mebufotenin for treatment-resistant depression | Positive Phase 2b; global pivotal program being prepared | About $425 million |
| Helus Pharma | HLP003, a modified psilocin medicine for depression | First Phase 3 study fully enrolled; second study running | At least $375 million |
| Reunion Neuroscience | Luvesilocin for postpartum depression | Positive Phase 2; pivotal study planned | About $153 million |
| Lykos Therapeutics | Midomafetamine with psychological intervention for PTSD | FDA rejection; another Phase 3 study required | Lifetime total unclear; latest disclosed financing raised $50 million |
Is Compass Pathways clearly ahead today?
Right now, Compass Pathways leads the psychedelic medicine race, and Definium Therapeutics has moved close enough to make the next major readout genuinely important.
Compass is closest to approval and has the most advanced launch preparations in the category. Definium owns one unusually strong Phase 3 result and several pivotal trials that could confirm or broaden it. Helus is approaching its first pivotal readout. GH Research and AtaiBeckley offer shorter treatment sessions, with lead programs that remain earlier.
The pecking order is fairly clear for now. Compass leads on approval proximity and completeness of evidence. Definium follows with late-stage efficacy, several pivotal trials and the largest cash reserve in the independent field. AtaiBeckley has attracted the strongest pharmaceutical buyer, GH Research may have the easiest treatment to deliver, and Helus could soon produce another Phase 3 result.
We would place Compass at 100 on a simple approval-readiness index and Definium around 70. Helus would sit near 45, with AtaiBeckley and GH Research around 35 to 40. These comparison numbers show distance rather than predict FDA outcomes, and they make the gaps easier to see than the word “competitive” does.
If you want more recent data on this point, please see our latest mental health market report.
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Which psychedelic medicine company is closest to FDA approval?
As of now, Compass Pathways is much closer to FDA approval than any other psychedelic medicine company.
The FDA has allowed Compass to submit the COMP360 application in rolling modules and has started reviewing the initial material. The agency also granted the program a Commissioner's National Priority Voucher. Compass says the final modules remain on track for submission later this year.
Definium comes next. Its Emerge study succeeded, while the confirmatory Ascend depression study is already dosing patients and is expected to report in 2027. Two separate Phase 3 studies in generalized anxiety disorder could add important evidence sooner, although they support another indication.
Helus has completed enrollment in APPROACH, its first pivotal depression study, with results expected later this year. EMBRACE is running alongside it. Reunion has agreed on a registrational path for a single pivotal postpartum depression study. GH Research has cleared its earlier U.S. clinical hold and is preparing a global program, while AtaiBeckley is moving BPL-003 into two Phase 3 studies.
Lykos shows how quickly apparent leadership can disappear. The FDA concluded that its submitted MDMA package could not support approval and requested another Phase 3 study. Compass has recently published an analysis separating its standardized monitoring and support model from psychotherapy, a useful response to one of the issues that complicated the Lykos review.
| Company | Where the lead program stands now | Regulatory position | What has to happen next |
|---|---|---|---|
| Compass Pathways | Application modules being submitted | Rolling FDA review and priority voucher | Complete the remaining modules and pass review |
| Definium Therapeutics | One successful pivotal study; confirmatory study running | Breakthrough Therapy program | Replicate the depression result and complete the filing package |
| Helus Pharma | Pivotal readout pending; second study underway | Breakthrough Therapy designation | Report APPROACH and finish EMBRACE |
| AtaiBeckley | Two pivotal studies planned for BPL-003 | Breakthrough Therapy designation | Execute both Phase 3 studies |
| GH Research | Phase 3 design and doses being finalized | U.S. clinical hold lifted | Start and complete the global pivotal program |
| Reunion Neuroscience | Phase 2 complete | Breakthrough Therapy designation and FDA-aligned path | Begin the postpartum depression pivotal study |
| Lykos Therapeutics | Development program being redesigned | New registrational evidence required | Agree and execute the new pivotal program |
Which startup has the strongest psychedelic clinical evidence?
Compass Pathways owns the strongest psychedelic clinical evidence in the startup field.
Compass has replicated efficacy across two Phase 3 studies in treatment-resistant depression. COMP005 enrolled 258 patients and produced a 3.6-point placebo-adjusted improvement on the MADRS depression scale at six weeks. The larger COMP006 study reported a 3.8-point difference between the 25-milligram dose and its one-milligram control. The closeness of those two results gives us more confidence than a single dramatic readout would.
The evidence has also matured beyond the primary endpoint. Compass recently reported that the clinical improvement remained visible through six months among patients who had responded, with no new safety pattern in the longer follow-up. That durability could become commercially important if a single administration delays the need for another intensive clinic visit.
The next strongest package belongs to Definium, which has credible late-stage evidence and a confirmatory study already running. GH Research ranks third because its randomized Phase 2b study was published in JAMA Psychiatry and combined a large antidepressant effect with a short visit. Helus remains harder to judge until APPROACH reports. AtaiBeckley has encouraging randomized evidence for BPL-003, while Reunion's positive postpartum depression result is promising but much smaller.
Lykos still has more late-stage patient data than several competitors, but the FDA raised concerns about study conduct, blinding, safety oversight and the therapy component. We discount that dataset accordingly.
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Did Definium's LSD trial beat Compass's psilocybin trials?
Definium's first Phase 3 LSD result beat Compass's psilocybin results on the headline efficacy number, but Compass still has the stronger total package.
Definium reported an 8.1-point placebo-adjusted MADRS improvement at six weeks in Emerge and a 7.3-point difference at twelve weeks. The six-week gap was slightly more than twice the 3.6-point and 3.8-point differences seen in the Compass studies. Definium also reported a rapid separation from placebo, including a 14.2-point difference after one week, with no serious adverse events or suicidality signal in the topline release.
The populations make a direct league table risky. Definium studied major depressive disorder, while Compass studied treatment-resistant depression, where patients had already failed several treatments. The trials also used different controls, site networks, patient-selection rules and statistical plans. A large placebo response can shrink the apparent drug effect even when treated patients improve substantially.
Replication decides the argument. Compass has already shown a similar effect in separate pivotal studies. Definium began Ascend recently, and that confirmatory result is expected next year. If Ascend lands anywhere near Emerge, Definium could take the clinical lead. A much smaller second result would make Emerge look like an outlier.
We trust Compass's full evidence package more, even though Definium owns the best single late-stage result.
If you want more recent data on this point, please see our latest mental health market report.
Which psychedelic treatment is easiest for clinics to deliver?
GH Research has the easiest psychedelic treatment model for clinics to deliver.
In GH Research's Phase 2b study, the median psychoactive experience after inhaled GH001 lasted about eleven minutes, and 99% of participants were considered ready for discharge within one hour. A clinic could theoretically use the same treatment room several times in a day, even after allowing time for preparation and cleaning.
AtaiBeckley's BPL-003 is the closest competitor. Most patients were ready for discharge after roughly 90 minutes, with average readiness within two hours. Intranasal delivery should also feel familiar to centers that already administer esketamine.
Definium's Emerge participants reached readiness for discharge after an average of 5.8 hours and a median of 5.1 hours. Helus says HLP003 should produce a more predictable and somewhat shorter experience than conventional psilocybin, although it still appears to require several hours of supervision.
Regulators will set the final monitoring rules, and clinics may have to keep patients longer than the trial protocols suggest. For now, GH has the clearest operating advantage. That is a real edge.
| Medicine | Observed or expected clinic time | Current evidence | Practical advantage |
|---|---|---|---|
| GH Research GH001 | Most patients ready within one hour | Randomized Phase 2b | Highest potential daily throughput |
| AtaiBeckley BPL-003 | Most ready around 90 minutes; average within two hours | Randomized Phase 2b | Fits existing interventional psychiatry workflows |
| Definium DT120 | Average readiness 5.8 hours | Phase 3 | Manageable in one day, with substantial staffing needs |
| Helus HLP003 | Several hours | Phase 3 program underway | May shorten and standardize the psilocin experience |
| Compass COMP360 | Approximately six to eight hours | Completed pivotal program | Deepest evidence, but lowest room throughput |
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Has any psychedelic medicine startup found paying patients yet?
No psychedelic medicine startup has found paying patients for the medicines in this ranking because none is approved or generating product sales.
Paid prescriptions, repeated clinic use and insurer coverage will provide the first convincing evidence. Current provider partnerships, site-readiness programs and announced collaborations only show that companies are preparing for demand. They cannot tell us how many patients will complete treatment once the full price, travel, waiting time and monitoring burden become real.
The closest public comparison is Johnson & Johnson's Spravato, an esketamine medicine delivered under supervision. Johnson & Johnson's latest annual results showed about $1.7 billion in Spravato sales, roughly 60% growth from the previous year. That result proves that clinics and payers can support a monitored rapid-acting psychiatric treatment at scale. Psychedelic startups still have to show that longer visits and more intense patient experiences can fit the same system.
Compass has gone furthest in preparing demand. The company is working with independent clinics, developing provider training and building referral infrastructure. GH Research and AtaiBeckley may eventually face an easier adoption problem because their treatments occupy less clinic time. Definium's wider depression and anxiety strategy could produce a larger prescriber base if the same formulation succeeds in both conditions.
Which startup has the broadest psychedelic medicine pipeline?
AtaiBeckley has the broadest serious psychedelic medicine pipeline.
BPL-003, an intranasal 5-MeO-DMT medicine, is entering Phase 3 for treatment-resistant depression and has also been studied in alcohol-use disorder. VLS-01 uses a buccal film to deliver DMT and recently finished dosing a 156-person Phase 2b depression study. EMP-01 adds an R-MDMA program for social anxiety disorder.
That portfolio gives AtaiBeckley several ways to win. The company can test different molecules, treatment lengths and delivery formats, which reduces its dependence on one formulation.
Definium has a narrower molecule strategy and a wider indication strategy. DT120 is being tested in depression and generalized anxiety disorder, with a PTSD program planned. Reusing one product across several conditions could simplify manufacturing, medical education and commercial deployment.
Helus has additional serotonergic programs behind HLP003, while Compass is extending COMP360 into PTSD. GH Research remains deliberately focused around mebufotenin. AtaiBeckley still leads this comparison because several assets have reached meaningful human studies. Managing that breadth will require more capital and sharper prioritization.
If you want more recent data on this point, please see our latest mental health market report.
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Which startup is most ready to launch a psychedelic medicine at scale?
Compass Pathways has done more than any rival to prepare a psychedelic medicine launch at scale.
Compass is already working on clinic readiness, provider training, patient identification and the digital systems needed to coordinate a monitored treatment. Its recent Osmind collaboration focuses on independent clinics, a channel that could carry much of an eventual national launch.
The launch still looks demanding. Each COMP360 appointment uses a treatment room and trained staff for most of a working day. A clinic with two dedicated rooms could serve only a small number of patients daily. Reimbursement must cover the surrounding care as well as the drug, or providers will have little reason to reserve that capacity.
Definium has enough cash to build a serious commercial operation and has started preparing the market around generalized anxiety disorder. Helus is still focused mainly on completing Phase 3. Compass stays first here because the launch work is already happening, despite a less convenient delivery model.
Which psychedelic medicine startup has enough cash to win?
Definium Therapeutics now has far more cash than any independent psychedelic medicine startup.
Definium held $373.4 million in cash and investments at the end of its first quarter, then closed an $805 million gross offering after the Emerge result. After allowing for underwriting costs, the company appears to have roughly $1.1 billion available before subsequent spending. That is more than twice Compass's latest reported $466 million cash position.
GH Research held $267.3 million before receiving about $111 million in net proceeds from a new offering, leaving a pro forma total close to $379 million. Helus reported $157.3 million and then raised another $50 million, giving it roughly $207 million before ongoing trial costs. Reunion's $133 million Series A can start a pivotal program, although another raise may be needed before commercialization.
The spending record still matters. Compass has used its capital to reach the filing and launch-preparation stage. GH Research has preserved an unusually large balance while producing peer-reviewed Phase 2b evidence. Helus spent about $132 million in cash operating expenses during its latest fiscal year, a high pace relative to its available capital.
With roughly $1.1 billion available, Definium can run several pivotal studies, prepare manufacturing and commercialization, and absorb a delay without immediately returning to investors. Compass remains closer to approval, but Definium carries much less financing risk.
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Where is Big Pharma placing its biggest psychedelic medicine bets?
Big Pharma's largest psychedelic medicine bets are currently going to short-duration treatments, even though Compass is closest to approval.
Lilly has agreed to acquire AtaiBeckley for $2.8 billion upfront and as much as $1 billion more through contingent payments. The potential $3.8 billion value is the largest transaction in the category. BPL-003's short intranasal session sits at the center of the deal, supported by VLS-01 and the wider pipeline.
AbbVie paid for the same broad idea when it acquired Gilgamesh's bretisilocin program for up to $1.2 billion. Bretisilocin is designed as a shorter-acting next-generation psychedelic for depression. Otsuka has also completed its acquisition of Transcend Therapeutics and its methylone program for PTSD, a deal the Financial Times reported at about $700 million.
Across all three deals, the buyers paid for the same broad promise: rapid psychiatric efficacy in a visit that ordinary clinics might handle. The drugmakers accepted earlier clinical risk to secure better delivery economics.
Compass remains the independent approval leader, and AtaiBeckley has attracted the strongest buyer by far. The transaction suggests that convenience may ultimately be valued almost as highly as regulatory timing.
If you want more recent data on this point, please see our latest mental health market report.
Which psychedelic medicine startup has the strongest momentum now?
Definium Therapeutics has the strongest momentum in psychedelic medicines, even with Compass Pathways still ahead overall.
Definium produced the field's largest pivotal efficacy gap, began its confirmatory depression study and raised $805 million almost immediately afterward. The company has also completed enrollment in one generalized anxiety disorder Phase 3 study, with another late-stage anxiety readout expected after it. Few biotech companies move from clinical validation to a much stronger balance sheet so quickly.
Compass has recently added durable six-month data and a published analysis clarifying the role of monitoring and support in its trials. Those updates strengthen the leader's position, but Emerge changed the distance between the companies much more.
Helus has finished enrolling APPROACH and should deliver the next result capable of changing the middle of the ranking. GH Research has published its Phase 2b evidence, selected pivotal doses and raised fresh capital. AtaiBeckley has also finished dosing the VLS-01 Phase 2b study and is moving BPL-003 through pivotal development.
A strong anxiety result would extend Definium's momentum beyond depression. A weak result would remind investors that one molecule does not always travel cleanly across indications.
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What can the leading psychedelic startups do that competitors cannot easily copy?
Compass Pathways has built the strongest defensible position because competitors cannot quickly copy years of pivotal, regulatory and clinic-development work.
The underlying psychedelic molecules are familiar. Patents can protect formulations, delivery devices, manufacturing methods and dosing protocols. The deeper advantage comes from the evidence and systems wrapped around the drug. Compass has built experience across large studies, treatment sites, safety procedures and FDA interactions that a new entrant would need years to reproduce.
Definium's protection rests on its optimized orally disintegrating formulation and the possibility of building one medicine across several disorders. Success in both depression and anxiety would create physician familiarity and a broader data set. GH Research's inhalation method and individualized dosing support a very short visit. AtaiBeckley owns several formulation and delivery approaches, while Helus is developing modified molecules intended to create more predictable pharmacology.
Large pharmaceutical companies can still compress these advantages by buying rival assets and applying their existing payer, manufacturing and sales networks. The recent wave of pharmaceutical acquisitions shows that this process has already begun.
Compass owns the strongest moat because elapsed development time is hard to buy back. GH Research and AtaiBeckley may have more attractive product designs, and Definium may build the broadest clinical franchise. Routine clinical use will reveal which advantage patients and payers value most.
What could knock Compass Pathways out of first place?
Definium could knock Compass Pathways out of first place if it replicates its large depression result and Compass runs into approval or treatment-economics problems.
The FDA review is the first way the ranking could change. Rolling submission speeds the process but still leaves room for requests on manufacturing, safety monitoring, site procedures or follow-up data. Any substantial delay would give Definium and Helus more time to finish their pivotal programs.
Clinic economics are the second. COMP360 uses a full treatment day. Insurers must reimburse enough of the drug, supervision and facility cost to make that room profitable. Shorter treatments from GH Research or AtaiBeckley could win even with slightly weaker efficacy if they allow several patients to use the same room each day.
Definium presents the immediate clinical threat. A second large depression result would give physicians and regulators a much stronger reason to compare DT120 directly with COMP360. Successful anxiety studies would add another large patient group and make Definium less dependent on one indication.
Compass can keep first place by completing approval without a major detour, securing workable reimbursement and showing that benefits last long enough to justify the lengthy visit. Success on those three points would turn today's regulatory lead into a commercial head start.
If you want more recent data on this point, please see our latest mental health market report.
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Which psychedelic medicine startups are actually ahead?
Compass Pathways is still the psychedelic medicine startup ahead overall, with Definium Therapeutics close enough to threaten that lead.
Compass takes first place because its program is nearest to approval, supported by the deepest evidence and backed by the most developed launch system. Its application is already moving through rolling review. The remaining risk is commercial: a full-day treatment must work financially for clinics and insurers.
Definium ranks second and has changed more than any other competitor lately. Its late-stage program, now paired with roughly $1.1 billion of financial capacity, gives the company several chances to catch Compass. A confirming depression result would make the top two extremely close.
AtaiBeckley ranks third because its broad pipeline and proposed Lilly acquisition create exceptional strategic value. GH Research follows with the most clinic-friendly product profile and strong Phase 2b evidence. GH could jump several places if that profile survives Phase 3.
Helus ranks fifth. A positive APPROACH result could move the company above GH Research and possibly AtaiBeckley on regulatory readiness. Reunion remains the strongest specialist in postpartum depression. Lykos must run another pivotal study after its rejected application, leaving it last despite its historical head start.
Compass has a real but vulnerable lead. Definium is the only independent challenger with enough late-stage evidence and capital to take first place soon. AtaiBeckley and GH Research are the strongest bets on a more practical treatment model, while Helus owns the next major readout that could reorder the field.
| Rank | Startup | Why it ranks here today |
|---|---|---|
| 1 | Compass Pathways | Closest to approval, deepest evidence and the most advanced launch preparation |
| 2 | Definium Therapeutics | Several late-stage programs and by far the largest independent cash reserve |
| 3 | AtaiBeckley | Broad clinical pipeline and exceptional pharmaceutical validation |
| 4 | GH Research | Strong controlled evidence and a potentially disruptive product, with pivotal execution still ahead |
| 5 | Helus Pharma | Near-term pivotal readout and another late-stage trial running, with no pivotal result yet |
| 6 | Reunion Neuroscience | Clear lead in postpartum depression and an FDA-aligned pivotal route, but still earlier overall |
| 7 | Lykos Therapeutics | Longest recovery path and the weakest current approval position |
OUR METHODOLOGY
This analysis tests which independent psychedelic medicine startup is ahead based on the evidence available today. We compare clinical progress, regulatory timing, strength and replication of efficacy data, treatment practicality, financial capacity, pipeline breadth, launch preparation and pharmaceutical validation.
We include companies with a psychedelic or closely related psychoactive medicine at the center of their strategy, meaningful human efficacy data and a credible route into or through Phase 3. Acquired assets are removed from the independent-startup ranking once a transaction closes, while nonprofit research groups, treatment clinics, ketamine chains and discovery platforms without an advanced clinical asset are excluded.
Each question is assessed separately before the findings are brought together. Completed achievements carry more weight than announced plans, replicated evidence more than an isolated result, and direct clinical or regulatory evidence more than market narrative.
The approval-readiness comparison is not a prediction of FDA success. It is an editorial measure of distance based on completed trials, active pivotal work, filing status, regulatory designations and the remaining work required before a commercial launch.
Clinical results are not treated as directly interchangeable when the patient populations, controls, endpoints, site networks or statistical plans differ. That is why Definium's larger headline effect does not automatically outrank Compass's replicated Phase 3 package.
Treatment practicality is judged from observed or expected psychoactive duration, discharge readiness, route of administration and the likely amount of clinic time and staffing required. Final commercial workflows may differ because regulators and providers can impose longer monitoring periods than those used in trials.
Financial figures are conservative minimums drawn from identifiable financings, SEC filings and company disclosures. They are useful for judging whether a company can finish development and prepare a launch, but they are not perfectly comparable lifetime fundraising totals.
The final ranking is an editorial synthesis rather than a mechanical score. It reflects the position each company has earned across the full analysis, while allowing one company to lead on approval timing and another to lead on cash, convenience, pipeline breadth or current momentum.
Key sources include Compass Pathways on rolling FDA review and the Commissioner's National Priority Voucher, Compass's first-quarter 2026 SEC filing, Compass's Osmind clinic-readiness collaboration, ClinicalTrials.gov for Definium's Emerge study, Definium's SEC filing on the Emerge result, JAMA Psychiatry on GH Research's Phase 2b study, Helus Pharma on APPROACH enrollment, Reunion Neuroscience on Breakthrough Therapy designation and its registrational path, Eli Lilly on the proposed AtaiBeckley acquisition, AbbVie on completion of the bretisilocin acquisition, and FDA advisory-committee materials for Lykos Therapeutics' MDMA application.
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