[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  quantumup [@Quantumup1](/creator/twitter/Quantumup1) on x 3518 followers Created: 2025-07-10 11:03:50 UTC Canaccord Genuity reiterated $GHRS Buy-$35 and said it expects the FDA to respond soon to $GHRS's clinical hold response submission. $JNJ $ATAI $CMPS $CYBN $MNMD Canaccord Genuity: "On 6/20, $GHRS announced that it submitted its complete response to the FDA "in June" on the clinical hold that the agency had placed on the company's investigational new drug (IND) application for GH001 (inhaled mebufotenin or 5-MeO-DMT). The FDA typically has XX days to respond following a submission, which means we could get an answer from the FDA at any time. Recall $GHRS had announced solid data from its European Phase 2b trial for GH001 in treatment-resistant depression (TRD). As a result, we note that resolution of the clinical hold could pave the way for $GHRS to request an end-of-Phase X meeting with the FDA, at which it could discuss a Phase X program for GH001 in TRD that includes US sites. We recently caught up with management, which reiterated its position from the news release (see here) in which it characterized its submission as ahead of schedule and believes it addressed the FDA's requests with "comprehensive data and completed toxicology studies." As such, we have a glass half full approach on the stock ahead of potential FDA news on the clinical hold, and are reiterating our BUY rating." XXXXX engagements  **Related Topics** [ind](/topic/ind) [$mnmd](/topic/$mnmd) [$cybn](/topic/$cybn) [$cmps](/topic/$cmps) [$atai](/topic/$atai) [$jnj](/topic/$jnj) [$ghrss](/topic/$ghrss) [$ghrs](/topic/$ghrs) [Post Link](https://x.com/Quantumup1/status/1943264899552948624)
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quantumup @Quantumup1 on x 3518 followers
Created: 2025-07-10 11:03:50 UTC
Canaccord Genuity reiterated $GHRS Buy-$35 and said it expects the FDA to respond soon to $GHRS's clinical hold response submission. $JNJ $ATAI $CMPS $CYBN $MNMD
Canaccord Genuity: "On 6/20, $GHRS announced that it submitted its complete response to the FDA "in June" on the clinical hold that the agency had placed on the company's investigational new drug (IND) application for GH001 (inhaled mebufotenin or 5-MeO-DMT).
The FDA typically has XX days to respond following a submission, which means we could get an answer from the FDA at any time.
Recall $GHRS had announced solid data from its European Phase 2b trial for GH001 in treatment-resistant depression (TRD). As a result, we note that resolution of the clinical hold could pave the way for $GHRS to request an end-of-Phase X meeting with the FDA, at which it could discuss a Phase X program for GH001 in TRD that includes US sites.
We recently caught up with management, which reiterated its position from the news release (see here) in which it characterized its submission as ahead of schedule and believes it addressed the FDA's requests with "comprehensive data and completed toxicology studies." As such, we have a glass half full approach on the stock ahead of potential FDA news on the clinical hold, and are reiterating our BUY rating."
XXXXX engagements
Related Topics ind $mnmd $cybn $cmps $atai $jnj $ghrss $ghrs