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Wells Fargo Starts Cybin Inc. (HELP) at Overweight

Mon, 27 Jul 2026 06:57:50 -0400

(Updated - July 27, 2026 6:57 AM EDT)

Wells Fargo initiates coverage on Cybin Inc. (NASDAQ: HELP)) with a Overweight rating.

Wells Fargo sees psychedelics market reaching $11B by 2035

Mon, 27 Jul 2026 06:55:54 -0400

Investing.com -- Wells Fargo released a report on psychedelics treatments, forecasting the branded psychedelics category in depression could reach $11 billion by 2035.

The bank's analysis covers several companies including CMPS, DFTX, GHRS, and HELP, with Wells Fargo expressing a positive view ahead of Phase 3 data for DFTX and HELP.

Spravato, currently on the market, is generating sales that annualize at more than $2 billion. The treatment faced a slow start due to initial skepticism about clinical data and REMS requirements that mandated certified centers and two-hour patient monitoring periods. The COVID-19 pandemic also affected adoption rates.

Many ketamine clinics that previously

Wells Fargo sees psychedelics market reaching $11B by 2035

Mon, 27 Jul 2026 06:55:54 -0400

Investing.com -- Wells Fargo released a report on psychedelics treatments, forecasting the branded psychedelics category in depression could reach $11 billion by 2035.

The bank's analysis covers several companies including CMPS, DFTX, GHRS, and HELP, with Wells Fargo expressing a positive view ahead of Phase 3 data for DFTX and HELP.

Many ketamine clinics that previously

Wells Fargo sees psychedelics market reaching $11B by 2035

Mon, 27 Jul 2026 06:55:54 -0400

Investing.com -- Wells Fargo released a report on psychedelics treatments, forecasting the branded psychedelics category in depression could reach $11 billion by 2035.

The bank's analysis covers several companies including CMPS, DFTX, GHRS, and HELP, with Wells Fargo expressing a positive view ahead of Phase 3 data for DFTX and HELP.

Many ketamine clinics that previously

Wells Fargo sees psychedelics market reaching $11B by 2035

Mon, 27 Jul 2026 06:55:54 -0400

Investing.com -- Wells Fargo released a report on psychedelics treatments, forecasting the branded psychedelics category in depression could reach $11 billion by 2035.

The bank's analysis covers several companies including CMPS, DFTX, GHRS, and HELP, with Wells Fargo expressing a positive view ahead of Phase 3 data for DFTX and HELP.

Many ketamine clinics that previously

H.C. Wainwright Reiterates Buy Rating on Helus Pharma (HELP)

Wed, 22 Jul 2026 06:52:52 -0400

H.C. Wainwright analyst Patrick R. Trucchio reiterated a Buy rating and $70.00 price target on Helus Pharma (NASDAQ: HELP).

The analyst commented: "This morning, Helus Pharma announced it completed enrollment of 223 patients in APPROACH, the first Phase 3 of HLP003 in adjunctive MDD. On our follow-up call, Helus' Executive Chairman and Interim CEO Eric So, and CMO Amir Inamdar, sharpened APPROACH topline readout guidance to the mid-to-third week of November (vs. 4Q26 prior). In addition, management reiterated that it is actively searching for a permanent CEO, which following Eli Lilly’s (LLY; not rated) acquisition of AtaiBeckley (ATAI; neutral) announced on

Form 6-K CYBIN INC. For: Jul 21

Tue, 21 Jul 2026 17:16:00 -0400

si-local-file:///var/storage/secattach/20260721/26796524.html

Form 6-K CYBIN INC. For: Jul 21

Tue, 21 Jul 2026 17:16:00 -0400

si-local-file:///var/storage/secattach/20260721/26796524.html

Helus Pharma completes enrollment in phase 3 depression study

Tue, 21 Jul 2026 10:55:30 -0400

Helus Pharma (Nasdaq: HELP, Cboe CA: HELP) announced it has completed enrollment in the APPROACH Phase 3 pivotal study of HLP003 as an adjunctive treatment for Major Depressive Disorder, finishing ahead of schedule.

The study enrolled 223 adults with moderate to severe MDD who showed inadequate response to a stable antidepressant regimen. Participants were randomized 1:1 to receive either HLP003 (16 mg) or placebo, with doses administered three weeks apart. The primary endpoint is change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score at six weeks after the first dose compared to placebo. Topline data from both the primary and

Helus Pharma completes enrollment in phase 3 depression study

Tue, 21 Jul 2026 10:55:30 -0400

Helus Pharma completes enrollment in phase 3 depression study

Tue, 21 Jul 2026 10:55:30 -0400

Helus Pharma completes enrollment in phase 3 depression study

Tue, 21 Jul 2026 10:55:30 -0400

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program

Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data

APPROACH topline data readout on track for Q4 2026 ^1,2

HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")

HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 10:54:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program
Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data
APPROACH topline data readout on track for Q4 2026 ^1,2
HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")
HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a

Helus Pharma completes enrollment in Phase 3 depression study

Tue, 21 Jul 2026 07:50:19 -0400

Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) announced it has completed enrollment in its APPROACH Phase 3 pivotal study of HLP003 as an adjunctive treatment for Major Depressive Disorder (MDD), ahead of the originally planned schedule.

The APPROACH study enrolled 223 adults with moderate to severe MDD, defined as a Montgomery-Asberg Depression Rating Scale (MADRS) score of 24 or higher, who were on a stable antidepressant regimen but responding inadequately. Participants were randomized 1:1 to receive either HLP003 (16 mg) or placebo, with two doses administered three weeks apart. The primary endpoint is the change from baseline in MADRS score at

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 07:50:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program

Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data

APPROACH topline data readout on track for Q4 2026^1,2

HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (“FDA”)

HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Tue, 21 Jul 2026 07:50:00 -0400

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program

Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data

APPROACH topline data readout on track for Q4 2026^1,2

HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (“FDA”)

HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates