$HELP

Wells Fargo Initiates Cybin at Overweight With CA$22.56 Price Target

Helus Pharma Completes Enrollment in Phase 3 Study for Depression Treatment

Helus Pharma (HELP) said Tuesday it has completed enrollment in its phase 3 study of HLP003 in patients living with major depressive disorder.The trial enrolled 223 adults with moderate to severe major depressive disorder who experience an inadequate response despite a stable antidepressant regimen, the company said.The pharmaceutical company expects to release topline data in Q4 and targets a potential new drug application with the US Food and Drug Administration in 2028, it added.Enrollment is continuing in the program's second pivotal study, and eligible participants can roll over into a long-term extension trial to further evaluate safety, Helus Pharma said.Shares of the company were up nearly 16% in Tuesday trading.Price: $8.33, Change: $+1.22, Percent Change: +17.16%

Helus Pharma Closes $50 Million Underwritten Offering

Helus Pharma (HELP) closed a previously announced underwritten offering that raised $50 million in gross proceeds through the sale of about 10.3 million common shares at $4.85 each, the company said Thursday.The company said it paid underwriters a $3 million cash commission.Helus Pharma said it plans to use the net proceeds to advance its HLP003 program for major depressive disorder, HLP004 for generalized anxiety disorder, and HLP005, as well as for working capital and other corporate purposes.The company said it expects Phase 3 APPROACH data from the HLP003 program in the fourth quarter of 2026.Shares of the company were up 4% in early Thursday trading.Price: $5.38, Change: $+0.29, Percent Change: +5.70%

FDA Fast-Tracks Psychedelic Drug Research Following Trump Directive; Psychedelic Drug Makers Gain

Shares of some psychedelic drug companies gained Friday morning after the US Food and Drug Administration said it was launching regulatory actions to back the development of psychedelic therapies to treat mental illness.Cybin (HELP) shares jumped past 4%, Psyence Biomedical (PBM) shares climbed 7%, and Clearmind Medicine (CMND) shares were up 2.4%.The FDA's move builds on President Donald Trump's recent executive order directing the Department of Health and Human Services to accelerate access to treatments for people with serious mental illness, the FDA said.The drugs have the potential to address mental health diseases like treatment-resistant depression, alcoholism and substance abuse, said FDA Commissioner Marty Makary.The agency said it is issuing national priority vouchers to three companies researching psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for post-traumatic stress disorder.The agency said it is also allowing an early-phase trial of noribogaine hydrochloride to proceed following an investigational new drug filing. The sponsor is investigating noribogaine to potentially treat alcohol use disorder, the FDA said, adding the move will allow the company developing the new drug, DemeRx NB, to start a phase 1 trial in the US.The agency said it will release final guidance "imminently" to provide recommendations to sponsors developing psychedelic medications.Price: $8.89, Change: $-0.27, Percent Change: -2.90%

TD Cowen Initiates Coverage on Cybin With Buy Rating