FINWIRES · TerminalLIVE
FINWIRES

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

By

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%

Related Articles

Wire

Unico Silver Reduces Rigs at Argentina Drilling Operations During Transition to Winter Operations

Unico Silver (ASX:USL) said it reduced the number of drill rigs under its drilling operations in Argentina to two from three as it moves into reduced winter operations, according to a Friday Australian bourse filing.The company plans to update the Joaquin project mineral resource estimate in the June quarter to incorporate recent infill drilling.In the same filing, the company said it is conducting pre-feasibility work streams, including geotechnical drilling and interpretation to define open-pit slope and design parameters, as well as comminution and metallurgical test work to confirm processing assumptions and recovery pathways.The company's shares fell past 1% in recent trading on Friday.

ASX:USL
Wire

Coursera Q1 Non-GAAP Earnings Fall, Revenue Rises; Shares Drop After Hours

Coursera (COUR) reported Q1 non-GAAP earnings late Thursday of $0.07 per diluted share, down from $0.12 a year earlier.Analysts polled by FactSet expected $0.08.Revenue in the three months ended March 31 rose to $195.7 million from $179.3 million a year earlier.Analysts surveyed by FactSet expected $195.1 million.Coursera expects Q2 revenue of $196 million to $200 million. Analysts project $200.7 million.The company reaffirmed full-year revenue guidance of $805 million to $815 million. Analysts project $812.7 million.Coursera shares fell 10% in after-hours trading.

$COUR
Wire

MaxLinear Q1 Swings to Adjusted Earnings, Revenue Rises; Q2 Guidance Set

MaxLinear (MXL) reported Q1 adjusted earnings late Thursday of $0.22 per diluted share, swinging from a loss of $0.05 a year earlier.Analysts polled by FactSet expected EPS of $0.18.Revenue for the three months ended March 31 was $137.2 million, up from $95.9 million a year earlier.Analysts surveyed by FactSet expected $134.6 million.For Q2, the company expects revenue of $160 million to $170 million. Analysts expect $137.1 million.The company also amended its credit agreement with certain lenders to extend the maturity of the revolving credit facility to March 2028 and also increased the amount available under the facility to $130 million.

$MXL