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Psyched: LSD, Psilocybin As Breakthrough Therapies, $14M Fed Grant For Ibogaine, Indiana's Research And More
Wednesday, March 20, 2024 - 2:49pm | 1376FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placement Clinical-stage psychedelics biopharma company Cybin Inc. (NYSE:CYBN) announced that the Food and Drug Administration has granted...
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FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placement
Wednesday, March 13, 2024 - 11:33am | 1092Clinical-stage psychedelics biopharma company Cybin Inc. (NYSE:CYBN) announced that the Food and Drug Administration has granted Breakthrough Therapy designation to CYB003, its proprietary deuterated psilocybin analog targeting the adjunctive treatment of Major Depressive Disorder (MDD.) The...
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MindMed Receives FDA 'Breakthrough Therapy' Designation For LSD As Anxiety Treatment, Shares Positive Results About Related Clinical Trials
Thursday, March 7, 2024 - 2:35pm | 618Mind Medicine (MindMed) (NASDAQ:MNMD) announced that the FDA has granted the "breakthrough therapy" designation to its MM120 (lysergide d-tartrate) program for the treatment of Generalized Anxiety Disorder (GAD). The clinical-stage psychedelics biotech firm will now join industry counterparts...
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COMPASS Pathways Q3 2023 Results: Cash Injection To Sustain Phase 3 Psilocybin Program
Thursday, November 2, 2023 - 2:16pm | 700COMPASS Pathways plc (NASDAQ: CMPS), the London-headquartered psychedelics biotech company reported financial results for the third quarter 2023 ended September 30, showing: Cash and cash equivalents of $248.0 million as of Sept. 30, 67% more than that held on last quarter’s...
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VA Docs May Soon Recommend Medical Marijuana, Psychedelics Research: Bill Gets House Greenlight
Thursday, July 27, 2023 - 2:06pm | 428The GOP-controlled House of Representatives recently passed two amendments of a comprehensive Military Construction, Veterans Affairs and Related Agencies (MilCon/VA) spending bill. One would allow VA doctors to recommend medical cannabis to veterans, and the other would promote research into...
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Bipartisan Lawmakers Introduce Rescheduling Bill To Enable Psychedelics Research
Wednesday, March 8, 2023 - 6:00pm | 408Senators Cory Booker (D-NJ), Rand Paul (R-KY) Reps Madeleine Dean (D-PA) and Nancy Mace (R-SC) filed a revised bill requesting an update on the federal scheduling of “breakthrough therapies” -an FDA designation for certain treatments involving psilocybin and MDMA- towards...
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Takeda's Narcolepsy Candidate Gets FDA Breakthrough Therapy Tag
Wednesday, July 28, 2021 - 11:22am | 179The FDA has granted Breakthrough Therapy Designation to Takeda Pharmaceutical Company Limited's (NYSE: TAK) TAK-994 for excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1). The oral orexin agonist is currently in Phase 2 study. EDS is a...
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Verastem's VS-6766/Defactinib Combo Gets Breakthrough Therapy Tag For Ovarian Cancer; BTIG Upgrades Stock
Monday, May 24, 2021 - 12:03pm | 251The FDA has granted Breakthrough Therapy designation to Verastem Inc (NASDAQ: VSTM) for the combination of its investigational VS-6766, with defactinib, for recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy...
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Acadia Continues Huge Rise Following FDA Panel Vote
Wednesday, March 30, 2016 - 7:52am | 177Shares of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) were trading higher by more than 22 percent early Wednesday morning. A U.S. Food and Drug Administration panel voted 12-2 on Tuesday that Acadia's drug pimavanserin, a treatment for psychosis associated with Parkinson's disease,...