In July 2012, Congress created what is known as Breakthrough Therapy designation, a distinction that affords biotechnology and pharmaceutical companies an expedited review process for experimental drugs that may have treatment advantages over existing therapies for hard-to-treat diseases. In November 2013, Gazyva, a drug used in combination with chlorambucil for patients with chronic lymphocytic leukemia, made history as the first breakthrough therapy to receive FDA marketing approval. Since then, hundreds of drugs have earned the designation, and several have reached commercialization. An area that remains underrepresented on the FDA breakthrough therapy list that could make waves in the coming years is that of the emerging market of psychedelics, where companies such as Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (Profile) is striving to provide relief for patients with chronic pain by developing evidence-based innovation in areas where today’s approved drugs and therapies are lacking. Tryp is part of a select group of companies that are advancing or have already advanced psychedelic treatments into Phase 2 of the FDA clinical trial process, a small collection of impressive companies that includes COMPASS Pathways Plc (NASDAQ: CMPS)Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ)ATAI Life Sciences N.V. (NASDAQ: ATAI) and Cybin Inc. (NEO: CYBN) (OTCQB: CLXPF).


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