COMPASS Pathways

Compass Pathways to be added to NASDAQ Biotechnology Index on Dec 23, 2024. The index tracks biotech and pharma companies on NASDAQ, reconstituted annually based on criteria like market cap and trading volume. Compass Pathways focuses on mental health innovation, developing a new psilocybin treatment model with COMP360, which has FDA Breakthrough Therapy designation.

Compass Pathways plc (Nasdaq: CMPS) announced its common stock will be added to the NASDAQ Biotechnology Index (Nasdaq: NBI) on December 23, 2024. The NBI tracks biotechnology and pharmaceutical companies on NASDAQ and is reconstituted annually.

Psilocybin mushrooms, or “magic mushrooms,” contain psychoactive compounds that affect mood and perception by interacting with serotonin receptors in the brain. Historically used in spiritual practices, particularly in Mesoamerican cultures, psilocybin is gaining attention for its potential to treat depression, anxiety, PTSD, and addiction, with promising results from clinical trials. However, their use carries risks, including psychological distress, especially for those with mental health conditions. While psilocybin remains illegal in many places, decriminalization and medical research are increasing, particularly in areas like Oregon. Caution is advised due to potential misidentification and psychological effects.

Psychedelic drug developers face setbacks but see potential in Johnson & Johnson's Spravato success. Cybin, a Toronto-based company, benefits from FDA insights gained from Lykos and Compass's issues, advancing its Phase 3 trial for deuterated psilocin (CYB003) for major depressive disorder. Cybin emphasizes FDA-desired trial details and patient safety measures, leveraging breakthrough therapy designation for real dialogue with the agency. The expanding infrastructure for Spravato administration supports future psychedelic drug rollouts.

New treatments like COMP360, Zuranolone, LY03005, REL-1017, Seltorexant, and ABV-1504 are expected to significantly transform the major depressive disorder (MDD) market. MDD affects 44 million diagnosed cases in the 7MM, with moderate cases being the most prevalent. Treatment approaches include pharmacological interventions, psychotherapy, and lifestyle changes. The market size for MDD is projected to grow from USD 7.1 billion in 2023, driven by disease awareness and new product launches.

The Association for Prescription Psychedelics (APP) launched to integrate safe, effective prescription psychedelic medicines into healthcare, guided by prominent researchers and supported by organizations like B.More Inc., Compass Pathways, Lykos Therapeutics, and MindMed.

Investors react negatively to Trump's nomination of RFK Jr. for HHS, causing COVID-19 vaccine stocks to tumble, with Moderna and BioNTech seeing significant losses. RFK Jr.'s criticism of COVID-19 vaccines and potential impact on vaccine policy contribute to investor concerns. Psychedelic drug companies, however, see stock increases due to RFK's support for the field.

CaaMTech received regulatory approval for its functional unblinding strategy in CT-4201 drug trials, addressing a major hurdle in psychedelic medicine development.