Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. In the age of COVID-19, some are seeing a more expedited process, but the risk/reward of these stocks remains great.
In terms of risk, biopharma stocks could be cratered should a study come back negative or a candidate not be approved. At the same time, if a drug is approved or passes a clinical trial, there can be massive upside. Even winning a simple approval from the U.S. Food and Drug Administration (FDA) can be big.
This past year especially has been a wild ride for the health care sector, and only recently markets have tanked into correction territory. It is anyone’s guess where markets could go from here, given the recent price action.
Here, 24/7 Wall St. has included a calendar of a few of the biggest clinical trial and FDA updates in regard to psychedelic therapeutics to watch for the second quarter of 2022.
Note that these dates may be subject to change due to various outside and internal factors, or some of these dates may have changed already. Some date changes are positive developments, while others can be disasters if a company is deeply financed.
Atai Life Sciences N.V. (NASDAQ: ATAI): Phase 2a for PCN-101 (r-ketamine) data is expected late in 2022. Phase 1 data on DMX-1002 (opioid-use disorder, OUD) and GRX-917 (generalized anxiety disorder, GAD) are due in the first half of 2022. The stock most recently closed at $5.14, in a 52-week range of $4.66 to $22.91.
Compass Pathways PLC (NASDAQ: CMPS): The company meets with the FDA early in 2022 to discuss COMP360 and expects to start Phase 3 in the second half of the year. Results of investigator-initiated studies in several indications could come in 2022, and there could be updates on ex-COMP360 programs. Note that COMP360 is a psilocybin-based treatment. Shares last closed at $15.51, and the stock has a 52-week trading range of $14.06 to $58.62.
Cybin Inc. (NYSE: CYBN): CYB003 is expected to enter the clinic in the second quarter of 2022. The company also plans to complete preclinical studies for CYB003 in the first quarter of 2022 and then file an IND in the second quarter. The company has multiple programs to use its psilocybin-based treatment for major depressive disorder, alcohol use disorder, anxiety disorders and therapy-resistant psychiatric disorders. The stock was last seen at $1.01, and it has a 52-week range of $0.82 to $3.38.
GH Research PLC (NASDAQ: GHRS): The company could start its Phase 2a trials in two new psychiatric indications in the first quarter of 2022. In the meantime, the company could see regulatory interaction updates, as it is looking for pre-IND meetings with the FDA and EMA. The stock was last seen at $16.78, in a 52-week range of $12.38 to $30.43.
Mind Medicine Inc. (NEO: MMED.NE): Be on the lookout for an update on 18-MC Phase 1 readout and an update on the clinical hold. Shares were last seen at $1.19, and the stock has a 52-week range of $1.04 to $5.99.
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