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atai Life Sciences Bags FDA Nod for PCN-101 Clinical Trials

Clinical-stage biopharmaceutical company atai Life Sciences N.V. (Nasdaq: ATAI) revealed that it has bagged clearance from the U.S. Food and Drug Administration (FDA) to conduct a clinical DDI study of PCN-101, designed to treat mental health disorders.

The company seeks to begin the study early in 2022 through its platform company Perception Neuroscience.

atai Life Sciences expects that PCN-101 carries some unique properties that are different from currently available antidepressants and has the potential to address key patient needs, including the potential of rapid action and anti-suicidal effect.

The company said that the clinical trial would be conducted alongside an existing Phase 2a proof-of-concept trial in treatment-resistant depression, recently initiated in Europe. Moreover, to make the treatment self-administered, atai Life Sciences plans to run a bioavailability study in 2022 to bridge the IV formulation to a subcutaneous formulation of PCN-101.

The CEO and Co-Founder of atai Life Sciences, Florian Brand, said, “We see great promise in PCN-101 as a potentially rapid-acting anti-depressant with a more favorable safety and tolerability profile than S-ketamine, which could enable at-home use.”

Price Target

Recently, RBC Capital analyst Brian Abrahams maintained a Hold rating on the stock with a price target of $12 (80.2% upside potential).

Overall, the rest of the Street has a bullish outlook on the stock with a Strong Buy consensus rating based on 7 Buys and 1 Hold. The average atai Life Sciences price target of $26.57 implies upside potential of about 299%.

Positive Sentiment

TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on ATAI with 7.7% of investors on TipRanks increasing their exposure to the stock over the past 30 days.

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