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Reunion Neuroscience

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CA76134G1037

Reunion Neuroscience Inc. Announces FDA Clearance of IND Application to Initiate A Phase 2 Study of Re104 for the Treatment of Postpartum Depression

September 18, 2023 at 07:30 am EDT

Reunion Neuroscience Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2 study of RE104, a novel serotonergic psychedelic compound, for the treatment of postpartum depression (PPD). The Phase 2 study, the RECONNECT Trial, is a multicenter, randomized, double-blind, parallel-group, active-dose placebo-controlled study, which will evaluate the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with PPD. The study is expected to begin in fourth quarter 2023 with a targeted data readout in late 2024.

Latest news about Reunion Neuroscience

Reunion Neuroscience Inc. Announces FDA Clearance of IND Application to Initiate A Phase 2 Study of Re104 for the Treatment of Postpartum Depression	23-09-18	CI
Reunion Neuroscience Brief: Reunion and MPM BioImpact Complete Plan of Arrangement Effective Today, whereby MPM Acquired Reunion in an all-cash transaction valued at Near US$13.1 million	23-08-01	MT
Reunion Neuroscience Inc.(NasdaqGS:REUN) dropped from NASDAQ Composite Index	23-08-01	CI
MPM Asset Management, L.L.C. acquired Reunion Neuroscience Inc. in a going private transaction.	23-07-31	CI
Reunion Neuroscience Gets Ontario Court's Final Approval for Acquisition by MPM BioImpact	23-07-14	MT
Reunion Neuroscience Brief: Adds In "Assuming Remaining Conditions Precedent Are Satisfied Or Waived", Anticipates Closing of Arrangement Will Occur On Or About July 21, 2023	23-07-14	MT
Reunion Neuroscience Brief: Says Obtained Final Court Order for Proposed Plan of Arrangement Whereby Affiliates of MPM BioImpact Will Buy REUN In An All-cash Deal Valued at Near US$13.1 Million	23-07-14	MT
Reunion Neuroscience Brief: Arrangement remains subject to receipt of a final order of the Ontario Superior Court of Justice (Commercial List); Expected to be completed on or around July 21, 2023	23-07-13	MT
Reunion Neuroscience Brief: Shareholders Approve Proposed Plan of Arrangement Whereby Affiliates of MPM BioImpact Will Buy REUN In An All-cash Tansaction Valued at Near US$13.1 Million	23-07-13	MT
Reunion Reports Q4 Results; Shareholders to Get US$1.12 Cash Per Share From Arrangement Agreement with MPM BioImpact	23-06-29	MT
Reunion Neuroscience Brief: Adds It Presented "Encouraging" Phase 1 Final Analysis at American Society of Clinical Psychopharmacology Annual Meeting	23-06-29	MT
Reunion Neuroscience Brief: Common Holders to Receive Consideration of US$1.12 Per Share in Cash from Arrangement Agreement with MPM BioImpact; Special Shareholder Meeting Scheduled July 12	23-06-29	MT
Reunion Neuroscience Brief: Says incurred a net loss from continuing operations of $6.5 million or $0.56 per share and $38.1 million or $3.28 per share for the three and 12 month periods ended March 31, 2023	23-06-29	MT
Reunion Neuroscience Brief: Says Rcognized a net loss from discontinued operations of $10.4 million for the 12 month period ended March 31, 2023; Adds No such loss was incurred during the three month period ended March	23-06-29	MT
Reunion Neuroscience Inc. Auditor Raises 'Going Concern' Doubt	23-06-27	CI
Reunion Neuroscience Inc. Reports Earnings Results for the Full Year Ended March 31, 2023	23-06-27	CI
Reunion Neuroscience Up More Than 50% In US Pre-Market After Announcing US$13.1 Million Take-Private Transaction with MPM BioImpact	23-06-01	MT
Reunion Neuroscience Brief: Up 60% In US Pre-Market After Announcing US$13.1 Million Take-Private Transaction with MPM BioImpact; Reunion Common Holders to Get Consideration of US$1.12 Per Share in Cash	23-06-01	MT
Reunion Neuroscience Brief: Says Presented 'Encouraging" Phase 1 Final Analysis at American Society of Clinical Psychopharmacology Annual Meeting, Enabling Advancement into Phase 2 in 2H 2023	23-06-01	MT
Reunion Neuroscience Brief: Represents a 43.1% Premium to the 30-Day Volume Weighted Average Price	23-06-01	MT
Reunion Neuroscience Brief: Common Shareholders to Receive Consideration of US$1.12 Per Share in Cash	23-06-01	MT
Reunion Neuroscience Brief: Announcing US$13.1 Million Take-Private Transaction with MPM BioImpact	23-06-01	MT
MPM Asset Management, L.L.C. entered into a definitive arrangement agreement to acquire Reunion Neuroscience Inc. for CAD 17.8 million in a going private transaction.	23-05-31	CI
ThinkEquity Initiates Reunion Neuroscience at Buy With $5 Price Target	23-05-01	MT
ThinkEquity Starts Reunion Neuroscience at Buy With $5 Price Target	23-05-01	MT

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Reunion Neuroscience Inc. is engaged in the psychedelic drug development company that provides therapeutic solutions for mental health conditions by developing serotonin receptor agonist compounds. The Company is developing the advancement of synthetic molecules targeting serotonin 5HT2A receptors. The Company's products include RE104 and RE200. The Company's lead asset, RE-104, which is a psychedelic drug being developed for post-partum and treatment resistant depression as a potential fast-acting antidepressant with durable efficacy. The RE104 as a potentially fast-acting treatment for the key indications of postpartum and treatment resistant depression. The Company is developing the RE200 series, which includes compounds with potential for more selective serotonin receptor activity with reduced psych activity for potential use in more chronic treatment paradigms and indications. The Company is focused on the research and development of its RE200 molecule group.

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