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Lead Product(s): Arketamine
Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2021
Details:
PCN-101 was safe and well-tolerated at all doses up to 150 mg, the highest dose tested. There were no serious adverse events reported. The pharmacokinetics of PCN-101 in plasma were approximately dose-proportional.
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Lead Product(s): ELE-Psilo+
Therapeutic Area: Psychiatry/Psychology Product Name: ELE-Psilo+
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Eleusis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 14, 2020
Details:
ELE-Ket+ and ELE-Psilo+ are expected to enter Phase II clinical trials for the adjunctive treatment of major depressive disorder at the end of 2021. Under the terms of the agreement, Eleusis will acquire Kalypso and its intellectual property in an all-stock transaction.
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Lead Product(s): Nalmefene
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: $8.1 million Upfront Cash: Undisclosed
Deal Type: Funding December 14, 2020
Details:
An earlier award of $4.6 million from BARDA, combined with a $7.4 million grant Opiant received from the NIDA, also supports the clinical development and U.S. regulatory submission of OPNT003. The grant increases total potential value of the BARDA contract to $8.1 million.
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Lead Product(s): D-Amphetamine Sulfate
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Results demonstrated that ADAIR had slower absorption and lower early exposure, and was less desirable to recreational drug abusers on key measures of abuse liability compared to commercially available dextroamphetamine.
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Lead Product(s): Nalmefene
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Opiant Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 29, 2020
Details:
Agreement combines Opiant’s opioid antagonist OPNT003 nasal nalmefene, with Aptar's FDA-approved Unit Dose System delivery device. OPNT003 is a nasal nalmefene for use in conjunction with Aptar’s Unit Dose System (UDS) for the treatment of opioid overdose.
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Lead Product(s): D-Amphetamine Sulfate
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering October 23, 2020
Details:
The company's clinical-stage product currently under development is Abuse-Deterrent Amphetamine Immediate-Release, or ADAIR. ADAIR has completed a Phase 1 pivotal bioequivalence study and a Phase 1 food effect study.
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Lead Product(s): Cyclobenzaprine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102 SL
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
FDA has cleared the Investigational New Drug (IND) application for the initiation of a Phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder (AUD).
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Lead Product(s): CVL-231
Therapeutic Area: Psychiatry/Psychology Product Name: CVL-231
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: PIPE
Deal Size: $445.0 million Upfront Cash: Undisclosed
Deal Type: Financing July 30, 2020
Details:
Upon completion of the business combination, the net proceeds will be used to advance development of Cerevel Therapeutics’ diverse neuroscience pipeline, including potential treatments for schizophrenia, epilepsy, and Parkinson’s diseas.
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Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: INP105
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
Study shows INP105 achieves rapid absorption which may provide an effective, convenient, & noninvasive future alternative for treating acute agitation in the home, community, or hospital setting.
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