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Lead Product(s): Reboxetine
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Axsome Therapeutics
Deal Size: $331.0 million Upfront Cash: $3.0 million
Deal Type: Licensing Agreement January 13, 2020
Details:
Agreement accelerates ongoing clinical development of AXS-12 (reboxetine) in narcolepsy which expands Axsome’s pipeline with new Phase 3-stage esreboxetine product candidate for fibromyalgia
Transforming oral delivery challenges into proprietary product solutions.
Lead Product(s): Mazindol
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: NLS Pharmaceutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 13, 2020
Details:
NLS Pharmaceutics entered a collaboration to develop mazindol (MZD) CR product candidates for the treatment of narcolepsy and ADHD utilizing Adare’s proprietary modified release technologies.
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Lead Product(s): Aroxybutynin,Atomoxetine Hydrochloride
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
First patient has been dosed in first Phase 2 clinical trial evaluating AD109, the company’s first-in-class, oral pharmaceutical under development for the treatment of OSA.
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Lead Product(s): Reboxetine
Therapeutic Area: Sleep Product Name: AXS-12
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
The expedited development plan includes one Phase 3 efficacy trial, which, along with the previously completed Phase 2 CONCERT trial, will be used to support the filing of an NDA (New Drug Application) for approval of AXS-12 for the treatment of cataplexy in narcolepsy.
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Lead Product(s): Oxybutynin,Atomoxetine Hydrochloride
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
In this healthy volunteer study, R-oxybutynin, a key component of AD109, demonstrated a favorable pharmacokinetic (PK) profile and was well tolerated with no adverse events related to the study drug.
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Lead Product(s): Reboxetine
Therapeutic Area: Sleep Product Name: AXS-12
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2020
Details:
Axsome will present efficacy & safety data from the CONCERT Ph 2 trial of AXS-12 in the treatment of narcolepsy at the 34th Annual SLEEP Meeting of the APSS. AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy.
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Lead Product(s): Reboxetine
Therapeutic Area: Sleep Product Name: AXS-12
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor. Axsome previously received Orphan Drug Designation from the FDA for AXS-12 for the treatment of narcolepsy.
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Lead Product(s): Seltorexant
Therapeutic Area: Sleep Product Name: MIN-202
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Janssen Pharmaceutica
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 01, 2020
Details:
Minerva Neuroscienceshas exercised its right to opt out of its agreement with Janssen Pharmaceutica future development of seltorexant. As a result, Minerva will now collect a royalty on worldwide sales of seltorexant in all indications.
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Lead Product(s): Golexanolone
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 08, 2020
Details:
Analyses of data for additional efficacy endpoints reveal that treatment with the golexanolone exerts a significant effect on brain signaling with a positive effect on excessive daytime sleepiness.
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