Sleep

Pfizer Inc

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United States

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ASCO 2020

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Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer’s Reboxetine Clinical and Nonclinical Data and for...

Lead Product(s): Reboxetine

Therapeutic Area: Sleep

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

Adare Pharmaceuticals

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United States

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Controlled Release Society & Expo

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Adare Pharmaceuticals and NLS Pharmaceutics Collaborate to Develop Mazindol Controlled Release (CR) for the Treatment of ADHD and Narcolepsy

Lead Product(s): Mazindol

Therapeutic Area: Sleep

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.

Umecrine Cognition

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SWEDEN Sweden

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ASCO 2020

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Karolinska Development’s Portfolio Company Umecrine Cognition Presents Positive Additional Results From A Phase 2a Study Of Golexanolone

Lead Product(s): Golexanolone

Therapeutic Area: Sleep

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.

Sosei Group Corporation

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JAPAN Japan

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ASCO 2020

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Sosei Heptares Announces Scientific Progress with Orexin Agonist Program in Conjunction With Spin-off Companies Orexia and Inexia

Lead Product(s): Undisclosed

Therapeutic Area: Sleep

Highest Development Status: Discovery Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2020

Details:

Sosei Heptares solves structure of the agonist bound orexin OX2 receptor and identifies small molecule binding site using unique StaR® technology and structure-based approach.

Avadel Pharmaceuticals

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IRELAND Ireland

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ASCO 2020

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Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218

Lead Product(s): Sodium Oxybate

Therapeutic Area: Sleep

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2020

Details:

The primary analysis of FT218 demonstrated highly statistically significant (p<0.001), and clinically meaningful improvement across all three co-primary endpoints compared to placebo .

Idorsia Pharmaceuticals

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Switzerland

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ASCO 2020

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Idorsia's Rival to Merck's Insomnia Drug Clears Phase 3 Test

Lead Product(s): Daridorexant

Therapeutic Area: Sleep

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 20, 2020

Details:

The study demonstrated efficacy of treatment with daridorexant on objective and subjective sleep parameters and daytime performance with no residual effect in the morning.

Zelira Therapeutics

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Australia

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ASCO 2020

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Zelira Therapeutics Meets Primary Endpoints for Phase (1b/2a) Medicinal Cannabis Trial for Insomnia

Lead Product(s): ZLT-101

Therapeutic Area: Sleep

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 18, 2020

Details:

23 chronic insomnia patients treated with ZLT-101, Zelira's proprietary and patented medicinal cannabis formulation, demonstrated statistically significant improvement in Insomnia Severity Index.

Jazz Pharmaceuticals

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IRELAND Ireland

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ASCO 2020

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Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy

Lead Product(s): JZP-258

Therapeutic Area: Sleep

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 22, 2020

Details:

The submission is based on a Phase 3 global randomized-withdrawal, multicenter study that demonstrated the efficacy and safety of JZP-258 in the treatment of narcolepsy.

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Pfizer Inc

Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer’s Reboxetine Clinical and Nonclinical Data and for...

Adare Pharmaceuticals

Adare Pharmaceuticals and NLS Pharmaceutics Collaborate to Develop Mazindol Controlled Release (CR) for the Treatment of ADHD and Narcolepsy

Umecrine Cognition

Karolinska Development’s Portfolio Company Umecrine Cognition Presents Positive Additional Results From A Phase 2a Study Of Golexanolone

Sosei Group Corporation

Sosei Heptares Announces Scientific Progress with Orexin Agonist Program in Conjunction With Spin-off Companies Orexia and Inexia

Avadel Pharmaceuticals

Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218

Idorsia Pharmaceuticals

Idorsia's Rival to Merck's Insomnia Drug Clears Phase 3 Test

Zelira Therapeutics

Zelira Therapeutics Meets Primary Endpoints for Phase (1b/2a) Medicinal Cannabis Trial for Insomnia

Jazz Pharmaceuticals

Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy