Approved

Eisai

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JAPAN Japan

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Natural Products Expo

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Eisai to Present Latest Insomnia Research, Including Data on New Treatment DAYVIGO™ (lemborexant) CIV, at the SLEEP 2020 Virtual Conferenc...

Lead Product(s): Lemborexant

Therapeutic Area: Sleep Product Name: Dayvigo

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 25, 2020

Details:

The main presentations from Eisai at this conference include presentations relating to the SUNRISE 2 Phase III clinical trial conducted globally, including sites in Japan.

Aytu BioScience

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United States

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Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration

Lead Product(s): Zolpidem Tartrate

Therapeutic Area: Sleep Product Name: Zolpimist

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 30, 2020

Details:

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and will be able to be commercialized and supplied within Australia.

Harmony Biosciences

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United States

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Harmony Biosciences Files for a $100 million IPO

Lead Product(s): Pitolisant

Therapeutic Area: Sleep Product Name: Wakix

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 27, 2020

Details:

The company expects to initiate a Phase 3 trial for EDS and cataplexy in pediatric patients in the 2H21. It also plans to start Phase 2 trials for EDS and other key symptoms in patients with Prader-Willi Syndrome and in adult patients with myotonic dystrophy in the 1H21.

Eisai

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JAPAN Japan

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Eisai to Launch In-House Developed New Anti-insomnia Drug in Japan

Lead Product(s): Lemborexant

Therapeutic Area: Sleep Product Name: Dayvigo

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 06, 2020

Details:

DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R).

Eisai

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Eisai Announces U.S. Availability of DAYVIGO® (lemborexant) CIV, a New Treatment Option for Adults With Insomnia

Lead Product(s): Lemborexant

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

Details:

In clinical studies, DAYVIGO helped some people with insomnia fall asleep faster and stay asleep longer compared to placebo. The effects of DAYVIGO at first use were generally consistent with later timepoints.

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Eisai

Eisai to Present Latest Insomnia Research, Including Data on New Treatment DAYVIGO™ (lemborexant) CIV, at the SLEEP 2020 Virtual Conferenc...

Aytu BioScience

Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration

Harmony Biosciences

Harmony Biosciences Files for a $100 million IPO

Eisai

Eisai to Launch In-House Developed New Anti-insomnia Drug in Japan

Eisai

Eisai Announces U.S. Availability of DAYVIGO® (lemborexant) CIV, a New Treatment Option for Adults With Insomnia