Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) showed no clinically significant impact on weight and height growth rate in pediatric patients. CNS stimulants prescribed for treatment of ADHD have been associated with height and wei...
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : Inapplicable
May 22, 2023
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) for patients six and older with ADHD, and ADLARITY (donepezil transdermal system) for patients with mild, moderate, or severe dementia of the Alzheimer's type.
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : Inapplicable
September 13, 2022
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Gurnet Point Capital
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AZSTARYS is the first and only medicine containing SDX, a prodrug of d-MPH, which provides for an extended duration of d-MPH release throughout the day. Once-daily AZSTARYS is available nationally in the U.S. in three SDX/immediate-release d-MPH dose str...
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : Inapplicable
March 28, 2022
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Gurnet Point Capital
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) significantly improved attention deficit hyperactivity disorder (ADHD) symptoms.
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : Inapplicable
October 29, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AZSTARYS is a once-daily product for the treatment of ADHD in patients aged six years and older consisting of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
Product Name : KP1077
Product Type : Controlled Substance
Upfront Cash : Inapplicable
October 27, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Hercules Capital
Deal Size : Undisclosed
Deal Type : Financing
Corium Secures $235 Million in Debt Financing
Details : The financing will provide funds to support continued U.S. commercialization of AZSTARYS which is used for the treatment of ADHD for patients 6 years of age and over that was approved by the FDA.
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : Undisclosed
September 27, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Hercules Capital
Deal Size : Undisclosed
Deal Type : Financing
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Gurnet Point Capital
Deal Size : $590.0 million
Deal Type : Licensing Agreement
Details : Gurnet Point Capital affiliate gets exclusive worldwide license to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate (SDX) and d-methylphenidate (d-MPH), including AZSTARYS for the treatment of ADHD.
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : $10.0 million
August 04, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Gurnet Point Capital
Deal Size : $590.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Commave Therapeutics
Deal Size : $590.0 million
Deal Type : Collaboration
Details : The License Agreement provides for an exclusive worldwide license to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate and d-methylphenidate (d-MPH), including AZSTARYS.
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : Undisclosed
April 21, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Commave Therapeutics
Deal Size : $590.0 million
Deal Type : Collaboration
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AZSTARYS is the first and only product containing a dexmethylphenidate (d-MPH) oral prodrug for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged six years and older.
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : Inapplicable
March 05, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA Approves Novel Once-Daily Capsule AZSTARYS
Details : AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH. After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day.
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : Inapplicable
March 03, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable