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Details:
The proceeds will fund company's research and development efforts primarily focused on advancing its lead candidate, DCCR (diazoxide choline) tablets for the treatment of PWS, through late-stage clinical development, regulatory approval and market development activities.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Guggenheim Securities
Deal Size: $69.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 02, 2023
Details:
The proceeds will fund company's research and development efforts primarily focused on advancing its lead candidate, DCCR (diazoxide choline) tablets for the treatment of PWS, through late-stage clinical development, regulatory approval and market development activities.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Adage Capital Partners LP
Deal Size: $120.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 28, 2023
Details:
The proceeds will fund company's research and development efforts primarily focused on advancing its lead candidate, DCCR (diazoxide choline) tablets for the treatment of PWS, through late-stage clinical development, regulatory approval and market development activities.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Guggenheim Securities
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering September 27, 2023
Details:
DCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of (diazoxide choline), which is being investigated for prader-willi syndrome.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 26, 2023
Details:
DCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of (diazoxide choline), which is being investigated for prader-willi syndrome.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
DCCR is a novel, extended-release dosage form containing crystalline salt of diazoxide (diazoxide choline). Diazoxide, has been used for decades in a few rare diseases in neonates, infants, children and adults. It is being developed for prader-willi syndrome.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2023
Details:
DCCR (diazoxide choline) is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily as extended-release tablets for the treatment of Prader-Willi syndrome (PWS).
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nantahala Capital Management
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Agreement December 19, 2022
Details:
DCCR (Diazoxide Choline) Extended-Release Tablet, is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
DCCR (Diazoxide Choline) Extended-Release Tablets, a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily in treatment of patients with PWS.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Folia Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 11, 2022
Details:
Patients demonstrated statistically significant improvements in several hormonal and cardiometabolic parameters following treatment with DCCR, (Diazoxide Choline) Extended-Release Tablets.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
DCCR (Diazoxide choline controlled-release) tablet is a novel, proprietary extended-release, crystalline salt formulation of diazoxide, which is administered once-daily.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2022
Details:
The company’s lead candidate, DCCR (diazoxide choline), a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS), is currently being evaluated in an ongoing Phase 3 clinical development program.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
Highly statistically significant reductions from before DCCR (diazoxide choline) treatment in HQ-CT total score for C601/C602, as well as in aggression, anxiety, compulsivity, depression, disordered thinking, and rigidity domains of PWS Profile questionnaire at Week 52.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
Soleno intends to use the net proceeds from this offering to fund its current research and development efforts primarily focused on advancing its lead candidate, DCCR tablets for the treatment of Prader-Willi Syndrome (PWS).
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oppenheimer & Co.
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 01, 2022
Details:
Soleno intends to use the net proceeds from this offering to fund its current research and development efforts primarily focused on advancing its lead candidate, DCCR tablets for the treatment of Prader-Willi Syndrome (PWS), and to provide for general corporate purposes.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oppenheimer & Co.
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 29, 2022
Details:
The goal of this study is to evaluate the effects of DCCR (diazoxide choline) in pre-hyperphagic individuals with PWS based on various behavioral and metabolic parameters and to assess if DCCR has the potential to prevent progression to hyperphagia and late-phase PWS.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
Soleno intends to submit plans to FDA to conduct further analyses of clinical data from completed and ongoing studies of DCCR, together with external, natural history studies.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2020
Details:
DESTINY PWS is a randomized, double-blind, placebo-controlled Phase III study that will assess the efficacy and safety of DCCR in subjects with genetically-confirmed PWS aged four years and older and weighing between 20 and 134 kg.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2020
Details:
Body composition data from the Soleno's Phase III trial, DESTINY PWS, evaluating once-daily Diazoxide Choline Controlled Release tablets for patients with Prader-Willi Syndrome, will be highlighted at The Obesity Society’s ObesityWeek® 2020 meeting.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
A significant exposure response relationship between DCCR plasma concentrations and change from baseline in HQ-CT score was observed in the study evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS).
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: DCCR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Details:
Soleno currently intends to use the net proceeds from the offering to fund its current research and development efforts primarily focused on advancing its lead candidate, Diazoxide Choline Controlled-Release tablets for the treatment of Prader-Willi Syndrome.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Guggenheim Securities
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 24, 2020
Details:
The study did not meet its primary endpoint of change from baseline in hyperphagia. The change was measured by the total score of a Hyperphagia Questionnaire for Clinical Trials (HQ-CT, 0‑36).
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
Details:
Treatment with DCCR can directly open the KATP channels in the NPY/AgRP neurons, reducing the synthesis and secretion of NPY and AgRP, and thereby, reducing hyperphagia.
Lead Product(s): Diazoxide
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2020
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