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Details:
LYN-005 (oral weekly risperidone), is being evaluated in phase 3 clinical trials for the treatment of people living with schizophrenia and bipolar 1 disorder.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: LYN-005
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 04, 2024
Details:
The financing will be used to obtain access to the technology for certain compounds and territories while also fostering the development of novel pharmaceutical delivery systems, including LYN-005 (risperidone), being developed for schizophrenia and bipolar I disorder.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: LYN-005
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Financing January 02, 2024
Details:
The net proceeds will support the development of Lyndra’s pipeline, including oral weekly LYN-005 (risperidone), which is near completion of a pivotal phase 3 study and is being developed for the treatment of people living with schizophrenia and bipolar I disorder.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: LYN-005
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sarissa Capital
Deal Size: $101.0 million Upfront Cash: Undisclosed
Deal Type: Series E Financing December 25, 2023
Details:
DLP-114 is an investigational therapy that employs Delpor's proprietary technology platform. It is placed sub-dermally to provide continuous and consistent dosing of risperidone for schizophrenia maintenance therapy lasting 6-12 months.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: DLP-114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2023
Details:
Oral weekly LYN-005 (risperidone) is a serotonin and norepinephrine reuptake inhibitor and is being developed for the treatment of people living with schizophrenia and bipolar I disorder.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: LYN-005
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 09, 2023
Details:
Uzedy (risperidone) is a dopamine type 2 (D2) and serotonin type 2 (5HT2) receptor antagonist. It is indicated for the treatment of schizophrenia in adults.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: Uzedy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2023
Details:
Rykindo® (risperidone) is an atypical antipsychotic for the treatment of schizophrenia anfd as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. It acts as combined D2 and 5HT2 receptor antagonist.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: Rykindo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2023
Details:
TV-46000 is a long-acting subcutaneous antipsychotic that uses a novel copolymer drug delivery technology in combination with a well-characterized molecule, risperidone, that is in clinical development as a treatment for schizophrenia.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: TV-46000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: European Investment Bank
Deal Size: $41.8 million Upfront Cash: Undisclosed
Deal Type: Agreement November 23, 2022
Details:
Uzedy, a risperidone subcutaneous Long-Acting Injectable (LAI) for the maintenance treatment of schizophrenia using MedinCell’s proprietary technology.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: Uzedy
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, 2022
Details:
mdc-IRM, (risperidone) extended-release injectable suspension for the treatment of patients with schizophrenia (Teva codename: TV-46000), is the most advanced investigational product based on MedinCell’s BEPO® technology.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: mdc-IRM
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Assia Chemical Industries Ltd
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2022
Details:
The application included Phase 3 data from two pivotal studies, for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: TV-46000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: MedinCell
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
MedinCell’s partner, Teva Pharmaceuticals, announced results from the pivotal Phase 3 Risperidone Subcutaneous Extended-release (RISE) study comparing TV-46000 once monthly (q1m) and TV-46000 once every two months (q2m) with placebo (1:1:1) in patients with schizophrenia.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: TV-46000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: $122.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration November 15, 2021
Details:
Risperidone extended-release injectable suspension is an antipsychotic medicine and dopamine D2, 5-HT2A, alpha1-adrenoceptor, and histamine-1 receptor antagonist used for subcutaneous use as a treatment in patients (ages 13-65 years) with schizophrenia.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: mdc-IRM
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 30, 2021
Details:
mdc-IRM, a risperidone extended-release injectable suspension for the treatment of patients with schizophrenia. AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2) inhibitor for the treatment of chorea associated with Huntington’s disease.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: mdc-IRM
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 21, 2021
Details:
MedinCell and Teva announced yesterday the FDA acceptance of the New Drug Application for mdc-IRM for patients with schizophrenia.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: mdc-IRM
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2021
Details:
LYN-005 is Lyndra's oral, ultra-long-acting, extended-release risperidone capsule, in development for the weekly treatment of schizophrenia. Funding will advance Lyndra’s lead product candidate into pivotal trials as the Company prepares for commercialization in the U.S.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: LYN-005
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AIG Investments
Deal Size: $60.5 million Upfront Cash: Undisclosed
Deal Type: Series C Financing June 24, 2021
Details:
Data demonstrate LYN-005 quickly reaches therapeutic levels in patients, provides sustained risperidone drug levels for repeat one-week dosing intervals and reduces peak drug exposure.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: LYN-005
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2021
Details:
Data from the study showed that patients who received risperidone had a statistically significant delay in time to relapse as compared to placebo, thus meeting the primary endpoint.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: TV46000-CNS-30072
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: MedinCell
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 07, 2021
Details:
Health Canada has approved HLS Therapeutics' PERSERIS® (risperidone for extended-release injectable suspension), 90 mg and 120 mg subcutaneous injection, a novel long-acting injectable of risperidone, for the treatment of schizophrenia in adults.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: Perseris
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
Lyndra Therapeutics completed enrollment and dosing of its Phase I clinical trial for an ultra-long-acting oral risperidone therapy to treat schizophrenia, ramping up manufacturing capabilities and growing its employee base by 28%.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
Details:
If approved by Health Canada, PERSERIS would become the first once-monthly risperidone long-acting injectable used in the treatment of schizophrenia.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology 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 January 23, 2020
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