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Details:
Skyclarys (omaveloxolone) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with Friedreich’s ataxia.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: Skyclarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2024
Details:
Skyclarys (omaveloxolone) is an oral, once-daily medication indicated for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: Skyclarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2023
Details:
Skyclarys (omaveloxolone) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with Friedreich’s ataxia.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: Skyclarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2023
Details:
Through the acquisition, Biogen bolster its neuromuscular and rare disease portfolio by gaining FDA-approved Skyclarys (omaveloxolone), the first and only approved treatment for Friedreich’s ataxia (FA) in the United States.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: Skyclarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: $7,300.0 million Upfront Cash: $7,300.0 million
Deal Type: Acquisition September 26, 2023
Details:
Through the acquisition, Biogen bolster its neuromuscular and rare disease portfolio by gaining FDA-approved Skyclarys (omaveloxolone), the first and only approved treatment for Friedreich’s ataxia (FA) in the United States.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: Skyclarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: $7,300.0 million Upfront Cash: $7,300.0 million
Deal Type: Acquisition July 28, 2023
Details:
Skyclarys™ (omaveloxolone) have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathways and indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: Skyclarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2023
Details:
Skyclarys™ (omaveloxolone) have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathways and indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: Skyclarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2023
Details:
Skyclarys™ (omaveloxolone) have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: Skyclarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2023
Details:
Omaveloxolone is an investigational, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 October 13, 2022
Details:
RTA 408 (omaveloxolone) is investigational, oral, once-daily activator of Nrf2, transcription factor that induces molecular pathways that promote resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, inhibiting pro-inflammatory signaling.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 August 09, 2022
Details:
RTA 408 (Omaveloxolone) is investigational, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, inhibiting pro-inflammatory signaling.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 May 26, 2022
Details:
Omaveloxolone is an investigational, oral, once-daily, activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, & inhibiting pro-inflammatory signaling.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 01, 2022
Details:
Omaveloxolone is an investigational activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 November 18, 2021
Details:
Omaveloxolone is an oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 September 30, 2021
Details:
Omaveloxolone improved motor function as measured by the modified Friedreich’s Ataxia Rating Scale in both Part 2 of the MOXIe study and the Baseline-Controlled study.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 November 24, 2020
Details:
Patients treated with omaveloxolone experienced a statistically significant, placebo-corrected mean improvement in mFARS of 2.40 points after 48 weeks of treatment. Omaveloxolone was generally reported to be well tolerated in this study.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 October 26, 2020
Details:
Reata Pharmaceuticals announced the forthcoming presentation of efficacy and safety results from the pivotal MOXIe Part 2 study, a randomized, double-blind, placebo-controlled trial of omaveloxolone in Friedreich’s ataxia.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 September 03, 2020
Details:
FDA is not convinced that the Omaveloxolone study MOXIe Part 2 results will support a single study approval without additional evidence that lends persuasiveness to the results.
Lead Product(s): Omaveloxolone
Therapeutic Area: Genetic Disease Product Name: RTA 408
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 August 10, 2020
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