Vanda Announces Completion of Transfer of FDA Marketing Authorization for PONVORY®
Details : Ponvory(ponesimod), an oral S1P1R modulator, whch has been approved for active forms of relapsing multiple sclerosis in adults.
Brand Name : Ponvory
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 30, 2024
Lead Product(s) : Ponesimod
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Juvise Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Juvisé Pharmaceuticals Acquires Ponvory® Ex-US/Canada and Opens Capital To Bpifrance
Details : Juvise Pharmaceuticals will leverage its expertise to commercialize Ponvory (ponesimod), a first-line treatment option for active forms of relapsing multiple sclerosis outside of North America.
Brand Name : Ponvory
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 26, 2024
Lead Product(s) : Ponesimod
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Juvise Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Ponesimod
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Vanda Pharmaceuticals
Deal Size : $100.0 million
Deal Type : Acquisition
Details : Through the acquisition, Vanda expands its commercial portfolio by including Ponvory (ponesimod), a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator, indicated to treat adults with relapsing forms of multiple sclerosis.
Brand Name : Ponvory
Molecule Type : Small molecule
Upfront Cash : Undisclosed
December 07, 2023
Lead Product(s) : Ponesimod
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Vanda Pharmaceuticals
Deal Size : $100.0 million
Deal Type : Acquisition
Lead Product(s) : Ponesimod
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod 20mg vs. once per day teriflunomide 14mg, an approved first-line oral treatment, in adult patients with RMS. In total, 1,133 adult patients were randomised at 162 sit...
Brand Name : Ponvory
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 13, 2021
Lead Product(s) : Ponesimod
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ponesimod
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : PONVORY™, a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, approved to treat adults with relapsing forms of MS in both the United States and European Union earlier this year.
Brand Name : Ponvory
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 29, 2021
Lead Product(s) : Ponesimod
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ponesimod
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
EC Approves PONVORYTM for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis
Details : Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation.
Brand Name : Ponvory
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 24, 2021
Lead Product(s) : Ponesimod
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Positive opinion is based on the pivotal Phase 3 OPTIMUM study evaluating the efficacy and safety of ponesimod vs. teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing multiple sclerosis.
Brand Name : Ponvory
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 26, 2021
Details : Head-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide. PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral compa...
Brand Name : Ponvory
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 19, 2021
Details : Head-to-head OPTIMUM Phase 3 study showed superior efficacy of ponesimod 20 mg on the primary endpoint as well as most secondary endpoints, compared to Aubagio® (teriflunomide).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 18, 2020
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