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Travere Therapeutics announced the completion of patient enrollment in the Phase 3 DUPLEX Study, which evaluates sparsentan for treating focal segmental glomerulosclerosis (FSGS). The study aims to address the urgent need for new treatments for this rare kidney condition. Interim data from the 36-week proteinuria endpoint are expected in Q1 2021, with the potential for FDA and European regulatory submissions following. Sparsentan combines two mechanisms of action and has shown promise in previous trials, offering hope for becoming the first approved therapy for FSGS.
Retrophin Inc. has officially changed its name to Travere Therapeutics, reflecting its commitment to patients with rare diseases. The new name and ticker symbol TVTX will take effect on November 19, 2020. CEO Eric Dube emphasizes a patient-inspired approach, focusing on developing life-changing therapies. The company's pipeline includes sparsentan, currently in Phase 3 trials for rare kidney diseases, and TVT-058, a therapy in Phase 1/2 development. Travere aims to enhance patient access and healthcare equity through strategic partnerships.
Retrophin Acquires Orphan Technologies - Retrophin, Inc. (NASDAQ: RTRX) announced the acquisition of Orphan Technologies Limited, focusing on developmental candidate OT-58 for treating classical homocystinuria (HCU). The deal involved an upfront payment of $90 million, with potential milestone payments up to $427 million. OT-58, a novel enzyme replacement therapy, aims to address the unmet needs of HCU patients.
Retrophin aspires to develop the first disease-modifying therapy for HCU, highlighting the company’s commitment to rare disease solutions.
Retrophin has announced its participation in two upcoming virtual investor conferences: the Jefferies 2020 Virtual London Healthcare Conference on November 18, 2020, at 6:45 p.m. GMT, and the 2020 Evercore ISI Virtual HealthCONx Conference on December 1, 2020, at 1:25 p.m. ET. Live webcasts and archived replays of these events will be available on the company's investor relations website for 30 days. Retrophin specializes in developing therapies for rare diseases, with a focus on conditions such as focal segmental glomerulosclerosis and IgA nephropathy.
Retrophin reported third-quarter 2020 net product sales of $51.1 million, a 15% increase from $44.4 million in Q3 2019. The DUPLEX Study for sparsentan in FSGS is nearing enrollment completion, with topline data expected in Q1 2021. The PROTECT Study for IgAN reached 280 patients enrolled, anticipating data in Q3 2021. Additionally, Retrophin announced plans to acquire OT-58 for classical homocystinuria, with an upfront payment of $90 million. The net loss narrowed to $22.5 million, or $0.44 per share, compared to $36.5 million, or $0.85 per share a year prior.
Retrophin has signed a definitive agreement to acquire Orphan Technologies for $90 million in cash, expanding its pipeline with OT-58, a novel enzyme replacement therapy for classical homocystinuria (HCU). OT-58 is currently in Phase 1/2 trials and shows promise in reducing homocysteine levels significantly. Additional payments of up to $427 million are contingent on developmental milestones. The acquisition aims to address the unmet medical needs of HCU patients and is expected to close in Q4 2020, subject to standard conditions.
Retrophin, Inc. (NASDAQ: RTRX) will report its third quarter 2020 financial results on November 5, 2020, after U.S. market close. A conference call is scheduled for 4:30 p.m. ET to discuss these results and provide a business update. Interested parties can join via a live webcast on Retrophin's website. A replay will be available from November 5 to November 12, 2020. Retrophin focuses on developing therapies for rare diseases, with key products and ongoing research initiatives in nephrology, supported by revenues from existing commercial products.
Retrophin announced on October 10, 2020, the granting of inducement equity grants totaling 58,750 shares to four new employees. This includes stock options for 37,500 shares and restricted stock units (RSUs) for 21,250 shares, granted outside of the 2018 Equity Incentive Plan. The stock options, priced at $20.68 per share, have a 10-year term and vest over four years, with 25% vesting after one year. The RSUs also vest over four years in a similar manner. This initiative is part of Retrophin's strategy to attract talent in the biopharmaceutical sector.
Retrophin (NASDAQ: RTRX) announced a presentation of new data from a post-hoc analysis related to focal segmental glomerulosclerosis (FSGS) at the ASN Kidney Week 2020. This includes findings from the Phase 2 DUET Study showing a significant reduction in proteinuria. The company will also showcase supporting preclinical data for its investigational treatment, sparsentan, which is under Phase 3 development. Sparsentan has received orphan drug designation for both FSGS and IgA nephropathy (IgAN), marking a potential breakthrough in treatment for rare kidney diseases.
Retrophin announced the enrollment of 280 patients in the pivotal Phase 3 PROTECT Study evaluating sparsentan for IgA nephropathy (IgAN). This study aims to assess the drug's safety and efficacy, with a critical proteinuria efficacy endpoint analysis expected in Q3 2021. The successful outcome could support accelerated approval in the U.S. and Europe. Sparsentan is an investigational product that combines endothelin receptor and angiotensin receptor blockade, representing a potential first treatment option for IgAN.
