Viridian Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of proprietary RNA-targeted therapeutics. Its product candidates include Cobomarsen, which treats patients with certain cancers, including cutaneous T-cell lymphoma and adult T-cell leukemia/lymphoma, and Remlarsen and MRG-229, which are made for the treatment of patients with pathological fibrosis. The company was founded by William S. Marshall and Bruce L. Booth in February 2006 and is headquartered in Waltham, MA.
相关临床试验
0
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
暂无试验阶段数据
暂无试验数据
暂无试验数据
暂无批准数据
- Sling Therapeutics raised a $123 million Series C led by Forbion to fund a late-stage trial of its oral thyroid eye disease drug linsitinib. - The global Phase 3 'Orbit' study will enroll about 130 adults with moderate-to-severe active TED, dosed at 150 mg or placebo twice daily for 24 weeks. - An earlier late-stage trial showed a statistically significant 52% response rate at 24 weeks with no drug-related hearing loss or tinnitus reported. - If approved, linsitinib would be the first oral therapy for TED, offering an alternative to injected IGF-1R antibodies Tepezza and Lumvoa.
- Sling Therapeutics has dosed the first patients in the global Phase III ORBIT trial of oral linsitinib in moderate to severe active thyroid eye disease. - ORBIT will randomize approximately 130 adults 1:1 to linsitinib 150 mg or placebo twice daily for 24 weeks, with proptosis response at week 24 as the primary endpoint. - The Phase IIb/III LIDS trial reported positive topline results in January 2025, meeting its primary endpoint with a 52% proptosis responder rate at week 24 (p = 0.01). - Linsitinib is the only oral IGF-1R inhibitor in Phase III TED development, positioned on oral administration and a differentiated safety profile versus infused biologics.
- Eli Lilly agreed to acquire privately held Merida Biosciences for up to $2.88 billion in cash, with the transaction expected to close in the fourth quarter. - The deal centers on lead candidate MER511, designed to block autoantibody binding to thyroid-stimulating hormone receptors for Graves' disease and thyroid eye disease. - Preliminary phase 1 data showed MER511 substantially lowered thyroid-stimulating antibodies linked to the diseases while demonstrating a favorable initial safety profile. - The acquisition marks Lilly's ninth since the start of the year, bringing its 2026 M&A spending to nearly $29 billion as it expands beyond obesity and diabetes.
- A large retrospective analysis of 34,590 thyroid eye disease patients found that 30% experienced disease progression during follow-up, challenging the traditional self-limited disease model. - The cumulative incidence of TED progression reached 31% at 5 years and 39% at 8 years, with notable variability in progression timing across patients. - The findings suggest TED has a more chronic, heterogeneous course than previously understood, highlighting the need for ongoing monitoring beyond the acute phase. - This real-world evidence reinforces the importance of early detection and appropriate thyroid function testing in clinical practice.
- Immunovant's FcRn blocker batoclimab failed to meet primary efficacy endpoints in two Phase 3 trials (GO-1 and GO-2) for thyroid eye disease, despite showing some improvement in eye bulging symptoms. - The drug demonstrated efficacy during the initial 12-week high-dose stage but missed targets in the subsequent 12-week low-dose phase, supporting the need for deeper IgG suppression according to the company. - Immunovant shares declined approximately 6% following the announcement, though the modest impact reflects the company's shifted focus toward its next-generation FcRn blocker IMVT-1402. - The company will review future plans for batoclimab with development partner HanAll Biopharma, while prioritizing IMVT-1402 which offers similar IgG reduction without affecting albumin and LDL cholesterol levels.
- The FDA has accepted Viridian Therapeutics' Biologics License Application for veligrotug in thyroid eye disease under Priority Review designation. - Analysts from Goldman Sachs and Needham have reiterated positive views on the company following the BLA submission for its lead thyroid eye disease therapy. - Viridian's strategy focuses on converting existing Tepezza prescribers and potentially broadening veligrotug's label with Phase 3 data. - The company's stock has shown strong momentum with a 90-day return of 44.50% and one-year total shareholder return of 58.38%.
- 4D Molecular Therapeutics has appointed Kristian Humer as Chief Financial Officer to lead financial strategy as the company advances multiple Phase III programs and prepares for commercial readiness. - Humer brings over two decades of experience in corporate finance and healthcare investment banking, having previously served as Managing Director at Citi's Healthcare Investment Banking Group and CFO at publicly traded companies Foghorn Therapeutics and Viridian Therapeutics. - The appointment comes as 4DMT's lead product candidate 4D-150 progresses through Phase III development for wet age-related macular degeneration, with a second indication in diabetic macular edema. - 4D-150 is designed as a backbone therapy providing multi-year sustained delivery of anti-VEGF agents with a single intravitreal injection, potentially reducing treatment burden for blinding retinal vascular diseases.
- Viridian Therapeutics secured up to $300 million in royalty financing from DRI Healthcare, including $55 million upfront and potential near-term milestones up to $115 million based on positive clinical trial results and regulatory approvals. - The company accelerated its regulatory timeline, expecting to submit a Biologics License Application for veligrotug imminently and anticipating VRDN-003 phase 3 trial data readouts in Q1 2026 for REVEAL-1 and Q2 2026 for REVEAL-2. - The financing, combined with existing cash, is expected to fully fund commercial launches of both veligrotug and VRDN-003 for thyroid eye disease treatment. - Viridian also amended its credit facility with Hercules Capital, providing additional access to up to $300 million in milestone-based capital.
- Viridian Therapeutics has entered into an exclusive licensing agreement with Kissei Pharmaceutical for veligrotug and VRDN-003 in Japan, receiving $70 million upfront with potential milestone payments up to $315 million. - Both drug candidates are anti-IGF-1R antibodies targeting thyroid eye disease, with veligrotug having demonstrated positive results in phase 3 THRIVE trials and VRDN-003 being a subcutaneous, half-life extended formulation. - The collaboration leverages Kissei's expertise in rare disease development and commercialization in Japan to address significant unmet medical needs for TED patients. - Viridian will also receive tiered royalties ranging from the 20s to mid-30s percent on net sales in Japan, while Kissei assumes all development and commercialization responsibilities.
- DelveInsight's 2025 pipeline analysis reveals 8+ key companies are developing 10+ novel Graves Disease treatment therapies across various clinical development phases. - Recent regulatory milestones include Amgen's TEPEZZA approval by UK MHRA for thyroid eye disease and FDA's breakthrough therapy designation for Viridian's veligrotug. - Emerging therapies targeting IGF-1R pathway show clinical promise, with Sling Therapeutics' linsitinib demonstrating favorable safety profile in over 900 patients across 15 trials. - Pipeline includes diverse therapeutic approaches spanning monoclonal antibodies, small molecules, and gene therapy with multiple routes of administration under investigation.
