VRDN 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• In June 2026, the FDA approved veligrotug under Priority Review. Veligrotug provides a compelling new treatment option for TED in the U.S., in addition to the previously approved Tepezza® (teprotumumab), which is marketed in the United States by Amgen, Inc (“Amgen”).

• The FDA approval of veligrotug was supported by our pivotal phase 3 clinical trials THRIVE and THRIVE-2, which evaluated veligrotug in active and chronic TED, respectively. Both the THRIVE and THRIVE-2 clinical trials met their respective primary and all secondary endpoints, consistently demonstrati…

• We have established commercial infrastructure to support the U.S. launch of veligrotug, including sales and marketing, market access, patient services, medical affairs, distribution, supply chain and commercial operations capabilities. Our launch priorities include driving awareness of veligrotug wi…

• We are also developing elegrobart, our subcutaneous anti-IGF-1R product candidate currently in pivotal clinical studies in TED, and designed to be administered via a simple autoinjector that patients can self-administer at home. In its phase 1 clinical study in healthy volunteers, elegrobart was sho…

• In March 2026, we announced topline data from the REVEAL-1 study, which enrolled 132 patients, randomized 1:1:1 to elegrobart Q4W (n=44), elegrobart Q8W (n=44), and placebo (n=44). REVEAL-1 met its primary endpoint of Q4W proptosis responder rate (“PRR”) with a highly statistically significant treat…

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• We are developing two anti-IGF-1R product candidates, veligrotug for intravenous (“IV”) administration and elegrobart (formerly known as VRDN-003) for subcutaneous administration, to treat patients who suffer from TED. Our most advanced program, veligrotug, is a differentiated humanized monoclonal a…

• treatment of TED. In previously presented in vitro nonclinical data, we showed that veligrotug is a potentially differentiated full antagonist of IGF-1R, compared to teprotumumab’s incomplete antagonism of IGF-1R. Elegrobart has the same binding domain as veligrotug, and was engineered to have a lon…

• We conducted a global pivotal clinical program for veligrotug, evaluating its efficacy and safety in two global well-controlled phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 were each designed to compare a five-dose IV tr…

• To meet the 300 patient safety database requirement for the veligrotug BLA, we are conducting STRIVE, a global phase 3 clinical trial. STRIVE enrolled 231 TED patients, utilized broad inclusion criteria (e.g., any severity or duration of disease), and randomized patients 3:1 (10 mg/kg IV with an act…

• We are also developing elegrobart, our subcutaneous anti-IGF-1R product candidate currently in pivotal clinical studies in TED, and designed to be administered via a simple autoinjector that patients cab self-administer at home. In its phase 1 clinical study in healthy volunteers, elegrobart was sho…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• end of the quarter covered by this Quarterly Report. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at a reasonable level of assurance.

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• research and development of our current product candidates to determine the potential to advance these product candidates to regulatory approval.

• Our future revenue will depend upon market acceptance and our ability to commercialize veligrotug, obtaining regulatory approval to market our additional product candidates, the size of any markets in which our product candidates may receive approval, and our ability to establish and maintain a comm…

• Servicing our 1.75% convertible senior notes due 2032 (the “2032 Notes”) requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt.

• In May 2026, we issued $250.0 million aggregate principal amount of the 2032 Notes, pursuant to an indenture dated as of May 11, 2026, between us as issuer, and U.S. Bank Trust Company, National Association, as trustee. Our ability to make scheduled payments of the principal of, to pay interest on, …

• We may not have the ability to raise the funds necessary to repurchase the 2032 Notes as required upon a fundamental change or event of default, and our future debt may contain limitations on our ability to repurchase the 2032 Notes.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• If we obtain regulatory approval to market a product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval, and our ability to establish and maintain a commercial supply chain in each market, achieve sufficient market acceptance, …

• to expand our operations or otherwise capitalize on potential business opportunities, which could materially harm our business, financial condition, and results of operations.

• We expect that the THRIVE and THRIVE-2 phase 3 clinical trials, together with a safety database comprising at least 300 treated patients (safety database inclusive of THRIVE and THRIVE-2 patients), will support global health authority registration for veligrotug for marketing approval in both active…

• Even if we obtain regulatory approval for a product candidate, we will remain subject to ongoing regulatory requirements.

• If any of our product candidates are approved, we will be subject to ongoing regulatory requirements with respect to manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing clinical trials, and submission of safety, efficacy, and other…