Shares of Viridian Therapeutics, Inc. VRDN surged 32.1% on Sept. 10 after the company announced positive top-line data from the phase III THRIVE study, which evaluated its lead pipeline drug, veligrotug (formerly known as VRDN-001) for treating patients with active thyroid eye disease (TED).
The THRIVE study met all the primary and all secondary endpoints by demonstrating highly statistically significant improvements in all measured signs and symptoms of TED at week 15 of treatment with veligrotug, an anti-IGF-1R antibody.
Data from the study showed that five intravenous infusions with veligrotug led to substantial improvements in proptosis, clinical activity score and diplopia in patients with TED.
Shares of Viridian have lost 13.9% so far this year compared with the industry’s decline of 1.6%.
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Data From VRDN’s THRIVE Study
Data from the THRIVE study showed that patients who received veligrotug had a 70% proptosis responder rate (PRR) compared with 5% for patients receiving a placebo. PRR was the study’s primary endpoint. Also, the mean reduction in proptosis from baseline was 2.9 mm in the veligrotug arm versus 0.5 mm reduction in the placebo arm.
Patients receiving veligrotug had 54% complete resolution of diplopia compared with 12% of patients who received a placebo. Also, 63% of patients treated with veligrotug achieved a diplopia response versus 20% of patients receiving a placebo.
Meanwhile, 64% of patients who were treated with veligrotug achieved maximal or near-maximal therapeutic effect on clinical activity score (CAS) of 0 or 1 versus 18% of patients who received placebo.
67% of patients who received veligrotug achieved an overall response versus 5% of patients who were treated with a placebo. Treatment with veligrotug was generally safe and well tolerated.
VRDN’s Upcoming Plans for Veligrotug & Other Eye Candidate
Viridian is also evaluating veligrotug, an IV-administered antibody, in the phase III THRIVE-2 study for treating chronic TED. Top-line data from this study is expected by 2024-end.
The company plans to file a biologics license application (“BLA”) for veligrotug for the treatment of TED in the second half of 2025.
Apart from veligrotug, Viridian is developing another candidate, VRDN-003, a subcutaneously (SC)-administered antibody, in two late-stage studies for treating active and chronic TED.
Last month, the company initiated the phase III REVEAL-1 and REVEAL-2 studies evaluating VRDN-003 in active and chronic TED, respectively. Top-line data from the studies are expected in the first half of 2026.
The BLA for VRDN-003 for the treatment of TED is expected to be filed by the end of 2026.
Per management, both veligrotug and VRDN-003 inhibit IGF-1R, which has been proven effective in treating TED.
Competition in the TED Market
If successfully developed and approved, Viridian’s veligrotug and VRDN-003 are likely to face strong competition from Amgen’s AMGN Tepezza, which is the first and only approved drug for TED.
Please note that Tepezza is administered intravenously (IV). Compared to IV drugs, SC drugs can be administered more comfortably and take much less time to be administered.
Amgen is also evaluating an SC formulation of Tepezza in a late-stage study in the TED indication.
Tepezza is part of Amgen’s rare disease franchise, which was added to its portfolio following the acquisition of Horizon Therapeutics in October 2023.
Zacks Rank & Stocks to Consider
Viridian currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 49.2%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 24.9%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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