Viridian Therapeutics (VRDN) has captured investors’ attention with recent breakthroughs in developing effective treatments for severe and rare diseases. Specifically, Viridian has forged progress with its lead asset, Veligrotug (VRDN-001). Together with a subcutaneous variant, VRDN-003, it is showing promise in global phase 3 clinical trials, promising a safer and more affordable alternative to Amgen’s (AMGN) blockbuster treatment, Tepezza. The recent topline results indicate high efficacy and safety with potential marketing authorization in Europe by 2025.
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Viridian’s pipeline also includes novel therapies that offer potential breakthroughs in treating multiple autoimmune diseases. The stock presents a high-risk, high-reward opportunity for biotech investors.
Viridian’s Promising Pipeline
Viridian is a biopharmaceutical company using antibody discovery and protein engineering to develop therapeutic candidates for validated drug targets within established disease areas. It is advancing several candidates in clinical trials for treating thyroid eye disease (TED), namely Veligrotrug (VRDN-001) and VRDN-003. Both are undergoing global phase 3 clinical trials – THRIVE, THRIVE-2, REVEAL-1, and REVEAL-2 – to evaluate their efficacy and safety. Additionally, Viridian is working on a new portfolio of neonatal Fc receptor (FcRn) inhibitors, such as VRDN-006 and VRDN-008, that show potential for development in multiple autoimmune diseases.
Viridian’s Veligrotug is progressing well in its phase 3 development for thyroid eye disease. Positive topline results in September confirmed that Veligrotug met both primary and secondary endpoints with high statistical significance. Projections for THRIVE-2 are optimistic as well, with a topline data readout scheduled for December 2024 after surpassing the enrollment target due to patient demand. A Biologics License Application (BLA) for Veligrotug is expected in the second half of 2025.
Other Potential Candidates
Another treatment under development, VRDN-003, is a subcutaneous, half-life extended anti-IGF-1R antibody. Viridian initiated REVEAL-1 and REVEAL-2 in August 2024 to evaluate VRDN-003. The company expects topline data from both trials by the first half of 2026, with a BLA submission expected by year-end 2026.
Newly developed VRDN-006 and VRDN-008 are FcRn inhibitors designed to be subcutaneous and self-administered by patients. VRDN-006 is set for an Investigational New Drug (IND) application by year-end 2024, with a phase 1 clinical trial expected early in 2025. VRDN-008 has shown promising results, with three times the half-life of its comparator, and an IND submission is expected by year-end 2025.
Analysis of Viridian’s Recent Financial Results
The company recently reported results for Q3 2024. Revenue hit $0.09 million, exceeding expectations by $0.04 million. R&D expenses rose year-over-year from $30.4 million to $69.2 million due to increased clinical trial costs and higher personnel costs to support its pipeline development. The company’s net loss was $76.7 million, compared to $47.7 million for the same period in 2023. The GAAP EPS of -$1.15 missed consensus estimates by $0.09.
As of the quarter’s end, the company reported a cash position of $753.2 million, a sharp increase from $571.4 million as of June 30, 2024. This was mainly due to a successful public offering in September 2024, which netted $243.2 million. Viridian believes it has sufficient funds to cover operations until the latter half of 2027.
Is VRDN a BUY?
The stock has been trending up recently, climbing 27% in the past three months. It trades near the middle of its 52-week price range of $11.40 – $27.20, though it shows negative price momentum as it trades below the 20-day (22.94) and 50-day (21.86) moving averages.
Analysts following the company have been constructive on VRDN stock. For example, H.C. Wainwright analyst Douglas Tsao, a five-star analyst according to Tipranks’ ratings, recently reiterated a Buy rating while raising the price target on the shares from $27 to $34, noting he expects Veligrotug to meet the endpoints in chronic thyroid eye trials and show efficacy at least comparable to Tepezza.
Viridian Therapeutics is rated a Strong Buy overall, based on the recommendations of 15 analysts. The average price target for VRDN stock is $40.67, representing a potential upside of 101.94% from current levels.
Viridian in Review
Viridian Therapeutics continues to pave the way in developing novel treatments for severe and rare diseases, with Veligrotug (VRDN-001) and VRDN-003 progressing successfully in global phase 3 clinical trials for thyroid eye diseases (TED). These treatments could offer a safer and more economical alternative to existing treatments, with promising indications for marketing approval in Europe by 2025. Viridian has secured a solid financial position through a successful public offering, securing enough funds for operations until the latter half of 2027. VRDN remains an attractive, high-risk, high-reward opportunity for biotech investors.
