Core Insights - Viridian Metals Inc. has reported final assay results from 17 drill holes completed during its 2025 drilling program at the Kraken Main Zone, confirming significant near-surface sulphide mineralization [1][6][10] Drilling Results - The final assays indicate consistent near-surface sulphide mineralization, extending confirmed mineralization north by 360 meters, with tens of meters of mineralization intersected above the primary target horizon [4][6] - Near-continuous sulphide mineralization has been defined over an area of approximately 600 meters by 200 meters, representing less than 10% of the interpreted 5 km Main Zone [6][11] - Drilling has consistently intersected sulphide mineralization within the lower Michikamau Intrusion and along its basal contact, suggesting a vertically extensive mineralized system [9][10] Future Plans - Planning for an expanded 2026 drilling program is underway, which will include step-outs along the 5-kilometer Main Zone Conductor and deeper holes beneath the strongest conductivity responses [12] Company Overview - Viridian Metals is focused on generative metal exploration with an emphasis on environmental responsibility and ethical practices, primarily targeting copper, nickel, and cobalt [25]

Live Chat on The Biotech Forum sees frequent discussion of specific covered call trades. To see what covered call trades I am currently executing along with a model portfolio of attractive biotech stocks, just initiate your free trial into The Biotech Forum by clicking HERE .Today, I am putting Viridian Therapeutics, Inc. ( VRDN ) in the spotlight for the first time since my article on this promising biopharma concern in early June of last year. The stock has experienced a nice rally since then. The lastBre ...

Core Insights - Viridian Therapeutics is focused on creating best-in-class medicines for serious and rare diseases, with key priorities set for 2026, including pivotal data delivery and potential product launches [2][5][8]. Group 1: Product Development and Pipeline - The FDA has accepted the Biologics License Application (BLA) for veligrotug under Priority Review, with a target action date of June 30, 2026, indicating a significant need for new treatment options in Thyroid Eye Disease (TED) [5][8]. - Veligrotug has shown positive results in two large Phase 3 trials (THRIVE and THRIVE-2), demonstrating rapid treatment effects and durable responses in patients with active and chronic TED [5][8]. - The company is on track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency in Q1 2026 [5]. - Topline data for elegrobart (VRDN-003) is expected in Q1 and Q2 2026 from ongoing Phase 3 trials (REVEAL-1 and REVEAL-2) [5][8]. - A new TSHR inhibitor program is being developed, with an Investigational New Drug (IND) application expected in Q4 2026 [5][9]. Group 2: Market Strategy and Commercialization - The U.S. TED market is valued at approximately $2 billion, with the company targeting around 2,000 core prescribers for its products [5][8]. - The commercial infrastructure for the veligrotug launch is anticipated to facilitate the launch of elegrobart, which is expected to be the only autoinjector for TED at the time of its launch [5][8][13]. - The company ended October 2025 with approximately $888 million in cash and investments, positioning it well to fund its business plans through profitability [12]. Group 3: Clinical Trials and Research - VRDN-006 has achieved proof-of-concept for IgG reduction in healthy volunteers, demonstrating its potential within the FcRn inhibitor class [5][9]. - VRDN-008's IND was submitted in December 2025, with Phase 1 healthy volunteer data expected in the second half of 2026 [12].

Pipeline and Milestones - Viridian aims to be a leading autoimmune company, starting with thyroid eye disease (TED)[6] - Viridian plans to submit a MAA for veligrotug in Q1 2026 and anticipates a PDUFA target date of June 30, 2026[19] - Topline data for REVEAL-1 (active TED) is expected in Q1 2026, and REVEAL-2 (chronic TED) in Q2 2026 for elegrobart[19] - An IND submission for an anti-TSHR subcutaneous product is anticipated in Q4 2026[10, 16, 19] - VRDN-008 healthy volunteer data is expected in 2H 2026[16, 19] Veligrotug (Anti-IGF-1R; Intravenous) - Veligrotug has a PDUFA target date of June 30, 2026, with Priority Review designation[10, 16, 18, 25] - In the THRIVE trial for active TED, veligrotug showed a 70% proptosis responder rate compared to 5% for placebo (p < 00001)[33, 95, 97] - In the THRIVE-2 trial for chronic TED, veligrotug showed a 56% proptosis responder rate compared to 8% for placebo (p < 00001)[35, 118] - 70% of proptosis responders in the THRIVE trial maintained their response at Week 52[33, 110, 111] Elegrobart (VRDN-003; Anti-IGF-1R; Subcutaneous) - Pivotal readouts for elegrobart in active TED REVEAL-1 study in Q1 2026 and chronic TED REVEAL-2 study in Q2 2026[10] - Phase 1 data showed an extended half-life of 40-50 days and approximately 4-fold increase in IGF-1 levels with subcutaneous elegrobart[134, 135] Financials - Viridian had $888 million in cash as of October 31, 2025, which, along with near-term DRI milestones and anticipated future revenues, is expected to fund current business plans through profitability[20] - The company secured access to up to approximately $900 million in capital in 2025[13] Market Opportunity - The annualized TED market is approximately $2 billion[10, 43] - The market sizes of MG and CIDP alone are projected to be over $112 billion by 2030[84, 85]

Summary of Viridian Therapeutics FY Conference Call Company Overview - **Company**: Viridian Therapeutics (NasdaqCM: VRDN) - **Focus**: Development of treatments for thyroid eye disease and other conditions Key Points Industry and Market Context - The company operates in a market valued at **$2 billion** in the U.S. for thyroid eye disease treatments [4] - The company is preparing for significant growth in **2026** with new product launches and regulatory filings [1] Product Development and Regulatory Progress - The company has submitted a **Breakthrough Therapy designation** for its treatment program, highlighting rapid treatment effects observed after just **three weeks** and one infusion [2] - The treatment regimen involves **five infusions** over three months, using **70% less drug** compared to currently approved products [2] - Upcoming **top-line data** for active and chronic populations using a subcutaneous program is expected in **Q1 and Q2** of the following year [3] Clinical Trials and Efficacy - The **REVEAL-1** study targets active patients, while **REVEAL-2** focuses on chronic patients, both designed similarly to previous successful trials [9] - The company aims for a **50%-70%** placebo-adjusted proptosis response, matching the efficacy levels of existing treatments like Tepezza [13] - The design of the studies aims to minimize placebo drift, with consistent operational teams across trials [15] Safety and Patient Impact - The safety profile of the treatment is well understood, with expectations of mild and transient side effects [21] - The urgency for treatment is emphasized, particularly for the predominantly female patient population in their **forties and fifties** suffering from debilitating symptoms [22] Commercial Strategy and Expansion - The company is looking to expand geographically, with plans to file for **Marketing Authorization Application (MAA)** in Europe in **Q1** of the coming year [4] - A partnership in Japan has been established, leveraging existing pricing strategies from approved products [5] Financial Position and Future Outlook - The company recently completed a **royalty deal** and an **equity raise**, positioning itself to reach profitability and break-even [26] - Current cash reserves are reported to be just shy of **$900 million**, providing a strong foundation for executing its portfolio [26] Conclusion - Viridian Therapeutics is poised for significant advancements in the treatment of thyroid eye disease, with a robust pipeline, strategic partnerships, and a solid financial position to support its growth initiatives [27]

Core Viewpoint - Viridian Metals Inc. has successfully closed the first tranche of its non-brokered private placement, raising a total of $591,543.68 through the issuance of flow-through shares and hard dollar units, driven by investor demand rather than capital need [1][2]. Group 1: Private Placement Details - The first tranche included the issuance of 955,671 common shares, with 296,672 designated as flow-through shares priced at $0.75 each, and 658,999 hard dollar units priced at $0.56 each [3][8]. - The company paid a finder's fee of $21,840.28, which is 7% of the proceeds raised from subscribers introduced by finders, and issued 32,667 finder warrants, each exercisable at $0.75 until December 2, 2027 [2][3]. Group 2: Use of Proceeds - Proceeds from the flow-through shares will be allocated to eligible Canadian exploration expenses related to the company's Labrador mining projects, specifically for surface geochemistry, geophysics, and drill targeting [4]. - Funds raised from the hard dollar units will be utilized for general working capital and corporate purposes [4]. Group 3: Amalgamation - The company has completed a vertical short-form amalgamation with its wholly-owned subsidiary, Viridian Metals Corp., effective December 1, 2025, to streamline financial and regulatory reporting and reduce administrative costs [6][7]. - No securities were issued in connection with the amalgamation, and the company's share capital remains unchanged, retaining the name "Viridian Metals Inc." [7][9]. Group 4: Finder Warrants Correction - The company corrected the issuance of finder warrants related to a previous private placement, increasing the total from 29,167 to 58,334 finder warrants, with an extended expiry date of June 4, 2028 [11][14]. Group 5: Company Overview - Viridian Metals is focused on generative metal exploration with an emphasis on environmental responsibility and ethical practices, primarily targeting critical metals such as copper, nickel, and cobalt [15].

Summary of Viridian Therapeutics Conference Call Company Overview - **Company**: Viridian Therapeutics (NasdaqCM: VRDN) - **Industry**: Biotechnology, specifically focusing on treatments for thyroid eye disease and FCRN-related conditions Key Points and Arguments Thyroid Eye Disease (TED) Portfolio - Viridian is targeting the thyroid eye disease market, which is currently valued at **$2 billion annually in the U.S.** with only one approved product available [6][14] - The company has two programs in this portfolio: an intravenous (IV) program (Veligrotug) and a subcutaneous (subQ) program [6][7] - Veligrotug has completed Phase III trials and received breakthrough therapy designation, with a **BLA submitted at the end of October 2025**, aiming for a potential commercial launch in **mid-2026** [7][20] - The subQ program is designed for self-administration via an autoinjector, which could significantly expand the market by allowing patients to manage their treatment at home [8][9] - The TED portfolio has shown robust clinical enrollment, with over **500 patients enrolled in trials this year**, indicating strong commercial demand [9][10] Market Dynamics - The TED market is characterized as a "new start market," meaning Viridian does not need to switch patients from existing therapies, allowing them to capture new patients [13] - There are approximately **20,000 new cases annually in the U.S.**, with a total of **500,000 individuals affected by thyroid eye disease**, of which **200,000 have moderate to severe cases** [14] - The current approved product has low penetration in the market, providing an opportunity for Viridian to capture market share [14][23] FCRN Portfolio - Viridian has two programs in the FCRN space: VRDN-006 (a fragment approach) and VRDN-008 (half-life extended) [10][32] - The company is optimistic about the efficacy and safety profile of VRDN-006, which is expected to show IgG suppression without adverse LDL spikes [11][32] - The FCRN portfolio is positioned to address multiple indications, including Myasthenia Gravis and CIDP, with potential for further expansion into additional indications [32][33] Regulatory and Launch Preparations - The FDA interactions have been positive, with consistent communication over the years, which bodes well for the BLA review process [18][20] - The company is preparing for a commercial launch, leveraging lessons learned from the successful launch of Tepezza, which had a strong market entry despite the pandemic [21][22] - Pricing and insurance coverage have improved, with **85% of commercial plans in the U.S. now covering the current approved product**, which will benefit Viridian as they enter the market [23] Upcoming Milestones - Key upcoming milestones include: - Priority review status for the BLA expected by the end of 2025 - Top-line readouts for the subQ program in **Q1 and Q2 of 2026** - Continued development and data generation for the FCRN programs [35] Additional Important Information - The company is well-capitalized, having completed a royalty deal and equity raise in October, positioning them for profitability [12] - The autoinjector for the subQ program is commercially validated, and a bridging study is underway to support its approval [31][32] This summary encapsulates the critical insights from the conference call, highlighting Viridian Therapeutics' strategic positioning, market opportunities, and upcoming developments in their product pipeline.

Core Insights - Viridian Therapeutics, Inc. (NASDAQ:VRDN) is recognized as a promising small-cap biotech stock with significant upside potential according to analysts [1] Financial Performance - RBC Capital raised its price target for Viridian Therapeutics from $41 to $45 while maintaining an "Outperform" rating, driven by a strong cash position of $888 million resulting from various financing deals [2] - The company reported a cash balance of $490.9 million at the end of Q3 2025, with an increase in R&D expenses from $69.2 million in the same quarter last year to $86.3 million [4] Clinical Developments - Viridian has completed key patient enrollments in late-stage clinical studies, with readouts for active and chronic Thyroid Eye Disease (TED) expected in Q1 and Q2 2026, respectively [3]

Core Viewpoint - Small-cap biotech stocks are experiencing a resurgence, driven by market rotation and improving technical indicators, with healthcare emerging as a constructive sector [2][4] Industry Overview - The Health Care Select Sector SPDR Fund (XLV) has increased by 11.09% in 2025, while the iShares Biotechnology ETF has gained approximately 25% year-to-date [2][3] - Analysts suggest that capital is flowing out of high-flying AI stocks into more attractive healthcare and biotech opportunities [3][4] M&A Activity - Increased mergers and acquisitions (M&A) activity in the biotech sector has been noted, with significant deals including Pfizer's $10 billion acquisition of Metsera and Roche's $3.5 billion acquisition of 89bio [4][5] - This M&A activity is expected to bolster potential upside for both large-cap and small-to-mid-cap biotech companies [4] Methodology for Stock Selection - The list of the best small-cap biotech stocks was curated based on companies with market capitalizations between $300 million and $2 billion, focusing on those with the highest upside potential as of November 10, 2025 [8] Company Highlights - **Viridian Therapeutics, Inc. (NASDAQ:VRDN)**: - Upside potential of 36.71% with a cash position of $888 million and key patient enrollments in late-stage clinical studies [10][11][12] - **UroGen Pharma Ltd. (NASDAQ:URGN)**: - Upside potential of 49.17%, reporting a significant increase in demand revenue and a cash position of $127.4 million [14][15][16] - **Liquidia Corporation (NASDAQ:LQDA)**: - Upside potential of 55.49%, with YUTREPIA achieving profitability earlier than expected and a cash position of $157.5 million [19][20][22]

Summary of Viridian Therapeutics Conference Call Company Overview - **Company**: Viridian Therapeutics - **Industry**: Biopharmaceuticals focusing on autoimmune diseases - **Key Participants**: Steve Mahoney (CEO), Tony Castianos (Chief Commercial Officer), Shan Wu (Chief Business Officer) [1][2] Core Points and Arguments Autoimmune Portfolio - Viridian is advancing an autoimmune portfolio with a focus on thyroid eye disease (TED), a market valued at approximately $2 billion in the U.S. [2] - The company has submitted a Biologics License Application (BLA) for its lead product, which has received breakthrough therapy designation from the FDA [4][2]. Market Dynamics - There is currently one competitor in the TED market, Tepezza, marketed by Amgen, which has shown a return to growth with sales of $560 million in the last quarter [10][11]. - The TED market consists of about 500,000 patients in the U.S., with 200,000 having moderate to severe forms of the disease [10][7]. Product Differentiation - Viridian's product, veligrotug, is expected to have a more favorable dosing regimen compared to Tepezza, requiring five infusions over three months versus eight infusions over five months for Tepezza [15][14]. - The onset of action for veligrotug is anticipated to be quicker, with significant proptosis response observed after just one infusion [15][16]. Clinical Data and Expectations - Phase three data from the THRIVE program indicates strong efficacy, with a proptosis response rate expected to meet or exceed the efficacy bar set by Tepezza [30][29]. - The company plans to launch with both active and chronic data in its label, which is a strategic advantage over Tepezza [17][16]. FCRN Portfolio - Viridian is also developing programs in the FCRN space, with two lead programs (006 and 008) targeting large markets projected to exceed $10 billion by 2030 [31][32]. - The company is focused on low-cost optionality in its FCRN portfolio, with ongoing studies to validate the efficacy and safety of its candidates [33][35]. Financial Position - Viridian recently announced a royalty deal with DRI, which is seen as a validation of its business model and does not encumber its lead products [37][38]. - The company expects to reach break-even and profitability, regardless of the FDA's review outcome [38][39]. Additional Insights - The TED market is characterized as a new start market, allowing for rapid adoption of new therapies without the need to switch patients from existing treatments [11][12]. - The concentration of prescribers in the TED market (approximately 2,000 core prescribers) allows for targeted commercial strategies [12][10]. - The company has engaged with over 500 key opinion leaders (KOLs) in October alone, indicating proactive market preparation [20][19]. This summary encapsulates the key points discussed during the conference call, highlighting the strategic positioning of Viridian Therapeutics within the biopharmaceutical industry, particularly in the treatment of autoimmune diseases.