US Market News
7時間前
Viridian Therapeutics Announces U.S. FDA Approval and Launch of Lumvoa™ (veligrotug-vvze) for the Treatment of Thyroid Eye DiseaseJune 26, 2026 6:00 PM
Business Wire - First approved treatment for thyroid eye disease (TED) with labeling that includes data for both active and chronic TED - - In two pivotal phase 3 clinical trials, Lumvoa treatment showed rapid, consistent, and durable reductions of the key signs and symptoms of both active and chronic TED - - Lumvoa is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution of diplopia in active and chronic disease - - Viridian plans to launch Lumvoa immediately, a pivotal milestone as the company’s first commercial product in TED with subcutaneous elegrobart on track for a biologics license application (BLA) submission in Q1 2027 - - Viridian will host a conference call and webcast Monday, June 29 at 8:00 a.m. ET - Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED). TED is a rare, debilitating autoimmune disease characterized by inflammation and tissue remodeling around and behind the eyes that can lead to proptosis, diplopia, pain, and vision impairment. “With the approval of Lumvoa, we take a significant step forward in providing a meaningful treatment option for people living with thyroid eye disease,” said Steve Mahoney, President and Chief Executive Officer of Viridian. “Lumvoa was designed with patient needs at the forefront and is Viridian’s first FDA-approved medicine and our first commercial product. This marks an important milestone for us and reflects years of focused execution by the Viridian cross-functional teams. Our commercial and medical affairs teams have been preparing for this moment for a long time, and in particular since receiving Breakthrough Therapy Designation last year. We are ready to support patients and physicians from day one.” “The Lumvoa development program was a robust evaluation of the drug across the full spectrum of TED, including both active and chronic disease, showing significant improvements in outcomes that matter to patients and clinicians,” said Michael Yen, M.D., Professor of Oculoplastic Surgery and Ophthalmology at Baylor College of Medicine and an investigator in the THRIVE program. “It’s encouraging to see a new treatment for the full spectrum of the disease with data showing rapid onset of proptosis reduction as well as improvements in diplopia. This is an exciting new option for physicians to offer their TED patients.” “The TED community is pleased to see this important advancement in the treatment of TED. TED can be physically painful and emotionally exhausting, and patients experience the disease as highly disruptive to their daily lives,” said Christine Gustafson, Founder, Chief Executive Officer, and Executive Director, TED Community Organization. “Having a new treatment available could be very important for the many patients who are seeking help for thyroid eye disease.” Immediate Launch of Lumvoa Supported by Comprehensive Patient Support Program
Viridian plans to launch Lumvoa immediately, and physicians can prescribe Lumvoa tomorrow. Viridian has worked closely with payers, healthcare providers, and patient advocates to support broad access to Lumvoa. As part of this commitment, Viridian has created ViridianCares™, a comprehensive patient support program that provides dedicated patient access liaisons, insurance coverage support and benefit verification, and financial assistance programs for eligible patients, to help patients and caregivers navigate the treatment journey and receive therapy as prescribed. For more information on ViridianCares, call 866-VCARES1 (866-822-7371). Approval Supported by Pivotal THRIVE and THRIVE-2 Clinical Trials
Lumvoa was approved by the FDA under Priority Review and supported by the THRIVE (active TED) and THRIVE-2 (chronic TED) pivotal phase 3 clinical trials. Lumvoa is a full antagonist of IGF-1R and the first approved treatment for TED with labeling that includes data for both active and chronic TED. Both the THRIVE and THRIVE-2 clinical trials met their respective primary and all secondary endpoints, consistently demonstrating statistically significant and clinically meaningful improvements at week 15 across all of the key signs and symptoms of TED. Across both clinical trials, patients received a 12-week course of Lumvoa designed to reduce the burden of treatment. Lumvoa demonstrated a rapid onset of clinical benefit, with reductions in proptosis observed as early as three weeks. Lumvoa is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution in active and chronic TED. Lumvoa was granted Breakthrough Therapy Designation and Priority Review by the FDA. Conference Call and Webcast Information
Viridian will host a conference call and webcast Monday, June 29 at 8:00 a.m. ET to discuss the FDA approval of Lumvoa. The dial-in number for the conference call is (800) 715-9871 for domestic participants and +1 (646) 307-1963 for international participants. The conference ID is 2419136. A live webcast of the conference call can be accessed through the “Events” page in the Investors section of the Viridian Therapeutics website. Following the live webcast, an archived version of the call will also be available on the website. Lumvoa U.S. Indication
Lumvoa is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. Important Safety Information Infusion Reactions
Lumvoa may cause infusion reactions. Infusion reactions have been reported in approximately 9% of patients treated with Lumvoa. Signs and symptoms of infusion-related reactions include transient increases in blood pressure, fever, chills, headache, and fatigue. Infusion reactions may occur during or soon after an infusion. Reported infusion reactions are usually mild or moderate in severity and can usually be successfully managed with corticosteroids, antihistamines, and antipyretics. In patients who experience an infusion reaction, consideration should be given to standard premedication and/or administering infusions at a slower infusion rate. Inflammatory Bowel Disease
Lumvoa may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients receiving insulin-like growth factor-1 receptor inhibitors without a prior diagnosis of IBD. Monitor patients for signs and symptoms of IBD, including patients without a history of IBD. If IBD is suspected, discontinue use of Lumvoa. Hyperglycemia
Hyperglycemia or increased blood glucose may occur in patients treated with Lumvoa. In clinical trials, 12% of patients, of whom one-half had preexisting diabetes or impaired glucose tolerance, experienced hyperglycemia. Hyperglycemic events should be controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with Lumvoa. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving Lumvoa. Continue monitoring after treatment for patients who experience hyperglycemia while on Lumvoa. Hearing Impairment Including Hearing Loss
Lumvoa may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with Lumvoa and consider the benefit-risk of treatment with patients. Most Common Adverse Events
Most common adverse reactions (incidence of 5% or more) are muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, blood creatine phosphokinase increased, dry skin, and hypertension. Females of Reproductive Potential
Appropriate forms of contraception should be implemented prior to initiation, during treatment, and for 6 months following the last dose of Lumvoa. Lumvoa (500 mg) is an injection for infusion. Please see the full Prescribing Information for Lumvoa at: https://www.viridiantherapeutics.com/lumvoa-prescribing-information/ About Lumvoa™ (veligrotug-vvze)
Lumvoa™ (veligrotug-vvze) is approved by the U.S. Food and Drug Administration for the treatment of thyroid eye disease (TED). Lumvoa is a full antagonist of IGF-1R and the first approved treatment for TED with labeling that includes data for both active and chronic TED data based on positive data from the two largest pivotal phase 3 clinical trials completed in TED to date. Lumvoa is administered over 12 weeks as five intravenous infusions, each given every three weeks. About Viridian Therapeutics
Viridian Therapeutics is a biotechnology company dedicated to developing better medicines for patients with autoimmune and rare diseases. Utilizing our expertise in antibody discovery and protein engineering, we aim to build on proven science to develop innovative medicines that address unmet needs and improve patient outcomes. With an immediate focus in thyroid eye disease (TED), we developed Lumvoa, a full IGF-1R antagonist approved by the U.S. FDA for the treatment of thyroid eye disease. We are also advancing elegrobart, a late-stage investigational subcutaneous therapy designed to further address unmet needs in TED and improve patient convenience. Beyond TED, we are advancing a pipeline of potential best-in-class medicines to address multiple serious autoimmune diseases. Viridian is headquartered in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X. Forward Looking Statements
This press release contains forward-looking statements. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “become,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation: that the Company intends to launch Lumvoa immediately and that physicians may prescribe Lumvoa tomorrow; that the Company’s commercial and medical affairs teams are ready to support patients and physicians; that Lumvoa will be a meaningful treatment option for people living with thyroid eye disease; Viridian’s product candidates potentially being best-in-class; whether elegrobart will serve an unmet need; elegrobart’s potential to improve patient convenience. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product and product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; expectations and changes regarding the timing for regulatory filings; regulatory interactions; uncertainty and potential delays related to clinical drug development; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; competition from other therapies or products; estimates of market size; our future operating results and financial performance; Viridian’s intellectual property position; that our product and product candidates may not be commercially successful, if approved; and other risks described from time to time in the “Risk Factors” section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260625016249/en/ Investors
Greg Rossino
grossino@viridiantherapeutics.com Media
Lisa Lopez
llopez@viridiantherapeutics.com Original: Viridian Therapeutics Announces U.S. FDA Approval and Launch of Lumvoa™ (veligrotug-vvze) for the Treatment of Thyroid Eye Disease
US Market News
2月前
Viridian Therapeutics Announces Pricing of Upsized Concurrent Public Offerings of 1.75% Convertible Senior Notes Due 2032 and Common Stock with Aggregate Gross Proceeds of $350.0 MillionMay 6, 2026 11:13 PM
Business Wire Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for autoimmune and rare diseases, today announced the pricing of its upsized underwritten public offering of $225.0 million aggregate principal amount of its 1.75% convertible senior notes due 2032 (the “Convertible Notes” and such offering, the “Convertible Notes Offering”) and its upsized underwritten public offering of 7,352,942 shares of its common stock at a public offering price of $17.00 per share (such offering, the “Equity Offering”). Viridian estimates that the aggregate net proceeds from the Convertible Notes Offering and the Equity Offering will be approximately $334.7 million, after deducting underwriting discounts and commissions and Viridian’s estimated offering expenses. In addition, Viridian has granted the underwriters of the Convertible Notes Offering a 30-day option to purchase up to an additional $25.0 million aggregate principal amount of Convertible Notes offered in the Convertible Notes Offering, solely to cover over-allotments and on the same terms and conditions. Viridian also granted the underwriters of the Equity Offering a 30-day option to purchase up to an additional 1,102,941 shares of its common stock, on the same terms and conditions. The Convertible Notes Offering and the Equity Offering are expected to close on May 11, 2026, subject in each case to the satisfaction of customary closing conditions. Neither the closing of the Convertible Notes Offering nor the closing of the Equity Offering is contingent upon the closing of the other offering. The Convertible Notes will be general, unsecured, senior obligations of Viridian and interest will be payable semi-annually in arrears on May 15 and November 15 of each year, beginning on November 15, 2026, at a rate equal to 1.75% per year. The Convertible Notes will mature on May 15, 2032, unless earlier converted, redeemed or repurchased by Viridian. Before February 15, 2032, noteholders may convert their Convertible Notes at their option only in certain circumstances. From, and including, February 15, 2032 until the close of business on the scheduled trading day immediately before the maturity date, noteholders may convert their Convertible Notes at any time at their option. Viridian will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Viridian’s election. The initial conversion rate is 40.5680 shares of Viridian’s common stock per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $24.65 per share of its common stock and represents a conversion premium of approximately 45.0% above the public offering price per share of its common stock in the Equity Offering. If a “make-whole fundamental change” (as defined in the indenture that will govern the Convertible Notes) occurs, then Viridian will in certain circumstances increase the conversion rate for a specified period of time. The Convertible Notes will be redeemable, in whole or in part (subject to certain limitations), at Viridian’s option at any time, and from time to time, on a redemption date on or after May 20, 2030 and on or before the 26th scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of its common stock exceeds 130% of the conversion price for the Convertible Notes on (1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date Viridian sends the related redemption notice; and (2) the trading day immediately before the date Viridian sends such notice. If a “fundamental change” (as defined in the indenture that will govern the Convertible Notes) occurs, then, subject to a limited exception, noteholders may require Viridian to repurchase their Convertible Notes at a cash repurchase price equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. Viridian intends to use the net proceeds from the Convertible Notes Offering and the Equity Offering to repay all outstanding indebtedness under the Loan and Security Agreement with Hercules Capital, Inc., to fund market expansion studies for its thyroid eye disease (“TED”) franchise, and to advance the research and development of its earlier pipeline, as well as for working capital and other general corporate purposes. Jefferies, Leerink Partners, and Goldman Sachs & Co. LLC are acting as joint book-running managers and LifeSci Capital is acting as lead manager for the Convertible Notes Offering. Jefferies, Leerink Partners, and Goldman Sachs & Co. LLC are acting as joint book-running managers and LifeSci Capital and Wedbush PacGrow are acting as lead managers for the Equity Offering. A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on September 5, 2025. A final prospectus supplement and accompanying base prospectus relating to and describing the terms of each of the Convertible Notes Offering and Equity Offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering will only be made by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022; telephone: 877-821-7388; email: Prospectus_Department@Jefferies.com); Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com; or Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282 (Tel: 866-471-2526) or by e-mail at prospectus-ny@ny.email.gs.com. About Viridian Therapeutics, Inc. Viridian is a biotechnology company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with autoimmune and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for validated drug targets and disease-driving mechanisms in autoimmune and rare diseases. Viridian is advancing multiple late-stage, anti-insulin-like growth factor-1 receptor (“IGF-1R”) candidates in the clinic for the treatment of patients with TED. The company conducted a pivotal program for veligrotug, including two global phase 3 clinical trials, THRIVE and THRIVE-2, to evaluate its efficacy and safety in patients with active and chronic TED. THRIVE and THRIVE-2 reported positive topline data, meeting their primary endpoints and all secondary endpoints. Viridian is also advancing elegrobart as the potential first subcutaneous autoinjector for the treatment of TED. Viridian is conducting an ongoing pivotal program for elegrobart, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of elegrobart in patients with active and chronic TED. REVEAL-1 and REVEAL-2 reported positive topline data, meeting their primary endpoints and multiple secondary endpoints. In addition to its IGF-1R inhibitor portfolio, Viridian is developing an anti–thyroid-stimulating hormone receptor (“TSHR”) program designed as a potential therapy for TED and Graves’ disease. Viridian is also advancing a novel portfolio of neonatal Fc receptor (“FcRn”) inhibitors, including VRDN-006 and VRDN-008, which have the potential to be developed in multiple autoimmune diseases. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern the company’s expectations, plans and intentions. Forward-looking statements include, without limitation, statements regarding the timing and completion of the offerings on the anticipated terms, or at all; statements regarding the expected net proceeds of the offerings and the anticipated use of proceeds from the offerings; the company’s plans regarding commercial launch activities related to veligrotug and elegrobart and research and development activities; the company’s belief that its product candidates may be best-in-class; and the potential for the company’s novel portfolio of FcRn inhibitors to be developed in multiple autoimmune diseases. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the company’s current beliefs, expectations and assumptions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: market conditions that may affect the timing, terms or conditions of the underwritten public offerings; the company’s successful completion of the underwritten public offerings; the satisfaction of customary closing conditions related to the underwritten public offerings; and other risks and uncertainties identified in the company’s filings with the SEC, including those risks set forth under the caption “Risk Factors” in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 5, 2026, and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260506078055/en/ Investors Greg Rossino
grossino@viridiantherapeutics.com Media Lisa Lopez
llopez@viridiantherapeutics.com Original: Viridian Therapeutics Announces Pricing of Upsized Concurrent Public Offerings of 1.75% Convertible Senior Notes Due 2032 and Common Stock with Aggregate Gross Proceeds of $350.0 Million
iHub News
2月前
PDUFA Decision Nears as Viridian Therapeutics (VRDN) Advances TED Pipeline and Reports Q1 ResultsMay 5, 2026 10:24 AM
IH Market News Regulatory milestones and late-stage clinical progress position the company ahead of a key FDA decision in June.Viridian Therapeutics, Inc. (NASDAQ:VRDN) reported first-quarter 2026 results alongside updates on its pipeline, with a PDUFA decision for veligrotug in thyroid eye disease (TED) set for June 30, 2026. The upcoming regulatory milestone is central for investors, as it could determine near-term commercialization and revenue potential. Key Investor Takeaways Viridian (NASDAQ:VRDN) faces a PDUFA decision on June 30, 2026 for veligrotug, a key catalyst. The company is launch-ready, with commercial infrastructure and supply chain already in place. Positive Phase 3 data for elegrobart supports a future BLA submission in Q1 2027. Cash position of $762M provides funding for pipeline execution and launch activities. Rising SG&A and net losses reflect increased commercialization spending ahead of potential approval. Press Release Overview Viridian reported progress across its thyroid eye disease (TED) portfolio, led by veligrotug, which is under FDA Priority Review with a PDUFA target action date of June 30, 2026. The company stated it has completed hiring of field teams and established supply chain infrastructure in preparation for launch.The company also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency in January 2026, which was accepted for review in February.In addition, Viridian announced positive topline data from two Phase 3 trials—REVEAL-1 and REVEAL-2—for elegrobart (VRDN-003), covering both active and chronic TED. The company plans to submit a Biologics License Application (BLA) in the first quarter of 2027.Beyond TED, the company continues to advance earlier-stage programs, including its TSHR antibody program and FcRn inhibitor portfolio, with additional data and development plans expected later in 2026.Financially, Viridian reported: Cash, cash equivalents, and investments of $762.2 million as of March 31, 2026 R&D expenses of $77.6 million, up slightly year over year SG&A expenses of $38.7 million, rising significantly due to commercial preparation Net loss of $104.9 million for the quarter Why This Matters for Investors The upcoming PDUFA decision represents a critical inflection point. Approval of veligrotug could transition Viridian from a development-stage biotech to a commercial-stage company, which may significantly alter its revenue profile and valuation framework.The company’s readiness for launch suggests it is positioned to move quickly if approval is granted. At the same time, increased operating expenses indicate higher execution risk tied to commercialization.Positive Phase 3 data for elegrobart strengthens the broader TED pipeline, potentially expanding the company’s long-term opportunity in the indication. However, regulatory outcomes and future trial results remain key variables. What to Watch For Next FDA PDUFA decision on veligrotug (June 30, 2026) Updates from the EMA review process Timing and details of elegrobart BLA submission (Q1 2027) Additional data from FcRn and TSHR programs in 2026 Commercial launch execution if approval is granted Conclusion Viridian Therapeutics is approaching a pivotal regulatory event with veligrotug, while continuing to build out a broader TED-focused pipeline. The outcome of the upcoming FDA decision, along with execution on commercialization plans, will likely shape near-term investor sentiment and the company’s strategic trajectory.Viridian Therapeutics stock price Original: PDUFA Decision Nears as Viridian Therapeutics (VRDN) Advances TED Pipeline and Reports Q1 Results