Simplify Propel Opportunities ETF(SURI.US)

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How M&A Unlocked A Biotech Rebound In 2025— And What Comes Next?

Small and mid-cap biotech stocks rebounded in 2025, driven by easing headwinds such as lower interest rates and increased M&A activity. M&A has become a stabilizing force, with small- and mid-cap companies accounting for 57% of biopharma acquisitions in Q3 2025. Investor focus has shifted from GLP-1 drugs to cancer and autoimmune treatments, with significant acquisitions in these areas. Key stocks to watch include BridgeBio Pharma, Argenx, DBV Technologies, Viridian Therapeutics, and Kyverna Therapeutics. Looking ahead, increased M&A and strategic partnerships are expected, although risks remain, including potential FDA staff turnover.

benzinga_article·
US
DBVT
+1.62%
US
BBIO
+0.52%
US
VRDN
+0.59%
benzinga_article·
US
DBVT
+1.62%
US
BBIO
+0.52%
US
VRDN
+0.59%

FDA Accepts Viridian's Veligrotug BLA For Priority Review In Thyroid Eye Disease

Viridian Therapeutics Inc. announced that the FDA has accepted its Biologics License Application for Veligrotug, a treatment for thyroid eye disease, for priority review. The decision is expected by June 30, 2026. The application is supported by positive Phase 3 trial data, and Veligrotug has been granted breakthrough therapy designation. Viridian plans to submit a Marketing Authorisation Application to the European Medicines Agency in early 2026.

rttnews·
US
VRDN
+0.59%
rttnews·
US
VRDN
+0.59%

FDA Grants Priority Review to Viridian Therapeutics' Veligrotug for Thyroid Eye Disease

Viridian Therapeutics announced that the FDA has accepted the Biologics License Application for veligrotug, a treatment for thyroid eye disease, granting it Priority Review. This shortens the review period to six months, with a target action date of June 30, 2026. The application is supported by positive phase 3 trial results, and preparations for commercial launch are underway. A similar application to the European Medicines Agency is planned for early 2026.

Reuters·
US
VRDN
+0.59%
Reuters·
US
VRDN
+0.59%

FDA Review Of Veli For Thyroid Eye Disease Might Change The Case For Investing In Viridian Therapeutics (VRDN)

Analysts from Goldman Sachs and Needham have reiterated positive views on Viridian Therapeutics after the company submitted a Biologics License Application to the FDA for its thyroid eye disease therapy, veli. The FDA review of veli could reshape expectations for Viridian's rare disease portfolio. The market sees this as incrementally positive, but not thesis changing. Investors should consider regulatory outcomes, potential dilution, and cash burn. Opinions on Viridian's long-term potential vary widely.

Simplywall·
US
VRDN
+0.59%
Simplywall·
US
VRDN
+0.59%

Viridian Therapeutics: Strong Market Position and Promising Catalysts Justify Buy Rating

Needham analyst Serge Belanger maintains a Buy rating on Viridian Therapeutics (VRDN) due to its strong market position in thyroid eye disease (TED) following competitors' setbacks. Upcoming catalysts include the FDA's decision on veligrotug's Biologics License Application, potentially leading to Priority Review and mid-2026 approval. Wedbush also maintains a Buy rating with a $47.00 price target.

Tip Ranks·
US
VRDN
+0.59%
Tip Ranks·
US
VRDN
+0.59%
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