Citizens has reaffirmed its Market Outperform rating on Solid Biosciences and retained a $15.00 price target, according to a research note published Tuesday. The note comes as Solid’s stock trades at $6.86 and has generated a 99.42% return over the last 12 months, according to InvestingPro data.
The research house said it sustained a positive view after Solid Biosciences reached agreement with the U.S. Food and Drug Administration on the overall trial design for the Phase 3 IMPACT DUCHENNE study. That alignment precedes additional planned interactions with the FDA, the note said.
Citizens identified the next material regulatory step as what it refers to as "meeting #2," which will concentrate on the endpoint for accelerated approval. That discussion is expected to consider external data sources and biomarkers, specifically microdystrophin expression in skeletal muscle and cardiovascular biomarkers, as part of the evidence package for accelerated approval.
The $15.00 price target in Citizens' model is derived from a discounted cash flow analysis, the firm said.
Although Solid faces financial headwinds in the form of negative earnings, Citizens pointed to the company’s liquidity profile as supporting continued development work. InvestingPro data cited in the note shows a current ratio of 6.74, which Citizens views as providing runway while Solid advances its clinical programs.
Separate updates from Solid Biosciences underscore progress across multiple programs:
- The company reported that it has reached agreement with the FDA on the Phase 3 clinical-trial design for SGT-003. That trial will be randomized, double-blind and placebo-controlled, enrolling ambulant participants aged 7 to under 12 years.
- Solid has dosed 33 participants in its Phase 1/2 INSPIRE DUCHENNE trial and reported that SGT-003 has been generally well tolerated with no significant adverse effects observed.
- The investigational gene therapy SGT-212, being developed for Friedreich’s ataxia, received Orphan Drug designation from the FDA, and the first participant has been dosed in the Phase 1b FALCON trial using a dual-route administration approach.
Citizens summarized its stance by noting that Solid Biosciences continues to "tackle the regulatory hoops" inherent to developing gene therapies and that recent regulatory alignment and clinical progress justify its maintained Market Outperform rating.
This assessment leaves open the company’s need to navigate remaining regulatory conversations, translate trial designs into successful execution, and manage ongoing financing requirements as programs progress.