1Q26: SGT-003 Phase 3 Initiated; Regulatory Dialogue Ongoing

研报英文原文证据摘录

1Q26: SGT-003 Phase 3 Initiated; Regulatory Dialogue Ongoing

C O M PA N Y N O T E

1 2 M a y 2 0 2 6

Solid Bio (SLDB) Overweight

CONCLUSION PRICE: US$7.72

In today’s 1Q26 financial results, SLDB reported that the first patient has been dosed TARGET: US$18.00

in the Phase 3 IMPACT DUCHENNE trial for SGT-003 and noted that 47 patients have Our $18 price target is based on a DCF through

now been dosed in the Phase 1/2 INSPIRE DUCHENNE study, with no reported cases 2035E (14% discount rate), and assumes

of myocarditis, DILI, or TMA/aHUS to date, and is on track for enrolling 50 patients by future revenue forecasts for SGT-003 in DMD

June. Mgmt continues to engage with the FDA regarding a potential accelerated approval (estimated US approval in 2027). We estimate

pathway for SGT-003, with additional follow-up data expected this summer to support peak risk-adjusted US sales of $655M and ex-

ongoing regulatory discussions. Outside DMD, SGT-212 (Friedreich’s ataxia) and SGT-501 US sales of $764M.

(CPVT) are on track for initial clinical updates at YE 2026 and 1H27, respectively. Biren Amin

Sr. Research Analyst, Piper Sandler & Co.

• SGT-003 (DMD): SLDB dosed the first participant in the Phase 3 IMPACT DUCHENNE 732 284-6909, biren.amin@psc.com

trial in May 2026. As of May 11, 2026, 47 participants have been dosed in the Phase 1/2 Felicia Berben, PharmD

INSPIRE trial (most recent dosing on May 7th), with mgmt continuing to report a clean Research Analyst, Piper Sandler & Co.

212 284-9412, felicia.berben@psc.com safety profile (no myocarditis, DILI, or TMA/aHUS). SLDB continues to engage with the

FDA to receive guidance on a potential accelerated approval pathway for SGT-003, Kailie Briza

Research Analyst, Piper Sandler & Co.