1Q26: Acne Program Accelerated With Deni And Additional Capital

研报英文原文证据摘录

1Q26: Acne Program Accelerated With Deni And Additional Capital

ed) conducted in China completed

Year* 0.0A 0.0A 0.0E enrollment of 480 patients in approximately nine months and positive top-line

EPS in $ data were reported in Jun. '25. SGMT's Ph3 study of deni in acne will enroll

FYE Dec 2024A 2025A 2026E approximately 800 patients, who will be 2:1 randomized to receive deni at 50mg Q1 Mar (0.23)A (0.56)A (0.33)E

Previous (0.30)E or placebo for 12 weeks of treatment. Management is confident in fast patient

Q2 Jun (0.25)A (0.32)A (0.20)E enrollment, likely within six months according to our follow-up discussion, and

Previous (0.19)E top-line data could be available by YE27 or in early 2028 to support a rolling NDA

Q3 Sep (0.45)A (0.40)A (0.19)E submission. The submission will begin with 12-week data and will include long-

Previous (0.18)E term extension study data through additional 40 weeks of treatment, and data

Q4 Dec (0.50)A (0.29)A (0.22)E from at least 100 patients 12 to 17 years old will be included to support a label for Previous (0.20)E

adolescent patients. Year* (1.45)A (1.58)A (0.89)E

Previous (0.83)E The Recent 52-wk Data from China Study Confirm Deni's Long-Term Safety, P/E NM NM NM

showing no deni-related SAEs or Grade 3/4 AEs, or AE-related discontinuations, and

Pricing data provided by Thomson Reuters. only one case of Grade 1 hair thinning in 250 patients, ut it resolved within eight

*Numbers may not add up due to rounding. weeks without treatment discontinuation or modification or other interventions

(note). Benefit continued to improve as measured by all efficacy endpoints beyond

the 12-week treatment period in the randomized portion of the study. According

to management, data from the China study will be the centerpiece of the IND