Alumis

Alumis presented compelling psoriasis data for the oral TYK2 inhibitor Envudeucitinib at the Morgan Stanley Healthcare Conference, reporting PASI-100 rates of around 40–54% and plans to file for FDA approval in Q4 2024. The phase IIb LUMUS lupus study missed its primary endpoint in the overall population but showed clear responses in patients with a positive interferon signature, so phase III planning will consider biomarker-driven designs. The company had over $500 million in liquidity as of June 30, 2024, sees cash runway to Q4 2027, and is evaluating partnerships as well as a possible standalone U.S. launch. » Mais em de.investing.com

Alumis shares climbed 6.3% premarket after presenting compelling long-term data on Envudeucitinib’s skin clearance at investor conferences. The drug showed roughly 40% complete skin clearance at six months and about 55% at 48 weeks, while the lupus program is being revised to target biomarker-defined patient groups. Director Srinivas Akkaraju bought more than $10.7 million of shares in early September, boosting confidence in the stock. Management is exploring partnerships for worldwide development, and Alumis plans to file an NDA for Envudeucitinib with the FDA in Q4 2026. » Mais em de.investing.com

Alumis reports convincing psoriasis results for Envudeucitinib (PASI‑100: ~40% after six months, 55% after 48 weeks) and plans, subject to safety data, an NDA submission in Q4 2024. The Phase IIb lupus study missed its primary endpoint in the overall population but showed robust effects in patients with a positive Type I interferon signature. Management is considering a strategic repositioning, broader partnerships across five to ten indications, and strict capital allocation given limited funds. » Mais em de.investing.com