- Concert Pharmaceuticals Inc (NASDAQ:CNCE) has released highly positive Phase 3 data for their alopecia areata drug CTP-543 from the THRIVE-AA1 trial.
- Mizuho says that the efficacy supports its view that CTP-543 potentially has best-in-class efficacy amongst the three main oral JAK inhibitors in late-stage development for alopecia areata (CTP-543, Eli Lilly And Co's (NYSE: LLY) Olumiant and Pfizer Inc's (NYSE: PFE) ritlecitinib).
- The analysts kept the Buy rating with a price target of $9 for the stock.
- Importantly, no pulmonary embolisms or deep vein thromboses were seen in the trial, an area of concern for other oral JAK inhibitors. Nine patients developed serious adverse events, but four were in the placebo group.
- According to Mizuho, Concert will need substantial funding to continue through to the launch of CTP-543.
- The analysts assume they will not be profitable on an ongoing basis until 2026.
- Cash, cash equivalents, and investments as of March 31 totaled $109.0 million.
- The FDA application filing for CTP-543 is projected for 1H 2023, and Mizuho expects Concert will have to raise capital to cover expenses well into 2023 to continue its operations and launch CTP-543.
- The analysts also noted FDA's recently announced safety warnings for JAK inhibitors, citing an increased risk of serious side effects.
- Such risks and sides effect may reduce patient uptake and compliance with JAK inhibitors, including Concert's CTP-543.
- Price Action: CNCE shares are down 4.23% at $4.30 during the market session on the last check Monday.
