Zinger Key Points
- Stifel initiateds coverage on Crinetics citing strong potential for Paltusotine and Atumelnant.
- Paltusotine, under FDA review for acromegaly, has a PDUFA target date of Sept. 25, 2025, with peak global sales projected at $2 billion.
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Stifel initiated coverage on Monday on Crinetics Pharmaceuticals Inc CRNX, a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors.
Crinetics’ lead development candidate, Paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors.
The Paltusotine U.S. application for acromegaly is under FDA review. The Prescription Drug User Fee Act (PDUFA) target action date for the Paltusotine NDA for the treatment and maintenance therapy of acromegaly is Sept. 25, 2025.
Analyst Alex Thompson writes Paltusotine can potentially disrupt the treatment paradigm in Acromegaly and Carcinoid Syndrome and achieve around $2 billion in combined peak global sales.
Stifel has initiated with a Buy rating and a price target of $60.
The company’s second pipeline asset, Atumelnant, is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome.
In January, Crinetics Pharmaceuticals released topline results from an open-label, Phase 2 congenital adrenal hyperplasia (CAH) study of investigational atumelnant.
For all doses, treatment with atumelnant resulted in a rapid, substantial, and sustained statistically significant reduction in A4 levels, the key biomarker for disease control.
The analyst notes that while early data for Atumelnant looks promising and stands out, concerns over temporary liver issues have drawn more attention. However, positive regulatory decisions are a good sign.
Stifel also says that while uptake in Carcinoid Syndrome may be slower until Crinetics generates PFS data, there is mechanistic translation and model modest uptake over time, translating to around $1.4 billion in peak global sales.
“Bottom line, with the stock now well-off 2024 highs, we can largely support today’s valuation with Paltusotine alone and see confirmation of Atumelnant’s efficacy/safety in CAH and progression of the broader pipeline as compelling upside drivers along with a strong a balance sheet and increasing investor interest in endocrinology,” analyst Thompson writes.
CRNX Price Action: Crinetics Pharmaceuticals stock is down 2.62% at $35 at publication Tuesday.
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