Jefferies Reiterates Hold Rating on Mineralys Therapeutics, Inc. (MLYS)

Jefferies analyst Dennis Ding reiterated a Hold rating and $15.00 price target on Mineralys Therapeutics, Inc. (NASDAQ: MLYS).

The analyst comments "Competitor AZN announced (+) topline Phase III data for baxdrostat, though the numerical efficacy and hyperkalemia data are embargoed until ESC on 8/30. We think the (+) data was expected on our view both MLYS's and AZN's ASI's look similar — i.e., both efficacy and safety data should be within the ballpark of each other. Commercial success, in our view, will depend on access, rebating, and marketing, which we think AZN should have a major edge currently. Thinking about the setup now. MLYS has openly communicated it wants to find a commercial partner for OUS (expected) but also potentially the US (we'll see with who and also deal economics / structure — could be a hybrid between co-promote and MLYS's own salesforce). We think the AZN topline and detailed data at ESC in Aug should help confirm the value / NPV for lorundrostat for partnering discussions and maybe even any M/A now that this will be a two player ASI market. We don't see a ton of catalysts over the next 12-18 months (whether the Phase II OSA-HTN catalyst is core to the thesis is up for debate), so this will be an execution period ahead of the US launch in H1:27. Next up: (1) FDA meeting in Q4:25 for pot'l filing in H1:26, and we expect standard review thus H1:27 US approval, (2) Phase II OSA-HTN data potentially Q4:25 or early 2026, (3) any partnering announcements for US / OUS territories. Note MLYS had $343M cash at the end of Q1:25, but we model $30-40M burn per quarter. We est MLYS will end 2026 with $50-100M cash going into the launch; thus, we think the company does need add'l financing whether it comes from equity, debt, or partnership deal. We also think consensus estimates for 2027+ are way too high, and our launch trajectory is well below consensus."

For an analyst ratings summary and ratings history on Mineralys Therapeutics, Inc. click here. For more ratings news on Mineralys Therapeutics, Inc. click here.

Shares of Mineralys Therapeutics, Inc. closed at $14.49 yesterday.

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