Congleton Jon sold $1.9M of MLYS

H.C. Wainwright reiterated a Buy rating and $56.00 price target for Mineralys Therapeutics (NASDAQ:MLYS), citing new clinical data for lorundrostat. The target implies 140% upside from the current stock price of $23.37. The firm highlights the drug's potential in treating difficult-to-treat hypertension ahead of a December 2026 PDUFA date. Mineralys reported a wider-than-expected Q2 2026 loss of $2.85 per share. UBS initiated coverage with a Neutral rating and $29.00 price target.

Mineralys Therapeutics (MLYS) reported Phase 3 data showing 46% of patients on lorundrostat 50 mg achieved SBP <130 mmHg at 12 weeks, with 70% seeing ≥10 mmHg reduction. Phase 2 data showed an 11.1 mmHg morning SBP drop at Week 4. The company aims for FDA approval and clear labeling for BP reduction in resistant hypertension.

Mineralys Therapeutics (MLYS) presented data at the American Heart Association Hypertension Scientific Sessions 2026. In the Launch-HTN trial, 46% of participants with difficult-to-treat hypertension achieved the AHA/ACC systolic blood pressure target of <130 mmHg with lorundrostat 50 mg. In the Explore-OSA trial, lorundrostat reduced morning systolic blood pressure by 11.1 mmHg at Week 4. Both trials showed favorable safety and tolerability profiles for lorundrostat.

Mineralys Therapeutics (MLYS) reported a Q2 2026 net loss of $241.07M. The company appointed James J. Ferguson III, M.D., as Chief Medical Officer. Shares are down 5.04% in 30 days and 14.07% in 90 days, but up 72.32% in 1 year and 97.31% in 3 years. Analysts suggest fair value at $50.88, above the current $25.65, based on lorundrostat's potential. Risks include regulatory outcomes and cash burn.

Mineralys Therapeutics (MLYS) reported Q2 2026 earnings, highlighting a net loss of $241.1 million due to royalty repurchase obligations. Key financial activities included a $150 million equity offering and a $100 million tranche from a $500 million loan. The company is preparing for the FDA's PDUFA date for lorundrostat, a hypertension treatment, with commercial launch plans and payer discussions underway. Management expressed optimism about the regulatory review and market potential.

Mineralys Therapeutics reported Q2 2026 updates on lorundrostat. The company said it repurchased future royalties from Mitsubishi Tanabe for $200 million, secured a $500 million senior secured term loan, and completed a $150 million equity offering. R&D rose to $221.4 million. It cited LAUNCH-HTN results and targeted a Dec. 22, 2026 PDUFA, with FDA discussions in Oct-Nov 2026.