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Mineralys Stock Rises as FDA Accepts NDA for Hypertension Drug
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Key Takeaways
MLYS shares rose after the FDA accepted the NDA for lorundrostat to treat adult hypertension.
Mineralys expects the FDA to deliver a final regulatory decision on lorundrostat by Dec. 22, 2026.
MLYS Explore-OSA study missed the AHI endpoint but showed blood pressure reduction and favorable safety.
Shares of Mineralys Therapeutics (MLYS - Free Report) were up 4.4% yesterday after the company announced that the FDA has accepted the new drug application (NDA) for its product candidate, lorundrostat, to treat adult patients with hypertension in combination with other antihypertensive drugs.
A final decision from the regulatory body in the United States is expected on Dec. 22, 2026.
Per management, if approved, lorundrostat has the potential to provide a new treatment option for patients with resistant and uncontrolled hypertension.
The above NDA was based on positive data from a successful clinical program, which demonstrated favorable safety and blood pressure reduction in adults with hypertension.
MLYS’ Price Performance
Shares of Mineralys have plunged 21.6% so far this year against the industry’s rise of 6.1%.
Image Source: Zacks Investment Research
MLYS’ Explore-OSA Data on Lorundrostat
Concurrent with the FDA accepting the NDA for lorundrostat, the company also reported top-line data from the phase II Explore-OSA exploratory study, which evaluated lorundrostat for treating overweight or obese adults with moderate-to-severe obstructive sleep apnea (OSA) and hypertension.
Data from the Explore-OSA study showed that four weeks of treatment with lorundrostat (50 mg), dosed in the evening, failed to demonstrate a clinically meaningful difference in the apnea-hypopnea index (AHI) versus placebo, the study’s primary endpoint.
However, treatment with lorundrostat did demonstrate a clinically meaningful reduction in blood pressure and favorable safety and tolerability in patients with difficult-to-control hypertension.
Lorundrostat, an orally administered, highly selective aldosterone synthase inhibitor, is being studied for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as chronic kidney disease (CKD) and OSA.
Last year, Mineralys announced that the pivotal phase III Launch-HTN study and the phase II Advance-HTN study of lorundrostat in patients with uncontrolled or resistant hypertension met their primary efficacy endpoints with statistical significance and showed favorable safety and tolerability.
The company also reported positive top-line data from the phase II Explore-CKD study, which showed that lorundrostat added to an SGLT2 inhibitor significantly improved outcomes in hypertensive patients with CKD.
Mineralys currently has no approved products in its portfolio. Hence, a potential FDA approval for lorundrostat would be a significant boost for the company.
Over the past 60 days, estimates for Phathom Pharmaceuticals’ 2026 earnings per share have increased from 24 cents to 28 cents, while the same for 2027 have increased from $2.22 to $2.25. PHAT’s shares have plunged 33% in the year-to-date period.
Phathom Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 14.06%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.28 to $9.00, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 3.8% in the year-to-date period.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Replimune’s 2026 loss have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have declined 15.3% in the year-to-date period.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.
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Mineralys Stock Rises as FDA Accepts NDA for Hypertension Drug
Key Takeaways
Shares of Mineralys Therapeutics (MLYS - Free Report) were up 4.4% yesterday after the company announced that the FDA has accepted the new drug application (NDA) for its product candidate, lorundrostat, to treat adult patients with hypertension in combination with other antihypertensive drugs.
A final decision from the regulatory body in the United States is expected on Dec. 22, 2026.
Per management, if approved, lorundrostat has the potential to provide a new treatment option for patients with resistant and uncontrolled hypertension.
The above NDA was based on positive data from a successful clinical program, which demonstrated favorable safety and blood pressure reduction in adults with hypertension.
MLYS’ Price Performance
Shares of Mineralys have plunged 21.6% so far this year against the industry’s rise of 6.1%.
Image Source: Zacks Investment Research
MLYS’ Explore-OSA Data on Lorundrostat
Concurrent with the FDA accepting the NDA for lorundrostat, the company also reported top-line data from the phase II Explore-OSA exploratory study, which evaluated lorundrostat for treating overweight or obese adults with moderate-to-severe obstructive sleep apnea (OSA) and hypertension.
Data from the Explore-OSA study showed that four weeks of treatment with lorundrostat (50 mg), dosed in the evening, failed to demonstrate a clinically meaningful difference in the apnea-hypopnea index (AHI) versus placebo, the study’s primary endpoint.
However, treatment with lorundrostat did demonstrate a clinically meaningful reduction in blood pressure and favorable safety and tolerability in patients with difficult-to-control hypertension.
Lorundrostat, an orally administered, highly selective aldosterone synthase inhibitor, is being studied for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as chronic kidney disease (CKD) and OSA.
Last year, Mineralys announced that the pivotal phase III Launch-HTN study and the phase II Advance-HTN study of lorundrostat in patients with uncontrolled or resistant hypertension met their primary efficacy endpoints with statistical significance and showed favorable safety and tolerability.
The company also reported positive top-line data from the phase II Explore-CKD study, which showed that lorundrostat added to an SGLT2 inhibitor significantly improved outcomes in hypertensive patients with CKD.
Mineralys currently has no approved products in its portfolio. Hence, a potential FDA approval for lorundrostat would be a significant boost for the company.
Mineralys Therapeutics, Inc. Price
Mineralys Therapeutics, Inc. price | Mineralys Therapeutics, Inc. Quote
MLYS Zacks Rank & Stocks to Consider
Mineralys currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Phathom Pharmaceuticals (PHAT - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Replimune Group (REPL - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Phathom Pharmaceuticals’ 2026 earnings per share have increased from 24 cents to 28 cents, while the same for 2027 have increased from $2.22 to $2.25. PHAT’s shares have plunged 33% in the year-to-date period.
Phathom Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 14.06%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.28 to $9.00, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 3.8% in the year-to-date period.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Replimune’s 2026 loss have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have declined 15.3% in the year-to-date period.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.