Jefferies Analyst Says AstraZeneca's Baxfendy FDA Approval is Positive for Mineralys
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 18 2026
0mins
Jefferies analyst Dennis Ding notes that AstraZeneca's (AZN) Baxfendy was approved by the FDA as the first-ever aldosterone synthase inhibitor, adding that Baxfendy's approval may be "incrementally constructive" for Mineralys Therapeutics (MLYS) partnering discussions now that there's full visibility on the label, pricing, and payer access. Baxfendy will be available in pharmacies no later than June 9, roughly six to seven months ahead of lorundrostat's PDUFA deadline of December 22, notes the analyst, who has a Hold rating on Mineralys shares.
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Analyst Views on MLYS
Wall Street analysts forecast MLYS stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 31.500
Low
46.00
Averages
52.60
High
56.00
Current: 31.500
Low
46.00
Averages
52.60
High
56.00
About MLYS
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Lorundrostat is designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for producing the hormone. It has completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). It is also investigating the benefits of lorundrostat in subjects with hypertension and CKD and in subjects with hypertension and OSA.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Velan Capital Reduces Stake in Mineralys Therapeutics
- Stake Reduction: According to an SEC filing dated May 15, 2026, Velan Capital sold 140,000 shares of Mineralys Therapeutics in Q1, with an estimated transaction value of $4.11 million, indicating a cautious outlook on the company's future prospects.
- Decline in Position Value: Following the sale, Velan Capital's position value decreased by $5.18 million, reflecting the dual impact of trading activities and stock price changes, suggesting a weakening market confidence in Mineralys.
- Current Holdings: As of quarter-end, Velan Capital holds 11,000 shares of Mineralys valued at $297,990, with this stake now representing only 0.19% of its total assets under management, thus falling outside its top five holdings.
- Financial Status Analysis: Mineralys reported a loss of $39.3 million in Q1, but with $646 million in cash on hand, it should be able to sustain operations while the FDA reviews its lorundrostat application, although the lack of approved products poses ongoing risks.
See More
Velan Capital Reduces Stake in Mineralys Therapeutics
- Share Reduction Details: According to an SEC filing dated May 15, 2026, Velan Capital sold 140,000 shares of Mineralys Therapeutics in Q1, valued at approximately $4.11 million, leaving it with 11,000 shares worth about $297,990, resulting in a net position decline of $5.18 million due to both share sales and price fluctuations.
- Holding Proportion Change: Following this reduction, Mineralys Therapeutics now represents only 0.19% of Velan Capital's reportable U.S. equity AUM, indicating a waning confidence in the company, while its top holdings include PRAX, TARA, and STRO.
- Market Performance Analysis: As of May 14, 2026, Mineralys Therapeutics shares were priced at $27.27, reflecting an 80.5% increase over the past year, significantly outperforming the S&P 500 by 53.18 percentage points, showcasing its strong position in the biopharmaceutical market.
- FDA Review Progress: Mineralys's lead product candidate, lorundrostat, is currently under FDA review, with an expected approval decision by December 22, 2026, which could present significant market opportunities for the company, despite reporting a loss of $39.3 million in Q1 and having no approved products yet.
See More
Lorundrostat Shows Significant Efficacy in Chronic Kidney Disease Patients
- Clinical Trial Results: In a study involving 800 participants, lorundrostat achieved a significant reduction of 9.6 mmHg in systolic blood pressure among chronic kidney disease patients, highlighting its potential in managing hypertension and CKD effectively.
- Urinary Albumin Reduction: Among 84 participants with baseline albuminuria, lorundrostat treatment led to a remarkable 52.2% reduction in urinary albumin-to-creatinine ratio after 12 weeks, indicating its potential for renal protection and improving long-term patient outcomes.
- Safety Profile: Over the 12-week study, lorundrostat demonstrated a low incidence of confirmed hyperkalemia at 2.4% in CKD patients, showcasing its favorable safety profile and enhancing its attractiveness as a treatment option.
- FDA Review Progress: Lorundrostat is currently under review by the U.S. FDA, with results expected by December 22, 2026, which could open new market opportunities for the company to address the unmet needs of hypertension patients.
See More
Mineralys Therapeutics Q1 2026 Earnings Call Highlights
- FDA Acceptance Milestone: Mineralys Therapeutics successfully received FDA acceptance for the NDA of lorundrostat in Q1 2026, with a PDUFA target date set for December 22, 2026, establishing a crucial foundation for future commercialization efforts.
- Stable Financial Position: As of March 31, 2026, the company reported cash and cash equivalents totaling $646.1 million, indicating that these resources are expected to support operations into 2028, reflecting strong financial health.
- Decline in R&D Expenses: R&D expenses for Q1 2026 were $24.4 million, significantly down from $37.9 million in Q1 2025, showcasing a strategic shift in spending during the clinical trial phase.
- Market Access Strategy: Management emphasized a focus on market access for fourth-line hypertension patients, ensuring “parity access” with competitors to enhance the market competitiveness of lorundrostat.
See More
Mineralys Grants Stock Options and RSUs to New Employees
- Stock Option Grants: On May 4, 2026, Mineralys Therapeutics granted a total of 29,760 stock options to two new non-executive employees, aimed at attracting and retaining talent, thereby enhancing the company's competitive edge in the biopharmaceutical sector.
- Restricted Stock Units: The company also awarded 22,320 restricted stock units that will vest over four years, with the first vesting occurring on the anniversary of the grant date, reflecting the company's long-term commitment to new employees and promoting team stability.
- Vesting Mechanism: The stock options will vest gradually over four years, with 25% vesting in the first year and 1/48 vesting monthly thereafter, ensuring that employees contribute continuously during their tenure, which enhances their sense of belonging.
- Compliance Assurance: This grant complies with Nasdaq Listing Rule 5635(c)(4), demonstrating the company's adherence to regulations and transparency in attracting new employees, which further boosts investor confidence in the company.
See More
Mineralys CEO Sells 75,000 Shares Amid Market Fluctuations
- Executive Stock Sale: Jon Congleton, CEO of Mineralys Therapeutics, sold 75,000 shares on March 31 through multiple open-market transactions valued at approximately $1.97 million, indicating active trading behavior in the company's stock.
- Holding Proportion Change: The sale impacted 9.61% of Congleton's direct holdings, leaving him with 705,051 shares, which represents about 58.6% of his position from August 2023, suggesting he still retains confidence in the company.
- Trading Plan Context: The stock sale was executed under Congleton's Rule 10b5-1 trading plan adopted in December 2025, which is designed to avoid legal issues related to insider trading, reflecting his cautious approach to compliance.
- Market Reaction and Risks: While Congleton's sale may raise market concerns, Mineralys stock has significantly dropped from its 52-week high of $47.65 last November in 2026, prompting investors to carefully assess the impact of the company's clinical trial results on future stock performance.
See More
Velan Capital Reduces Stake in Mineralys Therapeutics
- Stake Reduction: According to an SEC filing dated May 15, 2026, Velan Capital sold 140,000 shares of Mineralys Therapeutics in Q1, with an estimated transaction value of $4.11 million, indicating a cautious outlook on the company's future prospects.
- Decline in Position Value: Following the sale, Velan Capital's position value decreased by $5.18 million, reflecting the dual impact of trading activities and stock price changes, suggesting a weakening market confidence in Mineralys.
- Current Holdings: As of quarter-end, Velan Capital holds 11,000 shares of Mineralys valued at $297,990, with this stake now representing only 0.19% of its total assets under management, thus falling outside its top five holdings.
- Financial Status Analysis: Mineralys reported a loss of $39.3 million in Q1, but with $646 million in cash on hand, it should be able to sustain operations while the FDA reviews its lorundrostat application, although the lack of approved products poses ongoing risks.
See More
Velan Capital Reduces Stake in Mineralys Therapeutics
- Share Reduction Details: According to an SEC filing dated May 15, 2026, Velan Capital sold 140,000 shares of Mineralys Therapeutics in Q1, valued at approximately $4.11 million, leaving it with 11,000 shares worth about $297,990, resulting in a net position decline of $5.18 million due to both share sales and price fluctuations.
- Holding Proportion Change: Following this reduction, Mineralys Therapeutics now represents only 0.19% of Velan Capital's reportable U.S. equity AUM, indicating a waning confidence in the company, while its top holdings include PRAX, TARA, and STRO.
- Market Performance Analysis: As of May 14, 2026, Mineralys Therapeutics shares were priced at $27.27, reflecting an 80.5% increase over the past year, significantly outperforming the S&P 500 by 53.18 percentage points, showcasing its strong position in the biopharmaceutical market.
- FDA Review Progress: Mineralys's lead product candidate, lorundrostat, is currently under FDA review, with an expected approval decision by December 22, 2026, which could present significant market opportunities for the company, despite reporting a loss of $39.3 million in Q1 and having no approved products yet.
See More
Lorundrostat Shows Significant Efficacy in Chronic Kidney Disease Patients
- Clinical Trial Results: In a study involving 800 participants, lorundrostat achieved a significant reduction of 9.6 mmHg in systolic blood pressure among chronic kidney disease patients, highlighting its potential in managing hypertension and CKD effectively.
- Urinary Albumin Reduction: Among 84 participants with baseline albuminuria, lorundrostat treatment led to a remarkable 52.2% reduction in urinary albumin-to-creatinine ratio after 12 weeks, indicating its potential for renal protection and improving long-term patient outcomes.
- Safety Profile: Over the 12-week study, lorundrostat demonstrated a low incidence of confirmed hyperkalemia at 2.4% in CKD patients, showcasing its favorable safety profile and enhancing its attractiveness as a treatment option.
- FDA Review Progress: Lorundrostat is currently under review by the U.S. FDA, with results expected by December 22, 2026, which could open new market opportunities for the company to address the unmet needs of hypertension patients.
See More
Mineralys Therapeutics Q1 2026 Earnings Call Highlights
- FDA Acceptance Milestone: Mineralys Therapeutics successfully received FDA acceptance for the NDA of lorundrostat in Q1 2026, with a PDUFA target date set for December 22, 2026, establishing a crucial foundation for future commercialization efforts.
- Stable Financial Position: As of March 31, 2026, the company reported cash and cash equivalents totaling $646.1 million, indicating that these resources are expected to support operations into 2028, reflecting strong financial health.
- Decline in R&D Expenses: R&D expenses for Q1 2026 were $24.4 million, significantly down from $37.9 million in Q1 2025, showcasing a strategic shift in spending during the clinical trial phase.
- Market Access Strategy: Management emphasized a focus on market access for fourth-line hypertension patients, ensuring “parity access” with competitors to enhance the market competitiveness of lorundrostat.
See More
Mineralys Grants Stock Options and RSUs to New Employees
- Stock Option Grants: On May 4, 2026, Mineralys Therapeutics granted a total of 29,760 stock options to two new non-executive employees, aimed at attracting and retaining talent, thereby enhancing the company's competitive edge in the biopharmaceutical sector.
- Restricted Stock Units: The company also awarded 22,320 restricted stock units that will vest over four years, with the first vesting occurring on the anniversary of the grant date, reflecting the company's long-term commitment to new employees and promoting team stability.
- Vesting Mechanism: The stock options will vest gradually over four years, with 25% vesting in the first year and 1/48 vesting monthly thereafter, ensuring that employees contribute continuously during their tenure, which enhances their sense of belonging.
- Compliance Assurance: This grant complies with Nasdaq Listing Rule 5635(c)(4), demonstrating the company's adherence to regulations and transparency in attracting new employees, which further boosts investor confidence in the company.
See More
Mineralys CEO Sells 75,000 Shares Amid Market Fluctuations
- Executive Stock Sale: Jon Congleton, CEO of Mineralys Therapeutics, sold 75,000 shares on March 31 through multiple open-market transactions valued at approximately $1.97 million, indicating active trading behavior in the company's stock.
- Holding Proportion Change: The sale impacted 9.61% of Congleton's direct holdings, leaving him with 705,051 shares, which represents about 58.6% of his position from August 2023, suggesting he still retains confidence in the company.
- Trading Plan Context: The stock sale was executed under Congleton's Rule 10b5-1 trading plan adopted in December 2025, which is designed to avoid legal issues related to insider trading, reflecting his cautious approach to compliance.
- Market Reaction and Risks: While Congleton's sale may raise market concerns, Mineralys stock has significantly dropped from its 52-week high of $47.65 last November in 2026, prompting investors to carefully assess the impact of the company's clinical trial results on future stock performance.
See More
