Ionis Pharmaceuticals Receives FDA Priority Review for Olezarsen
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 26 2026
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Should l Buy IONS?
Source: Newsfilter
Ionis Pharmaceuticals' stock fell 4.09% and hit a 20-day low amid broader market declines, with the Nasdaq-100 down 1.12% and the S&P 500 down 0.96%.
The company announced that its drug olezarsen for severe hypertriglyceridemia has received FDA Priority Review, with a target date of June 30, 2026. This expedited review is crucial as it addresses the urgent need for new treatment options for approximately 3 million people in the U.S. suffering from this condition. The drug has shown significant efficacy in clinical trials, reducing triglyceride levels by up to 72% and acute pancreatitis events by 85%, highlighting its potential to improve patient outcomes.
Despite the stock's decline, the FDA's decision represents a significant milestone for Ionis, potentially paving the way for a successful market entry of olezarsen. The company is also focusing on its other products, which may contribute to future revenue growth.
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Analyst Views on IONS
Wall Street analysts forecast IONS stock price to rise
14 Analyst Rating
13 Buy
1 Hold
0 Sell
Strong Buy
Current: 76.020
Low
65.00
Averages
92.67
High
110.00
Current: 76.020
Low
65.00
Averages
92.67
High
110.00
About IONS
Ionis Pharmaceuticals, Inc. develops six marketed medicines for serious diseases, including medicines for neurologic and cardiovascular diseases. Its marketed medicines consist of TRYNGOLZA, WAINUA (eplontersen), SPINRAZA (nusinersen), QALSODY (tofersen), TEGSEDI (inotersen) and WAYLIVRA (volanesorsen). TRYNGOLZA reduces triglyceride levels in adults with familial chylomicronemia syndrome (FCS). WAINUA is approved for the treatment of the polyneuropathy of hereditary transthyretin-medicated amyloidosis (ATTRv-PN) in adults. SPINRAZA is used for the treatment of pediatric and adult patients with spinal muscular atrophy. QALSODY is approved for the treatment of Amyotrophic Lateral Sclerosis in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene, or SOD1-ALS. TEGSEDI is approved for the treatment of ATTRv-PN in adults. WAYLIVRA is approved as an adjunct to diet in adult patients with genetically confirmed FCS and at high risk of acute, potentially fatal pancreatitis.
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.
Ionis Pharmaceuticals (IONS.US) Director Plans to Sell $4.35 Million in Common Stock via Form 144
Stock Sale Announcement: Ionis Pharmaceuticals' director, Joseph Loscalzo, plans to sell 54,321 shares of the company's common stock on May 4, with an estimated market value of around $4.35 million.
Reduction in Shareholding: Loscalzo has decreased his shareholding in Ionis Pharmaceuticals by 1,032 shares since March 3, 2026, with a total value of approximately $82,833.
See More
Ionis Pharmaceuticals to Participate in Multiple Investor Conferences
- Investor Conference Schedule: Ionis Pharmaceuticals announced participation in the Bank of America Securities 2026 Health Care Conference on May 12, 2026, the RBC Capital Markets Global Healthcare Conference on May 19, 2026, and the Goldman Sachs 47th Annual Global Healthcare Conference on June 10, 2026, showcasing its innovations in RNA-targeted medicines.
- Live Webcast and Replays: Presentations will be accessible via a live webcast on the Investors & Media section of the Ionis website, with replays available within 48 hours post-event, ensuring investors stay updated on the company's latest developments.
- Company Background: For three decades, Ionis has focused on inventing medicines that improve the futures of patients with serious diseases, currently boasting marketed medicines and a leading pipeline in neurology, cardiometabolic diseases, and areas of high patient need, reflecting its deep expertise in the biopharmaceutical sector.
- Innovation-Driven Technology: As a pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies while advancing new approaches in gene editing, demonstrating a profound understanding of disease biology and industry-leading technology aimed at delivering life-changing treatments for patients.
See More
Ionis Pharmaceuticals Q1 2026 Earnings Call Highlights
- Sales Estimate Increase: Ionis Pharmaceuticals has raised its annual peak sales estimate for Olezarsen from over $2 billion to over $3 billion, reflecting continued demand growth for severe hypertriglyceridemia, with the FDA accepting priority review and a PDUFA date set for June 30.
- Significant Revenue Growth: Total revenue for Q1 2026 reached $246 million, an 87% increase year-over-year, including approximately $95 million in milestone payments from multiple partnerships, indicating strong performance in both product sales and collaboration revenue.
- Improved Financial Guidance: Ionis expects total revenue in the range of $875 million to $900 million for 2026, with a slight increase in commercial revenue share, while projecting a non-GAAP operating loss between $425 million and $475 million, reflecting confidence in future financial performance.
- Product Sales Outlook: The company anticipates full-year sales for TRYNGOLZA and DAWNZERA to be between $100 million and $110 million and $110 million and $120 million, respectively, although a significant decline in second-quarter TRYNGOLZA revenue is expected due to the price reset effective April 1, with a gradual recovery anticipated post-June 30 approval.
See More
Ionis (IONS) Q1 2026 Earnings Call Transcript
See More
Ionis Pharmaceuticals Q1 Earnings Beat Expectations with 86.4% Revenue Growth
- Strong Earnings Report: Ionis Pharmaceuticals reported a Q1 GAAP EPS of -$0.56, beating expectations by $0.35, with revenue reaching $246 million, reflecting an impressive 86.4% year-over-year growth that boosts investor confidence.
- Cash Flow Status: As of March 31, 2026, Ionis had $1.9 billion in cash and short-term investments, a decrease of $633 million from year-end 2025, primarily due to the maturity of 0% convertible notes, indicating challenges in cash management.
- Sales Guidance Upgrade: The company raised its peak net sales guidance for olezarsen from over $2 billion to over $3 billion, driven by increased confidence in the sHTG market opportunity, signaling optimism for future growth.
- Improved 2026 Financial Guidance: Ionis revised its 2026 total revenue guidance from $800-825 million to $875-900 million, while reducing operating loss expectations from $500-550 million to $425-475 million, reflecting strong revenue performance and ongoing commercial success.
See More
Ionis Pharmaceuticals Q1 Earnings Announcement Scheduled
- Earnings Announcement: Ionis Pharmaceuticals is set to release its Q1 2023 earnings on April 29 before the market opens, with consensus EPS estimated at -$0.78 and revenue projected at $196.01 million, reflecting a 48.5% year-over-year increase.
- Earnings Estimate Adjustments: Over the last three months, EPS estimates have seen no upward revisions and three downward adjustments, while revenue estimates have experienced one upward revision and six downward changes, indicating market caution regarding Ionis's future performance.
- Product Review Progress: Ionis's zilganersen has received Priority Review for Alexander disease, which could support future revenue growth, although the overall market environment remains uncertain.
- Market Environment Impact: Amid disruptions in the Middle East, Ionis Pharmaceuticals and other healthcare stocks are viewed as oversold, potentially presenting buying opportunities for investors looking for value in the sector.
See More
Ionis Pharmaceuticals (IONS.US) Director Plans to Sell $4.35 Million in Common Stock via Form 144
Stock Sale Announcement: Ionis Pharmaceuticals' director, Joseph Loscalzo, plans to sell 54,321 shares of the company's common stock on May 4, with an estimated market value of around $4.35 million.
Reduction in Shareholding: Loscalzo has decreased his shareholding in Ionis Pharmaceuticals by 1,032 shares since March 3, 2026, with a total value of approximately $82,833.
See More
Ionis Pharmaceuticals to Participate in Multiple Investor Conferences
- Investor Conference Schedule: Ionis Pharmaceuticals announced participation in the Bank of America Securities 2026 Health Care Conference on May 12, 2026, the RBC Capital Markets Global Healthcare Conference on May 19, 2026, and the Goldman Sachs 47th Annual Global Healthcare Conference on June 10, 2026, showcasing its innovations in RNA-targeted medicines.
- Live Webcast and Replays: Presentations will be accessible via a live webcast on the Investors & Media section of the Ionis website, with replays available within 48 hours post-event, ensuring investors stay updated on the company's latest developments.
- Company Background: For three decades, Ionis has focused on inventing medicines that improve the futures of patients with serious diseases, currently boasting marketed medicines and a leading pipeline in neurology, cardiometabolic diseases, and areas of high patient need, reflecting its deep expertise in the biopharmaceutical sector.
- Innovation-Driven Technology: As a pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies while advancing new approaches in gene editing, demonstrating a profound understanding of disease biology and industry-leading technology aimed at delivering life-changing treatments for patients.
See More
Ionis Pharmaceuticals Q1 2026 Earnings Call Highlights
- Sales Estimate Increase: Ionis Pharmaceuticals has raised its annual peak sales estimate for Olezarsen from over $2 billion to over $3 billion, reflecting continued demand growth for severe hypertriglyceridemia, with the FDA accepting priority review and a PDUFA date set for June 30.
- Significant Revenue Growth: Total revenue for Q1 2026 reached $246 million, an 87% increase year-over-year, including approximately $95 million in milestone payments from multiple partnerships, indicating strong performance in both product sales and collaboration revenue.
- Improved Financial Guidance: Ionis expects total revenue in the range of $875 million to $900 million for 2026, with a slight increase in commercial revenue share, while projecting a non-GAAP operating loss between $425 million and $475 million, reflecting confidence in future financial performance.
- Product Sales Outlook: The company anticipates full-year sales for TRYNGOLZA and DAWNZERA to be between $100 million and $110 million and $110 million and $120 million, respectively, although a significant decline in second-quarter TRYNGOLZA revenue is expected due to the price reset effective April 1, with a gradual recovery anticipated post-June 30 approval.
See More
Ionis (IONS) Q1 2026 Earnings Call Transcript
See More
Ionis Pharmaceuticals Q1 Earnings Beat Expectations with 86.4% Revenue Growth
- Strong Earnings Report: Ionis Pharmaceuticals reported a Q1 GAAP EPS of -$0.56, beating expectations by $0.35, with revenue reaching $246 million, reflecting an impressive 86.4% year-over-year growth that boosts investor confidence.
- Cash Flow Status: As of March 31, 2026, Ionis had $1.9 billion in cash and short-term investments, a decrease of $633 million from year-end 2025, primarily due to the maturity of 0% convertible notes, indicating challenges in cash management.
- Sales Guidance Upgrade: The company raised its peak net sales guidance for olezarsen from over $2 billion to over $3 billion, driven by increased confidence in the sHTG market opportunity, signaling optimism for future growth.
- Improved 2026 Financial Guidance: Ionis revised its 2026 total revenue guidance from $800-825 million to $875-900 million, while reducing operating loss expectations from $500-550 million to $425-475 million, reflecting strong revenue performance and ongoing commercial success.
See More
Ionis Pharmaceuticals Q1 Earnings Announcement Scheduled
- Earnings Announcement: Ionis Pharmaceuticals is set to release its Q1 2023 earnings on April 29 before the market opens, with consensus EPS estimated at -$0.78 and revenue projected at $196.01 million, reflecting a 48.5% year-over-year increase.
- Earnings Estimate Adjustments: Over the last three months, EPS estimates have seen no upward revisions and three downward adjustments, while revenue estimates have experienced one upward revision and six downward changes, indicating market caution regarding Ionis's future performance.
- Product Review Progress: Ionis's zilganersen has received Priority Review for Alexander disease, which could support future revenue growth, although the overall market environment remains uncertain.
- Market Environment Impact: Amid disruptions in the Middle East, Ionis Pharmaceuticals and other healthcare stocks are viewed as oversold, potentially presenting buying opportunities for investors looking for value in the sector.
See More
