Ionis Pharmaceuticals CEO Teases Late-June Olezarsen Launch After FDA Priority Review Acceptance

• Olezarsen sNDA was accepted with priority review and a June 30 PDUFA date, and CEO Brett Monia said Ionis is positioned to launch “end of June, early July” with commercial supply and a ~200‑rep U.S. field team ready.

• Ionis expects three product approvals and launches in 2026 — olezarsen (sHTG), zilganersen (Alexander disease) and bepirovirsen (HBV via GSK) — alongside several other late‑stage readouts that could broaden its commercial portfolio.

• Commercial momentum: TRYNGOLZA delivered a strong first year with $108 million in revenue and a 56% quarter‑over‑quarter increase, leading Ionis to raise peak sales expectations for the combined FCS/sHTG opportunity to over $2 billion.

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Ionis Pharmaceuticals (NASDAQ:IONS) CEO Brett Monia told investors at Oppenheimer’s 36th Annual Healthcare Life Sciences Conference that the company received FDA acceptance of its supplemental NDA for olezarsen in severe hypertriglyceridemia (sHTG), including priority review and a June 30 PDUFA date. Monia said the timing positions the company to launch “at the end of June, early July,” and he characterized the review decision as a favorable surprise that accelerates the company’s entry into the sHTG market.

Monia said Ionis has been preparing under the assumption that a priority review could occur, and the company is now moving forward with commercial plans aligned to a summer launch window. He noted that Ionis’ existing presence in the triglyceride patient and physician community through its familial chylomicronemia syndrome (FCS) launch has helped build credibility with clinicians who also manage sHTG patients.

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Ionis has hired its full U.S. field team to support the anticipated launch, which Monia said totals “about 200 or so” representatives. He also said commercial supply is in place and that medical affairs has been educating clinicians about severe hypertriglyceridemia in advance of the expanded label.

Monia described 2025 as a “pivotal” and “transformational” period in which Ionis became a fully integrated commercial-stage biotechnology company. He pointed to two independent launches that began last year—TRYNGOLZA for FCS and DAWNZERA for hereditary angioedema (HAE) prophylaxis—and said both were off to a strong start.

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Looking ahead, Monia said Ionis expects three product approvals and launches in 2026, including:

• Olezarsen in sHTG, with a June 30 PDUFA date under priority review

• Zilganersen for Alexander disease, which the company expects to approve and launch in the second half of the year

• Bepirovirsen for chronic hepatitis B (HBV) through partner GSK, which he said is working toward approvals and launches in more than one market by year-end following positive results announced in early January

Monia also cited additional anticipated phase III readouts during the year, including pelacarsen for Lp(a) cardiovascular disease and eplontersen for ATTR cardiomyopathy in the second half, as well as a mid-year phase II readout for a partnered tau program with Biogen.

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On TRYNGOLZA, Monia said the product delivered quarter-over-quarter growth in its first year on the market. He highlighted a “56% increase” in revenue from the third to the fourth quarter and said the first-year total reached $108 million, which he stated exceeded consensus expectations.

Ionis emphasized the larger opportunity in sHTG, which Monia estimated affects more than 3 million people in the U.S. (defined as triglycerides of 500 and above). He highlighted an estimated “about 1 million” high-risk segment, including patients with a history of acute pancreatitis or triglycerides above 880. In discussing clinical results presented at the American Heart Association, he said the company observed up to 72% triglyceride reductions on top of standard of care and a “highly statistically significant” reduction in acute pancreatitis attacks.

Monia added that Ionis recently increased its peak sales expectations for the combined TRYNGOLZA opportunity in FCS and sHTG from more than $1 billion to more than $2 billion, citing healthcare provider demand research.

For DAWNZERA, Monia said the drug is resonating with physicians and patients as the “first and only RNA-targeted medicine” for prevention of HAE attacks. He described the market as a “switch market,” with patients transitioning from existing prophylactic therapies, and also noted use in patients previously managed with on-demand treatment as well as newly diagnosed patients. He also said DAWNZERA received European approval in January and is launching in Europe with partner Otsuka.

In Q&A, Monia said Ionis’ initial sHTG launch focus will center on the highest-risk patients—those with triglycerides above 500 with a history of acute pancreatitis, and those above 880 with or without such history—reflecting feedback from endocrinologists, cardiologists, lipid specialists, and pancreatologists.

On financial guidance, Monia said the company’s previously presented guidance assumed a standard review and that priority review would allow entry into the sHTG market “four months faster,” which he said would improve guidance. He said Ionis plans to update guidance at its end-of-first-quarter earnings call and expects to provide product-level revenue guidance at that time for TRYNGOLZA and DAWNZERA.

Monia also highlighted Ionis’ neurology franchise and upcoming potential launch of zilganersen for Alexander disease. He said the company reported positive phase III data in September, submitted an NDA, and initiated an expanded access program. He described the phase III results as showing a disease-modifying benefit and positioned the launch as Ionis’ first independent commercialization effort in neurology.

He added that Ionis’ phase III program in Angelman syndrome (obinutersen) is ongoing, with enrollment expected to complete this year and data expected next year. On commercialization strategy outside the U.S., Monia said Ionis remains focused on the U.S. market while seeking partners or distributors for ex-U.S. regions, adding that the company expects to secure an ex-U.S. partner for zilganersen before launch.

Ionis Pharmaceuticals, Inc is a biotechnology company focused on the discovery and development of RNA-targeted therapies designed to modulate gene expression. The company’s proprietary antisense oligonucleotide (ASO) technology enables the selective binding of short synthetic strands of nucleic acids to messenger RNA (mRNA), thereby inhibiting or altering the production of disease-causing proteins. Ionis’ pipeline spans a range of therapeutic areas, including neurological disorders, cardiovascular conditions, metabolic diseases and rare genetic disorders.

Since its founding in 1989 by Dr.

The article “Ionis Pharmaceuticals CEO Teases Late-June Olezarsen Launch After FDA Priority Review Acceptance” was originally published by MarketBeat.