StreetInsider.com News Articles

FDA approves GSK's Hibsago for chronic hepatitis B treatment

Wed, 21 Oct 2026 06:11:57 -0400

The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen), developed by GSK in collaboration with Ionis Pharmaceuticals (NASDAQ: IONS), for the treatment of chronic hepatitis B virus infection in adult patients without cirrhosis who have been on nucleos(t)ide analogue therapy for at least six months with suppressed HBV DNA and HBV surface antigen levels at or below 3,000 IU/ml.

The approval was granted under FDA priority review and Breakthrough Therapy Designation. Bepirovirsen is also approved in Japan and has received Breakthrough Therapy and Priority Review designation in China, as well as SENKU designation in Japan.

Phase 3 B-Well trial data, conducted

FDA approves GSK's Hibsago for chronic hepatitis B treatment

Wed, 21 Oct 2026 06:11:57 -0400

Phase 3 B-Well trial data, conducted

Citi defending Ionis Pharmaceuticals

Wed, 21 Oct 2026 04:08:01 -0400

Citi analyst Eric Joseph reiterated a Buy rating and $100.00 price target on Ionis Pharmaceuticals (NASDAQ: IONS).

Joseph noted that attention is focused on the early launch performance of Tryngolza for severe hypertriglyceridemia (sHTG) ahead of third-quarter results. He cited Ionis management's decision to defer reiterating fiscal year 2026 guidance at recent broker conferences as a factor contributing to expectations of a potential downward revision.

Ionis shares have declined approximately 24% over the past 60 days, compared to a 2% decline in the NBI index over the same period.

The analyst said sequential Tryngolza prescription trends leave him optimistic about an in-line quarter,

Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)

Tue, 20 Oct 2026 21:20:00 -0400

– Approval based on Phase 3 data showing unprecedented functional cure rates compared to standard of care –

– Six-month treatment with option of at-home administration after first dose –

– CHB affects approximately 1.7 million people in the U.S. –

CARLSBAD, Calif.--(BUSINESS WIRE)-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner GSK today announced that the U.S. Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at

Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)

Tue, 20 Oct 2026 21:20:00 -0400

Ionis Pharmaceuticals (IONS) PT Lowered to $79 at Raymond James

Tue, 20 Oct 2026 06:35:14 -0400

Raymond James analyst Tiago Fauth lowered the price target on Ionis Pharmaceuticals (NASDAQ: IONS) to $79.00 (from $84.00) while maintaining a Outperform rating.

Form 4 IONIS PHARMACEUTICALS For: Oct 15 Filed by: Swayze Eric

Mon, 19 Oct 2026 21:40:00 -0400

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Form 4 IONIS PHARMACEUTICALS For: Oct 15 Filed by: Devers Shannon L.

Mon, 19 Oct 2026 21:40:00 -0400

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Form 144 IONIS PHARMACEUTICALS Filed by: Devers Shannon L.

Fri, 16 Oct 2026 17:17:00 -0400

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EU panel recommends Ionis olezarsen for severe hypertriglyceridemia

Fri, 16 Oct 2026 06:45:16 -0400

Ionis Pharmaceuticals (Nasdaq: IONS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending an indication extension for TRYNGOLZA (olezarsen) to treat adult patients with severe hypertriglyceridemia (sHTG) with fasting triglyceride levels of 880 mg/dL or higher.

The recommendation, which arrived ahead of the previously anticipated timeline, covers use of the drug as an adjunct to diet in combination with other lipid-lowering therapies. A final decision from the European Commission is expected in the fourth quarter of 2026.

The CHMP opinion is based on results from the Phase 3 CORE

TRYNGOLZA® (olezarsen) recommended for approval in the EU by CHMP for severe hypertriglyceridemia (sHTG)

Fri, 16 Oct 2026 06:45:00 -0400

CARLSBAD, Calif.--(BUSINESS WIRE)-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the indication extension for TRYNGOLZA® (olezarsen) as an adjunct to diet, in combination with other lipid-lowering therapies, for the treatment of adult patients with severe hypertriglyceridemia (sHTG, fasting triglyceride levels of ≥880 mg/dL [≥10 mmol/L]). If confirmed by the European Commission (EC), TRYNGOLZA would be the first and only RNA-targeted therapy authorized in the EU for adults with sHTG and triglyceride

TRYNGOLZA® (olezarsen) recommended for approval in the EU by CHMP for severe hypertriglyceridemia (sHTG)

Fri, 16 Oct 2026 06:45:00 -0400

H.C. Wainwright Reiterates Buy Rating on Ionis Pharmaceuticals (IONS)

Thu, 24 Sep 2026 06:45:28 -0400

H.C. Wainwright analyst Mitchell Kapoor reiterated a Buy rating and $100.00 price target on Ionis Pharmaceuticals (NASDAQ: IONS).

The analyst commented: "Roche’s 459-patient Phase 3 IMAgINATION study met the pre-specified Week 37 primary endpoint, with once-monthly sefaxersen producing a statistically significant reduction in 24-hour UPCR vs. placebo; the blinded study continues through Week 105 for eGFR. The proteinuria win supports regulatory discussions that could precede the two-year kidney-function readout. Roche’s March commercial framework put sefaxersen peak sales at €1B-2B; Ionis retains tiered royalties from the high teens to 20% of net sales. The Phase 3 effect size remains undisclosed. The next

Oppenheimer Reiterates Outperform Rating on Ionis Pharmaceuticals (IONS)

Thu, 24 Sep 2026 05:41:33 -0400

Oppenheimer analyst Jay Olson reiterated an Outperform rating and $85.00 price target on Ionis Pharmaceuticals (NASDAQ: IONS).

The analyst comments "IONS reported two meaningful late-stage successes with positive Ph3 results for ulefnersen in FUS-ALS and positive interim Ph3 results for sefaxersen in IgA nephropathy. We believe these advances further validate the breadth of IONS's RNA-targeted technology platform while highlighting growing capabilities across neurology and renal disease. Management emphasized that learnings from Qalsody informed the successful FUSION study design and now provide a framework for future ALS development. We also view recent progress as supporting our confidence in IONS's wholly-owned programs including

BMO Capital Reiterates Market Perform Rating on Ionis Pharmaceuticals (IONS)

Wed, 23 Sep 2026 08:56:00 -0400

BMO Capital analyst David Lebowitz reiterated a Market Perform rating and $54.00 price target on Ionis Pharmaceuticals (NASDAQ: IONS).

The analyst commented: "ASO Still Works; Ulefnersen Pivotal Success in ALS Provides Needed Validation; IONS reported positive results from ulefnersen FUSION study in FUS-ALS, meeting primary endpoint on functional improvement and survival (here). Statistically significant improvements in serum NfL, a secondary marker of disease progression, and favorable tolerability support ulefnersen’s profile. FUSION represents the first positive placebocontrolled Ph3 study of a therapy targeting the underlying genetic cause of FUS-ALS. While IONS retains minority economics in Otsuka-partnered ulefnersen, the study provides further validation

Canaccord Reiterates Buy Rating on Ionis Pharmaceuticals (IONS)

Wed, 23 Sep 2026 06:39:17 -0400

Canaccord analyst Gary Nachman reiterated a Buy rating and $85.00 price target on Ionis Pharmaceuticals (NASDAQ: IONS).

The analyst commented: "IONS/Otsuka announced positive topline results from the Ulefnersen Ph3 trial in FUS-ALS, a nice win for an IONS-developed neurology program. Ulefnersen (developed by IONS, outlicensed to Otsuka in late-2024) demonstrated highly statistically significant results on its primary endpoint for this rare/devastating genetic subtype of ALS (FUS-ALS affects ~0.6% of all ALS cases). Key secondary endpoints were also statistically significant and Ulefnersen had a favorable safety/ tolerability profile (most AEs mild/moderate in severity). Notably, the Ph3 FUSION trial is the first-ever placebo

Form 8-K IONIS PHARMACEUTICALS For: Sep 23

Wed, 23 Sep 2026 06:03:00 -0400

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Roche's sefaxersen meets Phase 3 primary endpoint in kidney disease trial

Wed, 23 Sep 2026 01:01:13 -0400

Ionis Pharmaceuticals (Nasdaq: IONS) and partner Roche announced positive prespecified interim results from the ongoing Phase 3 IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy (IgAN), according to a press release.

The study met its primary endpoint, with sefaxersen achieving statistically significant reductions in proteinuria compared to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR). The safety and tolerability profile was consistent with previously reported data, with no new safety signals identified.

The IMAgINATION study enrolled 459 participants, randomized 1:1 to receive sefaxersen or placebo for 105 weeks. The study will continue as a blinded

Ionis announces positive interim data from partner Roche’s Phase 3 IMAgINATION study in IgA nephropathy (IgAN)

Wed, 23 Sep 2026 01:00:00 -0400

– Sefaxersen demonstrated statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, showing best-in-class potential –

– IgAN is a progressive kidney disease that is typically diagnosed in young adults and up to 50% of people progress to kidney failure within 20 years, requiring dialysis or transplantation –

– Interim data will be presented at an upcoming medical meeting and shared with health authorities –

CARLSBAD, Calif.--(BUSINESS WIRE)-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and partner Roche today announced positive prespecified interim results from the ongoing Phase 3 IMAgINATION study

Ionis announces positive interim data from partner Roche’s Phase 3 IMAgINATION study in IgA nephropathy (IgAN)

Wed, 23 Sep 2026 01:00:00 -0400

– Sefaxersen demonstrated statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, showing best-in-class potential –

– IgAN is a progressive kidney disease that is typically diagnosed in young adults and up to 50% of people progress to kidney failure within 20 years, requiring dialysis or transplantation –

– Interim data will be presented at an upcoming medical meeting and shared with health authorities –

CARLSBAD, Calif.--(BUSINESS WIRE)-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and partner Roche today announced positive prespecified interim results from the ongoing Phase 3 IMAgINATION study

Ionis Pharmaceuticals (IONS) PT Lowered to $70 at JPMorgan Amid Negative Sentiment

Tue, 22 Sep 2026 08:37:29 -0400

(Updated - September 22, 2026 8:37 AM EDT)

JPMorgan analyst Jessica Fye lowered the price target on Ionis Pharmaceuticals (NASDAQ: IONS) to $70.00 (from $76.00) while maintaining an Overweight rating.

The analyst commented, "With recent pipeline disappointments in the rear view, we see the IONS story as cleanly focused on the Tryngolza launch. Even after those setbacks would have presumably been priced in, however, the stock has acted heavy over the past ~2 weeks (-23% vs XBI -3%) and we have heard investors questioning mgmt’s tone specifically on Tryngolza’s early launch."

Ionis Pharmaceuticals (IONS) PT Lowered to $70 at JPMorgan Amid Negative Sentiment

Tue, 22 Sep 2026 08:37:29 -0400

(Updated - September 22, 2026 8:37 AM EDT)

JPMorgan analyst Jessica Fye lowered the price target on Ionis Pharmaceuticals (NASDAQ: IONS) to $70.00 (from $76.00) while maintaining an Overweight rating.

Ionis drug ulefnersen meets primary endpoint in FUS-ALS Phase 3 trial

Tue, 22 Sep 2026 08:01:04 -0400

Ionis Pharmaceuticals (Nasdaq: IONS) and Otsuka Pharmaceutical Development & Commercialization announced positive topline results from the Phase 3 FUSION trial evaluating ulefnersen, an investigational RNA-targeted medicine, in people living with FUS-ALS, a rare genetic form of amyotrophic lateral sclerosis.

The study met its primary endpoint, with ulefnersen showing a statistically significant improvement on a joint rank analysis of time to death or permanent ventilation, time to rescue, and change in ALS Functional Rating Scale Revised score from baseline to Day 505 compared to placebo (p=0.0005). The primary analysis population included 73 participants.

The trial also met statistically significant secondary endpoints, including change

Ionis announces positive topline results from Phase 3 FUSION study of ulefnersen marking significant milestone in advancing first potential disease modifying treatment for FUS-ALS

Tue, 22 Sep 2026 08:00:00 -0400

– Ulefnersen demonstrated a statistically significant improvement on the primary endpoint assessing functional impairment and survival in people living with FUS-ALS, supporting the potential to modify disease progression –

– Results will be discussed with the U.S. FDA and health authorities globally to enable potential expedited regulatory submission pathways for approval –

CARLSBAD, Calif.--(BUSINESS WIRE)-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Otsuka Pharmaceutical Development & Commercialization, Inc., today announced positive topline results from the Phase 3 FUSION trial evaluating ulefnersen, an investigational RNA-targeted medicine, in people living with amyotrophic lateral sclerosis (ALS) caused

Ionis announces positive topline results from Phase 3 FUSION study of ulefnersen marking significant milestone in advancing first potential disease modifying treatment for FUS-ALS

Tue, 22 Sep 2026 08:00:00 -0400

– Results will be discussed with the U.S. FDA and health authorities globally to enable potential expedited regulatory submission pathways for approval –