Ionis Pharma

Ionis Pharmaceuticals, Inc. engages in the development and commercialization of human therapeutic drugs using antisense technology. It operates through the Ionis Core and Akcea Therapeutics segments. The Ionis Core segment exploits a novel drug discovery platform to generate a pipeline of drugs. The Akcea Therapeutics segment develops and commercializes drugs for cardiometabolic diseases. The company was founded by Stanley T. Crooke, David J. Ecker, Christopher K. Mirabelli, and Brett P. Monia in 1989 and is headquartered in Carlsbad, CA.

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Ionis Pharma excels in Q4, eyes revenue growth and strategic expansion

Ionis Pharma's Q4 2022 performance reflects strong revenue growth, pipeline advancements, and strategic positioning for future success.
The company's focus on commercialization, R&D innovation, and financial discipline underscores its resilience and growth potential in the biopharmaceutical industry.
While facing challenges in operational costs and market dynamics, Ionis Pharma remains well-positioned to leverage opportunities in genetic medicines and revenue diversification.

Ionis Pharma reports strong Q1 earnings and outlines growth plans

Ionis Pharma's Q1 performance solid with revenue growth and strong cash position
Company's strengths lie in FDA approvals, positive study data, and pipeline progress
Challenges include rising expenses, competitive landscape, and pricing strategies
Opportunities seen in PV market, HAE program, and growth prospects in coming years

Ionis Pharma reports strong Q2 performance and prepares for launches

Ionis Pharma's Q2 2023 earnings call highlighted strong performance, with revenue growth, key milestones in pipeline advancements, and a solid financial position.
The company faces challenges in study readout timing, competitive landscape changes, and market competition but has opportunities for growth through successful enrollment and product launches.
Key strengths include successful collaborations, encouraging interim results for SPINRAZA, and preparations for upcoming product launches, positioning Ionis Pharma for future success.
Overall, Ionis Pharma remains focused on advancing its pipeline, meeting financial guidance, and leveraging opportunities for growth in the biopharmaceutical market.

Ionis Pharma reports strong Q3 performance and neurology pipeline advancements

Ionis Pharma's Q3 earnings call highlighted strong performance, strategic successes, and advancements in the neurology pipeline.
The company faces challenges in a competitive landscape but has strengths in partnerships, innovation, and pricing strategies.
Opportunities lie in upcoming data releases, potential treatment benefits, and market differentiation strategies.
Overall, Ionis Pharma remains focused on delivering value to patients and investors through its innovative therapeutics.

Ionis Pharma reports robust 2023 results and eyes growth opportunities

Ionis Pharma's strong financial performance in 2023 and projected revenue for 2024 reflect a promising outlook for the company's growth and commercialization efforts.
While facing challenges in patient eligibility and treatment optimization, Ionis Pharma's focus on pipeline advancement and strategic investments positions it well for future success.
The company's emphasis on neurological disease platforms, upcoming data readouts, and collaborations present significant opportunities for expansion and innovation.

Ionis Pharma reports robust Q1 performance and advances key treatments

Ionis Pharma's Q1 2024 performance reflects strong revenue growth and progress in key pipeline programs, positioning the company for future success and sustained positive cash flow.
With a focus on strategic investments, innovative treatments, and upcoming data presentations, Ionis demonstrates a commitment to driving growth and addressing unmet medical needs.
While facing challenges in managing expenses and securing regulatory approvals, Ionis Pharma remains well-positioned to capitalize on market opportunities and partnerships for continued development and commercial success.

Ionis Pharma reports solid Q2 earnings, eyes growth through innovation

Ionis Pharma's Q2 performance reflects steady revenue growth and positive feedback on recent launches and ongoing trials.
The company's strengths lie in its innovative therapies, strong clinical profile, and strategic focus on expanding the product portfolio.
Challenges include sustaining momentum in competitive markets and ensuring successful commercialization of upcoming products.
Opportunities exist in market expansion, new patient segments, partnerships for pipeline growth, and investments in next-gen technologies.

Ionis Pharma reports strong pipeline progress and commercial success

Ionis Pharma's Q3 earnings call highlighted positive pipeline developments, successful product launches, and sustained investment for growth.
While facing challenges in competitive positioning and data availability, Ionis Pharma remains focused on leveraging opportunities in patient engagement and market expansion.
Overall, Ionis Pharma's performance reflects a promising outlook with strong potential for future growth and market impact.

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Ionis Pharmaceuticals, Inc. engages in the development and commercialization of human therapeutic drugs using antisense technology. It operates through the Ionis Core segment. The Ionis Core segment exploits a novel drug discovery platform to generate a pipeline of drugs. The company was founded by Stanley T. Crooke, David J. Ecker, Christopher K. Mirabelli, and Brett P. Monia on January 10, 1989 and is headquartered in Carlsbad, CA.

Although the revenue and EPS for Ionis Pharmaceuticals (IONS) give a sense of how its business performed in the quarter ended June 2024, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

Ionis Pharmaceuticals (IONS) Q2 Earnings: Taking a Look at Key Metrics Versus Estimates

Ionis Pharmaceuticals (IONS) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.95. This compares to loss of $0.60 per share a year ago.

Ionis Pharmaceuticals (IONS) Reports Q2 Loss, Tops Revenue Estimates

WAINUA TM  U.S. launch progressing well; approved in Canada; EU approval decision expected this year Olezarsen PDUFA December 19, 2024 for FCS Positive Phase 3 donidalorsen data for HAE; preparing U.S. and EU regulatory submissions On track to achieve 2024 financial guidance CARLSBAD, Calif. , Aug. 1, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) (the "Company"), today reported financial results for the second quarter of 2024.

Ionis reports second quarter 2024 financial results

Biogen

Alcyone's ThecaFlex is an implantable medical device under investigation for routine subcutaneous administration of therapeutics to the cerebrospinal fluid (CSF). The first stage of the pivotal IDE PIERRE trial has been completed.

Alcyone Therapeutics Announces Continued Enrollment Approval from FDA of the PIERRE Pivotal IDE Clinical Study of the ThecaFlex DRx™ System for Administration of nusinersen

Ionis Pharmaceuticals (IONS) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Ionis Pharmaceuticals (IONS) Expected to Beat Earnings Estimates: Should You Buy?

Data from an early-stage study shows that treatment with Ionis' (IONS) ION582 helps improve communication, cognition and motor function in patients with Angelman syndrome, a rare nerve disorder.

Ionis (IONS) Up 6% on Detailed Data From Angelman Drug Study

Ionis Pharmaceuticals, Inc. (NASDAQ:IONS ) HALOS Study of ION582 in Angelman Syndrome Conference Call July 22, 2024 8:00 AM ET Company Participants Wade Walke - Senior Vice President of Investor Relations Brett Monia - Chief Executive Officer Holly Kordasiewicz - Senior Vice President, Neurology Elizabeth Jalazo - Assistant Professor of Pediatrics, Division of Genetics & Metabolism, University of North Carolina School of Medicine Becky Crean - Executive Director, Neurology Lynne Bird - Professor of Clinical Pediatrics, University of California, San Diego, Rady Children's Hospital San Diego Eugene Schneider - Executive Vice President, Chief Clinical Development and Operations Officer Conference Call Participants Debjit Chattopadhyay - Guggenheim Securities Denis Reznik - Raymond James David Lebowitz - Citi Amy Li - Jefferies Yanan Zhu - Wells Fargo Securities Jessica Fye - JPMorgan Jay Olson - Oppenheimer Gena Wang - Barclays Paul Matteis - Stifel Andy Chen - Wolfe Research Salveen Richter - Goldman Sachs Yale Jen - Laidlaw & Company Brendan Smith - Yaron Werber Kostas Biliouris - BMO Capital Markets Jason Gerberry - Bank of America Myles Minter - William Blair Operator Good morning and welcome to Ionis' Conference Call to discuss Ionis' HALOS Study Results. As a reminder, this call is being recorded.

Ionis Pharmaceuticals, Inc. (IONS) HALOS Study of ION582 in Angelman Syndrome - (Transcript)

Ultragenyx Pharmaceutical

Ionis Pharmaceuticals Inc IONS released results Monday from the completed multiple ascending dose (MAD) portion of the Phase 1/2 open-label study of ION582 in people with Angelman syndrome (AS).

Ionis' Rare Development Disorder Drug Candidate 'Could Be Differentiated' From Peer Ultragenyx: Analyst

Ionis Pharmaceuticals stock surged Monday after the company unveiled promising results for a drug that treats a rare genetic condition.

Ionis Pharmaceuticals Surges Into Buy Zone As It, Possibly, Proves Biogen Wrong

ION582 showed robust and consistent benefit in communication, cognition and motor function in a broad patient population evaluated with a comprehensive set of assessment tools that collect input from parents and clinicians 97% of patients in the medium and high dose groups saw improvement in overall Angelman syndrome symptoms as measured by the SAS-CGI-C Improvements on the Bayley-4 in cognition, communication and motor function exceeded those observed in natural history studies Ionis plans to initiate Phase 3 development in H1 2025 Ionis to host webcast on Monday, July 22 at 8:00am ET CARLSBAD, Calif. , July 22, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive results from the completed multiple ascending dose (MAD) portion of the Phase 1/2 open-label study of ION582 in people with Angelman syndrome (AS) demonstrating consistent and encouraging clinical improvement on measures assessing all functional domains including communication, cognition and motor function.

Ionis announces positive detailed results from the HALOS Study of ION582 in people with Angelman syndrome

Ionis' (IONS) late-stage study is evaluating zilganersen in a rare neurological disorder called Alexander disease. Top-line data from this study is expected by the end of the next year.

Ionis (IONS) Completes Enrolment for Rare Disease Drug Study

Webcast scheduled for Thursday, August 1 at 11:30 a.m. Eastern Time CARLSBAD, Calif.

Ionis to hold second quarter 2024 financial results webcast

Zilganersen is the first investigational medicine in clinical development for people with Alexander disease, a rare, life-threatening neurological condition CARLSBAD, Calif. , July 18, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that it has completed enrollment in the pivotal trial of zilganersen (ION373), an investigational RNA-targeted medicine in development for the treatment of children and adults with a rare, progressive and ultimately fatal neurological disorder known as Alexander disease (AxD).

Ionis completes enrollment in pivotal trial evaluating zilganersen in people living with Alexander disease

Webcast scheduled for Monday, July 22 at 8:00 a.m. Eastern Time CARLSBAD, Calif.

Ionis announces webcast to report HALOS study results for ION582 in Angelman syndrome

The FDA grants priority review to Ionis' (IONS) filing seeking approval for olezarsen to treat adults with familial chylomicronemia syndrome. A final decision is expected in December 2024.

FDA Accepts Ionis' (IONS) NDA for Rare Disease Drug Olezarsen

Ionis Pharmaceuticals (IONS) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.

Ionis Pharmaceuticals (IONS) Soars 6.8%: Is Further Upside Left in the Stock?

–         Olezarsen PDUFA date set for December 19, 2024 for treatment of familial chylomicronemia syndrome – –         Phase 3 enrollment completed in CORE, CORE2 and ESSENCE evaluating olezarsen for the treatment of severe hypertriglyceridemia, with results expected in 2H 2025 – CARLSBAD, Calif. , June 25, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for olezarsen, an investigational RNA-targeted medicine for the treatment of adults with familial chylomicronemia syndrome (FCS).

Ionis announces olezarsen FCS New Drug Application accepted for Priority Review and enrollment in Phase 3 sHTG program completed

Ionis (IONS) out-licenses the rights for its HAE drug to Otsuka in the Asia-Pacific region. The companies signed a similar deal last year granting Otsuka rights to market the drug in Europe.

Ionis (IONS) Expands Licensing Deal With Otsuka for HAE Drug

Amgen

Bristol-Myers

SPDR S&P Biotech ETF

Mergers and acquisitions are on pace for a solid year. Small-cap biotech and tech look interesting.

M&A Is Back. 4 Stocks That Could Be Targets.

Otsuka will be responsible for commercialization efforts for donidalorsen across both Asia Pacific and Europe Ionis plans to independently bring donidalorsen to U.S. patients, if approved CARLSBAD, Calif. , June 18, 2024  /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that it has entered into a license agreement with Otsuka Pharmaceutical Co., Ltd.

Ionis announces expanded licensing agreement with Otsuka in Asia Pacific for investigational medicine donidalorsen in hereditary angioedema

CARLSBAD, Calif. , June 17, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that management will participate in a fireside chat at the virtual TD Cowen Genetic Medicines & RNA Summit on Thursday, June 20, 2024.

Ionis to present at TD Cowen Genetic Medicines & RNA Summit

Donidalorsen delivered significant and sustained reductions in HAE attacks, with high levels of disease control and improvement in quality of life measures with monthly or every two-month dosing; continued attack rate reduction over time In first-of-its-kind prospective analysis, patients switching from prior prophylactic treatment to donidalorsen experienced further reductions in mean monthly HAE attack rates from baseline Donidalorsen demonstrated a favorable safety and tolerability profile across all cohorts Data to be presented today at EAACI Congress 2024 Ionis to host webcast on Friday, May 31 at 8:00am ET CARLSBAD, Calif. , May 31, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive results from the Phase 3 OASIS-HAE and OASISplus studies of donidalorsen in patients with hereditary angioedema (HAE) demonstrating significant and sustained reduction in mean monthly HAE attack rates and continued attack rate improvement of >90% with one year of treatment for both monthly or every two-month dosing.

Ionis presents positive results from OASIS-HAE and OASISplus studies of investigational medicine donidalorsen in patients with hereditary angioedema

Ionis Pharmaceuticals' Q1 2024 earnings showed a loss of $143m, a larger loss than the $87m in the previous year. The company has a healthy cash balance of $2.2bn and expects revenues of +$575m in 2024, albeit with further heavy losses. Ionis has several upcoming pipeline opportunities, including the potential approval of pelacarsen and label expansions for Wainua and Olezarsen.

Ionis: Tough Run For Share Price Belies Multiple Reasons For Optimism

Webcast scheduled for Friday, May 31 at 8:00 a.m. Eastern Time CARLSBAD, Calif.

Ionis to hold donidalorsen Phase 3 data webcast

– Results across NEURO-TTRansform subgroups show consistent benefit in neuropathy impairment and improved quality of life, regardless of patient segmentation – CARLSBAD, Calif. , May 23, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that it will present new subgroup analyses from Ionis and AstraZeneca's Phase 3 NEURO-TTRansform study of WAINUA™ (eplontersen) at the 2024 International Symposium on Amyloidosis (ISA) in Rochester, Minnesota, May 26-30.

New data from the Phase 3 NEURO-TTRansform study evaluating WAINUA™ (eplontersen) to be presented at the 2024 International Symposium on Amyloidosis (ISA)

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