Ionis Pharmaceuticals, Inc.
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961 articles with Ionis Pharmaceuticals, Inc.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen's effect on neurofilament light chain (NfL) could be a reasonable predictor of clinical benefit.
Ionis announces FDA advisory committee voted unanimously for a potential accelerated approval of tofersen for SOD1-ALS
Ionis announced the outcome of the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational antisense medicine for the treatment of people with superoxide dismutase 1 amyotrophic lateral sclerosis.
Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
An advisory committee will meet March 22 to discuss the fate of Biogen and Ionis’ ALS hopeful tofersen. For that and more, see inside.
The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.
Ionis announces FDA acceptance of New Drug Application for eplontersen for the treatment of hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN)
Ionis Pharmaceuticals (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for eplontersen, an investigational antisense medicine for the treatment of people living with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN).
Ionis to present at upcoming investor conferences - February 28, 2023
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that management will present at the following investor conferences.
Ionis reports fourth quarter and full year 2022 financial results
Ionis Pharmaceuticals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2022.
Ionis announces new donidalorsen data and presentations at the 2023 American Academy of Allergy, Asthma & Immunology Annual Meeting
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced additional positive interim data from a Phase 2 open-label extension (OLE) study of donidalorsen, an investigational antisense medicine for the treatment of patients with hereditary angioedema (HAE).
Ionis to hold fourth quarter and full year 2022 financial results webcast
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that it will host a live webcast on Wednesday, February 22 nd at 11:30 a.m. Eastern Time to discuss its fourth quarter and full year 2022 financial results.
Ionis announces GSK has advanced bepirovirsen into Phase 3 development
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that GSK has initiated two randomized, double-blind, placebo-controlled Phase 3 studies evaluating the safety and efficacy of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B infection (CHB).
Ionis Chief Scientific Officer C. Frank Bennett, Ph.D. to receive Rainwater Prize for Outstanding Innovation in Neurodegenerative Disease Research
Ionis Pharmaceuticals, Inc. announced that Chief Scientific Officer C. Frank Bennett, Ph.D., has been named a co-recipient of the Rainwater Prize for Outstanding Innovation in Neurodegenerative Disease Research.
The FDA's Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis's ALS candidate tofersen on March 22nd.
At JPM Wednesday, Ionis CEO Brett Monia touted nine positive late- and mid-stage readouts from 2022 and set up the company's commercial prospects for 2023.
Ionis and Royalty Pharma enter into royalty agreement for up to $1.1 billion to further advance Ionis' genetic medicines and commercial readiness
Ionis Pharmaceuticals, Inc. and Royalty Pharma plc announced that Royalty Pharma has acquired an interest in Ionis' royalty in Biogen's SPINRAZA® and Novartis' pelacarsen for up to $1.125 billion, including an upfront payment of $500 million and up to $625 million in additional pelacarsen milestone payments.
Ionis to present at 41st Annual J.P. Morgan Healthcare conference
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that Brett P. Monia , Ph.D., chief executive officer, will present a company overview and participate in a Q&A session at the 41st Annual J.P. Morgan Healthcare Conference at 9:45 a.m. PT ( 12:45 p.m. ET ) on Wednesday, January 11, 2023.
Ionis announces European Medicines Agency accepts Marketing Authorization Application of tofersen to treat rare, genetic form of ALS
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for review of tofersen, an investigational medicine for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
Ionis Pharmaceuticals inked a collaboration deal with Metagenomi with the goal of adding DNA editing to its RNA-targeted technologies focused on up to four genetic targets.
Ionis partners with Metagenomi to add gene editing to its broad technology platform
Ionis Pharmaceuticals, Inc. and Metagenomi announced that the companies have entered a collaboration that will leverage Ionis' extensive expertise in RNA-targeted therapeutics and Metagenomi's versatile next-generation gene editing systems to pursue a mix of validated and novel genetic targets that have potential to expand therapeutic options for patients.
Ionis presents positive Phase 2 data from open label extension study of donidalorsen at 2022 ACAAI Annual Meeting
Ionis Pharmaceuticals, Inc. presented positive results from a Phase 2 open-label extension study evaluating the safety and efficacy of its investigational antisense medicine, donidalorsen, in patients with hereditary angioedema, a rare and devastating inflammatory disease.