BIIB's sNDA for Higher Dose of SMA Drug Spinraza Gets FDA's CRL
FDA issues CRL to Biogen's regulatory filing seeking approval for a higher dose of SMA drug, Spinraza. The company plans prompt resubmission.
Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen
CAMBRIDGE, Mass., Sept. 23, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. ( Nasdaq: BIIB ) today announced that the U.S. Food and Drug Administration ( FDA ) issued a Complete Response Letter ( CRL ) for the Company's supplemental New Drug Application ( sNDA ) for the high dose regimen of nusinersen for ...
Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen - Ionis Pharmaceuticals ( NASDAQ:IONS ) , Biogen ( NASDAQ:BIIB )
CAMBRIDGE, Mass., Sept. 23, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. BIIB today announced that the U.S. Food and Drug Administration ( FDA ) issued a Complete Response Letter ( CRL ) for the Company's supplemental New Drug Application ( sNDA ) for the high dose regimen of nusinersen for the ...
IONS' Rare Neurological Disease Drug Meets Late-Stage Study Goal
Ionis' zilganersen hits its phase III goal in Alexander disease, paving the way for a potential FDA filing in early 2026.
Ionis Pharmaceuticals Reveals 'Unprecedented Results' From Rare Neurological Disease Trial - Ionis Pharmaceuticals ( NASDAQ:IONS )
Ionis Pharmaceuticals, Inc. IONS released topline results on Monday from the pivotal study of zilganersen in children and adults living with Alexander disease ( AxD ) , a rare, progressive, and often fatal neurological condition.
Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates
CAMBRIDGE, Mass., Sept. 18, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. ( Nasdaq: BIIB ) announced the company has entered into a definitive agreement to acquire Massachusetts-based Alcyone Therapeutics. As part of an existing partnership with Alcyone Therapeutics, the companies are advancing ...
IONS Up on FDA's Breakthrough Tag for ION582 in Angelman Syndrome
Ionis jumps as FDA grants Breakthrough Therapy status to ION582 for treating Angelman syndrome, with the phase III study now underway.
Ionis Rare Neurological Disease Candidate Receives FDA Breakthrough Status - Ionis Pharmaceuticals ( NASDAQ:IONS )
FDA grants Breakthrough Therapy status to ION582 based on strong Phase 1/2 results in Angelman syndrome. Phase 3 REVEAL study targeting Angelman syndrome patients is set to enroll until 2026. Get the strategy to turn September's volatility into 10x trades → On Tuesday, the U.S.
IONS Hits 52-Week High on Tryngolza's Success in Lowering Triglyceride
Ionis surges to a 52-week high after Tryngolza shows strong triglyceride reductions and cuts acute pancreatitis risk by 85% in late-stage studies.
Air Lease, Ionis Pharmaceuticals, Arrowhead Pharmaceuticals And Other Big Stocks Moving Higher On Tuesday - Apollo Asset Management ( NYSE:APO ) , Air Lease ( NYSE:AL )
U.S. stocks were lower, with the Dow Jones index falling over 250 points on Tuesday. Shares of Air Lease Corporation AL rose sharply during Tuesday's session after the aircraft lessor said it will be acquired by a newly formed Dublin-based holding company backed by Sumitomo Corp.
Why Is Ionis Pharma Stock Skyrocketing Tuesday? - Ionis Pharmaceuticals ( NASDAQ:IONS )
Olezarsen cut triglycerides by up to 72% and pancreatitis events by 85% in pivotal Phase 3 trials. Ionis plans an FDA filing by year-end following strong trial results for severe hypertriglyceridemia. Ionis Pharmaceuticals, Inc.
Raina Biosciences Unveils Breakthrough Generative AI Platform for mRNA Therapeutics Featured in Science
- GEMORNA is world's first generative AI platform purpose-built for mRNA design and optimization, demonstrating state-of-the-art performance across diverse mRNA therapeutic applications -
What's Going On With Takeda Stock On Friday? - Takeda Pharmaceutical Co ( NYSE:TAK )
Dawnzera is priced at $57,462 per dose, with peak annual sales estimated at $509 million by 2032. Takeda's Takhzyro sales rose 3.7% to 55.1 billion yen in Q2 2025 despite rising competition. See the seasonal trading strategy that's beating the S&P 500 by 6X this year. Details here →
Why Is Ionis Pharma Stock Gaining Thursday? - Ionis Pharmaceuticals ( NASDAQ:IONS )
Dawnzera cut monthly HAE attacks by 81% vs placebo in Phase 3, with up to 87% reduction after second dose. Patients switching from Takhzyro or Orladeyo saw a 62% lower HAE attack rate with Dawnzera. See the 6X seasonal strategy set to target this fall's biggest opportunities. Details here →
IONS Premarket Gains 2.4% After C-Suite Insider Sells $440K In Stock - Stifel Financial ( NYSE:SF ) , Ionis Pharmaceuticals ( NASDAQ:IONS )
Ionis Pharmaceuticals Inc. IONS closed regular trading at $42.81, up 0.78% for the day, before gaining an additional 2.38% in premarket trading to $43.83, according to Benzinga Pro data, following disclosure of insider trading activity by its chief scientific officer.
BioCryst Pharmaceuticals Before Q2 Earnings: How to Play the Stock
BCRX gears up for Q2 results with Orladeyo growth in focus, but 2025 EPS forecasts dip as investors eye pipeline progress.
Ionis ( IONS ) Q2 Revenue Soars 101%
Ionis Pharmaceuticals ( NASDAQ:IONS ) , a biotechnology company focused on RNA-targeted therapeutics, reported its second quarter 2025 earnings on July 30, 2025. The headline news was a substantial beat on both GAAP revenue and non-GAAP earnings compared to Wall Street estimates.
Ionis Beats on Q2 Earnings & Sales, Stock Up 5% on Raised '25 Outlook
Ionis crushes Q2 estimates with EPS of $0.86 and sales of $452 million, lifting its 2025 revenue forecast and sending shares up 5%.
Ionis ( IONS ) Q2 2025 Earnings Call Transcript
Image source: The Motley Fool.Tuesday, July 29, 2025 at 8 p.m. ETChief Executive Officer - Brett MoniaContinue reading ...
Why Ionis Pharmaceuticals Shares Are Up After Q2 Report - Ionis Pharmaceuticals ( NASDAQ:IONS )
Ionis posted Q2 EPS of 85 cents vs. a 52 cents loss expected, with revenue at $452 million, beating $282.95 million consensus. FY25 revenue guidance raised to $825-$850 million; Tryngolza sales outlook hiked to $75-$80 million. Missed the rally? Learn exactly where the next leaders are emerging ...
Ionis Pharmaceuticals ( IONS ) Q2 Earnings and Revenues Beat Estimates
Ionis Pharmaceuticals (IONS) delivered earnings and revenue surprises of +218.52% and +66.96%, respectively, for the quarter ended June 2025. Do the numbers hold clues to what lies ahead for the stock?
Ionis Pharmaceuticals ( IONS ) Earnings Expected to Grow: Should You Buy?
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.
BioVie Appoints Industry Veterans Amy Chappell, MD, FAAN, and Kameel Farag to Board of Directors
Seasoned leaders bring deep expertise in neuroscience drug development, strategic growth, and corporate finance to support BioVie's mission Seasoned leaders bring deep expertise in neuroscience drug development, strategic growth, and corporate finance to support BioVie's mission ...
Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025
CAMBRIDGE, Mass., July 21, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. ( Nasdaq: BIIB ) today announced upcoming scientific presentations at the 2025 Alzheimer's Association International Conference ( AAIC ) , taking place July 27-31 in Toronto, Canada.
Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025 - Biogen ( NASDAQ:BIIB )
Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued care Presentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations ...
Should You Buy Ionis Pharmaceuticals ( IONS ) After Golden Cross?
Should investors be excited or worried when a stock's 50 -day simple moving average crosses above the 200-day simple moving average?
Ionis Pharmaceuticals ( IONS ) Moves 9.1% Higher: Will This Strength Last?
Ionis Pharmaceuticals (IONS) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
New Data for Nusinersen Underscore Biogen's Commitment to Advancing Clinical Research to Improve Outcomes in SMA
CAMBRIDGE, Mass., June 27, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. ( Nasdaq: BIIB ) today announced new data that reinforce the clinical impact of nusinersen across a broad spectrum of individuals affected by spinal muscular atrophy ( SMA ) .
Biogen/Ionis Drug Shows Promise In Children With Spinal Muscular Atrophy - Ionis Pharmaceuticals ( NASDAQ:IONS ) , Biogen ( NASDAQ:BIIB )
Biogen's salanersen cut neurofilament levels by 70% in spinal muscular atrophy patients previously treated with Zolgensma. 50% of children with spinal muscular atrophy gained new WHO motor milestones after 1 year of salanersen treatment. Ready to turn the market's comeback into steady cash flow?
Biogen to Advance Investigational Spinal Muscular Atrophy Asset to Registrational Studies Based on Positive Interim Phase 1 Results - Ionis Pharmaceuticals ( NASDAQ:IONS ) , Biogen ( NASDAQ:BIIB )
Salanersen ( BIIB115/ION306 ) is a novel antisense oligonucleotide ( ASO ) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy ( SMA )
Biogen to Advance Investigational Spinal Muscular Atrophy Asset to Registrational Studies Based on Positive Interim Phase 1 Results
CAMBRIDGE, Mass., June 25, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. ( Nasdaq: BIIB ) announced topline results from the Phase 1 study of salanersen ( BIIB115/ION306 ) , an antisense oligonucleotide ( ASO ) being developed for the treatment of spinal muscular atrophy ( SMA ) .
Why Is Esperion Therapeutics ( ESPR ) Up 28.6% Since Last Earnings Report?
Esperion Therapeutics (ESPR) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Recursion Pharmaceuticals ( RXRX ) Up 5.7% Since Last Earnings Report: Can It Continue?
Recursion Pharmaceuticals (RXRX) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Ionis' Tryngolza Cuts Triglyceride Levels in Late-Stage Study
Late-stage data shows that treatment with an 80mg dose of IONS' Tryngolza achieved a 61% placebo-adjusted reduction in triglyceride levels in six months.
Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2025 Financial Results
On track for six major study readouts across four programs over the next 12 months ...
Ionis Q1 Earnings and Sales Top Estimates, Stock Gains on Raised '25 View
IONS reports better-than-expected first-quarter results. The company raises its sales guidance for 2025 by more than 20% on the back of two new licensing deals.
Ionis Pharmaceuticals Narrows Q1 Loss, Lifts Revenue Forecast While Drug Sales Surge - Ionis Pharmaceuticals ( NASDAQ:IONS )
Q1 revenue rises 10% to $132 million, exceeding the $125.3 million estimate; EPS loss improves to 93 cents vs. $1.12 consensus. 2025 revenue forecast raised to $725 million-$750 million from $600 million+; cash expected at ~$1.9 billion. Don't face extreme market conditions unprepared.
Ionis Pharmaceuticals ( IONS ) Reports Q1 Loss, Tops Revenue Estimates
Ionis Pharmaceuticals (IONS) delivered earnings and revenue surprises of 32.43% and 9.86%, respectively, for the quarter ended March 2025. Do the numbers hold clues to what lies ahead for the stock?
Amneal Pharmaceuticals ( AMRX ) Earnings Expected to Grow: Should You Buy?
Amneal (AMRX) 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: What to Know Ahead of Q1 Release
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.
Oncotelic's ASO Platform Could Mark A New Era In RNA Therapeutics - Oncotelic Therapeutics ( OTC:OTLC )
Oncotelic Therapeutics Inc. OTLC, the RNA-based therapeutics company, says it is making progress advancing its antisense oligonucleotide ( ASO ) platform, fueled by promising clinical data and growing evidence that Transforming Growth Factor Beta 2 ( TGFB2 ) may be a critical driver of immune ...
Ionis Pharmaceuticals ( IONS ) Surges 8.9%: Is This an Indication of Further Gains?
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 doesn't suggest further strength down the road.
Drugmaker Ionis Pharmaceuticals Garners Analyst Praise For 'Pipeline Depth' - Ionis Pharmaceuticals ( NASDAQ:IONS )
Ionis reported $705 million in 2024 revenue, topping guidance and boosted by two new product launches. U.S. Phase 3 results for Tryngolza in sHTG expected in H2 2025, targeting 2.3 million patients. Feel unsure about the market's next move?
This Reddit Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For Monday - Ionis Pharmaceuticals ( NASDAQ:IONS ) , Axsome Therapeutics ( NASDAQ:AXSM )
Top Wall Street analysts initiated coverage on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page. HC Wainwright & Co. analyst Mitchell Kapoor initiated coverage on Ionis Pharmaceuticals, Inc.
BIIB's Experimental Alzheimer's Drug Gets FDA Fast Track Tag
The FDA's fast track designation will facilitate rapid development and expedited review of Biogen's Alzheimer's disease candidate.
Biogen's Investigational Tau-Targeting Therapy BIIB080 Receives FDA Fast Track Designation for the Treatment of Alzheimer's Disease
CAMBRIDGE, Mass., April 02, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. ( Nasdaq: BIIB ) today announced that the U.S. Food and Drug Administration ( FDA ) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide ( ASO ) therapy targeting tau, for the treatment of ...
Biogen's Investigational Tau-Targeting Therapy BIIB080 Receives FDA Fast Track Designation for the Treatment of Alzheimer's Disease - Biogen ( NASDAQ:BIIB )
CAMBRIDGE, Mass., April 02, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. BIIB today announced that the U.S. Food and Drug Administration ( FDA ) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide ( ASO ) therapy targeting tau, for the treatment of Alzheimer's ...
Catalyst ( CPRX ) Up 14.7% Since Last Earnings Report: Can It Continue?
Catalyst (CPRX) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
IONS Out-Licenses ex-U.S. Rights for Rare Disease Drug Tryngolza to Sobi
In return, Ionis will receive an undisclosed upfront payment from Sobi. It is also eligible to receive milestone payments and a tiered royalty on the drug's future sales.
Praxis Precision Medicines to Present on Late-Stage Programs across Epilepsy and Movement Disorders at the American Academy of Neurology 2025 Annual Meeting - Ionis Pharmaceuticals ( NASDAQ:IONS ) , Praxis Precision Medicine ( NASDAQ:PRAX )
BOSTON, March 24, 2025 ( GLOBE NEWSWIRE ) -- Praxis Precision Medicines, Inc.
