BIIB News - Candlesense

C4 Therapeutics Highlights Recent Achievement in Biogen Collaboration

(NASDAQ:BIIB) Development Candidate Targeting IRAK4 Now Progressing Toward Clinical Development Development Candidate Targeting IRAK4 Now Progressing Toward Clinical Development

What are the broader implications for C4 Therapeutics' pipeline valuation and future partnership opportunities with Biogen if the IRAK4 candidate successfully advances toward clinical development? How does the progression of C4 Therapeutics' IRAK4 candidate compare to similar programs at competing biotech firms, and could it affect market share in the immune‑signaling space? What potential short‑term catalyst does the IRAK4 development candidate represent for BIIB's stock price?

Clinical trials

3 days ago

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Stoke Therapeutics and Biogen Present Data at the 36th International Epilepsy Congress that Support the Potential for Zorevunersen to be the First Disease-Modifying Medicine for Dravet Syndrome

(NASDAQ:BIIB) BEDFORD, Mass. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s...

How might this partnership with Stoke Therapeutics influence Biogen's pipeline diversification and competitive positioning in the rare neurological space? What are the potential regulatory timelines and market exclusivity for a disease‑modifying therapy in Dravet syndrome compared to existing treatments? How will the Phase 1/2a results for zorevunersen affect Biogen's valuation and upcoming earnings guidance?

Clinical trials

5 days ago

Biogen and Stoke Therapeutics Present Data at the 36th International Epilepsy Congress that Support the Potential for Zorevunersen to be the First Disease-Modifying Medicine for Dravet Syndrome

(NASDAQ:BIIB) – Durable reductions in seizures and continuing improvements in cognition and behavior through 3 years in patients who continued to receive zorevunersen in the open-label extension st...

What are the expected timelines for regulatory submission and possible approval, and how might that shape the long‑term growth prospects for Biogen and Stoke Therapeutics? How does Zorevunersen’s efficacy and safety profile compare to existing and pipeline treatments for Dravet syndrome and other epilepsies? What potential impact could the 3‑year open‑label extension data on Zorevunersen have on Biogen’s (BIIB) stock price in the short term?

Clinical trials

5 days ago

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FDA Approval of Leqembi Subcutaneous Formulation Charts Path to Combination Therapies for Alzheimer's Disease

(NASDAQ:BIIB) Subcutaneous delivery increases accessibility and introduces potential for at-home administration, following model of diabetes and GLP-1 drugs NEW YORK, Aug. 29, 2025 /PRNewswire/ -- ...

How might this approval affect the outlook for combination‑therapy pipelines and potential partnerships within the Alzheimer's treatment space? What could be the revenue upside and market share impact for BIIB relative to existing AD therapies and emerging competitors? How will the FDA approval of Leqembi's subcutaneous formulation influence Biogen's short‑term stock price and volume dynamics?

Approval

8 days ago

ALZHEIMER'S ASSOCIATION WELCOMES FDA ACTION APPROVING LEQEMBI WEEKLY SUBCUTANEOUS MAINTENANCE DOSING

(NASDAQ:BIIB) CHICAGO, Aug. 29, 2025 /PRNewswire/ -- The Alzheimer's Association welcomes today's U.S. Food and Drug Administration (FDA) action to approve weekly subcutaneous maintenance dosing of...

What are the potential risks related to insurance coverage, pricing, and supply chain that could influence the long‑term profitability of Leqembi after this approval? What impact will this new dosing regimen have on Biogen's revenue forecasts and market share compared to competing Alzheimer’s therapies such as Aduhelm and donanemab? How will the FDA approval of weekly subcutaneous dosing for Leqembi affect Biogen's (BIIB) stock price and trading volume in the short term?

Fda approval

8 days ago

FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease

(NASDAQ:BIIB) LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease afte...

How might this at‑home delivery option influence market share dynamics against competitors like Eli Lilly's donanemab and other upcoming Alzheimer's treatments? What pricing strategy and reimbursement landscape can be expected for the subcutaneous injection compared to existing intravenous anti‑amyloid therapies? How will the FDA approval of LEQEMBI® IQLIK™ affect Biogen's projected revenue and earnings forecasts?

Regulatory

8 days ago

FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease

(NASDAQ:BIIB) LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease aft...

What are the reimbursement, pricing and payer acceptance outlook and potential risks for commercial uptake of the new maintenance dosing regimen? What is the expected market share and revenue potential of the at‑home subcutaneous formulation compared with existing anti‑amyloid therapies and competitors? How will the FDA approval of LEQEMBI® IQLIK™ affect Biogen's (BIIB) stock price in the short and medium term?

Approval

8 days ago

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Stoke Therapeutics and Biogen Announce Presentations of Clinical Data from Studies of Zorevunersen for the Potential Treatment of Dravet Syndrome at the 36th International Epilepsy Congress

BEDFORD, Mass. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential wit...

How does zorevunersen's efficacy and safety profile compare to existing and pipeline treatments for Dravet syndrome, and what competitive advantage could it provide? What are the anticipated regulatory milestones and timeline for zorevunersen based on these new data, and how might they influence market valuation? How will the upcoming clinical data presentations at the IEC affect the short‑term price movement of Biogen (BIIB) and Stoke Therapeutics (STOK) stocks?

Clinical trials

13 days ago

Biogen and Stoke Therapeutics Announce Presentations of Clinical Data from Studies of Zorevunersen for the Potential Treatment of Dravet Syndrome at the 36th International Epilepsy Congress

– 3-year data from open-label extension (OLE) studies demonstrate the potential for disease modification with durable seizure reductions and improvements in cognition and behavior on top of standar...

What is the expected regulatory timeline and potential market size if the data supports disease‑modifying claims? How does Zorevunersen’s efficacy and safety profile compare to existing Dravet syndrome therapies and other pipeline candidates? How will the 3‑year open‑label extension data impact Biogen’s valuation and short‑term stock price movement?

Clinical trials

13 days ago

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Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab)

TOKYO and CAMBRIDGE, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Ma...

How does the approval and launch timeline of LEQEMBI® compare to competitors’ pipeline candidates targeting early Alzheimer’s disease? What is the expected market uptake and reimbursement landscape for LEQEMBI® in these EU markets compared to existing Alzheimer’s therapies? How will the launch of LEQEMBI® in Austria and Germany affect Biogen’s (BIIB) stock price and trading volume?

Drug launch

13 days ago

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