BIIB

New Biomarker Data Add Further Evidence Supporting the Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs after Gene Therapy

Retrieved on: 
Wednesday, March 6, 2024

* The Phase 4 study evaluates clinical outcomes and safety following treatment with SPINRAZA over a 2-year period in infants and toddlers with spinal muscular atrophy (SMA) who have unmet clinical needs after treatment with Zolgensma® (onasemnogene abeparvovec).

Key Points: 
  • * The Phase 4 study evaluates clinical outcomes and safety following treatment with SPINRAZA over a 2-year period in infants and toddlers with spinal muscular atrophy (SMA) who have unmet clinical needs after treatment with Zolgensma® (onasemnogene abeparvovec).
  • The new data show that plasma neurofilament light chain (NfL) levels, an objective biomarker of axonal injury and neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA.
  • These data will be presented at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 3-6, 2024).
  • “Our evolving understanding of gene therapy indicates there may be an opportunity for better outcomes,” said Crystal Proud, M.D., Pediatric Neurologist at Children’s Hospital of the King’s Daughters.

Biogen Highlights New Data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024 Annual Meeting

Retrieved on: 
Monday, March 4, 2024

The presentations include new data for its oral small molecule inhibitor of tau aggregation (BIIB113), as well as presentations providing insights into the underlying mechanisms of Alzheimer’s disease.

Key Points: 
  • The presentations include new data for its oral small molecule inhibitor of tau aggregation (BIIB113), as well as presentations providing insights into the underlying mechanisms of Alzheimer’s disease.
  • In addition to BIIB113, Biogen is researching the potential of tau reduction in AD with its investigational antisense oligonucleotide targeting the microtubule associated protein tau (MAPT) gene (BIIB080).
  • Oral presentation: Results of the first in-human, randomized, blinded, placebo-controlled, single- and multiple-ascending dose study of BIIB113 in healthy volunteers.
  • Oral presentation: Lecanemab for the treatment of early Alzheimer’s disease; the extension of efficacy results from Clarity AD.

BIOGEN ALERT: Bragar Eagel & Squire, P.C. is Investigating Biogen Inc. on Behalf of Biogen Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, February 24, 2024

NEW YORK, Feb. 24, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB) on behalf of Biogen stockholders.

Key Points: 
  • NEW YORK, Feb. 24, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB) on behalf of Biogen stockholders.
  • Our investigation concerns whether Biogen has violated the federal securities laws and/or engaged in other unlawful business practices.
  • Click here to participate in the action.
  • On this news, Biogen’s stock price fell $5.91, or 2.6%, to close at $220.74 per share on February 14, 2024, thereby injuring investors.

Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP

Retrieved on: 
Friday, February 23, 2024

If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).

Key Points: 
  • If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).
  • “The CHMP’s positive opinion reinforces the impact QALSODY can have in SOD1-ALS and further demonstrates Biogen’s commitment to address the unmet needs of people living with ALS and neuromuscular diseases,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen.
  • Trends towards improvement in the physical abilities of participants who received QALSODY were seen compared to those who received placebo, as measured by the ALS Functional Ratings Scale-Revised (ALSFRS-R).
  • Serious neurologic events, including myelitis and/or radiculitis; papilledema and elevated intracranial pressure; and aseptic meningitis have also been reported.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Biogen Inc. (BIIB) on Behalf of Investors

Retrieved on: 
Friday, February 23, 2024

Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) investors concerning the Company’s possible violations of the federal securities laws.

Key Points: 
  • Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) investors concerning the Company’s possible violations of the federal securities laws.
  • If you suffered a loss on your Biogen investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at www.glancylaw.com/cases/Biogen-Inc-1/ .
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • Whistleblower Notice: Persons with non-public information regarding Biogen should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Biogen Inc. (BIIB) on Behalf of Investors

Retrieved on: 
Thursday, February 22, 2024

Law Offices of Howard G. Smith announces an investigation on behalf of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) investors concerning the Company’s possible violations of federal securities laws.
  • On February 14, 2024, Biogen disclosed that it had received a subpoena from the DOJ seeking information about its “business operations in several foreign countries.” On this news, Biogen’s stock price fell $5.91, or 2.6%, to close at $220.74 per share on February 14, 2024, thereby injuring investors.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
  • View source version on businesswire.com: https://www.businesswire.com/news/home/20240222700198/en/

The Law Offices of Frank R. Cruz Announces Investigation of Biogen Inc. (BIIB) on Behalf of Investors

Retrieved on: 
Thursday, February 22, 2024

The Law Offices of Frank R. Cruz announces an investigation of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) on behalf of investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) on behalf of investors concerning the Company’s possible violations of federal securities laws.
  • If you are a shareholder who suffered a loss, click here to participate.
  • If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia

Retrieved on: 
Monday, February 12, 2024

“Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial experienced important and clinically meaningful improvements for their daily lives.

Key Points: 
  • “Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial experienced important and clinically meaningful improvements for their daily lives.
  • At the end of the 48-week study, patients who received SKYCLARYS had significantly improved modified Friedreich Ataxia Rating Scale (mFARS) scores relative to placebo.
  • Biogen is committed to working closely with all stakeholders to ensure that eligible European patients can have access to this treatment.
  • SKYCLARYS is also approved for use in the United States, and Biogen is engaging with regulatory authorities in other regions.

Aptar Signs Enterprise Agreement with Biogen to Operate and Develop Digital Health Solutions

Retrieved on: 
Friday, February 9, 2024

Aptar Digital Health, part of AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, has entered into an enterprise agreement with Biogen Inc. (Nasdaq: BIIB) to operate and develop digital health solutions for neurological and rare diseases.

Key Points: 
  • Aptar Digital Health, part of AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, has entered into an enterprise agreement with Biogen Inc. (Nasdaq: BIIB) to operate and develop digital health solutions for neurological and rare diseases.
  • As part of the agreement, Biogen will transfer ownership of select digital health solutions to Aptar Digital Health (Aptar).
  • In addition to these solutions, Biogen and Aptar will further collaborate to potentially develop and bring to market new digital health solutions for the management of spinal muscular amyotrophy, Friedreich’s ataxia and lupus in selected countries.
  • “We are excited to leverage our end-to-end capabilities to support Biogen and enable patients and their care teams to benefit from advanced digital solutions for better disease management,” said Pierre Leurent, President, Aptar Digital Health.

Biogen to Realign Resources for Alzheimer's Disease Franchise

Retrieved on: 
Wednesday, January 31, 2024

CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area expected to drive near and long-term growth.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area expected to drive near and long-term growth.
  • A large portion of the resources released resulting from termination of the ADUHELM program will be redeployed in Biogen’s AD franchise.
  • “As a pioneer in Alzheimer’s disease, Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs.
  • Biogen has recorded a one-time charge of approximately $60 million related to close out costs for the program in the fourth quarter of 2023.