Sarepta Therapeutics

Autolus Therapeutics Announces Changes to its Board of Directors

Retrieved on: 
Monday, April 1, 2024
Cubist Pharmaceuticals, DBV Technologies, MB, Alnylam Pharmaceuticals, Harvard Medical School, University of Cambridge, Faculty, Imperial College London, Development, GSK plc, Biologics license application, Hematology, Patient, ALL, Merck, Bristol Myers Squibb, Marketing, Biogen, Doctor of Philosophy, Bates College, Oxford Biomedica, Sarepta Therapeutics, Pharmaceutical medicine, Therapy, Swedish Orphan Biovitrum, Royal college, FDA, BLA, Autoimmunity, Economics, Food, Pharmaceutical industry

John H. Johnson advised the Board of his decision to step down from his role as Chairman of the Board and Non-Executive Director.

Key Points: 
  • John H. Johnson advised the Board of his decision to step down from his role as Chairman of the Board and Non-Executive Director.
  • We wish John much success with his new projects,” said Dr. Christian Itin, Chief Executive Officer of Autolus.
  • He is currently a director of Alnylam Pharmaceuticals and chair of Dunad Therapeutics and Gulf of Maine Research Institute.
  • Mr. Bonney has served as a director with many companies previously including Celgene, Kaleido Biosciences, Magenta Therapeutics, Bristol Myers Squibb, Sarepta Therapeutics and Syros Pharmaceuticals.

Global Cell Counting Market to Hit $15.72 Billion by 2029, Fueled by Advancements in Cell Biology and Therapy - ResearchAndMarkets.com

Retrieved on: 
Friday, March 29, 2024
Research, Technology, University, Genetics, Artificial Intelligence, Education, Science, Nanotechnology, Biotechnology, Stem Cells, Other Technology, Health, Other Science, Automation, Quality control, Interdisciplinarity, Acute lymphoblastic leukemia, Growth, Prevalence, Application, Novartis, Patient, Conditional sentence, Cell biology, Lung, Concha bullosa, Hospital, Artificial intelligence, National Cancer Institute, AI, Regenerative medicine, Duchenne muscular dystrophy, Therapy, DEB, Miniaturization, Sarepta Therapeutics, CGT, FDA, DMD, Tisagenlecleucel, PDUFA, Pharmaceutical industry

The global cell counting market was valued at US$9.98 billion in 2023 and is expected to reach US$15.72 billion by 2029.

Key Points: 
  • The global cell counting market was valued at US$9.98 billion in 2023 and is expected to reach US$15.72 billion by 2029.
  • Advancements in cell biology, biotechnology, and medical research are driving demand for precise cell counting, especially with the rise of personalized medicine and regenerative therapies.
  • PDUFA dates for therapies could translate into an order book boost for the cell counting players in the market, resulting in market growth.
  • The global cell counting market is consolidated, with top five players holding approximately 70% share of the market.

Hansa Biopharma Expects Strong First Quarter 2024 Sales Performance

Retrieved on: 
Tuesday, April 2, 2024
Sarepta Therapeutics, Interest, Growth, CFO, CCO, CSO, Person

LUND, Sweden, April 2, 2024 /PRNewswire/ -- Hansa Biopharma AB (STO: HNSA) expects to report revenue of approximately SEK 54m for Q1 ending March 31, 2024 (preliminary and unaudited), consisting of SEK 48m in product sales and SEK 6m in revenue recognition primarily related to its agreement with Sarepta Therapeutics, Inc. Revenue growth during the first quarter 2024 was driven by product sales in the Company's largest markets including France, UK, and Germany, as well as initial sales in Belgium.

Key Points: 
  • LUND, Sweden, April 2, 2024 /PRNewswire/ -- Hansa Biopharma AB (STO: HNSA) expects to report revenue of approximately SEK 54m for Q1 ending March 31, 2024 (preliminary and unaudited), consisting of SEK 48m in product sales and SEK 6m in revenue recognition primarily related to its agreement with Sarepta Therapeutics, Inc. Revenue growth during the first quarter 2024 was driven by product sales in the Company's largest markets including France, UK, and Germany, as well as initial sales in Belgium.
  • Søren Tulstrup, President and CEO, Hansa Biopharma, said: "Q1 represents a strong start to the year with solid product sales for the second quarter in a row and the best IDEFIRIX® product sales recorded in a quarter.
  • The Company will publish Q1 2024 results on April 18, 2024.
  • The information was submitted for publication, through the contact persons set out below, at 07:00: CET on April 2, 2024.

Hansa Biopharma Expects Strong First Quarter 2024 Sales Performance

Retrieved on: 
Tuesday, April 2, 2024
Sarepta Therapeutics, Interest, Growth, CFO, CCO, CSO, Person

LUND, Sweden, April 2, 2024 /PRNewswire/ -- Hansa Biopharma AB (STO: HNSA) expects to report revenue of approximately SEK 54m for Q1 ending March 31, 2024 (preliminary and unaudited), consisting of SEK 48m in product sales and SEK 6m in revenue recognition primarily related to its agreement with Sarepta Therapeutics, Inc. Revenue growth during the first quarter 2024 was driven by product sales in the Company's largest markets including France, UK, and Germany, as well as initial sales in Belgium.

Key Points: 
  • LUND, Sweden, April 2, 2024 /PRNewswire/ -- Hansa Biopharma AB (STO: HNSA) expects to report revenue of approximately SEK 54m for Q1 ending March 31, 2024 (preliminary and unaudited), consisting of SEK 48m in product sales and SEK 6m in revenue recognition primarily related to its agreement with Sarepta Therapeutics, Inc. Revenue growth during the first quarter 2024 was driven by product sales in the Company's largest markets including France, UK, and Germany, as well as initial sales in Belgium.
  • Søren Tulstrup, President and CEO, Hansa Biopharma, said: "Q1 represents a strong start to the year with solid product sales for the second quarter in a row and the best IDEFIRIX® product sales recorded in a quarter.
  • The Company will publish Q1 2024 results on April 18, 2024.
  • The information was submitted for publication, through the contact persons set out below, at 07:00: CET on April 2, 2024.

Hansa Biopharma publishes 2023 Annual and Sustainability Reports

Retrieved on: 
Thursday, March 21, 2024
Certification, Culture, Crigler–Najjar syndrome, Science, Partnership, Patient, Neutron, Hansa, Duchenne muscular dystrophy, Kidney transplantation, Commercial, Syndrome, GBS, Clinical trial, Therapy, Drug development, Sarepta Therapeutics, Safety, Pharmacokinetics, ANCA, DMD, Pharmaceutical industry

LUND, Sweden, March 21, 2024 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports. In 2023, the company made solid progress in both Commercial and R&D priorities and continued its journey to become a default sustainable organization.

Key Points: 
  • LUND, Sweden, March 21, 2024 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports.
  • Peter Nicklin, Chairman of the Board, Hansa Biopharma, said: "2023 was another important year for Hansa Biopharma.
  • Søren Tulstrup, President and CEO, Hansa Biopharma, said: "In 2023, the Company's focus remained firmly on advancing cutting-edge science and delivering new treatments in areas of high unmet need.
  • This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.

Hansa Biopharma publishes 2023 Annual and Sustainability Reports

Retrieved on: 
Thursday, March 21, 2024
Certification, Culture, Crigler–Najjar syndrome, Science, Partnership, Patient, Neutron, Hansa, Duchenne muscular dystrophy, Kidney transplantation, Commercial, Syndrome, GBS, Clinical trial, Therapy, Drug development, Sarepta Therapeutics, Safety, Pharmacokinetics, ANCA, DMD, Pharmaceutical industry

LUND, Sweden, March 21, 2024 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports. In 2023, the company made solid progress in both Commercial and R&D priorities and continued its journey to become a default sustainable organization.

Key Points: 
  • LUND, Sweden, March 21, 2024 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports.
  • Peter Nicklin, Chairman of the Board, Hansa Biopharma, said: "2023 was another important year for Hansa Biopharma.
  • Søren Tulstrup, President and CEO, Hansa Biopharma, said: "In 2023, the Company's focus remained firmly on advancing cutting-edge science and delivering new treatments in areas of high unmet need.
  • This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.

Genethon Pursues Different Strategies for Ensuring Patient Access to Gene Therapies for Rare Diseases

Retrieved on: 
Thursday, February 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Health Technology, Genetics, Clinical Trials, Duchenne, Crigler–Najjar syndrome, LGMD, Muscular dystrophy, Partnership, Food, Sarepta Therapeutics, Female, Duchenne muscular dystrophy, DSM-IV codes, Weakness, Doctor of Philosophy, Prevalence, Therapy, Muscle weakness, Patient, Disease, Male, IND, Pharmaceutical industry

Genethon , a non-profit research organization focused on developing gene therapies for rare diseases, today marks International Rare Disease Day by highlighting its efforts to bring gene therapies to patients suffering from rare diseases such as limb girdle muscular dystrophies, Crigler Najjar syndrome and Duchenne muscular dystrophy.

Key Points: 
  • Genethon , a non-profit research organization focused on developing gene therapies for rare diseases, today marks International Rare Disease Day by highlighting its efforts to bring gene therapies to patients suffering from rare diseases such as limb girdle muscular dystrophies, Crigler Najjar syndrome and Duchenne muscular dystrophy.
  • Globally more than 300 million people, most of them children, are living with 7,000 rare diseases.
  • Because patient populations are small, these diseases don’t readily fit into the biopharma industry’s business models.
  • “Despite challenges in generating interest with biopharma companies and investors, Genethon will never abandon patients suffering from rare and ultra-rare diseases,” said Dr. Revah.

Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, February 28, 2024
Health, Genetics, Research, Pharmaceutical, Science, Biotechnology, SRPT, Hart–Scott–Rodino Antitrust Improvements Act, Investment, Interest, Sarepta Therapeutics, Part, Sale, University, Trial of the century, Ageing, BLA, GAAP, Therapy, BioMarin Pharmaceutical, Income tax, PMR, Depreciation, Magnesium deficiency, Nationwide Children's Hospital, Hospital, Safety, Patent, Clinical trial, Biologics license application, Mutation, Priority review, Acquisition, PIN, Dystrophin, FDA, Food, DMD, Duchenne muscular dystrophy, U.S. FDA, Agency, Patient, PRV, PMO, Pharmaceutical industry

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2023.

Key Points: 
  • Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2023.
  • Beginning in the fourth quarter of 2023, amortization of in-licensed rights (formerly included within depreciation and amortization expense) and income tax (benefit) expense are no longer excluded from the non-GAAP results.
  • Non-GAAP financial results for the fourth quarter and full-year 2022 have been updated to reflect this change for comparability.
  • All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table “Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures.”

Limb-Girdle Muscular Dystrophy Leaders Advance Collaborative Dialogue to Accelerate Drug Development to Address the Urgent Unmet Need in Limb-Girdle Muscular Dystrophy

Retrieved on: 
Tuesday, February 27, 2024
LGMD, Nationwide Children's Hospital, Analysis Group, OND, FDA, Clinical trial, Food, Drug development, Sarepta Therapeutics, Virginia Commonwealth University, Hospital, Treatment, Senior advisor, Documentation, University, CDER, Therapy, Keynote, Patient, Science, Limb–girdle muscular dystrophy

The meeting focused on six LGMD subtypes: 2A/R1, 2B/R2, 2C/R5, 2D/R3, 2E/R4, and 2I/R9.

Key Points: 
  • The meeting focused on six LGMD subtypes: 2A/R1, 2B/R2, 2C/R5, 2D/R3, 2E/R4, and 2I/R9.
  • We are thrilled that the workshop advanced a collaborative dialogue and brought people together from every facet of the drug development process to drive progress for patients.
  • This was truly a monumental event for the LGMD community and a model for others to follow in the future."
  • In-depth documentation of the workshop's findings and next steps is in progress and will be shared when available.

Sarepta Therapeutics Announces U.S. FDA Acceptance of an Efficacy Supplement to Expand the ELEVIDYS Indication

Retrieved on: 
Friday, February 16, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Infectious Diseases, Genetics, SRPT, Roche, Physician, Food, Sarepta Therapeutics, DMD, Duchenne muscular dystrophy, BLA, Agency, Therapy, Priority review, Patient, Disease, Biologics license application, Efficacy, Mutation, Pharmaceutical industry

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's efficacy supplement to the Biologics License Application (BLA) for ELEVIDYS (delandistrogene moxeparvovec-rokl) (the “Efficacy Supplement”).

Key Points: 
  • Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's efficacy supplement to the Biologics License Application (BLA) for ELEVIDYS (delandistrogene moxeparvovec-rokl) (the “Efficacy Supplement”).
  • The goals of the Efficacy Supplement are twofold:
    To expand the labeled indication for ELEVIDYS as follows: “[ELEVIDYS is indicated for] the treatment of Duchenne muscular dystrophy (DMD) patients with a confirmed mutation in the DMD gene.”
    To convert the ELEVIDYS accelerated approval to a traditional approval.
  • The FDA has granted the Efficacy Supplement a Priority Review with a review goal date of June 21, 2024.
  • The Agency has also confirmed they are not planning to hold an advisory committee meeting to discuss the supplement.