Cell

Eisai Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA

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понедельник, апреля 1, 2024
Biogen, FDA, Brain, Administration, MCI, State, Fast Track, Dementia, Cell, Clarity, Eisai, Biologics license application, European, Alzheimer's disease, OLE, Patient, BLA, Neuron, Plaque, Lecanemab

LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

Key Points: 
  • LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
  • Eisai had aimed to submit a Biologics License Application (BLA) for weekly maintenance therapy using subcutaneous (SC) administration in March 2024.
  • However, Eisai was recently informed by the FDA that a Fast Track designation specific for the SC formulation is needed to receive rolling review.
  • Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Fosun's Next Step: "Deep Mining" for Stable Profits

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четверг, марта 28, 2024
Cell, World Health Organization, NMPA, Club Med, Growth, DLBC, Fashion Group International, Mining, KOD, Breast cancer, Gene, National Medical Products Administration, Tourism, Snow, Happiness, Leonardo da Vinci, HKEX, SCLC, Research, Marketing, Fosun Pharma, Lithium, Ice, FTG, Carcinoma, European, Patient, Artesunate, Letter, COVID-19, Fine chemical

With the implementation of the business streamlining strategy, Fosun divested some non-core businesses that had previously provided stable cash flows.

Key Points: 
  • With the implementation of the business streamlining strategy, Fosun divested some non-core businesses that had previously provided stable cash flows.
  • The subsequent improvement in cash flow has brought market attention to how Fosun will sustain stable profit growth as it did over the past decade.
  • The results announcement shows that Fosun's focus on its core businesses in the household consumption sector has gradually yielded results.
  • Leveraging on the two core growth drivers of innovation and globalization, Fosun has continued to deepen its efforts in advantageous industries and reap more stable profits.

Avance Clinical at World Vaccine Congress to Share Latest Vaccine Clinical Trial News Including an HIV-1 Study

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четверг, марта 28, 2024
FDA, Congress, Psoriasis, News, Food, Infection, GMO, Cell, Vaccine, Knowledge, OMICS Publishing Group, Hypertension, EMA, Drug development, Clinical trial, OGTR, COVID-19, TGA, RSV, Pharmaceutical industry

(Booth #267)

Key Points: 
  • (Booth #267)
    Avance Clinical CEO, Yvonne Lungershausen said the World Vaccine Congress was an important event for the company's US and Australian teams as they continue to excel in biotech vaccine CRO services.
  • Lungershausen said Avance Clinical is a mid-sized, agile, and responsive CRO with a proven track record of swiftly advancing high-quality clinical programs.
  • She said Avance Clinical is proud to be working with many innovative vaccine biotech companies including Uvax Bio who have just announced another milestone in their Phase I HIV study.
  • Lungershausen said Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

Azitra, Inc. Announces Q1 2024 Financial Results and Provides Business Updates

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четверг, мая 9, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, FDA, Society, Cancer, Skin, Safety, Research, Joint, Research and development, IRB, Cell, Administration, IND, LEKTI, ASCO, Ichthyosis, Patent, Patient, Gene, Bayer, Prevalence, Rash, Quarter, EGFR, G&A, Netherton syndrome, BTK, Chemotherapy, Pharmaceutical industry

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended March 31, 2024, and provided a business update.

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended March 31, 2024, and provided a business update.
  • Moreover, preclinical evidence suggests that ATR-12 can markedly reduce IL-36g, a pro-inflammatory cytokine implicated in Netherton syndrome, further validating the potential of our approach.
  • Net Loss was $2.9 million for the quarter ended March 31, 2024, compared to $2.5 million for the comparable period in 2023.
  • Cash and cash equivalents: As of March 31, 2024, the Company had cash and cash equivalents of $3.0 million.

Atara Biotherapeutics Announces First Quarter 2024 Financial Results and Operational Progress

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четверг, мая 9, 2024
Stem Cells, Biotechnology, Health, General Health, Pharmaceutical, Oncology, Research, Infectious Diseases, Genetics, Science, Clinical Trials, Mantle cell lymphoma, Cancer, International Society, Investment, Cell, Phenotype, Safety, Risk, Pharmacokinetics, Poster, Lymphoproliferative disorders, Depreciation, Cytokine, Partnership, Lymphoma, Biologics license application, ATRA, Follicular lymphoma, CD19, ASH, Epstein–Barr virus, Patient, NHL, LD, Toxicity, BLA, Memory, Workforce, EBV, Biomarker, SLE, Tabelecleucel, Pharmaceutical industry

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the first quarter 2024, recent business highlights, and key upcoming milestones for 2024.

Key Points: 
  • Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the first quarter 2024, recent business highlights, and key upcoming milestones for 2024.
  • “This is anticipated to provide multiple near-term clinical milestones for ATA3219, including initial non-Hodgkin’s lymphoma data expected in the fourth quarter 2024, and initial lupus nephritis data in the first half of 2025, with plans to expand into a new SLE cohort without lymphodepletion.
  • Subjects will receive lymphodepletion treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • Subjects will receive LD treatment followed by ATA3219 at a dose of 40, 80, 240, or 480 x 106 CAR+ T cells.

Xencor Reports First Quarter 2024 Financial Results

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четверг, мая 9, 2024
Oncology, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, FDA, CD3, Cancer, Bangladesh Technical Education Board, CLDN6, Investment, Cell, NIH, Xtend, Malaria, NMOSD, Research, IND, Prostate cancer, European, CD28, Ravulizumab, Patient, ENPP3, Alexion, Immune system, Clinical trial, Ovarian cancer

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a review of recent clinical and business highlights.

Key Points: 
  • Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a review of recent clinical and business highlights.
  • New Chief Financial Officer Appointed: Bart Cornelissen was appointed as Xencor’s senior vice president and chief financial officer.
  • Financial Results for the First Quarter Ended March 31, 2024
    Cash, cash equivalents and marketable debt securities totaled $646.7 million as of March 31, 2024, compared to $697.4 million on December 31, 2023.
  • Revenues for the first quarter ended March 31, 2024 were $12.8 million, compared to $19.0 million for the same period in 2023.

BioLife Solutions Reports First Quarter 2024 Financial Results

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четверг, мая 9, 2024
Net, Takeda Pharmaceutical Company, Cell, Webcast, CBS, GAAP, Growth, GCI, Video game

Gross margin (GAAP) for the first quarter of 2024 was 38% compared with 35% for the first quarter of 2023.

Key Points: 
  • Gross margin (GAAP) for the first quarter of 2024 was 38% compared with 35% for the first quarter of 2023.
  • Operating loss (GAAP) for the first quarter of 2024 was $10.1 million compared with $13.6 million for the first quarter of 2023.
  • Adjusted operating loss (non-GAAP) for the first quarter of 2024 was $9.1 million compared with $10.6 million for the first quarter of 2023.
  • Net loss (GAAP) for the first quarter of 2024 was $10.2 million compared with $13.7 million for the first quarter of 2023.

Ginkgo Bioworks Reports First Quarter 2024 Financial Results

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четверг, мая 9, 2024
Public, Safety, Burn, Cell, Webcast, Forecasting, Cell engineering, Automation, DNA, Bill, G&A, Growth, Mobile phone

BOSTON, May 9, 2024 /PRNewswire/ -- Ginkgo Bioworks Holdings, Inc. (NYSE: DNA, "Ginkgo"), which is building the leading platform for cell programming and biosecurity, today announced its results for the first quarter ended March 31, 2024. The update, including a webcast slide presentation with additional details on the first quarter and supplemental financial information, will be available at investors.ginkgobioworks.com.

Key Points: 
  • Initiatives include a reduction of $200 million in annualized run-rate operating expenses by mid-2025, with anticipated substantial reduction occurring in 2024
    BOSTON, May 9, 2024 /PRNewswire/ -- Ginkgo Bioworks Holdings, Inc. (NYSE: DNA, "Ginkgo"), which is building the leading platform for cell programming and biosecurity, today announced its results for the first quarter ended March 31, 2024.
  • The update, including a webcast slide presentation with additional details on the first quarter and supplemental financial information, will be available at investors.ginkgobioworks.com .
  • This trend needs to change, and we are simplifying both what we sell to customers and how we do the work that drives revenue at Ginkgo.
  • Ginkgo revised its expectation for Cell Engineering services revenue to $120-140 million in 2024.

Poseida Highlights Strong Progress on Its Genetic Medicine Programs at the American Society for Gene and Cell Therapy 27th Annual Meeting

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четверг, мая 9, 2024
Cancer, Blood, Tissue, Poster, MD, Cell, Hereditary angioedema, KLKB1, Patient, Gene, Society, HAE, Annual general meeting, Therapy, DSM-IV codes, SAN, Vaccine

SAN DIEGO, May 9, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, today highlights new preclinical data supporting the potential of its fully non-viral lead genetic medicines programs and related platform technologies. The data was included in three oral and three poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting, being held in Baltimore, MD and virtually on May 7-11, 2024.

Key Points: 
  • The data was included in three oral and three poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting, being held in Baltimore, MD and virtually on May 7-11, 2024.
  • HAE patients have significant unmet need for a durable, effective, and convenient treatment option that eliminates recurrent attacks.
  • P-KLKB1-101 is a fully non-viral investigational gene editing therapy designed to enable high fidelity editing at pre-kallikrein, or KLKB1, for targeted correction of HAE.
  • Poseida also identified a class of amphipathic small molecules called Poseida Delivery Excipients (PDEs) with unique capabilities for enhancing DNA delivery.

Epitor Therapeutics Unveils CasNano: A Compact, All-in-One CRISPR/Cas for Single AAV Therapies at the American Society of Gene & Cell Therapy Annual Meeting

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четверг, мая 9, 2024
Dicarboxylic acid, Disorder, CRISPR, Cas, RNA, Cell, AAV, DNA, TET, Demethylation, Gene, Society, Annual general meeting, Therapy, Biotechnology

NEW YORK, May 9, 2024 /PRNewswire/ -- Epitor Therapeutics, a biotechnology pioneer in epigenetic editing, announces the creation of CasNano, a groundbreaking ultracompact Cas protein.

Key Points: 
  • NEW YORK, May 9, 2024 /PRNewswire/ -- Epitor Therapeutics, a biotechnology pioneer in epigenetic editing, announces the creation of CasNano, a groundbreaking ultracompact Cas protein.
  • The company unveiled new data during the 27th American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, showcasing over a 20-fold improvement in targeting efficiency via directed evolution of CasNano and innovative re-engineering of the tracrRNA component of the guide RNA.
  • "In addition to its nuclease activity, CasNano can efficiently demethylate, methylate, and activate target genes when catalytically deactivated, with protein effectors attached.
  • "CasNano is 70% smaller than spCas9 and has been engineered to optimize DNA targeting," added Epitor CEO, Dr. Megan McGill.