Cohort study

Capricor Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 14, 2023
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SAN DIEGO, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today its financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Next steps for Cohort A:
    Plan to report the outcome from the interim futility analysis in the fourth quarter of 2023.
  • Held a positive Type-B clinical meeting with FDA in the third quarter of 2023.
  • Next steps for Cohort B:
    Expect to commence enrollment for Cohort B in the fourth quarter of 2023.
  • Revenues for the third quarter of 2023 were approximately $6.2 million compared with approximately $1.6 million for the third quarter of 2022.

Kronos Bio Reports Recent Business Progress and Third-Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Safety, SAN, D, Carcinoma, Sarcoma, Investment, PD, Cohort study, Patient, Research, Chordoma, Lung cancer, Conference, KRON, Ovarian cancer, Cancer, Mechanism of action, AACR, Genentech, Life insurance, Rare-earth element, Pharmaceutical industry

SAN MATEO, Calif., and CAMBRIDGE, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and third-quarter 2023 financial results.

Key Points: 
  • $198.4 million in cash, cash equivalents and investments as of September 30, 2023
    SAN MATEO, Calif., and CAMBRIDGE, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and third-quarter 2023 financial results.
  • “This quarter, we made great strides in advancing our clinical programs as well as our discovery projects and Genentech collaboration,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio.
  • Kronos Bio expects that these efforts, which include a 19% reduction in force, will extend its cash runway into 2026.
  • Net Loss: Net loss for the third quarter of 2023 was $31.4 million, or $0.54 per share, including non-cash stock-based compensation expense of $6.3 million.

Invivyd Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, November 9, 2023
Webcast, Accounting, Research, Safety, Engineering, Food, Conference call, Risk, Immunodeficiency, Clinical trial, Serum, Cohort study, Abstract, FDA, Research and development, COVID-19, Conference, CDC, R, Antibody, Patent, SARS-CoV-2, Mutation, Pharmaceutical industry, Vaccine, Omicron

ET

Key Points: 
  • ET
    WALTHAM, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) --  Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced financial results for the quarter ended September 30, 2023, and recent business highlights.
  • “I am immensely proud of our team and their remarkable performance throughout the third quarter.
  • William Duke appointed Chief Financial Officer: On September 5, 2023, Invivyd announced the appointment of William (Bill) Duke as Chief Financial Officer.
  • Third Quarter 2023 Financial Results:
    Cash position: Cash, cash equivalents and marketable securities were $264.9 million as of September 30, 2023.

Positive Results from Pivotal Trials of CASGEVY™ (exagamglogene autotemcel) Highlighted in Oral Presentations at the American Society of Hematology (ASH) Annual Meeting and Exposition

Retrieved on: 
Tuesday, December 12, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Genetics, Clinical Trials, Medicaid, Food, BLA, Sickle cell disease, ASH, Vertex, Patient, Prevalence, Cohort study, Medical Affairs Bureau, TDT, Volatile organic compound, SCD, PDUFA, Pharmaceutical industry

Data from 96 patients (44 sickle cell disease [SCD], 52 transfusion-dependent beta thalassemia [TDT]) treated with CASGEVY in pivotal studies, with the longest follow-up of more than four years, continue to reinforce the consistent and durable response to treatment.

Key Points: 
  • Data from 96 patients (44 sickle cell disease [SCD], 52 transfusion-dependent beta thalassemia [TDT]) treated with CASGEVY in pivotal studies, with the longest follow-up of more than four years, continue to reinforce the consistent and durable response to treatment.
  • In addition, new data illustrating improvements in patient-reported outcomes after treatment with CASGEVY were featured in poster presentations at ASH.
  • The use of CASGEVY for the treatment of TDT in the U.S. remains investigational.
  • In addition to the two oral presentations, there are additional poster presentations by Vertex at ASH.

Immutep Completes Enrollment in TACTI-003 Phase IIb Trial of Efti and KEYTRUDA® in First Line Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

Retrieved on: 
Thursday, November 9, 2023
ASX, MHC, Neoplasm, Patient, PD-L1, Pembrolizumab, Head, HNSCC, CPS, Phase, MHC class II, Autoimmune disease, Safety, IMM, Cancer, Cohort study, Pharmaceutical industry, Cohort

SYDNEY, AUSTRALIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the completion of patient enrollment in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alpha (efti), its proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Key Points: 
  • Dr. Frédéric Triebel, CSO of Immutep, said: “The completion of patient enrollment in TACTI-003 represents an important milestone in the clinical development of efti.
  • We hope to build upon the encouraging data previously seen combining efti with the anti-PD-1 KEYTRUDA® in the second line HNSCC setting.
  • Head and neck squamous cell carcinomas represent a difficult-to-treat, heterogenous cancer and an area of high unmet need.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Gilead Sciences Announces Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
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Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter of 2023.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter of 2023.
  • During the third quarter of 2023, Gilead generated $1.8 billion in operating cash flow.
  • During the third quarter of 2023, Gilead repaid $2.3 billion of debt, paid dividends of $953 million and repurchased $300 million of common stock.
  • Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables.

Lisata Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 2, 2023
Neoplasm, Research, Colon, Standard of care, GBM, Temozolomide, Peritoneum, Ovarian cancer, Therapy, RNA, IDMC, Cohort study, Head, Cholangiocarcinoma, National Health, Cytoreductive surgery, Pancreatic cancer, University, Safety, Cancer, PDAC, Patient, Gemcitabine, Glioblastoma, FOLFIRINOX, HIPEC, ASCEND, SOC, CRS, Chemistry, FDA, Glioma, Tumor microenvironment, Randomized controlled trial, Neck, Intramuscular injection, Pharmaceutical industry, Cryptocurrency

BASKING RIDGE, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced its financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Lisata and its development collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics.
  • The trial continues to make steady progress with enrollment completion expected by the fourth quarter of 2023 and data readouts expected in 2024.
  • We anticipate the first patient treated to be in the fourth quarter of 2023.
  • Lisata will hold a live conference call on Thursday, November 2, 2023, at 4:30 p.m. Eastern time to discuss financial results, provide a business update and answer questions.

Vertex to Present New Data on Exagamglogene Autotemcel (exa-cel) at the American Society of Hematology (ASH) Annual Meeting and Exposition

Retrieved on: 
Thursday, November 2, 2023
Health, Genetics, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, VRTX, SCD, Sickle cell disease, Vertex Pharmaceuticals, Prevalence, TDT, Cohort study, Society, ASH, PST, Abstract, Medicaid, Exposition, Pharmaceutical industry, Communications satellite, Flour, Patient

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that seven abstracts have been accepted for presentation at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that seven abstracts have been accepted for presentation at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition.
  • Abstract #1052 entitled “Exagamglogene Autotemcel for Severe Sickle Cell Disease” will be an oral presentation on Monday, December 11 at 4:45 p.m. PST.
  • Abstract #1053 entitled “Exagamglogene Autotemcel for Transfusion-Dependent Βeta-Thalassemia” will be an oral presentation on Monday, December 11 at 5:00 p.m. PST.
  • Five additional abstracts have been accepted, including two on the improvements in patients’ quality of life following treatment with exa-cel.

Sernova Announces Positive Ongoing Interim Phase 1/2 Clinical Data for the Cell Pouch System™ for Type 1 Diabetes Trial at the 2023 IPITA, IXA, and CTRMS Joint Congress

Retrieved on: 
Friday, October 27, 2023
Transplant, Cohort study, Patient, Portal vein, Glycated hemoglobin, Dentistry, Pharmaceutical industry

Enrollment in Cohort A, which utilizes the 8-channel Cell Pouch, is complete with post-transplant data available for periods of follow-up ranging from 6 months to 3.5 years.

Key Points: 
  • Enrollment in Cohort A, which utilizes the 8-channel Cell Pouch, is complete with post-transplant data available for periods of follow-up ranging from 6 months to 3.5 years.
  • In Cohort B, 6 of the planned 7 patients have been implanted with the higher capacity 10-channel Cell Pouch, without complications.
  • Among the 6 patients that have been implanted, 5 have completed at least one of the two protocol-defined islet transplants to Cell Pouch.
  • “Having recently advanced the trial into Cohort B, using our higher capacity 10-channel Cell Pouch, we are already seeing positive signals for both safety and efficacy.

Excision BioTherapeutics Presents Positive Interim Clinical Data from Ongoing Phase 1/2 Trial of EBT-101 for the Treatment of HIV at ESGCT 30th Annual Congress

Retrieved on: 
Wednesday, October 25, 2023
Aes, Infection, SVP, CRISPR, HIV, Northwest Biotherapeutics, DNA, ART, Male, Cell, HIV/AIDS, Gene, Blood, HIV-1, Safety, European Society of Gene and Cell Therapy, Cohort study, Toxicity, Abstract, SAN, Pharmaceutical industry, Vaccine, Excision, Cohort

EBT-101 is a dual-guide, CRISPR-based investigational gene therapy for the treatment of human immunodeficiency virus type 1 (HIV-1).

Key Points: 
  • EBT-101 is a dual-guide, CRISPR-based investigational gene therapy for the treatment of human immunodeficiency virus type 1 (HIV-1).
  • The data was presented at the European Society for Gene & Cell Therapy annual meeting on October 25, 2023 in Brussels, Belgium.
  • “Excision is dedicated to developing curative, CRISPR-based therapies for people with infectious disease,” said Daniel Dornbusch, Chief Executive Officer of Excision.
  • Excision uses a multiplexed and in vivo CRISPR-based gene editing approach to excise large segments of latently integrated proviral HIV DNA.