Venetoclax

Kura Oncology Reports First Quarter 2024 Financial Results

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Giovedì, Maggio 2, 2024
FDA, Cancer, KURA, Investment, Venetoclax, HNSCC, Food, Prognosis, Research, Renal cell carcinoma, FTI, AML, Webcast, Disease, LDAC, Patient, Azacitidine, QT interval, BTD, Acute myeloid leukemia, FLT3, Head, Initiate, ID, Breakthrough therapy, Pharmaceutical industry

ET –

Key Points: 
  • ET –
    SAN DIEGO, May 02, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported first quarter 2024 financial results and provided a corporate update.
  • Research and development expenses for the first quarter of 2024 were $36.3 million, compared to $25.2 million for the first quarter of 2023.
  • General and administrative expenses for the first quarter of 2024 were $18.2 million, compared to $11.4 million for the first quarter of 2023.
  • ET / 1:30 p.m. PT today, May 2, 2024, to discuss the financial results for the first quarter 2024 and to provide a corporate update.

MEI Pharma Board of Directors Aligns on Strategy to Advance Voruciclib and ME-344

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Giovedì, Aprile 11, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Agreement, Patient, Cancer, Mutation, CDK9, Venetoclax, Colorectal cancer, MEI, Bevacizumab, AML, Research, Cohort, Salvage therapy, Disease, Exercise, Therapy, IDH, Incidence, Neoplasm, Toxicity, Acute myeloid leukemia, FLT3, Standard of care, Death, Clinical trial, VEGF, Calendar, Pharmaceutical industry

With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.

Key Points: 
  • With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.
  • The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported today.
  • Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice.
  • The goal of the formulation effort is to increase biological activity, improve patient convenience of administration and increase commercial opportunity.

PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers

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Giovedì, Aprile 11, 2024
Oncology, Health, FDA, Clinical Trials, Research, Science, Biotechnology, Cancer, Fast Track, Venetoclax, Food, Prognosis, Survival, AML, Bone marrow, Patient, Tislelizumab, Acute myeloid leukemia, PRTC, Head, Clinical trial, BeiGene, Pharmaceutical industry

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (“head and neck cancers”).

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (“head and neck cancers”).
  • It is being evaluated in two ongoing clinical trials:
    a Phase 1/2 adaptive design trial in advanced/metastatic solid tumors, including head and neck cancers.
  • “By granting Fast Track designation to LYT-200 for head and neck cancers, the FDA continues to highlight areas of critical need within oncology as well as the potential for LYT-200,” said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech.
  • The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML .

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update

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Venerdì, Marzo 29, 2024
Patient, PTCL, G&A, IND, Prednisone, Neoplasm, Therapy, SMDC, Medicinal chemistry, Lymphoma, Research, Frontiers Media, RNA polymerase II, Body modification, Primate, RNA, NIH, CPT, Potential, Safety, CDK9, ADC, MCL1, Solubility, Oncogene, RNA polymerase, Venetoclax, Journal, Manuscript, Cancer, Peripheral T-cell lymphoma, AACR, Antibody, MYC, Downregulation and upregulation, DLBCL, Annual general meeting, HER2, European Hematology Association, EHA, Spacecraft, PDX, Bangladesh Technical Education Board, Journal of Medicinal Chemistry, Blood, Pharmaceutical industry

PALO ALTO, Calif., March 29, 2024 (GLOBE NEWSWIRE) --  Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Vincerx presented preclinical data at the 2023 AACR Annual Meeting demonstrating significant activity in patient-derived xenograft (PDX) lymphoma mouse models.
  • Vincerx shared preclinical data at the 2023 ASH Annual Meeting showing superior activity and safety compared with commercially available B-cell targeted ADCs.
  • For the fourth quarter and full year 2023, Vincerx reported a net loss of $4.9 million, or $0.23 per share, and a net loss of $40.2 million, or $1.89 per share, respectively.
  • For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.8 million, or $0.65 per share, and a net loss of $63.0 million, or $3.00 per share, respectively.

Aptose Reports Results for the Fourth Quarter and Full Year 2023

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Martedì, Marzo 26, 2024
Indian stock exchange, Absorption, Plasma, Exercise, Hanmi Pharmaceutical, AML, BID, Patient, APS, SAN, Venetoclax, G1, VEN, FLT3, EHA, LUX, Acute myeloid leukemia, Trial of the century, TUS, TSX, Hanmi, Azacitidine, G3, Pharmaceutical industry

This included 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option.

Key Points: 
  • This included 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option.
  • Total gross proceeds from the public offering were approximately $9.7 million before deducting underwriting costs, placement agent commissions and other offering-related expenses.
  • Private Placement – On January 31, 2024, Aptose closed a US $4 million private placement of common shares with strategic partner Hanmi Pharmaceutical.
  • Luxeptinib G3 Evaluation Completed – During 2023 and early 2024, clinical evaluation of the new generation 3 (G3) formulation of luxeptinib (LUX) was completed.

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression

Retrieved on: 
Martedì, Aprile 9, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, Aplastic anemia, Syros, Tamibarotene, AML, Patient, Fast Track, Venetoclax, Acute myeloid leukemia, Azacitidine, Prognosis, MDS, Bone marrow, RARA, Pharmaceutical industry

Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.

Key Points: 
  • Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.
  • “We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML.
  • Syros is evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA overexpression in the ongoing SELECT-AML-1 Phase 2 trial.
  • In January 2023, the FDA granted Fast Track Designation to tamibarotene for the treatment of HR-MDS patients with RARA overexpression.

Syros Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Mercoledì, Marzo 27, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Research, Aplastic anemia, Pfizer, AML, Webcast, Patient, Venetoclax, NDA, G&A, Azacitidine, ID, MDS, Bone marrow, RARA, Pharmaceutical industry

Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.

Key Points: 
  • Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.
  • Cash, cash equivalents and marketable securities as of December 31, 2023, were $139.5 million, as compared with $202.3 million on December 31, 2022.
  • ET to discuss the fourth quarter and full-year 2023 financial results and provide a corporate update.
  • A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com .

MEI Pharma Reports Update from Clinical Study Evaluating Oral CDK9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia

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Martedì, Marzo 26, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Toxicity, Aplastic anemia, Salvage therapy, CLL, AML, CRi, Patient, Venetoclax, Biomarker, Diarrhea, BCL2, University, Acute myeloid leukemia, ELN, Safety, Pharmacokinetics, CDK9, Phase 1, Associate professor, Pharmaceutical industry

The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.

Key Points: 
  • The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.
  • A total of 29 patients with R/R AML, median age 67 years (range 34-89), enrolled in the dose escalation stage of the study evaluating voruciclib in combination with venetoclax.
  • The primary objectives of the study are to determine the safety and biologic effective dose of voruciclib monotherapy or voruciclib in combination with venetoclax.
  • Secondary objectives of the study include assessing the preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers of voruciclib monotherapy or voruciclib in combination with venetoclax.

Syros Announces Completion of Enrollment of 190 Patients Necessary to Support Primary Endpoint Analysis in SELECT-MDS-1 Phase 3 Trial

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Lunedì, Marzo 25, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, New Drug Application, Patient, Venetoclax, NDA, Standard of care, Acute myeloid leukemia, Clinical trial, Azacitidine, Bone marrow, Food, RARA, Pharmaceutical industry

This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis.

Key Points: 
  • This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis.
  • Syros expects to report these pivotal data by the middle of the fourth quarter of 2024.
  • “We are pleased to announce the completion of enrollment of the 190 patients necessary to support the primary CR endpoint in SELECT-MDS-1.
  • Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in the SELECT-AML-1 Phase 2 clinical trial in newly diagnosed unfit acute myeloid leukemia patients with RARA gene overexpression.

ORYZON Reports Financial Results and Corporate Update for Quarter Ended December 31, 2023

Retrieved on: 
Lunedì, Febbraio 26, 2024
Borderline personality disorder, HOPE, HDAC6, National Cancer Institute, EVOLUTION, CMT, Agitation, Data analysis, Convertible bond, ICIS, ALS, SCLC, Azacitidine, Duration, ICI, IIS, Sciatic nerve, Deficit spending, Paclitaxel, DSM-IV codes, Development, Genomics, ALS Association, FMS, LSD1, AML, Clinical Global Impression, MSKCC, Conference, Aggression, Safety, Biomarker, CNS, Venetoclax, CRADA, OHSU, MRD, Clinical trial, BPD, Measure (mathematics), IND, FCCC, Dor, Human, Innovation, EMA, Kabuki syndrome, NET, NCI, Aes, Glomus tumor, FDA, GST, Food, Platinum, Schizophrenia, Phase II, Charcot–Marie–Tooth disease, Medicine, Patient, BEST, Disease, Pharmaceutical industry

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.
  • Research and development (R&D) expenses were $3.9 and $16.6 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $5.0 and $18.1 million for the quarter and twelve months ended December 31, 2022.
  • General and administrative expenses were $1.2 and $4.2 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.2 and $4.8 million for the quarter and twelve months ended December 31, 2022.
  • Net losses were $1.4 and $5.0 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.6 and $5.9 million for the quarter and twelve months ended December 31, 2022.