Incyte

MacroGenics Earns $15 Million Milestone Following U.S. FDA Approval of ZYNYZ™ (retifanlimab-dlwr)

Retrieved on: 
Wednesday, March 22, 2023
Therapy, Merkel-cell carcinoma, Cancer, Macrogen, Patient, FDA, BLA, Food, Pharmaceutical industry, Incyte, MD

ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017.

Key Points: 
  • ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017.
  • “The FDA approval of ZYNYZ represents the third approval of a product originating from MacroGenics’ pipeline of proprietary or partnered product candidates,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics.
  • In addition, MacroGenics is eligible to receive tiered royalties of 15% to 24% on any global net sales of the product.
  • Finally, MacroGenics has an agreement with Incyte under which it manufactures a portion of Incyte’s global commercial supply of retifanlimab.

MacroGenics Provides Corporate Update and 2022 Financial Results

Retrieved on: 
Wednesday, March 15, 2023
Gilead Sciences, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, B7-H3, Cytokine release syndrome, ADC, New Board, ASCO, Clinical trial, Investigational New Drug, DRI, Cancer, Macrogen, Half-life, Telephone, Acute myeloid leukemia, CD123, Docetaxel, T1D, Sale, Syndrome, Webcast, RPF, Patient, PSA, Prostate-specific antigen, Parliamentary Information Technology Committee, FDA, ID, Conference call, Ageing, Gilead, D, Prostate cancer, B7, Research, Food, Therapy, IND, Pharmaceutical industry, Vaccine, Medical imaging, Cryptocurrency, Conference, Incyte

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Key Points: 
  • ET
    ROCKVILLE, Md., March 15, 2023 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2022.
  • MacroGenics initiated the Phase 2 portion of the TAMARACK study of vobra duo in patients with mCRPC in late 2022.
  • MacroGenics believes that removal of the control arm should allow the Company to provide a clinical update in 2024 potentially in support of a subsequent Phase 3 study in mCRPC.
  • The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm.

Incyte Announces Data from Across its Oncology Portfolio will be Presented at the AACR Annual Meeting 2023

Retrieved on: 
Tuesday, March 14, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Molecule, Phosphatidylinositol, AACR, Lenalidomide, Lung cancer, APC Activator, Abstract, DLBCL, Clinical trial, Refractory, Anemia, Relapse, Potent, Tumor microenvironment, Phosphatase, BTK, BET inhibitor, Drug resistance, Bone marrow, MPN, Myeloproliferative neoplasm, ALK2, American Association for Cancer Research, Efficacy, Treatment, Fibroblast growth factor receptor, FGFR, Pharmaceutical industry, Vaccine, Patient, Macrophage, Incyte, Primary myelofibrosis, Pemigatinib

Incyte (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, in Orlando, Florida.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, in Orlando, Florida.
  • ET)
    Five-Year Safety and Efficacy of Tafasitamab in Patients with Relapsed or Refractory DLBCL: Final Results from the Phase 2 L-MIND Study1(Abstract #CT022.
  • ET)
    For registered attendees, the virtual meeting platform and all on-demand sessions will be available through July 19, 2023.
  • More information regarding the AACR Annual Meeting 2023 can be found at https://www.aacr.org/meeting/aacr-annual-meeting-2023/ .

Multiple Abstracts from Incyte’s Growing Dermatology Portfolio Featured at American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Monday, March 6, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Cream, Shift, Janus, American Academy, Chronic, Journal, Dermatology, Conference call, Patient, Interest, Hidradenitis suppurativa, American Academy of Dermatology, AAD, Janus kinase inhibitor, Inflammation, JAK1, Use, Adolescence, Atopic dermatitis, Randomness, Post hoc analysis, Autoimmunity, Maintenance, JAAD, Conference, Abstract, HS, Safety, Cryptocurrency, Pharmaceutical industry, Communications satellite, Disease, Vitiligo, Incyte

Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2023 American Academy of Dermatology (AAD) Annual Meeting, held March 17-21, 2023, in New Orleans.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2023 American Academy of Dermatology (AAD) Annual Meeting, held March 17-21, 2023, in New Orleans.
  • “The research being featured at this year’s AAD Annual Meeting highlights the potential of Incyte therapies to meet the needs of patients living with vitiligo and other serious skin conditions,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
  • Saturday, March 18, 9:30 a.m. CT)
    Efficacy and Safety of Povorcitinib in Vitiligo: Results from a Phase 2, Placebo-Controlled, Dose Ranging Study (Session: S042 – Late-Breaking Research: Session 2.
  • They will also be published online via the Journal of the American Academy of Dermatology (JAAD) supplement in Fall 2023.

Caris Life Sciences and Incyte Enter Into Broad Precision Medicine Partnership to Advance Incyte's Oncology Pipeline

Retrieved on: 
Tuesday, March 7, 2023
MBA, National Center for Advancing Translational Sciences, Research, Biomarker, Clinical trial, Incyte, DNA, Partnership, Patient, Cancer, Medicine, Sequence, RNA, Pharmaceutical industry, Medical imaging

IRVING, Texas, March 7, 2023 /PRNewswire/ -- Caris Life Sciences ®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today announced a strategic research partnership with Incyte Corporation (NASDAQ:INCY) to augment precision medicine approaches for Incyte's oncology pipeline.

Key Points: 
  • IRVING, Texas, March 7, 2023 /PRNewswire/ -- Caris Life Sciences ®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today announced a strategic research partnership with Incyte Corporation (NASDAQ:INCY) to augment precision medicine approaches for Incyte's oncology pipeline.
  • "This partnership with Incyte will leverage Caris' leading molecular science and technology solutions to support Incyte's oncology research and development efforts," said David Spetzler , M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences.
  • Incyte will also leverage Caris' biomarker-driven patient selection for clinical trials including options to partner on developing companion diagnostics for programs in the partnership.
  • "Our partnership with Caris will bring a comprehensive suite of precision medicine capabilities to augment Incyte's success in developing key programs in our robust oncology portfolio."

Incyte Provides Update on Interim Analysis of Phase 3 LIMBER-304 Study of Parsaclisib and Ruxolitinib in Patients with Myelofibrosis

Retrieved on: 
Friday, March 3, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Magnetic resonance imaging, TSS, Patient, Safety, Ruxolitinib, Maintenance, IDMC, Medical imaging, Incyte

The recommendation to stop the study was not due to safety.

Key Points: 
  • The recommendation to stop the study was not due to safety.
  • LIMBER-304 is a randomized, double-blind study evaluating the efficacy and safety of parsaclisib plus ruxolitinib (Jakafi®) versus placebo plus ruxolitinib in adult (age ≥18 years) patients living with myelofibrosis (MF) who have an inadequate response to ruxolitinib monotherapy.
  • Data from this study will be submitted for presentation at an upcoming scientific meeting.
  • The primary endpoint of LIMBER-304 ( NCT04551053 ) was the proportion of patients achieving targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography.

Merus Announces Financial Results for the Fourth Quarter and Full Year 2022 and Provides Business Update

Retrieved on: 
Tuesday, February 28, 2023
Clinical trial, Eli Lilly and Company, Therapy, Cancer, Prostate cancer, EGFR, Pancreatic cancer, Research, Lung cancer, Afatinib, Enrollment, BLA, International Conference on Nuclear Disarmament, Oslo, 2008, FDA, Collaboration, Patient, Financial toxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, EAP, ADT, Betta, NSCLC, Conference, AACR, Castration, Head, CRPC, General counsel, Drug design, CD3, Food, Lung, Bank, Pharmaceutical industry, Medical imaging, Nursing, Lilly, HNSCC, Incyte, Meru Networks

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the fourth quarter and full year and provided a business update.

Key Points: 
  • Further, Merus is evaluating Zeno in combination with an ADT (enzalutamide or abiraterone) in men with CRPC, irrespective of NRG1+ status.
  • Merus plans to provide initial clinical data on Zeno in CRPC in the second half of 2023.
  • Merus plans to provide a clinical update on petosemtamab in the first half of 2023 at a medical conference.
  • In the fourth quarter of 2022, Merus achieved a milestone payment of €1.0 million from Ono for preclinical advancement of a lead candidate arising from this license.

CLEARA Biotech Appoints Nicholas J. Sarlis, MD, PhD as Chief Medical Officer and Head of Clinical Development

Retrieved on: 
Wednesday, February 22, 2023
Oncology, Professional Services, Health, Venture Capital, Clinical Trials, Pharmaceutical, Biotechnology, Lynx, American College, Immunotherapy, Doctor of Philosophy, Royal, University, FOXO4, National Board of Medical Examiners, Registry, CMO, Medical Affairs Bureau, Incyte, American Board of Internal Medicine, MD Anderson Cancer Center, Patient, Head, University of London, American College of Physicians, Imperial College London, Doctor Medicinae (Danish and Norwegian degree), Conditional sentence, Internal medicine, Textbook, Multimedia, National and Kapodistrian University of Athens, American Board of Commissioners for Foreign Missions, Royal Society, Physician, Pharmaceutical industry, Surgeon, Sanofi, EU

Dr. Sarlis brings more than 25 years of clinical and pharmaceutical/biotechnology experience to his position at CLEARA, including leading multidisciplinary teams to advance early to late-stage clinical development programs in the biotechnology industry as well as approved drugs.

Key Points: 
  • Dr. Sarlis brings more than 25 years of clinical and pharmaceutical/biotechnology experience to his position at CLEARA, including leading multidisciplinary teams to advance early to late-stage clinical development programs in the biotechnology industry as well as approved drugs.
  • He is an experienced clinician, senior medical researcher and recognized pharmaceutical and biotech industry leader.
  • Before that, Dr. Sarlis served as Head of Medical Affairs at Incyte Corp. and held positions of increasing seniority at Sanofi, both in the US and France.
  • I look forward to partnering with the company’s energetic and talented team to build our clinical development organization and advance this new therapeutic option for patients in need.”

Pia Baumann takes up her position as Chief Medical Officer

Retrieved on: 
Tuesday, February 21, 2023
CMO, Karolinska University Hospital, SMAC, Pia, Drug development, Patient, Osimertinib, Nasdaq Stockholm, Takeda, ARIAD Pharmaceuticals, Partnership, MD, Karolinska Institute, AstraZeneca, Market capitalization, Incyte, Cancer, Pharmaceutical industry, Medivir

STOCKHOLM, Feb. 21, 2023 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that the company's new Chief Medical Officer (CMO) Pia Baumann took up her position.

Key Points: 
  • STOCKHOLM, Feb. 21, 2023 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that the company's new Chief Medical Officer (CMO) Pia Baumann took up her position.
  • Pia Baumann, an MD specialized in oncology who earned her Ph.D. at Karolinska Institute, has substantial experience in drug development in the cancer field.
  • Pia most recently held a position at AstraZeneca as Vice President Medical with global responsibility for the company's Tagrisso and Lung Cancer franchise.
  • "I am very pleased that Pia now has taken up the role as Chief Medical Officer.

Dr. Andi Grant is appointed to CEO at BioOra

Retrieved on: 
Thursday, February 2, 2023
Automation, Malaghan Institute of Medical Research, Patient, University, Research, Medical research, Partnership, IP, Incyte, Doctor of Philosophy, Pharmaceutical industry

MIAMI and WELLINGTON, New Zealand, Feb. 2, 2023 /PRNewswire/ -- BioOra Limited, a Bridgewest Group portfolio company, appoints new CEO, Dr. Andi Grant.

Key Points: 
  • MIAMI and WELLINGTON, New Zealand, Feb. 2, 2023 /PRNewswire/ -- BioOra Limited, a Bridgewest Group portfolio company, appoints new CEO, Dr. Andi Grant.
  • "We are excited to welcome Andi to BioOra," said Dr. Peter Crabtree, Chairman of BioOra.
  • "There is no question that BioOra is on the frontier of developing therapies that will change lives," says Dr. Grant.
  • I am honored to join BioOra and to lead the team on this remarkable journey," said Dr. Grant.