ASCT

DGAP-News: National Comprehensive Cancer Network(R) Updates Designation of Monjuvi(R) (tafasitamab-cxix) to Preferred Regimen in its Clinical Practice Guidelines in Oncology for B-cell Lymphomas

Retrieved on: 
Martedì, Marzo 15, 2022
FC, Bruise, CD19, ASCT, Immunotherapy, Lymphoma, Education, Death, Patient, Lymph, Incyte, Apoptosis, FDA, National Comprehensive Cancer Network, Nursing, Lymphoid leukemia, Rash, Flushing, Bone marrow, Safety, NCCN, NASDAQ, Adult, Fever, B cell, DLBCL, ORR, Food, Spleen, Pharmacist, Liver, Research, ADCC, Population, Chills, Headache, Bleeding, MorphoSys, Incorporation (business), Lenalidomide, Physician, Health, FSE, ADCP, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Medical imaging, Vaccine, EU, Infection, Tafasitamab, Diffuse Large B-cell Lymphoma (DLBCL), Monjuvi (tafasitamab-cxix), MorphoSys, DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), MONJUVI (TAFASITAMAB-CXIX), MORPHOSYS

"Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma.

Key Points: 
  • "Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma.
  • We are gratified the NCCN panel acknowledged the additional data submitted for Monjuvi and updated the designation of Monjuvi in combination with lenalidomide to a Preferred Regimen in its Clinical Practice Guidelines in Oncology."
  • This indication is approved under accelerated approval based on overall response rate (ORR) from the one-year primary analysis of the L-MIND study.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMV Announces First Patient Dosed in the VITALIZE Phase 2B Clinical Study Evaluating its Lead Compound, MVP-S, in Combination with KEYTRUDA® (pembrolizumab) in Patients with r/r DLBCL

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Mercoledì, Gennaio 12, 2022
Health, Oncology, Clinical Trials, MSD, Forward-looking statement, SEDAR, Patient, PD-L1, LinkedIn, DPX, Clinical trial, Survivin, Hematological Cancer Research Investment and Education Act, Modulation, NASDAQ, Pembrolizumab, Merck, Merck Sharp & Dohme Federal Credit Union, Review, CPA, ASH, Endpoint security, Bladder cancer, IMV, DLBCL, Company, ASCT, Merck & Co., Doctor of Philosophy, Partial, Immune system, TSX, Twitter, Immunotherapy, Mission statement, EDGAR, ORR, Terminology, Pharmaceutical industry, Medical imaging

The VITALIZE study represents a critical step in advancing MVP-S toward registration, said Jeremy Graff, PhD, Chief Scientific Officer at IMV.

Key Points: 
  • The VITALIZE study represents a critical step in advancing MVP-S toward registration, said Jeremy Graff, PhD, Chief Scientific Officer at IMV.
  • Importantly, this is an open label study, so we expect to review early data in the summer 2022.
  • In December 2020, results of the SPiReL study were presented at the ASH annual meeting.
  • The VITALIZE Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess MVP-S in combination with KEYTRUDA with or without CPA.

DGAP-News: MorphoSys Reports Preliminary 2021 Monjuvi U.S. Sales and Provides 2022 Financial Guidance

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Venerdì, Gennaio 7, 2022
Constellation, Clinical trial, Lenalidomide, FC, Food, Acquisition, Regulation of tobacco by the U.S. Food and Drug Administration, Growth, Communication, ADCP, Patient, Adult, SG, Cancer, Science, U.S. Securities and Exchange Commission, Risk, Twitter, Income, Annual report, LinkedIn, DLBCL, Apoptosis, Achievement, Judgement, Royalty Pharma, Industry, ASCT, Investment, Lymphoid leukemia, ADCC, Bookkeeping, Financial services, Medical device, Health insurance, Music, Fine chemical, Vaccine, Incyte, EU, Tafasitamab, MorphoSys, Monjuvi(R) (tafasitamab), MorphoSys:, MONJUVI(R) (TAFASITAMAB), MORPHOSYS:

Gross Margin for Monjuvi U.S. Net Product Sales

Key Points: 
  • Gross Margin for Monjuvi U.S. Net Product Sales
    100% of Monjuvi U.S. product cost of sales is recorded on MorphoSys' income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.
  • For 2022, we anticipate a year-over-year decline in SG&A, excluding transaction/restructuring/other charges related to Constellation acquisition recorded in 2021.
  • Additional information related to 2022 Financial Guidance:
    - Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys' income statement.
  • Guidance for these royalties is not being provided as MorphoSys does not receive any sales forecasts from its partner Incyte.

DGAP-News: MorphoSys AG Reports First Nine Months and Third Quarter 2021 Results

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Mercoledì, Novembre 10, 2021
Constellation, Cancer, Industry, Investor, Tafasitamab, Incyte, Clinical trial, U.S. Securities and Exchange Commission, FSE, NASDAQ, Conference, Food, Risk, Lymphoma, IFRS, Janssen Pharmaceuticals, Psoriasis, Regulation of tobacco by the U.S. Food and Drug Administration, Annual report, DLBCL, LLC, ASCT, Judgement, ADCP, Antibody, Degenerative disease, FC, CET, Securities and Exchange Commission (Philippines), Lenalidomide, ADCC, Communication, Apoptosis, Lymphoid leukemia, Patient, Adult, Pharmaceutical industry, Vaccine

*Value as of December 31, 2020

Key Points: 
  • *Value as of December 31, 2020
    MorphoSys will hold its conference call and webcast tomorrow, November 11, 2021, to present the results for the third quarter and first nine months of 2021 and the further outlook for 2021.
  • The statement for the third quarter/first nine months of 2021 (IFRS) is available online:
    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees.

DGAP-News: MorphoSys Announces Departure of Roland Wandeler

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Martedì, Novembre 9, 2021
Constellation, Cancer, Industry, COO, Incyte, Medicine, Clinical trial, U.S. Securities and Exchange Commission, S-1 Executive Committee, FSE, NASDAQ, CEO, Executive Committee, Food, Risk, Lymphoma, Janssen Pharmaceuticals, Supervisory board, Regulation of tobacco by the U.S. Food and Drug Administration, FDA, Psoriasis, Annual report, DLBCL, LLC, ASCT, Judgement, ADCP, Antibody, Degenerative disease, FC, Lenalidomide, ADCC, Communication, Apoptosis, Lymphoid leukemia, Patient, Adult, Pharmaceutical industry, Vaccine, MorphoSys, Monjuvi(R) (tafasitamab), MORPHOSYS, MONJUVI(R) (TAFASITAMAB)

Planegg/Munich, Germany, November 9, 2021 - MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that Roland Wandeler, Ph.D., has decided to step down from his position as Chief Operating Officer (COO) and member of the MorphoSys Management Board effective December 31, 2021 to pursue other opportunities.

Key Points: 
  • Planegg/Munich, Germany, November 9, 2021 - MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that Roland Wandeler, Ph.D., has decided to step down from his position as Chief Operating Officer (COO) and member of the MorphoSys Management Board effective December 31, 2021 to pursue other opportunities.
  • "MorphoSys is now well positioned to continue its growth journey and bring breakthrough therapies to people living with cancer."
  • "It has been my honor to work with the exceptional team at MorphoSys," said Roland Wandeler.
  • Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees.

DGAP-News: MorphoSys to present MANIFEST and RE-MIND2 data from expanded hematology-oncology portfolio at the 2021 American Society of Hematology (ASH) Annual Meeting

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Giovedì, Novembre 4, 2021
Constellation, Judgement, DLBCL, Collaboration, FSE, Poster, FC, Cancer, Industry, TD, Incyte, Lenalidomide, Arm, ADCC, NASDAQ, Psoriasis, Apoptosis, Janssen Pharmaceuticals, Food, Antibody, U.S. Securities and Exchange Commission, Lymphoma, ADCP, Communication, Blood, Degenerative disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Adult, Annual report, LLC, Clinical trial, ASCT, Safety, Lymphoid leukemia, Bone marrow, Securities and Exchange Commission (Philippines), MF, Risk, University College, Oxford, Ruxolitinib, Medical imaging, Vaccine, Pharmaceutical industry, Kerosene, Tafasitamab, MANIFEST, MorphoSys, TAFASITAMAB, MANIFEST, MORPHOSYS

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally.
  • Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees.
  • Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Specialised Therapeutics Enters into a New Supply and Distribution Agreement with Incyte to Launch Two New Cancer Therapies, Tafasitamab and Pemigatinib, in Australia, New Zealand and Singapore

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Venerdì, Ottobre 22, 2021
Cancer, DLBCL, Neurology, Partnership, Patient, ADCC, NASDAQ, FDA, FGFR, Apoptosis, Food, MorphoSys, ADCP, FGFR2, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BTC, Adult, Pemigatinib, Collaboration, ASCT, Lenalidomide, Lymphoid leukemia, Ophthalmology, Airline, Pharmaceutical industry, Vaccine

SINGAPORE, Oct. 21, 2021 /PRNewswire/ -- Independent pharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) will partner with Incyte Biosciences International Sàrl, the Swiss-based affiliate of Incyte (NASDAQ:INCY), to launch and distribute two new medicines for its haematology and oncology portfolios, tafasitamab (sold as Monjuvi® in the United States and Minjuvi® in Europe) and pemigatinib (Pemazyre®).

Key Points: 
  • "Both pemigatinib and tafasitamab address strong unmet needs in rare patient populations.
  • Our teams look forward to working closely with Incyte to ensure all eligible patients have access to these therapies at the earliest opportunity."
  • "We look forward to a successful and mutually beneficial partnership, working together with a shared goal of improving patient outcomes."
  • In January 2020, MorphoSys and Incyte entered into a Collaboration and License agreement to further develop and commercialize tafasitamab globally.

BioLineRx Announces Positive Results from Pharmacoeconomic Study Positioning Motixafortide as Potential Standard of Care in Stem Cell Mobilization

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Mercoledì, Ottobre 13, 2021
SCM, ASCT, G-CSF, Cell, NDA, Hospital, Length of stay, Stem cell, Transplant, WTP, QALY, FDA, Patient, TASE, Cryopreservation, Trial of the century, Multiple myeloma, Company, GENESIS, HRU, Neutrophil, TEL, Safety, NASDAQ, BioLineRx, Pharmaceutical industry

TEL AVIV, Israel, Oct. 13, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a pharmacoeconomic study evaluating the cost-effectiveness of using investigational drug Motixafortide as a primary stem cell mobilization (SCM) agent on top of granulocyte colony stimulating factor (G-CSF), versus G-CSF alone, in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT). The study was performed by the Global Health Economics and Outcomes Research (HEOR) team of IQVIA, and was a pre-planned study conducted in parallel with the GENESIS Phase 3 trial. These results, together with the highly significant and clinically meaningful data from the GENESIS trial, strongly support the potential use of Motixafortide, on top of G-CSF, as the standard of care in SCM for ASCT.

Key Points: 
  • These cost savings should leave substantial room in the future to optimize our pricing strategy for Motixafortide at product launch and thereafter, if approved.
  • "It is also important to note that fewer administrations and apheresis sessions confer meaningful safety and time benefits to patients.
  • "We believe the data from the GENESIS study, together with the results from this pharmacoeconomic study, set Motixafortide apart from all other mobilization agents either currently available or in development.
  • Motixafortide plus G-CSF was associated with a statistically significant HRU decrease during the autologous stem cell transplantation process compared to standard-of-care G-CSF alone.

Knight Therapeutics Enters into Exclusive Supply and Distribution Agreement with Incyte for Tafasitamab and Pemigatinib in Latin America

Retrieved on: 
Giovedì, Settembre 23, 2021
Tafasitamab, Food, Therapy, Nature, ADCP, Cholangiocarcinoma, Regulation of tobacco by the U.S. Food and Drug Administration, TSX, Annual report, Pemigatinib, CD19, Intention, NASDAQ, DLBCL, FDA, Patient, GUD, Cancer, ASCT, Adult, Lymphoid leukemia, FGFR, Lymphoma, FC, Hematology, International, Apoptosis, FGFR2, Collaboration, BTC, Incidence, MorphoSys, Lenalidomide, ADCC, GLOBE, Pharmaceutical industry, Health insurance, Vaccine, Generic drug

Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply to Knight of tafasitamab and pemigatinib, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America.

Key Points: 
  • Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply to Knight of tafasitamab and pemigatinib, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America.
  • We are delighted to partner with Incyte, a leading global biopharmaceutical company, to bring tafasitamab and pemigatinib to patients in Latin America upon approval, said Samira Sakhia, President and Chief Executive Officer of Knight.
  • We are eager to work together to expand access to tafasitamab and pemigatinib so that eligible patients in Latin America have access to these innovative medicines.
  • In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally.

Oncopeptides presents phase 3 OCEAN study results at the IMW meeting

Retrieved on: 
Sabato, Settembre 11, 2021

The data was presented today by Fredrik Schjesvold, Head of Oslo Myeloma Center, Norway, at the 18th International Myeloma Workshop (IMW) in Vienna.

Key Points: 
  • The data was presented today by Fredrik Schjesvold, Head of Oslo Myeloma Center, Norway, at the 18th International Myeloma Workshop (IMW) in Vienna.
  • This benefit of pomalidomide over melflufen in the ASCT subgroup has contributed to the HR of 1.1 in the ITT population.
  • "The oral presentation of OCEAN study results at the IMW meeting represents an important milestone for Oncopeptides", says Marty J Duvall, Chief Executive Officer at Oncopeptides.
  • "The efficacy and safety data from the OCEAN study provide new and important insights for the multiple myeloma society", says PieterSonneveld, MD, PhD, Professor of Hematology at theErasmusUniversity of Rotterdam, and Principal Investigator of the OCEAN study.