WOBURN, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Yield10 Bioscience, Inc. (Nasdaq:YTEN), an agricultural bioscience company, today announced successful field testing of prototype lines of the oilseed Camelina sativa that have been programed to produce PHA bioplastics directly in seed.

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Yield10 Bioscience Announces Achievement of Proof-of-Concept Milestone for Producing PHA Bioplastic in Field Grown Camelina Plants

PHILADELPHIA, PA, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals Inc., (“Vallon” or the “Company”), a biopharmaceutical company focused on the development of novel drugs for CNS disorders, today announced the presentation of pharmacokinetics (PK) and pharmacodynamic (PD) data from two studies evaluating its investigational new drug, Abuse Deterrent Amphetamine Immediate Release (ADAIR), at the 2021 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting which was held virtually January 15-17, 2021.

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Vallon Pharmaceuticals Announces Presentation of ADAIR Pharmacokinetics and Pharmacodynamic Data at the Virtual 2021 APSARD Annual Meeting

FLORHAM PARK, N.J., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it has completed patient enrollment in PHALCON-HP, a pivotal Phase 3 clinical trial of vonoprazan in combination with amoxicillin (vonoprazan dual therapy) and vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) for the eradication of H. pylori infection. Phathom continues to expect topline results from the study in the second quarter of 2021.

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Phathom Pharmaceuticals Announces Completion of Patient Enrollment in Pivotal Phase 3 Helicobacter pylori (H. pylori) Trial

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Tarsus Pharmaceuticals, Inc. Appoints Bryan Wahl, MD, JD as General Counsel

Name change reflects Company’s evolution, renewed team and strategic focus on advancing its lead compound into human trials Company to trade under ticker SKYE effective January 19, 2021 Name change reflects Company’s evolution, renewed team and strategic focus on advancing its lead compound into human trials Company to trade under ticker SKYE effective January 19, 2021

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Emerald Bioscience Launches Rebrand Including Name Change to Skye Bioscience

GAITHERSBURG, Md., Jan. 19, 2021 (GLOBE NEWSWIRE) -- NexImmune, a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology, today announced the appointment of Grant Verstandig to its Board of Directors.

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NexImmune Appoints Healthcare Innovator Grant Verstandig as New Board Member

SAN CARLOS, Calif., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that senior leadership plans to present at the following virtual healthcare conferences:

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Iovance Biotherapeutics to Present at Upcoming Healthcare Conferences

– B-SIMPLE4 pivotal Phase 3 study in molluscum contagiosum reaches 90% enrollment with topline data targeted for Q2 2021 –

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Novan Provides Enrollment Update and Announces New Corporate Headquarters

DOYLESTOWN, Pa., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Neuropathix, Inc. (“Neuropathix” or the “Company”) (OTCQB: NPTX), a socially responsible pain management life sciences company, announced the publication of its global WIPO/PCT Patent WO 2020/ 264324 – “Use of Certain Phosphatidylcholines Containing Long Chain Polyunsaturated Fatty Acids (“PUFAs”) as Neuroprotective Agents” (the “PUFA Patent”).

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Neuropathix, Inc. Announces Publication of Its Global PCT Patent for NPTX-204, a Novel Hops-Inspired Neuroprotectant

SUNNY ISLES, Fla., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Bespoke Extracts, Inc. (OTC Pink: BSPK), producer of high quality, hemp-derived CBD products, today announced that it has entered into an amendment with the holders of the Company’s original issue discount convertible debentures with an original issuance date of December 24, 2019 and subsequently amended on May 28, 2020, August 21, 2020 and December 10, 2020, in the aggregate outstanding principal amount of $500,000. Pursuant to the latest amendment (No. 4), the conversion price of the debentures was increased from $0.001 to $0.05 per share, subject to adjustment for stock splits, stock dividends and similar transactions.

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Bespoke Extracts Increases Conversion Price of Outstanding Discount Convertible Debentures

-Enhanced Signaling Pathways Show Increased Potency Through Expression of MicroRNAs-

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Capricor Therapeutics Announces Publication Demonstrating Methods for Enhanced Potency of Cardiosphere-Derived Exosomes

EAST SETAUKET, NY, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, today announced an agreement on a Phase 1b clinical trial with City of Hope, a world-renowned independent cancer research and treatment center. The trial will assess the combination of Lixte’s first-in-class protein phosphatase inhibitor LB-100 with a standard regimen for untreated, extensive stage-disease small cell lung cancer (ED-SCLC).

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Lixte Biotechnology and City of Hope to Initiate Phase 1b Clinical Trial of Lixte’s Lead Compound LB-100 to Treat Small Cell Lung Cancer

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Theratechnologies Announces Closing of US$46 Million Bought-Deal Public Offering, Including Full Exercise of the Over-Allotment Option

NEW YORK, NY, Jan. 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Tauriga Sciences, Inc. (OTCQB: TAUG) (“Tauriga” or the “Company”), a revenue generating, diversified life sciences company, with a proprietary line of CBD & CBG infused Supplement chewing gums (Flavors: Pomegranate, Blood Orange, Peach-Lemon, Pear Bellini, Mint, Black Currant) as well as an ongoing Pharmaceutical Development initiative, today announced that it is constructing a Product Showroom (“Showroom”) inside its new corporate headquarters.  The Company has made this decision in anticipation of and in preparation for important future Agreement(s) & Partnership(s).  The Company expects to host a broad array of prospective new customers, once this Showroom is functional.  These potential new customers include, but are not limited to: Individual Customers, Mom & Pop Stores, Gas Station Convenience Stores, Large Regional & National Retailers, Major Distributors, and College Campus Stores.

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Tauriga Sciences Inc. to Construct Product Showroom Within its New Corporate Headquarters

President and CEO Sanjeev Luther and Co-Chief Medical Officer Tim Pardee, M.D., Ph.D., will discuss clinical trial launches, FDA-granted Fast Track designations and other recent accomplishments on Wednesday, Jan. 20 President and CEO Sanjeev Luther and Co-Chief Medical Officer Tim Pardee, M.D., Ph.D., will discuss clinical trial launches, FDA-granted Fast Track designations and other recent accomplishments on Wednesday, Jan. 20

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Rafael Pharmaceuticals to Present at B. Riley Securities Virtual Oncology Investor Conference

1 Growth at constant exchange rates and scope is the organic growth of sales, excluding the impact of exchange rate changes, by calculating the indicator for the financial year in question and that for the previous financial year on the basis of identical exchange rates (the exchange rate used is that in effect for the previous financial year), and excluding the impact of changes in scope, by calculating the indicator for the financial year in question on the basis of the scope of consolidation for the previous financial year, and by excluding sales of Sentinel for the two financial years in question.

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VIRBAC:2020 annual revenue shows strong growth of +5.7% at constant exchange rates and scope (+3.2% at constant rates)

LEXINGTON, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that Dr. Jennifer Buell, President and COO of Agenus, and Dr. Steven O’Day, CMO of Agenus, will participate in B. Riley Securities’ Oncology Investor Conference on January 20-21, 2021.

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Agenus to Participate in B. Riley Securities' Oncology Investor Conference

18 January 2021

A new way of controlling the immune system's 'natural killer' cells has been identified, which could help prevent rejection of transplanted cells.

Natural killer cells act as a front-line defence against foreign cells in the body. Overcoming this defence has represented a major challenge to transplant, cancer immunotherapy and regenerative medicine. The new research provides a possibility to disguise transplanted cells so that they are 'invisible' to this immune defence.

'As a cardiac surgeon, I would love to put myself out of business by being able to implant healthy cardiac cells to repair heart disease', said the study's lead author Professor Tobias Deuse, from the Department of Surgery at University of California, San Francisco. 'And there are tremendous hopes to one day have the ability to implant insulin-producing cells in patients with diabetes or to inject cancer patients with immune cells engineered to seek and destroy tumours. The major obstacle is how to do this in a way that avoids immediate rejection by the immune system'.

Professor Deuse and his colleagues genetically engineered cells to express the protein CD47 and found that these were not attacked by natural killer cells. They discovered that this was because the CD47 protein activates another protein found in the natural killer cells called SIRP.

SIRP was known to be important in other immune cell responses, but scientists had not previously been able to identify it in natural killer cells. 'All the literature said that natural killer cells don't have this checkpoint, but when we looked at cells from human patients in the lab we found SIRP there, clear as day', said corresponding author Professor Sonja Schrepfer.

The team investigated whether this finding could be used to help transplanted stem cells to avoid immune rejection. To do this, they genetically engineered human cells to express rhesus monkey CD47 and transplanted these cells into monkeys. They found that the engineered cells activated the SIRP on natural killer cells, which prevented them from being attacked.

In the future the same procedure could be performed in reverse, expressing human CD47 in pig cardiac cells, for instance, to prevent them from activating natural killer cells when transplanted into human patients.

The research team aims to create a 'hypoimmune' cell line for use in regenerative medicine that will be able to avoid immune rejection.

'Currently engineered cell therapies for cancer and fledgling forms of regenerative medicine all rely on being able to extract cells from the patient, modify them in the lab, and then put them back in the patient. This avoids rejection of foreign cells, but is extremely laborious and expensive', said Professor Schrepfer. 'Our goal in establishing a hypoimmune cell platform is to create off-the shelf products that can be used to treat disease in all patients everywhere'.

The research was recently published in the Journal of Experimental Medicine.

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Controlling the immune system with 'invisible stem' cells - BioNews

PFFFIKON, Switzerland, Jan. 19, 2021 /PRNewswire/ -- DiNAQOR, a gene therapy platform company,today announcedthat it has acquired EHT Technologies GmbH, a Germany-based engineered heart tissue (EHT) technology platform company. Financial terms of the transaction were not disclosed.

EHT Technologies was founded in 2015 based upon research on human induced pluripotent stem cells (hiPSC) at the University Medical Center Hamburg-Eppendorf. Cardiomyocytes derived from hiPSC are an innovative research technology for cardiac drug development programs. Engineered heart tissues are three-dimensional, hydrogel-based muscle constructs that can be generated from isolated heart cells of chicken, rat, mouse, human embryonic stem cells and hiPSC. Proof-of-concept studies have shown that EHT can be transduced efficiently with adeno-associated virus (AAV) vectors, including AAV9, validating the use of this platform for gene therapy applications.

"EHT Technologies' proprietary hiPSC platform for disease modeling is a perfect complement to DiNAQOR's research and development efforts and leaps forward our ability to develop creative approaches for treating heart diseases in the future. EHT's intellectual property and know-how is industry-leading and we are excited to be able to harness its platform at DiNAQOR," commented Johannes Holzmeister, M.D., Chairman and CEO at DiNAQOR.

"After more than 25 years of development, I'm very excited that our engineered heart tissue technology is making the transition from an academic research model to a drug development tool. The combined application of human cardiomyocytes and a versatile, 3D in vitro assay will facilitate development and reduce reliance on animal studies. The hiPSC-derived EHT assay has great potential for the development of innovative cardiovascular therapeutics and DiNAQOR is the perfect fit for this enterprise," commented Professor Thomas Eschenhagen, M.D., co-founder of EHT Technologies. Professor Eschenhagen serves on DiNAQOR's Scientific Advisory Board.

"The EHT technology will accelerate the advancement of our discovery pipeline and bridge the translational gap between the animal model and human disease. We are proud that DiNAQOR is on the forefront of implementing this innovative technology to expedite new therapies into the clinic," said Valeria Ricotti, M.D., Chief Medical Officer at DiNAQOR.

About DiNAQORFounded in 2019,DiNAQOR is a global gene therapy platform company focused on advancing novel solutions for patients suffering from heart disease.The company is headquartered in Pfffikon, Switzerland, with additional presence in London, England and Hamburg, Germany. For more information visitwww.dinaqor.com.

ContactKWM CommunicationsKellie Walsh[emailprotected] or Stephanie Marks[emailprotected]

SOURCE DiNAQOR

DiNAQOR: A global gene therapy platform company

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DiNAQOR Acquires EHT Technologies GmbH to Advance Engineered Heart Tissue R&D Capabilities - PRNewswire

Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Company Announcement

Copenhagen, Denmark; January 15, 2021 Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis. A supplemental Biologics License Application (sBLA) for this indication was submitted by Janssen Biotech, Inc. (Janssen), in September 2020. The U.S. FDA reviewed the submission of data for approval in this indication under their Real-Time Oncology Review (RTOR)1 pilot program and Project Orbis2. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). DARZALEX FASPRO is not indicated and is not recommended for the treatment of patients with light-chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

AL amyloidosis is a devastating and potentially fatal blood disorder that, until now, did not have any U.S. FDA-approved therapies. This makes todays approval of DARZALEX FASPRO a critical step forward for patients in the U.S. in dire need of treatment options, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval was based on data from the Phase 3 ANDROMEDA (AMY3001) study of daratumumab and hyaluronidase-fihj in combination with VCd as treatment for patients with newly diagnosed AL amyloidosis.

The most common adverse reactions (20%) were upper respiratory tract infection, diarrhea, peripheral edema, constipation, fatigue, peripheral sensory neuropathy, nausea, insomnia, dyspnea and cough. Serious adverse reactions occurred in 43% of patients who received DARZALEX FASPRO in combination with VCd. Serious adverse reactions that occurred in at least 5% of patients in the D-VCd arm were pneumonia (9%), cardiac failure (8%) and sepsis (5%). Fatal adverse reactions occurred in 11% of patients. Fatal adverse reactions that occurred in more than one patient included cardiac arrest (4%), sudden death (3%), cardiac failure (3%) and sepsis (1%).3

Among patients who received DARZALEX FASPRO in combination with VCd, 72% of patients had baseline cardiac involvement with Mayo Cardiac Stage I (3%), Stage II (46%) and Stage III (51%). Serious cardiac disorders occurred in 16% of patients (8% of patients with Mayo Cardiac Stage I and II and 28% of patients with Stage III). Serious cardiac disorders in more than 2% of patients included cardiac failure (8%), cardiac arrest (4%) and arrhythmia (4%). Fatal cardiac disorders occurred in 10% of patients (5% of patients with Mayo Cardiac Stage I and II and 19% of patients with Stage III) who received DARZALEX FASPRO in combination with VCd. Fatal cardiac disorders that occurred in more than one patient in the D-VCd arm included cardiac arrest (4%), sudden death (3%) and cardiac failure (3%).3

Full prescribing information will be available at http://www.DARZALEX.com.

Genmab will receive a milestone payment of USD 30 million in connection with the first commercial sale of DARZALEX FASPRO in this indication, which is expected to occur quickly after approval. The milestone will be reflected in Genmabs 2021 guidance, which will be published on February 23, 2021.

About the ANDROMEDA (AMY3001) studyThe Phase 3 study (NCT03201965) included 388 patients newly diagnosed with AL amyloidosis. Patients were randomized to receive treatment with either daratumumab and hyaluronidase-fihj in combination with bortezomib (a proteasome inhibitor), cyclophosphamide (a chemotherapy), and dexamethasone (a corticosteroid) or treatment with VCd alone. The primary endpoint of the study was the percentage of patients who achieve hematologic complete response.

About Light-chain (AL) AmyloidosisAmyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. Until now there were no approved therapies for AL amyloidosis in the U.S., though it is currently being treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies.4 It is estimated that there are approximately 3,000 to 4,000 new cases of AL amyloidosis diagnosed annually in the U.S.5

About DARZALEX (daratumumab)DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. It is also approved in the U.S. for the treatment of adult patients with multiple myeloma: in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology. .DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmabs proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV.

1 Real-Time Oncology Review Pilot Program. https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program Accessed September 20202 Project Orbis. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis. Accessed September 2020.3DARZALEX FASPRO Prescribing Information. Horsham, PA: Janssen Biotech, Inc.4 Mayo Clinic website: http://www.mayoclinic.com/health/amyloidosis/DS004315 Research and Markets, Amyloidosis Treatment Market Size, Share & Trends Analysis Report by Treatment (Stem Cell Transplant, Chemotherapy, Supportive Care, Surgery, Targeted Therapy), By Country, And Segment Forecasts, 2018 - 20256 DARZALEX Prescribing information, August 2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s029lbl.pdf Last accessed August 20207 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 20208 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20209 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.10 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.11 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.12 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012; 120(21): abstract 2974

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Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for Patients with Newly Dia...