MRK Merck & Company Inc. (new)

74.62
+0.05  (+0%)
Previous Close 74.57
Open 74.2
52 Week Low 65.25
52 Week High 87.8
Market Cap $188,791,169,689
Shares 2,530,034,437
Float 2,528,507,274
Enterprise Value $209,973,766,933
Volume 10,408,010
Av. Daily Volume 10,324,828
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
MK-7110 (CD24Fc)
COVID-19
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Molnupiravir (MK-4482)
COVID-19
Phase 2/3
Phase 2/3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Keytruda + chemo (KEYNOTE-590)
Esophageal Cancer
PDUFA priority review
PDUFA priority review
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
V114
Pneumococcal disease
PDUFA priority review
PDUFA priority review
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Keytruda
Cutaneous squamous cell carcinoma (cSCC)
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Lynparza - OlympiA
BRCAm adjuvant breast cancer
Phase 3
Phase 3
Phase 3 trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) versus placebo - February 17, 2021.
ARQ 531
B-cell malignancies
Phase 1
Phase 1
Phase 1 presentation at ASH December 9, 2019. 89% ORR in CLL patients; 50% in Richter’s Transformation.
Keytruda KN-522
Triple negative breast cancer (TNBC)
PDUFA
PDUFA
PDUFA date March 29, 2021. Advisory Committee meeting advised that the date should be extended pending further data.
Pembrolizumab vs chemotherapy
Malignant pleural mesothelioma (MPM)
Phase 3
Phase 3
Phase 3 data presented at ESMO September 2019.
V591 (Themis)
COVID-19 vaccine
Phase 1
Phase 1
Phase 1 trial discontinued due to inferior immune responses - January 25, 2021.
V590 (IAVI)
COVID-19 vaccine
Phase 1
Phase 1
Phase 1 trial discontinued due to inferior immune responses - January 25, 2021.
Keytruda KN-361
Bladder cancer
Phase 3
Phase 3
Phase 3 data did not meet dual primary endpoints - June 9, 2020.
Vericiguat
Heart Failure
Approved
Approved
FDA approval announced January 20, 2021.
Keytruda (pembrolizumab) and Ipilimumab
Non-Small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial to discontinue due to futility - November 9, 2020.
Keytruda KN-355
Triple negative breast cancer (TNBC)
Approved
Approved
FDA Approval announced November 13, 2020.
Keytruda and Lenvima
Endometrial Cancer
Phase 3
Phase 3
Phase 3 trial met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) - December 16, 2020.
ARQ 092
Overgrowth Diseases
Phase 1/2
Phase 1/2
Phase 1/2 MOSAIC initiation of dosing announced October 2, 2019.
Keytruda (pembrolizumab) and Lenvima (lenvatinib)
Renal Cell Carcinoma
Phase 3
Phase 3
Phase 3 trial met PFS and OS endpoints versus Sunitinib - November 10, 2020.
Keytruda KN-604
Small cell lung cancer (SCLC)
Phase 3
Phase 3
Phase 3 data met PFS primary endpoint; overall survival primary endpoint not met - January 6, 2020.
Keytruda - KEYNOTE-204
Classical Hodgkin lymphoma
Approved
Approved
FDA Approval announced October 15, 2020.
MK-7264
Chronic cough
Phase 3
Phase 3
Phase 3 data released March 17, 2020. 45 mg arm met primary endpoint; 15 mg arm did not meet the primary efficacy endpoint.
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
Approved
Approved
FDA approval announced April 22, 2019.
Keytruda and Lenvima
Hepatocellular Carcinoma
CRL
CRL
CRL issued July 8, 2020.
Keytruda KN-177
Colorectal cancer (CRC)
Approved
Approved
FDA Approval announced June 29, 2020.
Keytruda
Cutaneous squamous cell carcinoma (cSCC)
Approved
Approved
FDA approval announced June 24, 2020.
Keytruda
Solid tumors - TMB-H ≥10 mutations/megabase
Approved
Approved
FDA Approval June 17, 2020.
GARDASIL 9
Prevention HPV-Related Head and Neck Cancers
Approved
Approved
FDA Approval announced June 12, 2020.
Recarbrio
Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
Approved
Approved
FDA approval announced June 4, 2020.
ERVEBO (V920)
Ebola
Approved
Approved
FDA Approval announced December 19, 2019.
Lynparza
Castration-Resistant Prostate Cancer
Approved
Approved
FDA Approval announced May 19, 2020.
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
Approved
Approved
FDA Approval announced May 8, 2020.
Keytruda
6-week dosing for melanoma and other indications
NDA Filing
NDA Filing
CRL issued February 18, 2020. Resubmission announced April 23, 2020.
Selumetinib
Neurofibromatosis type 1 plexiform neurofibromas
Approved
Approved
FDA Approval announced April 13, 2020.
Keytruda KN-240
Hepatocellular Carcinoma
Phase 3
Phase 3
Phase 3 data February 19, 2019 did not meet primary endpoints.
Keytruda KN-062
Gastric cancer
Phase 3
Phase 3
Phase 3 data released April 25, 2019 noted that monotherapy arm met noninferiority primary endpoint. Combo arm did not meet OS/PFS endpoints.
DIFICID (fidaxomicin)
Clostridium difficile infections (CDI)
Approved
Approved
FDA Approval announced January 27, 2020.
ARQ 751
Solid tumors
Phase 1
Phase 1
Phase 1b trial ongoing.
Keytruda KN-057
NMIBC Bladder cancer
Approved
Approved
FDA Approval announced January 8, 2020.
Lynparza (POLO)
Pancreatic cancer
Approved
Approved
FDA Approval announced December 30, 2019.
DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate)
HIV
Approved
Approved
FDA Approval for sNDA announced September 20, 2019.
Keytruda and Lenvima
Endometrial cancer
Approved
Approved
FDA Approval announced September 17, 2019.
Keytruda KN-181
Esophageal Cancer
Approved
Approved
FDA Approval announced July 31, 2019.
MK-8591
HIV
Phase 2
Phase 2
Phase 3 trial planned.
Imipenem/ cilastatin
Complicated urinary tract infections (cUTI) and Complicated intra-abdominal infections (cIAI)
Approved
Approved
FDA Approval announced July 17, 2019.
Keytruda - KN-158
Small cell lung cancer (SCLC)
Approved
Approved
FDA Approval announced June 18, 2019.
Keytruda - KEYNOTE-042
Non-small cell lung cancer (NSCLC)
Approved
Approved
FDA Approval announced April 11, 2019.
KEYTRUDA + carboplatin-paclitaxel or nab-paclitaxel KEYNOTE-407
Squamous non-small cell lung cancer (sNSCLC)
Approved
Approved
FDA approval announced October 30, 2018.
Keytruda KN-048
Head and neck squamous cell carcinoma (HNSCC)
Approved
Approved
FDA Approval announced June 11, 2019.
Keytruda KN-119
Triple negative breast cancer (TNBC)
Phase 3
Phase 3
Phase 3 data May 20, 2019 did not meet primary endpoint.
ZERBAXA(ceftolozane and tazobactam)
Hospital-acquired bacterial pneumonia (HABP)
Approved
Approved
FDA approval announced June 3, 2019.
KEYTRUDA - EORTC1325/KEYNOTE-054
Melanoma
Approved
Approved
FDA Approval announced February 19, 2019.
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Approved
Approved
FDA label expansion announced January 31, 2019.
Lynparza - SOLO 1
First-line ovarian cancer following platinum-based chemotherapy
Approved
Approved
FDA Approval announced December 19, 2018.
Keytruda KN-17
Merkel Cell Carcinoma
Approved
Approved
FDA Approval announced December 19, 2018.
Keytruda - KEYNOTE-224
Hepatocellular carcinoma (HCC)
Approved
Approved
FDA approval announced November 9, 2018.
GARDASIL 9
Human Papilloma virus vaccine
Approved
Approved
Approval announced October 5, 2018.
LENVIMA (lenvatinib)
Hepatocellular Carcinoma (HCC)
Approved
Approved
FDA approval announced August 16, 2018.
Keytruda
Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
Approved
Approved
Approval announced June 13, 2018.
KEYTRUDA
Cervical cancer
Approved
Approved
Approval announced June 12, 2018.
KEYTRUDA + chemo (KEYNOTE-021)
First-Line Nonsquamous Non-small cell lung cancer (NSCLC)
Approved
Approved
FDA approval (label expansion) announced June 5, 2018.
Epacadostat with Keytruda - ECHO-301
Cancer - first-line metastatic melanoma.
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted April 6, 2018.
MK-8931 (019) - Verubecestat
Mild-to-moderate Alzheimer's
Phase 3
Phase 3
Phase 3 interim analysis by DMC advised trial to be discontinued due to lack of benefit vs risk.
Lynparza
Breast cancer
Approved
Approved
Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death). Approval announced January 12, 2018.
Letermovir
Cytomegalovirus (CMV) Infection
Approved
Approved
Approval announced November 9, 2017.
MK-8931 (017) - Verubecestat
Mild-to-moderate Alzheimer's
Phase 3
Phase 3
Phase 3 trial stopped due to lack of efficacy - February 14, 2017.
KEYTRUDA
Relapsed or Refractory Classical Hodgkin Lymphoma
Approved
Approved
Approval announced March 14, 2017.
KEYTRUDA
Microsatellite Instability-High Cancer
Approved
Approved
PDUFA date March 8, 2017 extended to June 9, 2017 due to submission of extra data. Approved May 23, 2017.
RENFLEXIS - SB2 (infliximab biosimilar)
Biosimilar candidate of Remicade
Approved
Approved
BLA acceptance announced May 23, 2016 by partner Samsung Bioepis. Approval annuonced April 21, 2017.
ISENTRESS
HIV-1
Approved
Approved
Approval announced May 30, 2017.
Keytruda
First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Approved
Approved
Approved May 10, 2017.
Ertugliflozin
Type 2 diabetes
Approved
Approved
Approval announced December 20, 2017.
KEYTRUDA
First and Second line locally advanced or metastatic urothelial cancer - bladder cancer
Approved
Approved
Approved May 18, 2017.
Odactra (MK-8237)
House dust mite allergies
Approved
Approved
Approved March 1, 2017.
Januvia (Sitagliptin)
Type 2 Diabetes
CRL
CRL
CRL issued April 7 2017. sNDA for approved drug requested to include data on cardiovascular effects
Keytruda
Cancer - Third-line Gastric or Gastroesophageal Junction Adenocarcinoma
Approved
Approved
Approved Sept. 22, 2017 under accelerated approval in patients undergoing third-line treatment following data from Phase 2 Keynote-59 trial. Phase 3 data released December 14, 2017 in patients undergoing second-line treatment, did not meet the primary endpoint of overall survival, nor did it show a significant improvement in PFS.
KEYNOTE-040 KEYTRUDA
Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Approved
Approved
Phase 3 trial did not meet primary endpoint - July 24, 2017. Awarded accelerated approval in 2016.

Latest News

  1. Proprietary Technology Enhances Health and Environmental Monitoring Solutions for Poultry Producers

    Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE:MRK), today announced the completion of its acquisition of PrognostiX Poultry Limited d/b/a Poultry Sense Ltd. from its founding shareholders. Poultry Sense Ltd. is an innovator in health and environmental monitoring solutions for the poultry industry. In March 2019, Merck Animal Health invested in Poultry Sense Ltd., to support their development. Specific terms of the agreement were not disclosed.

    Poultry Sense Ltd., a privately held company located in Exeter, U.K., provides enhanced technology…

    Proprietary Technology Enhances Health and Environmental Monitoring Solutions for Poultry Producers

    Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE:MRK), today announced the completion of its acquisition of PrognostiX Poultry Limited d/b/a Poultry Sense Ltd. from its founding shareholders. Poultry Sense Ltd. is an innovator in health and environmental monitoring solutions for the poultry industry. In March 2019, Merck Animal Health invested in Poultry Sense Ltd., to support their development. Specific terms of the agreement were not disclosed.

    Poultry Sense Ltd., a privately held company located in Exeter, U.K., provides enhanced technology for poultry farmers to continuously track and analyze overall health performance for the life of the flock; it provides users the capability to measure, compare and record key health and environmental indicators captured by battery-powered, wireless sensors in the poultry barn, as well as to identify patterns and trends to predict health and well-being and, ultimately, prevent disease and improve performance.

    This innovative technology is an important tool used to assess an animal's health and well-being, which contributes to enhanced productivity and efficacy measures on the farm and, ultimately, to better food safety and security. The sensors allow farmers to monitor and assess vital parameters by measuring weight, water usage, humidity, light, temperature and carbon dioxide. Farmers can therefore gain insight into the housing environment, as well as bird health and performance.

    This proprietary technology can detect health conditions earlier in poultry that can lead to illness, thus reducing the potential for disease outbreak. This notification is done via software reports in an easy-to-read dashboard in real-time on any mobile device, desktop, tablet or secure website, which also connects to the cloud.

    "We are pleased to take this step forward with the acquisition of Poultry Sense Ltd., as we continue to broaden our portfolio with complementary products and technologies to advance animal well-being and outcomes for our customers," said Rick DeLuca, president, Merck Animal Health. "We now will be able to provide enhanced health and environmental monitoring technology to the poultry industry, which adds to our technological expertise within our livestock monitoring business with beef and dairy cattle as well as aquaculture, strengthening our leadership in shaping the future of animal health."

    "Our goal is to improve the detection of animal illness and enable more preventative solutions, including vaccination, to maintain the health of livestock. We are at the technological forefront of shaping the future of animal health through our commitment to leveraging our scientific and technical capabilities and expertise through comprehensive solutions to manage the health, well-being and performance of animals."

    The Poultry Sense Ltd. product portfolio joins Merck Animal Health Intelligence, a newly formed specialized operating unit which takes its name from the company's strategic vision for animal health intelligence and data expertise. Merck Animal Health Intelligence is a complementary business that specializes in identification, traceability, monitoring solutions and services to help improve animal management and health outcomes.

    "The addition of specialized, digital technology within our portfolio of medicines, vaccines and services, provides holistic solutions to help advance animal health and complements our existing identification and monitoring technology that delivers real-time, actionable data and insights to help, improve or enhance animal management and health outcomes," said DeLuca.

    "I am delighted that Merck Animal Health has chosen to acquire this tremendous technology," said Alan Beynon, CEO of PrognostiX. "They have the expertise and geographic range to expand the footprint of this product and reach more customers."

    In April 2019, Merck Animal Health announced the completion of its acquisition of market leading brands Allflex Livestock Intelligence, Sure Petcare and Biomark as leaders in emerging digital technology with animal identification, animal monitoring and smart data management for Livestock and Companion Animals. In December 2019, the company acquired Vaki, a leader in fish farming and wild fish conservation monitoring equipment and real-time video monitoring technology to advance fish health and welfare. In June 2020, the company acquired Quantified Ag®, an innovator in data and analytics that monitors cattle body temperature and movement in order to detect illness early. In August 2020, the company acquired IdentiGEN, a leader in DNA-based animal traceability solutions for Livestock and Aquaculture.

    About Merck Animal Health

    For 130 years, Merck, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, is the global animal health business unit of Merck. Through its commitment to The Science of Healthier Animals®, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com or connect with us on LinkedIn, Facebook, and Twitter at @MerckAH.

    Poultry Sense Limited

    Poultry Sense combines a wealth of expertise and evidence with the knowledge of specialist vets, engineers and data analysts to bring together real-time data across both environmental and health parameters to help facilitate improvements in bird performance, economics and welfare.

    The wireless system feeds accurate, live data into a bespoke analytics platform that uses artificial intelligence to produce insight assisting in better informed on-farm and supply chain decision making. For more information contact: .

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    View Full Article Hide Full Article
  2. Acquisition Adds Pipeline of Candidates Targeting a Broad Range of Autoimmune Diseases

    Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pandion Therapeutics, Inc. (NASDAQ:PAND) today announced that the companies have entered into a definitive agreement, under which Merck, through a subsidiary, will acquire Pandion, a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, for $60 per share in cash. This represents an approximate total equity value of $1.85 billion.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005318/en/

    "This acquisition builds upon Merck's…

    Acquisition Adds Pipeline of Candidates Targeting a Broad Range of Autoimmune Diseases

    Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pandion Therapeutics, Inc. (NASDAQ:PAND) today announced that the companies have entered into a definitive agreement, under which Merck, through a subsidiary, will acquire Pandion, a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, for $60 per share in cash. This represents an approximate total equity value of $1.85 billion.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005318/en/

    "This acquisition builds upon Merck's strategy to identify and secure candidates with differentiated and potentially foundational characteristics," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Pandion has applied its TALON technology to develop a robust pipeline of candidates designed to re-balance the immune response with potential applications across a wide array of autoimmune diseases."

    Pandion is advancing a pipeline of precision immune modulators targeting critical immune control nodes. The company's lead candidate, PT101, is an engineered IL-2 mutein fused to a protein backbone designed to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of ulcerative colitis and other autoimmune diseases. Earlier this year, Pandion announced that PT101 had completed a Phase 1a clinical trial, which achieved its primary objective of safety and tolerability. The company's pipeline also includes PD-1 agonists in development for numerous autoimmune diseases.

    "Pandion grew out of our founders' personal and scientific mission to change the way patients living with autoimmune diseases are treated. In just a few years, we have taken that mission from idea to clinical proof of mechanism with PT101, our lead IL-2 mutein. We are proud that Merck has recognized our team's innovation and drive in creating a pipeline of diverse candidates that activate natural immune regulatory mechanisms and thereby have the potential to achieve better clinical responses for patients," said Dr. Rahul Kakkar, chief executive officer, Pandion Therapeutics. "We believe Merck is well positioned to bring our novel approach to the millions of those living with autoimmune diseases, and we look forward to seeing these molecules progress in the clinic."

    Under the terms of the acquisition agreement, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Pandion. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Pandion's shares of fully-diluted common stock, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the successful completion of the tender offer, Merck's acquisition subsidiary will be merged into Pandion, and any remaining shares of common stock of Pandion will be canceled and converted into the right to receive the same $60 per share price payable in the tender offer. The transaction is expected to close in the first half of 2021.

    Credit Suisse Securities (USA) LLC acted as financial advisor to Merck and Covington & Burling LLP as its legal advisor. Centerview Partners LLC acted as financial advisor to Pandion and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor.

    About Regulatory T Cells (Tregs)

    Tregs act as a control node within the immune system and can inhibit the activity of several different pro-inflammatory immune cell types. Tregs are critical for self-tolerance, or the ability of the immune system to recognize a hosts' cells and not produce an immune attack against them. Defects in Tregs result in multi-organ inflammation and their dysfunction is associated with many autoimmune diseases. Multiple third-party clinical trials suggest that expansion of Tregs by low-dose IL-2 can benefit patients with autoimmune diseases.

    About PT101

    PT101 is an engineered IL-2 mutein fused to a protein backbone designed to selectively activate and expand regulatory T cells for the treatment of autoimmune diseases. In autoimmune diseases, the immune system inappropriately attacks a host's cells, and targeting Tregs could allow the immune system to regain control and return to homeostasis. PT101 has completed a Phase 1a clinical trial, which achieved its primary objective of safety and tolerability. In the trial, PT101 demonstrated proof of mechanism by selectively expanding Tregs in healthy volunteers.

    Important Information About the Tender Offer

    The tender offer described in this press release (the "Offer") has not yet commenced. This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Pandion Therapeutics, Inc. ("Pandion") or any other securities. At the time the planned tender offer is commenced, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed by Merck Sharp & Dohme Corp. ("Merck") and Panama Merger Sub, Inc., a wholly-owned subsidiary of Merck, with the Securities and Exchange Commission (the "SEC"), and a solicitation/recommendation statement on Schedule 14D-9 will be filed by Pandion with the SEC. The offer to purchase shares of Pandion common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO.

    INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.

    Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 423-1000. In addition, Merck and Pandion will file annual, quarterly and current reports and other information with the SEC. Merck's and Pandion's filings with the SEC also will be available to the public from commercial document-retrieval services and at the SEC's website at www.sec.gov.

    About Pandion Therapeutics

    Pandion Therapeutics is developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases. Pandion's TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format. Pandion's lead product candidate PT101, a combination of an interleukin-2 mutein effector module with a protein backbone, is designed to selectively expand regulatory T cells systemically, without activating proinflammatory cells, such as conventional T cells and natural killer cells. Pandion is continuing to develop and expand its library of effector and tether modules as part of its earlier-stage research and discovery pipeline. For more information, please visit www.pandiontx.com and engage with us on Twitter @PandionTX or on LinkedIn.

    About Merck

    For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Pandion Therapeutics Forward-Looking Statements

    This press release contains "forward-looking statements" that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding PT101 as a potential treatment for patients with autoimmune diseases, the timing of future clinical trials of PT101, the Company's strategy and clinical development plans, timelines and prospects, and information related to the proposed acquisition of Pandion are forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed acquisition, the parties' ability to satisfy the conditions to the consummation of the tender offer and the other conditions to the consummation of the acquisition; statements about the expected timetable for completing the transaction; and the anticipated timing of closing of the proposed acquisition. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Pandion's ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; initiate preclinical studies and clinical trials of PT101 and its other product candidates; advance PT101 and its other product candidates in preclinical research and clinical trials; replicate in clinical trials positive results found in preclinical studies; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives; risks related to the satisfaction of waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all; uncertainties as to how many of Pandion's stockholders will tender their shares of Pandion common stock in the tender offer and the possibility that the acquisition does not close; the possibility that competing offers may be made; risks related to obtaining the requisite consents to the acquisition, including, without limitation, the timing (including possible delays) and receipt of clearance under the Hart-Scott-Antitrust Improvements Act of 1976, as amended; disruption from the transaction making it more difficult to maintain business and operational relationships; and significant transaction costs. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Merck & Co., Inc., Kenilworth, N.J., USA Forward-Looking Statements

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (https://www.sec.gov/).

    View Full Article Hide Full Article
  3. Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that Frank Clyburn, executive vice president and chief commercial officer, is scheduled to participate in the Cowen 41st Annual Health Care Conference on March 3, 2021 at 1:20 p.m. EST.

    Investors, analysts, members of the media and the general public are invited to watch a live video webcast of the presentations at https://investors.merck.com/events-and-presentations/default.aspx.

    About Merck

    For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our…

    Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that Frank Clyburn, executive vice president and chief commercial officer, is scheduled to participate in the Cowen 41st Annual Health Care Conference on March 3, 2021 at 1:20 p.m. EST.

    Investors, analysts, members of the media and the general public are invited to watch a live video webcast of the presentations at https://investors.merck.com/events-and-presentations/default.aspx.

    About Merck

    For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    View Full Article Hide Full Article
  4. Phase 3 OlympiA Trial Evaluated LYNPARZA in Germline BRCA-mutated High-Risk HER2-Negative Early-Stage Breast Cancer Following Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

    AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the Phase 3 OlympiA trial for LYNPARZA will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC).

    Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) versus placebo in the adjuvant treatment of germline BRCA-mutated (gBRCAm), high-risk human epidermal growth factor…

    Phase 3 OlympiA Trial Evaluated LYNPARZA in Germline BRCA-mutated High-Risk HER2-Negative Early-Stage Breast Cancer Following Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

    AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the Phase 3 OlympiA trial for LYNPARZA will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC).

    Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) versus placebo in the adjuvant treatment of germline BRCA-mutated (gBRCAm), high-risk human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer following definitive local treatment and neoadjuvant or adjuvant chemotherapy.

    The OlympiA Phase 3 trial is a partnership between Breast International Group (BIG), NRG Oncology, the U.S. National Cancer Institute (NCI), Frontier Science & Technology Research Foundation (FSTRF), AstraZeneca and Merck. The trial is sponsored by NRG Oncology in the U.S. and by AstraZeneca outside the U.S.

    An estimated 2.3 million women were diagnosed with breast cancer worldwide in 2020, and BRCA mutations are found in approximately 5% of breast cancer patients. Around 55–65% of women with a BRCA1 mutation and approximately 45% with a BRCA2 mutation are estimated to develop breast cancer before the age of 70.

    Andrew Tutt, global chair of the OlympiA Phase 3 trial and professor, Institute of Cancer Research and Kings College London, said, "We are delighted that our global academic and industry partnership has been able to help investigate a possible personalized treatment for women with hereditary breast cancer. The most common cause of hereditary breast cancer is an inherited mutation in the BRCA1 or BRCA2 genes, which also may cause the disease to develop at a significantly earlier age than is usual. The OlympiA trial has allowed us to go beyond using genetic testing to identify patients who are at risk of this disease and explore the potential of LYNPARZA to prevent disease recurrence for these patients. We look forward to analyzing and presenting the full results of the trial at a forthcoming medical meeting."

    Dr. José Baselga, executive vice president, oncology R&D, AstraZeneca, said, "Breast cancer remains one of the most common cancers globally and despite advances in treatment, many patients with high-risk disease will unfortunately develop a recurrence. We look forward to reviewing the results."

    Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, "Analysis of the OlympiA trial, based upon the IDMC recommendation, could represent a potential step forward for patients with early-stage, high-risk primary breast cancer with a germline BRCA mutation."

    In its communication on the planned interim analysis, the IDMC did not raise any new safety concerns. The trial will continue to assess the key secondary endpoints of overall survival and distant disease-free survival.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    There are no contraindications for LYNPARZA.

    WARNINGS AND PRECAUTIONS

    Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

    Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

    If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

    Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

    Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

    Females

    Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

    Males

    Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

    Venous Thromboembolic Events: Including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

    ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/ nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

    ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

    Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab compared to a ≥5% frequency for placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

    In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).

    ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

    Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

    ADVERSE REACTIONS—Advanced gBRCAm Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

    ADVERSE REACTIONS—gBRCAm, HER2-negative Metastatic Breast Cancer

    Most common adverse reactions (Grades 1-4) in ≥20% of patients in OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

    Most common laboratory abnormalities (Grades 1-4) in >25% of patients in OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

    ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

    Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

    ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

    Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

    DRUG INTERACTIONS

    Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

    CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

    CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

    USE IN SPECIFIC POPULATIONS

    Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

    Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

    Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

    Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

    INDICATIONS in the United States

    LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

    First-Line Maintenance BRCAm Advanced Ovarian Cancer

    For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    First-Line Maintenance HRD Positive Advanced Ovarian Cancer in Combination with Bevacizumab

    In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:

    • a deleterious or suspected deleterious BRCA mutation and/or
    • genomic instability

    Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    Maintenance Recurrent Ovarian Cancer

    For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

    Advanced gBRCAm Ovarian Cancer

    For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    gBRCAm HER2-negative Metastatic Breast Cancer

    For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer

    For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    HRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

    For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

    About Breast Cancer

    Breast cancer is the most common cancer among women worldwide. The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease, and one of the most biologically diverse tumor types with various factors fueling its development and progression.

    About BRCA Mutations

    BRCA1 and BRCA2 (breast cancer susceptibility genes 1/2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

    About OlympiA

    OlympiA is a Phase 3, double-blind, parallel group, placebo-controlled, multicenter trial testing the efficacy and safety of LYNPARZA tablets versus placebo as adjuvant treatment in patients with gBRCAm high-risk HER2-negative early breast cancer, who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. The primary endpoint of the trial is iDFS defined as time from randomization to date of first treatment failure that is loco-regional or distant recurrence or new cancer or death from any cause.

    About NRG Oncology

    NRG Oncology is a network group funded by the NCI, a part of the National Institutes of Health. All of the NCI funded network groups participated in the trial. The NCI and AstraZeneca are collaborating under a Cooperative Research and Development Agreement.

    NRG Oncology brings together the National Surgical Adjuvant Breast and Bowel Project, the Radiation Therapy Oncology Group, and the Gynaecologic Oncology Group, with the mission to improve the lives of cancer patients by conducting practice-changing multi-institutional clinical and translational research.

    About BIG

    The Breast International Group (BIG) is an international not-for-profit organization for academic breast cancer research groups from around the world, based in Brussels, Belgium.

    Founded by leading European opinions leaders in 1999, the organization aims to address fragmentation in European breast cancer research and now represents a network of over 55 like-minded research groups affiliated with specialized hospitals, research centers and leading experts across approximately 70 countries on six continents.

    BIG's research is supported in part by its philanthropy unit, known as BIG against breast cancer, which is used to interact with the general public and donors, and to raise funds for BIG's purely academic breast cancer trials and research programs.

    About FSTRF

    Frontier Science & Technology Research Foundation (FSTRF) is a non-profit, research organization which supports research networks, pharmaceutical companies and investigators to conduct scientifically meaningful, high-quality clinical trials. The OlympiA trial involved research staff in the U.S. and in the Affiliate office in Scotland.

    FSTRF works with scientists and technicians in more than 800 laboratories, universities and medical centers around the world to provide a comprehensive range of research services throughout the clinical trial process including design, analysis and reporting.

    Through its work, FSTRF aims to advance the application of statistical science and practice and data management techniques in science, healthcare and education.

    About LYNPARZA® (olaparib)

    LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

    LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

    About the AstraZeneca and Merck Strategic Oncology Collaboration

    In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize certain oncology products including LYNPARZA, the world's first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.

    Merck's Focus on Cancer

    Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

    About Merck

    For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    View Full Article Hide Full Article
  5. Westport, CT, Feb. 16, 2021 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it appointed Ms. Brenda Castrodad to lead its Human Resources department.

    A seasoned executive, Ms. Castrodad brings a wealth of experience in leading organizational development in start-ups and Fortune 500 companies within the life sciences sector. Most recently, Ms. Castrodad led the HR department at TissueTech, Inc., a Miami, FL-based biotech leader in regenerative amniotic tissue-based products, where she was responsible…

    Westport, CT, Feb. 16, 2021 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it appointed Ms. Brenda Castrodad to lead its Human Resources department.

    A seasoned executive, Ms. Castrodad brings a wealth of experience in leading organizational development in start-ups and Fortune 500 companies within the life sciences sector. Most recently, Ms. Castrodad led the HR department at TissueTech, Inc., a Miami, FL-based biotech leader in regenerative amniotic tissue-based products, where she was responsible for transformation and automation of the company's HR practices, talent planning, and team building. Prior to TissueTech, Inc., Ms. Castrodad spent six years at HeartWare, Inc., a heart failure medtech company acquired by Medtronic (NYSE:MDT) in 2016 for $1.1 billion. By optimizing the internal talent acquisition function and aligning business practices, Ms. Castrodad helped grow the organization from approx. 80 to 500+ staff which achieved approx. $250 million in revenues before the acquisition. Earlier in her career, Ms. Castrodad spent 16 years at Schering-Plough Corp, a pharmaceutical company acquired in 2009 for $41.1 billion by Merck & Co. (NYSE:MRK). Ms. Castrodad holds a Master's Degree in Public Administration and a Bachelor's Degree in Social Sciences – Human Welfare from the University of Puerto Rico and a Labor Relations Certificate from the University of Michigan.

    "A proven champion of culture, growth, and transformation, Brenda impressed us with her experience in positioning HR as a strategic business partner to create a platform for successful talent acquisition and employee engagement. Brenda's expertise in supporting rapid growth, combined with her knowledge of our industry, should be invaluable as we scale up our customer-facing teams while further developing the in-house talent to drive the innovation engine. We look forward to working with Brenda as we prepare the Company for commercial success," commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

    "It is a privilege to join the BioSig team of dedicated and experienced professionals across the organization. I'm energized by the company's culture of innovation and commercialization plans.  I'm thrilled to be a valuable contributor to the incredible growth path ahead of us," commented Brenda Castrodad.

    About BioSig Technologies

    BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

    The Company's first product, PURE EPä System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

    Forward-looking Statements

    This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.



    Andrew Ballou
    BioSig Technologies, Inc. 
    Vice President, Investor Relations 
    54 Wilton Road, 2nd floor
    Westport, CT 06880
    
    203-409-5444, x133
    
    

    Primary Logo

    View Full Article Hide Full Article
View All Merck & Company Inc. (new) News