On November 6, 2019 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported an expansion of its QIAseq NGS portfolio to offer a one-day workflow for simultaneous preparation of DNA and RNA libraries using next-generation sequencing (NGS) technologies (Press release, Qiagen, NOV 6, 2019, View Source [SID1234550522]).

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The new QIAseq Multimodal Panels are the only solution to offer a consolidated workflow to simultaneously detect DNA variants, RNA fusions and gene expression levels from a single sample, with an input as low as 10 ng of total nucleic acid. This unmatched low-input solution reduces a typical 2-3 day workflow to approximately only nine hours by eliminating the need for two separate time-consuming, inefficient and costly workflows for library preparation from separate DNA and RNA samples. Both libraries are generated from the same sample input, sample utilization and, in turn, sampling-induced bias is also reduced. This enables labs to conserve samples of limited availability for further downstream applications.

The new QIAseq products will be showcased this week together with QIAGEN’s full range of Sample to Insight solutions for molecular oncology research and diagnostics at the Association for Molecular Pathology (AMP) 2019 Annual Meeting in Baltimore, Maryland.

On November 6, 2019 Biopharmaceutical company Alvotech and global pharmaceutical company STADA Arzneimittel AG ("STADA") reported that they have entered into an exclusive strategic partnership for the commercialization of seven biosimilars in all key European markets and selected markets outside Europe (Press release, Alvotech, NOV 6, 2019, View Source [SID1234550537]). The initial pipeline contains biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions as well as ophthalmology for patients around the world.

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Under this partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars within the EU. STADA will be exclusively commercializing the products in the majority of the key European markets. The originator products of the seven biosimilars currently generate $50 billion in sales globally, allowing the two parties to agree on a particularly lucrative contract. The agreement includes an upfront payment with subsequent milestone payments over the next four years.

Robert Wessman, Alvotech’s founder and Chairman, added, "This is an important moment for biosimilars. This partnership has the resources and vision to accelerate the introduction and adoption of new biosimilars for patients in Europe who will get better access to high-quality products. It’s also another important milestone for Alvotech and crowns an exceptional year where we have continued to extend our network of partners around the globe."

"We’re delighted to establish this latest partnership with STADA, who is an ideal commercial partner in Europe and shares the same purpose of improving the quality of life of patients around the world," added Mark Levick, CEO of Alvotech.

Peter Goldschmidt, Chairman of the Executive Board/CEO of STADA, said, "The collaboration with Alvotech, with its highly experienced and fully committed team, is a great opportunity to accelerate the expansion of our biosimilar portfolio and to strengthen our market position in this segment. We are looking forward to provide patients with state-of-the-art medicine and cost-effective alternatives to biologicals."

On November 6, 2019 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) reported its third quarter 2019 financial results and highlights (Press release, Synta Pharmaceuticals, NOV 6, 2019, View Source [SID1234550553]):

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"Madrigal continued to execute its clinical development strategy in non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD) during the third quarter. We opened clinical sites and enrolled subjects in accordance with the plan for our Phase 3 study of MGL-3196 (resmetirom) in patients with biopsy-proven NASH and liver fibrosis (MAESTRO-NASH)," stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. "We also made progress toward initiating a second Phase 3 clinical study in a broader segment of NASH patients, many of whom also have hyperlipidemia, MAESTRO-NAFLD-1. These patients, like the later stage NASH patients, are at high risk of cardiovascular disease. In this regard, we are pleased that Seth Baum, M.D., Immediate Past President, American Society for Preventive Cardiology, will present "Managing Cardiovascular Risk in NAFLD/NASH" from 1:30 – 2:00 PM ET on Monday, November 11, 2019, during the AASLD Annual Meeting."

Becky Taub, M.D.,CMO, President, Research & Development of Madrigal, added, "We are pleased to announce that The Lancet has accepted for publication Madrigal’s Phase 2 study results in patients with NASH. We are also pleased to announce that FDA has granted Madrigal’s request for Fast Track designation of resmetirom for NASH. We look forward to the upcoming Liver Meeting AASLD 2019 in Boston this month, where our abstract "Effects of Resmetirom (MGL-3196) on Hepatic Fat, Lipids, Liver Enzymes and Markers of Liver Fibrosis in an Open-Label 36-Week Extension Study in NASH Patients" has been selected for oral presentation, and our poster, "Steatosis and Fibrosis Measured as Continuous Variables on Paired, Serial Liver Biopsies in the Resmetirom (MGL-3196) 36-Week Phase 2 NASH Study" will also be presented."

Details of the presentations mentioned above are as follows:

Seth Baum, M.D., Immediate Past President, American Society for Preventive Cardiology, will present "Managing Cardiovascular Risk in NAFLD/NASH," Monday November 11, 1:30 – 2:00 PM, Product Theater, Exhibition Floor.

Stephen Harrison, M.D. TITLE: "Effects of Resmetirom (MGL-3196) on Hepatic Fat, Lipids, Liver Enzymes and Markers of Liver Fibrosis in an Open-Label 36-Week Extension Study in NASH Patients" Parallel Session 39 (oral) (4:30-6:00 PM) Hynes Convention Center Ballroom BC, Monday November 11, 5:30 PM.

Poster 2133 "Steatosis and Fibrosis Measured as Continuous Variables on Paired, Serial Liver Biopsies in the Resmetirom (MGL-3196) 36-Week Phase 2 NASH Study," Monday November 11, 8:00 AM, Poster Hall. NAFLD and NASH Therapeutics: Pharmacologic and Other.

Madrigal will also have a medical information booth – #513 on the exhibition floor.

Additional information about Madrigal’s Phase 3 study in patients with NASH [NCT03900429] can be obtained at www.clinicaltrials.gov.

Financial Results for the Three and Nine Months Ended September 30, 2019

As of September 30, 2019, Madrigal had cash, cash equivalents and marketable securities of $453.6 million, compared to $483.7 million at December 31, 2018. The decrease of $30.1 million was largely the result of $29.3 million cash used in operating activities during the first nine months of 2019.

Operating expenses were $24.2 million and $65.0 million for the three and nine month periods ended September 30, 2019, compared to $11.3 million and $26.2 million in the comparable prior year periods.

Research and development expenses for the three and nine month periods ended September 30, 2019 were $19.4 million and $47.4 million compared to $6.2 million and $16.5 million in the comparable prior year periods. The increases are primarily attributable to additional activities related to initiation of our Phase 3 clinical trial in NASH, including a payment due related to a milestone achieved under our agreement with Roche, an increase in headcount and increased non-cash stock compensation from stock option awards.

General and administrative expenses for the three and nine month periods ended September 30, 2019 were $4.7 million and $17.6 million compared to $5.1 million and $9.7 million in the comparable prior year periods. The decrease for the three month period is due primarily to lower non-cash stock compensation expense from stock option awards. The increase for the nine month period is due primarily to increased non-cash stock compensation from stock option awards.

Interest income for the three and nine month periods ended September 30, 2019 was $2.8 million and $8.8 million compared to $2.8 million and $4.7 million in the comparable prior year periods. The change in interest income for the nine month period was due primarily to a higher average principal balance in our investment portfolio in 2019, and increased interest rates.

About resmetirom (MGL-3196)

Among its many functions in the human body, thyroid hormone, through activation of its beta receptor, plays a central role in controlling lipid metabolism, impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Attempts to exploit this pathway for therapeutic purposes in cardio-metabolic and liver diseases have been hampered by the lack of selectivity of older compounds for the thyroid hormone receptor (THR)-ß, chemically-related toxicities and undesirable distribution in the body.

Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-ß and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-ß agonism. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver- directed, truly ß-selective THR agonist.

Based on the positive Phase 2 clinical study results in patients with NASH (Phase 2 36-Week Results Press Release), Madrigal initiated a Phase 3 multinational, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic steatohepatitis (NASH) and fibrosis to resolve NASH and reduce progression to cirrhosis and/or hepatic decompensation (Phase 3 Initiation Press Release and ClinicalTrials.gov NCT03900429). Additionally, in both the NASH Phase 2 study, and a second positive Phase 2 clinical study in patients with heterozygous familial hypercholesterolemia (Phase 2 HeFH Results Press Release), significant reductions in multiple atherogenic lipids were observed. Madrigal is planning a Phase 3 study in NASH and NAFLD patients to further assess effects on LDL-cholesterol, other atherogenic lipids, biomarkers of fibrosis, MRI-PDFF and fibroscans to better characterize potential clinical benefits of resmetirom on cardiovascular and liver related endpoints using noninvasive measures.

On November 6, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that it has commenced a global offering of up to $450 million (approximately €405.8 million) of ordinary shares, which may be in the form of American Depository Shares ("ADSs") (Press release, argenx, NOV 6, 2019, View Source [SID1234550645]). The global offering will be comprised of an offering of ordinary shares in the form of ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are expected to close simultaneously.

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In addition, argenx intends to grant the underwriters of the offering a 30-day option to purchase additional ordinary shares (including in the form of ADSs) in an aggregate amount of up to 15% of the total number of ordinary shares (including in the form of ADSs) proposed to be sold in the offering, on the same terms and conditions.

Baillie Gifford Overseas Limited and entities affiliated with it have indicated an interest in purchasing an aggregate of up to $220 million (approximately €199 million) of ordinary shares in this offering at the offering price per share and on the same terms as the other purchasers in this offering. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, fewer or no ordinary shares to these potential purchasers, and these potential purchasers could determine to purchase more, fewer or no shares in this offering.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX." and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX.".

Morgan Stanley, Cowen, BofA Securities and Evercore are acting as joint bookrunning managers for the offering. Kempen is acting as lead manager for the offering and Wolfe Capital Markets and Advisory is acting as co-manager.

The securities are being offered pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

The U.S. offering and the European private placement are expected to close simultaneously, and such closing date may be impacted by holidays in the United States or the EEA, as applicable.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained for free from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, New York 10014, United States, Attention: Prospectus Department; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200.

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made following pricing of the offering.

On November 6, 2019 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported the pricing of its initial public offering of 5,000,000 shares of common stock at a public offering price of $12.00 per share, for total gross proceeds of $60.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Galera (Press release, Galera Therapeutics, NOV 6, 2019, View Source [SID1234553561]). All of the common stock is being offered by Galera. In addition, Galera has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock at the initial public offering price less the underwriting discounts and commissions. Galera’s common stock is expected to begin trading on the Nasdaq Global Market on November 7, 2019, under the ticker symbol "GRTX." The offering is expected to close on November 12, 2019, subject to customary closing conditions.

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BofA Securities, Citigroup and Credit Suisse are acting as joint book-running managers for the offering and BTIG is acting as co-manager for the offering.

A registration statement relating to the securities being sold in the offering has been declared effective by the U.S. Securities and Exchange Commission on November 6, 2019. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, by contacting: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, by e-mail at [email protected], Citigroup Global Markets Inc. c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at +1 (800) 831-9146, or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd Floor, New York, NY 10010, or by telephone at +1 (800) 221-1037, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.