Report
Chris Kallos, CFA
EUR 147.86 For Business Accounts Only

Advancing the R&D pipeline with CSL830 Biologics License Application: Maintaining FVE for CSL

CSL recently announced the that the U.S. Food and Drug Administration, or FDA, had accepted its Biologics License Application for review of CSL830. This is typically the final step before marketing and product launch subject to approval. CSL830 is a low-volume subcutaneous and prophylactic version of CSL’s Berinert product, a C1-INH replacement therapy used to treat hereditary angioedema, or HAE, a rare genetic disorder caused by a deficiency of C1-Esterase Inhibitor, or C1-INH. This condition i...
Underlying
CSL Limited

CSL is engaged in the research, development, manufacture, marketing and distribution of biopharmaceutical and allied products. Co.'s operations are divided into three segments: CSL Behring, Seqirus, and CSL Intellectual Property. CSL Behring is engaged in manufacturing, marketing and developing plasma therapies (plasma products and recombinants). Seqirus is engaged in manufacturing and distributing non-plasma biotherapeutic products. CSL Intellectual Property is engaged in the licensing of intellectual property of Co. to unrelated third parties. Co. operates primarily in five specific geographic areas, namely Australia, the U.S., Germany, Switzerland, and the U.K.

Provider
Morningstar
Morningstar

Morningstar, Inc. is a leading provider of independent investment research in North America, Europe, Australia, and Asia. The company offer an extensive line of products and services for individual investors, financial advisors, asset managers, and retirement plan providers and sponsors.

Morningstar provides data on approximately 530,000 investment offerings, including stocks, mutual funds, and similar vehicles, along with real-time global market data on more than 18 million equities, indexes, futures, options, commodities, and precious metals, in addition to foreign exchange and Treasury markets. Morningstar also offers investment management services through its investment advisory subsidiaries and had approximately $185 billion in assets under advisement and management as of June 30, 2016.

We have operations in 27 countries.

Analysts
Chris Kallos, CFA

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