On Wednesday, BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)’s shares declined -0.65% to $146.30.
BioMarin Pharmaceutical Inc. (BMRN) declared the U.S. Food and Drug Administration (FDA) has accepted for review the submission of a New Drug Application (NDA) for drisapersen for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping, and the Prescription Drug User Fee Act (PDUFA) aim date for a decision is December 27, 2015. The FDA has granted drisapersen Priority Review status, which is designated to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.
In the FDA’s filing communication, the Agency informed the company that it is presently planning to hold an advisory committee meeting to talk about the application. No date has been set for this meeting. Drisapersen formerly has been granted Orphan and Fast Track status, in addition to Breakthrough Therapy designations by the FDA. The U.S. filing is based on three randomized placebo-controlled trials and two long-term open-label studies of more than 300 patients in which some boys have been treated for more than three years.
BioMarin Pharmaceutical Inc. develops and commercializes pharmaceuticals for serious diseases and medical conditions in the United States, Europe, Latin America, and internationally. Its commercial products comprise Vimizim, an enzyme replacement therapy for the treatment of MPS IV A, a lysosomal storage disorder; Naglazyme, a recombinant form of N-acetylgalactosamine 4-sulfatase for patients with mucopolysaccharidosis VI; Kuvan, a proprietary synthetic oral form of 6R-BH4 used to treat patients with phenylketonuria (PKU), an inherited metabolic disease; Aldurazyme used for the treatment of patients with mucopolysaccharidosis I, a genetic disease; Firdapse, a form of 3,4-diaminopyridine used for the treatment of Lambert Myasthenic Syndrome, an autoimmune disease.
American Equity Investment Life Holding (NYSE:AEL)’s shares gained 0.85% to $27.24.
American Equity Investment Life Holding Company (AEL) declared that it will release second quarter 2015 earnings after the close of market on Wednesday, July 29, 2015. The second quarter earnings release and financial supplement will be posted on the American Equity website (www.american-equity.com) at that time.
American Equity Investment Life Holding Company, through its auxiliaries, develops and sells fixed index and fixed rate annuity products in 50 states and the District of Columbia. It issues fixed index annuities and fixed rate annuities, in addition to single premium immediate annuities.
At the end of Wednesday’s trade, Grupo Televisa SAB (ADR) (NYSE:TV)‘s shares surged 0.44% to $36.24.
Foxa and Grupo Televisa SAB (ADR) (TV) declared that, together with Univision’s major shareholders, they have reached a Memorandum of Understanding (“MOU”) and that certain auxiliaries of Univision and Televisa reached an amendment to their existing Program Licensing Agreement (the “PLA Amendment”).
Under the PLA Amendment, the terms of the existing planned relationship between Univision and Televisa have been amended as follows:
- Term Extension – Univision’s exclusive U.S. broadcast and digital rights (with limited exceptions) to Televisa’s programming counting premium Spanish-language telenovelas, sports, sitcoms, reality series, new programming and feature films, will remain unchanged. Subject to Univision concluding a public offering of its common stock that results in net proceeds to Univision of a minimum agreed upon amount and no change of control having occurred, the PLA Amendment extends the term of the PLA from its current expiration date of at least 2025 to at least 2030.
- Revised Royalty Computation – In exchange for Univision agreeing to make certain additional revenue subject to the royalty, effective January 1, 2015 and through December 2017, the royalty rate on substantially all of Univision’s Spanish-language media networks revenue is 11.84 percent, contrast to 11.91 percent under the preceding terms. On January 1, 2018, the royalty rate will enhance to 16.13 percent, contrast to 16.22 percent under the preceding terms. Additionally, Televisa will continue to receive an incremental 2 percent in royalty payments on such media networks’ revenues above an raised revenue base of $1.66 billion, contrast to the preceding revenue base of $1.65 billion. The royalty rate will again enhance to 16.45 percent starting in June 1, 2018 and for the remainder of the term, contrast to the preceding rate of 16.54 percent. With this second rate enhance, Televisa will receive an incremental 2 percent in royalty payments above a reduced revenue base of $1.63 billion.
Grupo Televisa, S.A.B. operates as a media company in the Spanish-speaking world. The company operates through four segments: Content, Sky, Telecommunications, and Other Businesses. The Content segment is involved in the production of television programming and nationwide broadcasting of Channels 2, 4, 5, and 9; the sale of advertising time on programs; and the production of television programming and broadcasting for local television stations in Mexico and the United States.
United Microelectronics Corp (ADR) (NYSE:UMC), ended its Wednesday’s trading session with -1.52% loss, and closed at $1.95.
United Microelectronics Corporation (UMC) , a leading independent semiconductor foundry, will hold its quarterly conference call to talk about second quarter 2015 results on Wednesday, July 29, 2015, at 5:00 a.m. US Eastern Time.
United Microelectronics Corporation provides semiconductor wafer foundry solutions. Its foundry solutions comprise silicon verification, libraries and IP, design verification, design for manufacturing, MM/RF foundry design kit and design support manual, and design flow reference, in addition to mask services, such as mask inspection, IP protection and data preparation, and tape-out status tracking.
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