Top Pick of the Day: AMGN

Amgen Inc. (AMGN) announced that it has received positive results from a Phase 3 clinical trial, ARCH, assessing EVENITY (romosozumab) for preventing fractures in postmenopausal women at high risk of fracture. The company conducted the trial in collaboration with UCB. EVENITY is an investigational bone-forming agent that rapidly increases bone formation and reduces bone resorption simultaneously, increases bone mineral density and reduces the risk of fracture. The study involved women received subcutaneous injection of EVENITY monthly for 12 months followed by oral alendronate weekly for at least 12 months. Amgen stock has gained 7 percent this year so far while it climbed 4 percent in the past 12 months.

Focus Ticker: FOLD

Amicus Therapeutics (FOLD) announced that it has completed the analysis plan for the primary endpoints in the blinded ongoing Phase 3 clinical study named ESSENCE of the novel topical medicine SD-101 for treating Epidermolysis Bullosa. ESSENCE  is a double-blind, placebo-controlled registration study. It has completed the enrollment of more than 160 patients with a documented diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB. SD-101 is one of the first treatments to receive the FDA’s Breakthrough Therapy designation.
Amicus stock has gained 56 percent in the past 12 months while its 12 months gain stands at 13 percent.

Sector News

Insmed (INSM) announced rejigging its top executive team with the appointment of Paolo Tombesi as its Chief Financial Officer and Paul Streck as its new Chief Medical Officer. The company also reported the appointment of Eugene Sullivan as its Chief Product Strategy Officer.
Johnson & Johnson (JNJ) announced that its Janssen unit has filed a lawsuit to attempt blocking the entry of a biosimilar to top seller Remicade (infliximab) made by Samsung Bioepis, which is the joint venture between Samsung BioLogics and Biogen. The case has been filed in a New Jersey court. Janssen has accused Bioepis of violating Remicade patents and refusing to participate in a patent resolution process for biosimilars.

Approvals

AstraZeneca (AZN) reported receiving a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its IL-17 inhibitor brodalumab for the treatment of adult patients with moderate-to-severe plaque psoriasis. The final decision is likely to be out in about 60 days. The marketing application was submitted by licensee LEO Pharma which owns exclusive rights in Europe.

Mylan (MYL) announced that it has prevailed in  in challenging Valeant's U.S. Patent No. 8,865,688 covering UC med Apriso, which Valeant had obtained through its acquisition of Salix Pharmaceuticals in April 2015.  The USPTO determined that claims 1 and 16 of the '688 patent are unpatentable.

Deals and Collaborations

AstraZeneca (AZN) announced selling the European rights to its aging beta-blocker heart drug Seloken to Italian company Recordati. The deal is estimated to be worth $300 million. The company is looking to spin off its non core assets to streamline its business.
Bristol Myers Squibb (BMY) reported receiving validation from the  Europe Medicines Agency for its marketing application seeking approval for the use of Sprycel (dasatinib) in children and adolescents aged 1 to 18 years with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia, including the powder for oral suspension.

Earnings

Great Basin Scientific Inc. (GBSN) reported 14 percent increase in revenue for the first quarter of the year. It reported the revenue at $830,800 up from $731,400 in the first quarter of 2016. Its gross margin added 16 basis points in the first quarter of 2017 compared with the first quarter of 2016. The company’s net income for the quarter stood at $21.50 million, up from a net loss of $33.65 million for the corresponding quarter of the previous year.