Premarket Biotech Digest – AMGN Announces Positive Results, FOLD Completes Analysis Plan, JNJ Files Lawsuit

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.

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Author: Travis Esquivel

Travis Esquivel is an engineer, passionate soccer player and full-time dad. He enjoys writing about innovation and technology from time to time.

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