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The Daily Biotech Pulse: Amgen's Bone-Building Osteoporosis Drug Clears FDA Muster, PhaseBio Offering

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week highs on April 9)

  • Edap Tms SA (NASDAQ: EDAP)
  • INmune Bio Inc (NASDAQ: INMB)
  • NGM Biopharmaceuticals Inc (NASDAQ: NGM)(began trading on the Nasdaq last week)
  • PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS)(announced obtaining Breakthrough Therapy Designation for its reversal agent for blood thinner)

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 9)

  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Evoke Pharma Inc (NASDAQ: EVOK)
  • Revance Therapeutics Inc (NASDAQ: RVNC)(announced an executive appointment)
  • Vaxart Inc (NASDAQ: VXRT)(priced its common stock offering)
  • Teva Pharmaceutical Industries Ltd (NYSE: TEVA)

Stock In Focus PhaseBio To Offer 3M Shares

PhaseBio, which IPOed in late 2018, commenced an underwritten public offering of 3 million shares of its common shares. All the shares sold in the offering will be offered by the company.

The stock fell 6.09 percent to $13.72 in after-hours trading.

FDA Greenlights Amgen's Drug To Treat Osteoporosis In Postmenopausal Women

FDA approved Amgen, Inc. (NASDAQ: AMGN)'s said Evenity, chemically romosozumab-aqqg for treating osteoporosis in postmenopausal women at high risk of breaking a bone.

Evenity is a monoclonal antibody that blocks the effects of the protein sclerostin and works through increasing new bone formation. One dose of Evenity consists of two injections, one immediately following the other, given once a month by a healthcare professional.

Following the issue of a complete response letter in July 2017, the company resubmitted the BLA for Evenity in July 2018, including two more recent pivotal Phase 3 trials, dubbed ARCH and BRIDGE study.

The stock rallied 1.56 percent to $196 in after-hours trading.

Related Links:

Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates

The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trial Readouts

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