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Benzinga's Daily Biotech Pulse: Amgen Resubmits Osteoporosis Drug BLA, Auris Medical Prices Offering

Benzinga's Daily Biotech Pulse: Amgen Resubmits Osteoporosis Drug BLA, Auris Medical Prices Offering

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

Scaling the Peaks

(Stocks hitting 52-week highs on July 12)

  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Arbutus Biopharma Corp (NASDAQ: ABUS)
  • BioLife Solutions Inc (NASDAQ: BLFS)
  • Cytosorbents Corp (NASDAQ: CTSO)
  • DexCom, Inc. (NASDAQ: DXCM)
  • Endocyte, Inc. (NASDAQ: ECYT)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
  • Krystal Biotech Inc (NASDAQ: KRYS)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
  • Merit Medical Systems, Inc. (NASDAQ: MMSI)
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
  • PRA Health Sciences Inc (NASDAQ: PRAH)
  • Seattle Genetics, Inc. (NASDAQ: SGEN)(announced dosing of the first patient in the Phase 2 innovaTV clinical trial evaluating its tisotumab vedotin as monotherapy for selected solid tumors with high Tissue Factor expression)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
  • Zogenix, Inc. (NASDAQ: ZGNX)(announced positive top-line results from its second confirmatory Phase 2 study for its ZX008 for treating children and young adults with Dravet syndrome)

Down In The Dumps

(Stocks hitting 52-week lows on July 12)

  • Advaxis, Inc. (NASDAQ: ADXS)
  • Aralez Pharmaceuticals Inc (NASDAQ: ARLZ)
  • Auris Medical Holding AG (NASDAQ: EARS)
  • Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)
  • Cytori Therapeutics Inc (NASDAQ: CYTX)
  • Reshape Lifesciences Inc (NASDAQ: RSLS)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS)(announced pricing of upsized public offering of 11.52 million shares)
  • Vermillion, Inc. (NASDAQ: VRML)

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

Stocks In Focus

Amgen Resubmits BLA For Osteoporosis Treatment

Amgen, Inc. (NASDAQ: AMGN) and UCB announced it resubmitted the BLA for EVENITY, an investigational monoclonal antibody for treating osteoporosis in postmenopausal women at high risk for fracture.

The resubmission included two more recent pivotal Phase 3 trials, dubbed ARCH and BRIDGE study.

Earlier, the FDA had issued a complete response letter for the pipeline candidate in July 2017.

Auris Medical Prices Common Stock Offering

Auris Medical said it has priced an underwritten public offering of 17.95 million common shares, series A warrants to buy 6.28 million common shares and Series V warrants to purchase 4.49 million shares. The combined price per unit, comprising of one share, one Series A warrant and one Series B warrant, is 39 cents per share.

The company expects to raise gross proceeds of $7 million from the offering, with the closing likely to be on July 17.

The stock closed down 3.57 percent to $0.54 in after-hours.

FDA Tidbits

FDA said in a release it has struck new partnership agreements with Hawaii, Kentucky and Mississippi and renewed agreements with 43 other states to support efforts to implement the rule that establishes minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.

Separately, FDA Commissioner Scott Gottlieb announced the formation of a new Drug Shortages Task Force, led by Keagan Lenihan, FDA's associate commissioner for strategic initiatives. The Task force is tasked with finding holistic solutions to address the underlying causes for these shortages.


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