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Benzinga's Daily Biotech Pulse: vTv Swoons On Failed Alzheimer's Trial, Regenxbio Gets FDA Fast Track For RGX-111

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Benzinga's Daily Biotech Pulse: vTv Swoons On Failed Alzheimer's Trial, Regenxbio Gets FDA Fast Track For RGX-111
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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 June 12)

  • ABIOMED, Inc. (NASDAQ: ABMD)
  • AngioDynamics, Inc. (NASDAQ: ANGO)
  • Baxter International Inc (NYSE: BAX)
  • Bio-Rad Laboratories, Inc. (NYSE: BIO)
  • BIO-TECHNE Corp (NASDAQ: TECH)
  • CAS Medical Systems Inc (NASDAQ: CASM)
  • Edwards Lifesciences Corp (NYSE: EW)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD)
  • Helius Medical Technologies Inc (NASDAQ: HSDT)
  • ICU Medical, Incorporated (NASDAQ: ICUI)
  • Insulet Corporation (NASDAQ: PODD)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • Kindred Biosciences Inc (NASDAQ: KIN)
  • Neogen Corporation (NASDAQ: NEOG)
  • NeoGenomics, Inc. (NASDAQ: NEO)
  • Qiagen NV (NYSE: QGEN)
  • Seattle Genetics, Inc. (NASDAQ: SGE)
  • Xenon Pharmaceuticals Inc (NASDAQ: XENE)

Down In The Dumps

(Stocks hitting 52-week lows on June 12)

  • Agenus Inc (NASDAQ: AGEN)
  • Calithera Biosciences Inc (NASDAQ: CALA)
  • Mabvax Therapeutics Holdings Inc (NASDAQ: MBVX)
  • Nemaura Medical Inc (NASDAQ: NMRD)

Stocks In Focus

Sanofi Prices Bond Issue

Sanofi SA (ADR) (NYSE: SNY) said it has priced its $2 billion note offering, denominated in U.S. dollars, across two tranches. A $1 billon fixed rate note offering due June 19, 2023 bears an annual rate of 3.375 percent, while the remaining $1 billion fixed note offering due June 19, 2028 bears an interest rate of 3.625 percent.

vTv's Alzheimer's Pipeline Candidate Fails In Late-Stage Trial

vTv Therapeutics Inc (NASDAQ: VTVT) released top-line results from Part B of its Phase 3 STEADFAST study of its investigational medication azeliragon for treating mild Alzheimer's, which showed that the study did not meet the co-primary endpoints, namely statistically significant improvement in cognitive or functional outcomes, as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) at 12-months compared to placebo

Shares slumped 27.51 percent to $1.37.

Tigenix CEO Quits Ahead of Takeda Deal

TIGENIX/S ADR (NASDAQ: TIG), which has agreed to be taken over by Japan's Takeda Pharma, said Eduardo Bravo is quitting his CEO position as well as the company's board, effective June 15.

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

FDA Panel Backs Cardinal Health's Stent Graft System

Cardinal Health Inc (NYSE: CAH) announced FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 11 to 4 in favor of its its Incraft AAA Stent Graft System.

"The INCRAFT system is an advanced endovascular aneurysm repair (EVAR) technology for the treatment of infrarenal abdominal aortic aneurysms (AAAs), a severe and complex condition," the company said.

Regenxbio's Gene Therapy Gets Orphan Drug Status

Regenxbio Inc (NASDAQ: RGNX) said the FDA has granted fast track designation status for its RGX-111 gene therapy, a one-time investigational treatment for Mucopolysaccharidosis Type 1, or MPS 1. RGX-111 directly delivers human iduronidase gene directly to the central nervous system using the NAV AAV9 vector.

The fast track designation facilitates development and expedites review of drugs meant to treat serious, life-threatening conditions.

The company said it expects to enroll children and adults for the Phase 1 trial, with, patient recruitment and dosing likely in mid-2018.

The stock rallied 5.26 percent to $60 in after-hours trading.

ADMA Announces Closing Of Offering

ADMA Biologics Inc (NASDAQ: ADMA) said it has closed its previously underwritten public offering of 8.368 million shares at $4.78 per share. The company mustered gross proceeds of $40 million from the offering.

The stock rallied 7.84 percent to $5.23 in after hours.

On The Radar

THERAPIX BIOSCI/S ADR (NASDAQ: TRPX) is due to release Phase 2a data on its Tourette Syndrome therapy THX-110 at the European Society for the Study of Tourette syndrome meeting. The data was earlier released April 9.

Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) will present open label data from the Phase 2 study of Resunab for treating systemic sclerosis at the Annual European Congress of Rheumatology.

FDA Tidbits

FDA Commissioner Scott Gottlieb issued multiple statements, delving on issues related to voicing patient's views in drug development, to advancing communications, to support drug competition.

Gottlieb said the agency has prioritized working with companies and other stakeholders on gathering info from patients about their views and needs, and building tools to capture patient inputs in a way to provide meaningful data.

Separately, the commissioner delved on efforts by the FDA to help discover and develop new tools to fight antimicrobial-resistant infections.

Posted-In: Biotech News FDA Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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