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The Daily Biotech Pulse: Tonix Says No Surprises In FDA Meeting Minutes, Aravive Offering, FDA Nod For Qiagen

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The Daily Biotech Pulse: Tonix Says No Surprises In FDA Meeting Minutes, Aravive Offering, FDA Nod For Qiagen

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 Nov. 26)

  • Allakos Inc (NASDAQ: ALLK)
  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
  • Ardelyx Inc (NASDAQ: ARDX) ( announced a research collaboration with Japan's Kyowa Kirin and an investment in the company by the latter)
  • Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)(reacted to its full-year results)
  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL)
  • Axsome Therapeutics Inc (NASDAQ: AXSM)
  • Bio-Rad Laboratories, Inc. (NYSE: BIO)
  • BIO-TECHNE Corp (NASDAQ: TECH)
  • ChemoCentryx Inc (NASDAQ: CCXI)( announced positive late-stage results for rare inflammation disease drug)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL)
  • Cue Biopharma Inc (NASDAQ: CUE)
  • DexCom, Inc. (NASDAQ: DXCM)
  • ESSA Pharma Inc (NASDAQ: EPIX)
  • Flexion Therapeutics Inc (NASDAQ: FLXN)
  • Global Blood Therapeutics Inc (NASDAQ: GBT)(announced FDA nod for sickle cell disease drug)
  • Grifols SA - ADR ADR Class B (NASDAQ: GRFS)
  • Globus Medical Inc (NYSE: GMED)
  • Horizon Therapeutics PLC (NASDAQ: HZNP)
  • Insulet Corporation (NASDAQ: PODD)
  • Krystal Biotech Inc (NASDAQ: KRYS)
  • Merck & Co., Inc. (NYSE: MRK)(Keytruda was approved in China as a first-line treatment for lung cancer, in combination with chemotherapy)
  • Molecular Templates Inc (NASDAQ: MTEM)
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
  • Myokardia Inc (NASDAQ: MYOK)
  • Neoleukin Therapeutics Inc (NASDAQ: NLTX)
  • Qiagen NV (NYSE: QGEN)
  • Verrica Pharmaceuticals Inc (NASDAQ: VRCA)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
  • Xenon Pharmaceuticals Inc (NASDAQ: XENE)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 26)

  • Aethlon Medical, Inc. (NASDAQ: AEMD)
  • Evelo Biosciences Inc (NASDAQ: EVLO)
  • Interpace Biosciences Inc (NASDAQ: IDXG)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • La Jolla Pharmaceutical Company (NASDAQ: LJPC)
  • MEREO BIOPHARMA/ADR (NASDAQ: MREO)
  • Midatech Pharma PLC-ADR (NASDAQ: MTP)
  • MOTIF BIO PLC/S ADR (NASDAQ: MTFB)(announced plans to delist from the Nasdaq)
  • Nemaura Medical Inc (NASDAQ: NMRD)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Ocugen Inc (NASDAQ: OCGN)
  • Onconova Therapeutics Inc (NASDAQ: ONTX)
  • Predictive Oncology Inc (NASDAQ: POAI)
  • Sonoma Pharmaceuticals Inc (NASDAQ: SNOA)(announced a common stock offering)
  • TELA Bio Inc (NASDAQ: TELA)(IPOed Nov. 8)
  • Theratechnologies Inc (NASDAQ: THTX)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • Vir Biotechnology Inc (NASDAQ: VIR)
  • Viveve Medical Inc (NASDAQ: VIVE)

See Also: The Week Ahead In Biotech: Aquestive Awaits FDA Decision, Arrowhead Earnings And More

Stocks In Focus

Tonix Says FDA Meeting On Posttraumatic Stress Disorder Drug Consistent With Meeting Guidelines

Releasing details of the official minutes from the Breakthrough Therapy Type B Clinical Guidance meeting with the FDA regarding its Tonmya for the treatment of posttraumatic stress disorder, Tonix said the minutes were consistent with the guidance received at the meeting.

The company said plans to add an unblinded interim analysis that allows for a potential sample size adjustment.

Tonix said, having enrolled more than 50% of the current target number of participants, it expects to release results of the interim analysis in the first quarter of 2020. Top-line data is likely to be released in the second quarter of 2020.

The shares advanced 12.38% to $1.18 in after-hours trading.

Qiagen Says FDA Approves Latent TB Screening Test

Qiagen announced FDA approval for LIAISON QunatiFERON-TB Plus Test, which it has developed along with DiaSorin. The test is meant for streamlined laboratory automation for latent TB screening, supporting the conversion from tuberculin skin tests to modern blood-based QuantiFERON technology. The test is now commercially available in the U.S.

Offerings

Aravive Inc (NASDAQ: ARAV) commenced an underwritten public offering of its common stock. All the shares offered will be sold by Aravive. The company said it expects to use the net proceeds for R&D, development and manufacturing of product candidates, and for general corporate purposes.

The stock fell 12.77% to $8.20 in after-hours trading.

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

 

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