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The Daily Biotech Pulse: Breakthrough Therapy Designation For Iovance, Guardant Prices Offering, 2 Stocks to Debut

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 May 21)

  • Axsome Therapeutics Inc (NASDAQ: AXSM)
  • Milestone Pharmaceuticals Inc (NASDAQ: MIST) (IPOed on May 9)
  • Turning Point Therapeutics Inc (NASDAQ: TPTX) (IPOed on April 17)
  • ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 21)

  • Adamis Pharmaceuticals Corp (NASDAQ: ADMP)
  • AIT Therapeutics Inc (NASDAQ: AITB)
  • Arbutus Biopharma Corp (NASDAQ: ABUS)
  • Bellicum Pharmaceuticals Inc (NASDAQ: BLCM)
  • Biopharmx Corp (NYSE: BPMX)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL)
  • ITAMAR MED LTD/S ADR (NASDAQ: ITMR)
  • Minerva Neurosciences Inc (NASDAQ: NERV)
  • Myriad Genetics, Inc. (NASDAQ: MYGN)
  • Nuvectra Corp (NASDAQ: NVTR)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • TherapeuticsMD Inc (NASDAQ: TXMD)
  • Tocagen Inc (NASDAQ: TOCA) (announced its Phase 3 brain cancer gene therapy trial will continue)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)
  • United Therapeutics Corporation (NASDAQ: UTHR)

Stock In Focus Iovance's Cervical Cancer Candidate Gets Breakthrough Therapy Designation

Iovance Biotherapeutics Inc (NASDAQ: IOVA) said the FDA has granted Breakthrough Therapy designation to Iovance TIL therapy candidate LN-145 in treating recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy.

"The designation allows us to expedite our development program through more frequent interactions with the FDA and provides eligibility for rolling review and priority review, the company said.

The stock rallied 7.34 percent to $17.85 in after-hours trading.

Neovasc Announces Positive Long-Term Data For Its Refractory Angina Treatment Device

Neovasc Inc (NASDAQ: NVCN) announced the publication in the International Journal of Cardiology a peer-reviewed article on the long-term sustained efficacy and safety of the Reducer therapy in 50 patients suffering from refractory disabling angina. The study showed that the Reducer has a sustained therapeutic effect at two years, across a large patient population.

The stock rallied 58.89 percent to 75 cents in after-hours trading.

Guardant Prices Common Stock Offering

Guardant Health Inc (NASDAQ: GH) priced its previously-announced common stock offering of 4.5 million shares at $71 per share to raise gross proceeds of $319.5 million.

The stock gained 1.64 percent to $72.67 in after-hours trading.

On The Radar Earnings

Medtronic PLC (NYSE: MDT) (before the market open)

IPOs

Bicycle Therapeutics, a biotech company developing new therapeutics based on its proprietary bicyclic peptide product platform, priced its 4.33-million share IPO at $14 per share, at the lower bound of the estimated price range of $14-$16. The shares will be listed on the Nasdaq under the ticker symbol BCYC.

IDEAYA Biosciences, an oncology-focused precision medicine company priced its 5-million share IPO at $10, below the estimated price range of $13-$15. The shares are to be listed on the Nasdaq under the ticker symbol IDYA.

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