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The Daily Biotech Pulse: Ayala IPO, Pluristem Starts Phase 2 Trial Of COVID Treatment, European Nod For Takeda

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The Daily Biotech Pulse: Ayala IPO, Pluristem Starts Phase 2 Trial Of COVID Treatment, European Nod For Takeda

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 May 7)

Acceleron Pharma Inc (NASDAQ: XLRN)
Bio-Rad Laboratories, Inc. (NYSE: BIO)
BIO-TECHNE Corp (NASDAQ: TECH)
Catalent Inc (NYSE: CTLT)
Cytosorbents Corp (NASDAQ: CTSO)
DexCom, Inc. (NASDAQ: DXCM)
GENMAB A/S/S ADR (NASDAQ: GMAB)
Immunomedics, Inc. (NASDAQ: IMMU)
Immunovant Inc (NASDAQ: IMVT)
Kala Pharmaceuticals Inc (NASDAQ: KALA)
Masimo Corporation (NASDAQ: MASI)
Meridian Bioscience, Inc. (NASDAQ: VIVO)
Minerva Neurosciences Inc (NASDAQ: NERV)
Natera Inc (NASDAQ: NTRA)
ORIC Pharmaceuticals Inc (NASDAQ: ORIC)
Phathom Pharmaceuticals Inc (NASDAQ: PHAT)
Quidel Corporation (NASDAQ: QDEL)
Repligen Corporation (NASDAQ: RGEN)
Revolution Medicines Inc (NASDAQ: RVMD)
Scpharmaceuticals Inc (NASDAQ: SCPH)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 7)

Apyx Medical Corp (NASDAQ: APYX)
Biofrontera AG (NASDAQ: BFRA)
Sonnet Biotherapeutics Holdings Inc (NASDAQ: SONN)

Stocks In Focus

Pluristem Gets FDA Nod To Initiate Phase 2 Study Of PLX Cells In COVID-19

Pluristem Therapeutics Inc. (NASDAQ: PSTI) said the FDA cleared its IND application for a Phase 2 study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome.

The company has been treating patients in the U.S. and Israel through compassionate use programs. It also has a clinical trial authorization application pending in Europe for a Phase 2 trial.

In pre-market trading Friday, Pluristem shares were up 21.79% to $10.34.

European Commission Approves SC Formulation of Takeda's Entyvio For Inflammatory Bowel Diseases

Takeda Pharmaceutical Co Ltd (NYSE: TAK) said the European Commission has granted a Marketing Authorization for the subcutaneous – SC - formulation of Entyvio, a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn's disease. Entyvio SC will be made available in both a pre-filled syringe and a pre-filled pen, the company added.

This authorization allows the marketing of the drug in 27 member states of the European Union, plus the U.K., Norway, Liechtenstein and Iceland.

See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates

Offerings

Axonics Modulation Technologies Inc (NASDAQ: AXNX) said it has priced its public offering of 4 million shares of its common stock at a public offering price of $32.50 per share for generating gross proceeds of $130 million. The offering is expected to close May 12.

Earnings

Guardant Health Inc's (NASDAQ: GH) first-quarter revenues climbed 84% to $67.5 million. The net loss per share narrowed from 30 cents per share to 29 cents per share. The results exceeded estimates The company withdrew its full-year guidance.

The stock added 7.28% to $90.06 in after-hours trading.

Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) reported a first-quarter loss of 31 cents per share on revenues of $34 million. In the year-ago period, the company reported a loss of 38 cents per share on revenues of $3.1 million.

The results trailed estimates.

Dicerna said it believes that its cash, cash-equivalents and held-to-maturity investments will be sufficient to fund the execution of its current clinical and operating plan into 2023.

Separately, the company announced the appointment of Douglas Pagán as its CFO and a member of its executive leadership team, effective May 26, replacing the incumbent Jack Green, who is retiring.

The stock fell 11.38% to $20.25 in after-hours trading.

Calithera Biosciences Inc's (NASDAQ: CALA) first-quarter loss narrowed from 61 cents per share to 38 cents per share. The loss, however, was wider than the consensus loss estimate of 36 cents per share. Cash, cash-equivalents and investments totaled $138.1 million.

In after-hours trading, the stock lost 8.39% to $6.55.

On The Radar

Earnings

Meridian Bioscience, Inc. (NASDAQ: VIVO) (before the market open)
CV Sciences Inc (OTC: CVSI) (before the market open)
Synlogic Inc (NASDAQ: SYBX) (before the market open)
Mersana Therapeutics Inc (NASDAQ: MRSN) (before the market open)
Ocular Therapeutix Inc (NASDAQ: OCUL) (before the market open)
Axsome Therapeutics Inc (NASDAQ: AXSM) (before the market open)
Spero Therapeutics Inc (NASDAQ: SPRO) (before the market open)
Orthofix Medical Inc (NASDAQ: OFIX) (before the market open)

IPO

Ayala Pharma priced its initial public offering of 3.67 million shares at 15 per share, the mid-point of the previously estimated range of $14-$16. The shares will begin trading on the Nasdaq under the ticker symbol "AYLA."

 

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