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.