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The Daily Biotech Pulse: Celyad To Advance Leukemia Drug To Clinical Trial, Positive Data For Teva's Migraine Drug

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The Daily Biotech Pulse: Celyad To Advance Leukemia Drug To Clinical Trial, Positive Data For Teva's Migraine Drug

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 July 1)

  • Apellis Pharmaceuticals Inc (NASDAQ: APLS)
  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
  • Argenx SE – ADR (NASDAQ: ARGX)
  • ArQule, Inc. (NASDAQ: ARQL)
  • Axsome Therapeutics Inc (NASDAQ: AXSM) (the company's stock has been added to Russell 3000 and Russell 2000 Indexes)
  • Coherus Biosciences Inc (NASDAQ: CHRS)(announced that it has produced over 400,000 Udenyca pre-filled syringes to date)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • GALAPAGOS NV/S ADR (NASDAQ: GLPG)
  • MeiraGTx Holdings PLC (NASDAQ: MGTX)
  • Misonix, Inc. (NASDAQ: MSON) (the company's stock has been added to Russell 3000 and Russell 2000 Indexes)
  • Morphic Holding Inc (NASDAQ: MORF)(IPOed June 27)
  • Odonate Therapeutics Inc (NASDAQ: ODT)
  • Ra Pharmaceuticals Inc (NASDAQ: RARX)
  • ResMed Inc. (NYSE: RMD)
  • Tricida Inc (NASDAQ: TCDA)
  • Vapotherm Inc (NYSE: VAPO)
  • Zai Lab Ltd (NASDAQ: ZLAB)

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 1)

  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Artelo Biosciences Inc (NASDAQ: ARTL)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • ContraVir Pharmaceuticals Inc (NASDAQ: CTRV)
  • Enochian Biosciences Inc (NASDAQ: ENOB)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM)
  • Nuvectra Corp (NASDAQ: NVTR)
  • Prevail Therapeutics Inc (NASDAQ: PRVL)

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

Stocks In Focus

Mirati Adds Oncology Expert To Board

Mirati Therapeutics Inc (NASDAQ: MRTX) announced the appointment of Dr. Julie Cherringtom, an oncology expert, to its board. The company said it sees her knowledge of pre-Clinical and clinical drug development to assist it, as it progresses its itravatinib and MRTX849 programs and builds its pre-clinical pipeline.

The stock rose 2.3% to $105.38 in after-hours trading.

FDA Clears Celyad's IND For Leukemia CAR-T Therapy

Announcing strategic updates to its autologous relapse/refractory acute myeloid leukemia, or AML, and myelodysplastic syndromes, or MDS, CELYAD SA/ADR (NASDAQ: CYAD) said the FDA has accepted its IND application, including OptimAb manufacturing process, for CYAD-02 – its next-gen NKG2D-based CAR-T therapy-focused on improved persistence. The company said it would start the Phase 1 trial in early 2020.

The OptimAb manufacturing process enriches T cells with memory-like phenotype, and has been approved for use with CYAD-1, Celyad's lead candidate.

The stock climbed 6.36% to $12.20 in after-hours trading.

Gilead On Track To Submit NDA For Rheumatoid Arthritis Drug In 2019

Following a pre-NDA meeting with the FDA, Gilead Sciences, Inc. (NASDAQ: GILD) said it discussed with the regulatory agency the Phase 3 FINCH studies and the ongoing Phase 2 MANTA study that assessed seven parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn's disease.

As a result of the discussion, the company said a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019.

Filgotinib is co-developed by Gilead and Dutch pharma company Galapagos.

Galapagos shares moved up 1.17% to $130.44 in after-hours trading.

Teva Reports Positive Late-Stage Data For Migraine Drug

Teva Pharmaceutical Industries Ltd (NYSE: TEVA) announced positive results from the Phase 3b FOCUS study that evaluated its migraine treatment fremanezumab in adults with migraine.

"This study evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments," the company said.

Updated results were presented at the 5th Congress of the European Academy of Neurology being held in Oslo, Norway.

Teva said it expects to submit the full results of the FOCUS study for publication later in 2019.

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

 

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