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The Daily Biotech Pulse: European Cheer For Merck, Legal Victory For Coherus, Medpace Picks Up On Earnings

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 July 29)

  • Acasti Pharma Inc (NASDAQ: ACST)
  • Array Biopharma Inc (NASDAQ: ARRY)
  • GENMAB A/S/S ADR (NASDAQ: GMAB) (IPOed July 18)
  • Grifols SA - ADR ADR Class B (NASDAQ: GRFS)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Novocure Ltd (NASDAQ: NVCR)
  • Odonate Therapeutics Inc (NASDAQ: ODT)
  • Repligen Corporation (NASDAQ: RGEN)

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 29)

  • Acer Therapeutics Inc (NASDAQ: ACER)
  • Advaxis, Inc. (NASDAQ: ADXS)
  • Cancer Genetics Inc (NASDAQ: CGIX)
  • Champions Oncology Inc (NASDAQ: CSBR)
  • China SXT Pharmaceuticals Inc (NASDAQ: SXTC)
  • Genprex Inc (NASDAQ: GNPX)
  • Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)(slumped in reaction to Sanofi SA (NASDAQ: SNY)'s decision to terminate their collaboration agreement regarding sotagliflozin that is being evaluated for Type 2 diabetes)
  • Myovant Sciences Ltd (NYSE: MYOV)
  • Neovasc Inc (NASDAQ: NVCN)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Neuralstem, Inc. (NASDAQ: CUR)
  • Novavax, Inc. (NASDAQ: NVAX)
  • Oncolytics Biotech, Inc. (NASDAQ: ONCY)
  • Personalis Inc (NASDAQ: PSNL)( IPOed June 20)
  • Cytori Therapeutics (NASDAQ: PSTV)
  • Proteostasis Therapeutics Inc (NASDAQ: PTI)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • Unity Biotechnology Inc (NASDAQ: UBX)
  • Vistagen Therapeutics Inc (NASDAQ: VTGN)
  • Wave Life Sciences Ltd (NASDAQ: WVE) (reacted to a loss for Q2)
  • Xenetic Biosciences Inc (NASDAQ: XBIO)
  • Zafgen Inc (NASDAQ: ZFGN)

See Also: The Week Ahead In Biotech: Pending Clinical Readouts, Earnings Dominate

Stocks In Focus Coherus Wins Neulasta Biosimilar Patent Lawsuit

Coherus Biosciences Inc (NASDAQ: CHRS) said the U.S. Court of Appeals for the Federal Circuit has affirmed the decision of a U.S. district court that Coherus' Udenyca, Neulasta biosimilar, does not infringe Amgen, Inc. (NASDAQ: AMGN)'s asserted patent. Coherus launched Udenyca in the U.S. in January.

The stock gained 2.76% to $16.75 in after-hours trading.

Hepa Given Nod To Procced With IND Study Of CRV431 In NASH

Hepion Pharmaceuticals Inc (NASDAQ: HEPA), previously Contravir, said the FDA has authorized it to proceed with its planned investigational new drug application, or IND, opening study for CRV431 in non-alcoholic steatohepatitis following the review of its IND.

The company noted that the IND for NASH is in addition to the current open IND for hepatitis B virus.

The stock added 9.23% to $3.55 in after-hours trading.

Verastem Appoints Stuglik As CEO

Verastem Inc (NASDAQ: VSTM) announced the appointment of Brian Stuglik, a member of its board, as CEO. Stuglik has over three decades of experience in the pharmaceutical industry.

The stock fell 1.4% to $1.41 in after-hours trading.

Merck Combo Antibiotics Gets Backing Of European Regulatory Panel

Merck & Co., Inc. (NYSE: MRK) said the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion recommending Zerbaxa 3g dose – a combo drug of ceftolozane and tazobactam - for an additional indication for the treatment of hospital-acquired pneumonia, including ventilator-associated pneumonia, in adults.

View more earnings on IBB

The stock edged up 0.25% to $82.70 in after-hours trading.

Earnings

Medpace Holdings Inc )(NASDAQ: MEDP) reported second-quarter GAAP net income of 81 cents per share compared to 61 cents reported for the year-ago period and the consensus estimate of 66 cents per share. Revenues climbed 25.8% to $214.1 million, exceeding the $202.8 million consensus estimate.

The company issued above-consensus guidance for the fiscal year 2019.

The stock rallied 9.93% to $74.40 in after-hours trading.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported second-quarter EPS of 54 cents, higher than the 7 cents reported last year and the 11 cents per share consensus estimate. Revenues nearly doubled to $183.58 million

The stock gained 9.81% to $91.50 in after-hours trading.

On The Radar Earnings

Eli Lilly And Co (NYSE: LLY) (before the market open)
Iradimed Corp (NASDAQ: IRMD) (before the market open)
Blueprint Medicines Corp (NASDAQ: BPMC) (before the market open)
Meridian Bioscience, Inc. (NASDAQ: VIVO) (before the market open)
Merck & Co., Inc. (NYSE: MRK) (before the market open)
Incyte Corporation (NASDAQ: INCY) (before the market open)
Infinity Pharmaceuticals Inc. (NASDAQ: INFI) (before the market open)
NeoGenomics, Inc. (NASDAQ: NEO) (before the market open)
Pfizer Inc. (NYSE: PFE) (before the market open)
Amgen (after the market close)
AtriCure Inc. (NASDAQ: ATRC) (after the market close)
EXACT Sciences Corporation (NASDAQ: EXAS) (after the market close)
T2 Biosystems Inc (NASDAQ: TTOO) (after the market close)
BioTelemetry Inc (NASDAQ: BEAT) (after the market close)
Gilead Sciences, Inc. (NASDAQ: GILD) (after the market close)
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) (after the market close)
Veracyte Inc. (NASDAQ: VCYT) (after the market close)

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