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The Daily Biotech Pulse: Merck's Keytruda Secures Approval For Expanded Label, ProPhase Labs Q2 Loss Narrows

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling the Peaks

(Stocks hitting 52-week highs on Aug. 20)

  • Avanos Medical Inc (NYSE: AVNS)
  • Becton Dickinson and Co (NYSE: BDX)
  • DexCom, Inc. (NASDAQ: DXCM)
  • Eli Lilly And Co (NYSE: LLY)
  • Liquidia Technologies Inc (NASDAQ: LQDA)
  • Masimo Corporation (NASDAQ: MASI)
  • Merck & Co., Inc. (NYSE: MRK)
  • Neogen Corporation (NASDAQ: NEOG)
  • Pfizer Inc. (NYSE: PFE)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM)

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 20)

  • Alpine Immune Sciences Inc (NASDAQ: ALPN)
  • Aralez Pharmaceuticals Inc (NASDAQ: ARLZ)
  • Avadel Pharmaceuticals PLC (ADR) (NASDAQ: AVDL)
  • Cesca Therapeutics Inc (NASDAQ: KOOL)
  • Dynavax Technologies Corporation (NASDAQ: DVAX)
  • Exelixis, Inc. (NASDAQ: EXEL)
  • Novan Inc (NASDAQ: NOVN) )(reported positive results for its SB414 in two complementary Phase 1b clinical trials)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS)
  • Surface Oncology Inc (NASDAQ: SURF)
  • Sinovac Biotech Ltd. (NASDAQ: SVA)(announced conclusion of SEC investigation on allegations of some employees making improper payments to Chinese government officials)
  • Trinity Biotech plc (ADR) (NASDAQ: TRIB)

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates, Earnings And IPOs

Stocks In Focus FDA Approves Expanded Label For Merck's Keytruda

Merck announced the FDA has approved an expanded label for its Keytruda, with the drug in combination with pemetrexed and platinum chemotherapy now being approved as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.

View more earnings on IBB

The company said the approval was based on data from the KEYNOTE-189 trial.

ProPhase Labs Q2 Loss Narrows

ProPhase Labs Inc (NASDAQ: PRPH) reported a second-quarter net sales from continuing operations of $3.2 million compared to $1.9 million in the year-ago period. The company's net loss narrowed from 14 cents per share in Q217 to 2 cents per share in Q218.

On The Radar Earnings

Medtronic PLC (NYSE: MDT) Q1 Adj. EPS $1.17 Beats $1.11 Estimate, Sales $7.4B Beat $7.24B Estimate
Myriad Genetics, Inc. (NASDAQ: MYGN) (after the close)

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