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The Week Ahead In Biotech: Focus On Earnings Deluge, Mid-Year Clinical Trial Readouts

Shanthi Rexaline

Biotech stocks went about in a steady manner this week amid a slew of big pharma and biotech earnings announcements, a handful of FDA approvals and a few clinical trial readouts. Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) was a huge casualty as the micro-cap stock fell steeply on severing of a licensing pact with Sanofi SA (NASDAQ: SNY).

Here are the key catalysts that can sway biotech stocks in the unfolding week.

Conferences

  • SVB Leerink Spotlight Series: Rare & Genetic Diseases Conference – Aug. 7, in Boston, Massachusetts
  • Canaccord Genuity Growth Conference - Aug. 7-8, in Boston

Clinical Trial Readouts

Leap Therapeutics Inc (NASDAQ: LPTX) is scheduled to provide an update on DKN-01 in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in ornithine transcarbamylase deficiency.

Pending Mid-2019 Clinical Readouts

Immunic Inc (NASDAQ: IMUX) – interim Phase 2 dosing analysis for IMU-838 in ulcerative colitis

Conatus Pharmaceuticals Inc (NASDAQ: CNAT) – 48-week liver function data from a Phase 2 study dubbed ENCORE-PH for emricasan in non-alcoholic steatohepatitis cirrhosis

Alkermes Plc (NASDAQ: ALKS) – Phase 3 top-line data for diroximel fumarate in relapsing remitting multiple sclerosis

IMMUTEP LTD/S ADR (NASDAQ: IMMP) – initial Phase 2 data for eftilagimod alpha and Keytruda in non-small cell lung cancer and head and neck cancer

Aevi Genomic Medicine Inc (NASDAQ: GNMX) – Phase 1b data for AEVI-002 in pediatric onset Crohn's disease

Tricida Inc (NASDAQ: TCDA) – 12-month registration stability data from a Phase 3 study of TRC 101 in chronic kidney disease

Curis, Inc. (NASDAQ: CRIS) – Phase 1 data for CA-4948 in relapsed or refractory non-Hodgkin lymphoma

View more earnings on IBB

Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) – Phase 1/2 data from the second cohort that is evaluating its DTX401 in Glycogen storage disease type 1 & Phase 1/2 third cohort data for DTX301 in ornithine transcarbamylase

Allakos Inc (NASDAQ: ALLK) – Phase 2 top-line data for AK002 in eosinophilic gastritis

Leap Therapeutics Inc (NASDAQ: LPTX)– Phase 1/2 data for DKN-01 + Keytruda in esophagogastric adenocarcinoma

Cidara Therapeutics Inc (NASDAQ: CDTX) – Phase 2 data for rezafungin in candidemia

Akcea Therapeutics Inc (NASDAQ: AKCA) - Phase 3 data for volanesorsen in familial partial lipodystrophy

Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) and Zai Lab Ltd (NASDAQ: ZLAB) – Phase 3 data for DCC-2618 from a study dubbed INVICTUS in gastrointestinal stromal tumors

ZEALAND PHARMA/S ADR (NASDAQ: ZEAL) – Phase 1b data for dasiglucagon in obesity/diabetes

Aclaris Therapeutics Inc (NASDAQ: ACRS) – Phase 2 open label 6-month data for ATI-502 in vitiligo and Phase 2 data for ATI-502 in atopic dermatitis

AnaptysBio Inc (NASDAQ: ANAB) – Phase 2 data for ANB019 in generalized pustular psoriasis

Spark Therapeutics Inc (NASDAQ: ONCE) – additional Phase 1/2 data for SPK-8011 in hemophilia A

Earnings

Monday, Aug. 5

  • Acceleron Pharma Inc (NASDAQ: XLRN) (after the close)
  • Insulet Corporation (NASDAQ: PODD) (after the close)
  • Shockwave Medical Inc (NASDAQ: SWAV) (after the close)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD)

Tuesday, Aug. 6

  • Gamida Cell Ltd (NASDAQ: GMDA) (before the market open)
  • Karyopharm Therapeutics Inc (NASDAQ: KPTI) (before the market open)
  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) (after the close)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM) (after the close)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the close)

Wednesday, Aug. 7

  • Jounce Therapeutics Inc (NASDAQ: JNCE) (before the market open)
  • PDL BioPharma Inc (NASDAQ: PDLI) (after the close)
  • Cara Therapeutics Inc (NASDAQ: CARA) (after the close)
  • Sarepta Therapeutics Inc (NASDAQ: SRPT) (after the close)
  • Dynavax Technologies Corporation (NASDAQ: DVAX) (after the close)

Thursday, Aug. 8

  • Axsome Therapeutics Inc (NASDAQ: AXSM) (before the market open)
  • Achieve Life Sciences Inc (NASDAQ: ACHV) (before the market open)
  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS) (after the close)
  • Nektar Therapeutics (NASDAQ: NKTR) (after the close)
  • Puma Biotechnology Inc (NASDAQ: PBYI) (after the close)

Friday, Aug. 9

  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL) (before the market open)
  • Diplomat Pharmacy Inc (NYSE: DPLO) (before the market open)
  • PLx Pharma Inc (NASDAQ: PLXP) (before the market open)

IPO

BioVie, a biopharma company developing drug therapies for liver diseases, proposes to offer $1.26 million in an IPO, likely to be priced at $11.88. The company intends to list its shares on the Nasdaq under the ticker symbol BIVI.

Israeli medical device maker InMode filed for offering 5 million shares in an IPO, at an estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol INMD.

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