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

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. LXRX was a huge casualty as the micro-cap stock fell steeply on severing of a licensing pact with Sanofi SA 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 LPTX is scheduled to provide an update on DKN-01 in combination with Merck & Co., Inc. MRK's Keytruda in ornithine transcarbamylase deficiency.

Pending Mid-2019 Clinical Readouts

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

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

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

IMMUTEP LTD/S ADR 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 GNMX – Phase 1b data for AEVI-002 in pediatric onset Crohn's disease

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

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

Ultragenyx Pharmaceutical Inc 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 ALLK – Phase 2 top-line data for AK002 in eosinophilic gastritis

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

Cidara Therapeutics Inc CDTX – Phase 2 data for rezafungin in candidemia

Akcea Therapeutics Inc AKCA - Phase 3 data for volanesorsen in familial partial lipodystrophy

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

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

Aclaris Therapeutics Inc 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 ANAB – Phase 2 data for ANB019 in generalized pustular psoriasis

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

Earnings

Monday, Aug. 5

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

Tuesday, Aug. 6

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

Wednesday, Aug. 7

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

Thursday, Aug. 8

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

Friday, Aug. 9

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