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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