Biotech week ahead, Aug. 5

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 8.4% was a huge casualty as the micro-cap stock fell steeply on severing of a licensing pact with Sanofi SA SNY 1.29%.

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 2.23% is scheduled to provide an update on DKN-01 in combination with Merck & Co., Inc. MRK 0.93%‘s Keytruda in ornithine transcarbamylase deficiency.

Pending Mid-2019 Clinical Readouts

Immunic Inc IMUX 1.13% – interim Phase 2 dosing analysis for IMU-838 in ulcerative colitis

Conatus Pharmaceuticals Inc CNAT 7.1% – 48-week liver function data from a Phase 2 study dubbed ENCORE-PH for emricasan in non-alcoholic steatohepatitis cirrhosis

Alkermes Plc ALKS 3.04% – Phase 3 top-line data for diroximel fumarate in relapsing remitting multiple sclerosis

IMMUTEP LTD/S ADR IMMP 2.63% – 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 1.62% – Phase 1b data for AEVI-002 in pediatric onset Crohn’s disease

Tricida Inc TCDA 5.31% – 12-month registration stability data from a Phase 3 study of TRC 101 in chronic kidney disease

Curis, Inc. CRIS 2.17% – Phase 1 data for CA-4948 in relapsed or refractory non-Hodgkin lymphoma

Ultragenyx Pharmaceutical Inc RARE 7.89% – 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 4.59% – Phase 2 top-line data for AK002 in eosinophilic gastritis

Leap Therapeutics Inc LPTX 2.23%– Phase 1/2 data for DKN-01 + Keytruda in esophagogastric adenocarcinoma

Cidara Therapeutics Inc CDTX 1.48% – Phase 2 data for rezafungin in candidemia

Akcea Therapeutics Inc AKCA 3.84% – Phase 3 data for volanesorsen in familial partial lipodystrophy

Deciphera Pharmaceuticals Inc DCPH 0.49% and Zai Lab Ltd ZLAB 1.72% – Phase 3 data for DCC-2618 from a study dubbed INVICTUS in gastrointestinal stromal tumors

ZEALAND PHARMA/S ADR ZEAL 1.66% – Phase 1b data for dasiglucagon in obesity/diabetes

Aclaris Therapeutics Inc ACRS 8.26% – 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 4.39% – Phase 2 data for ANB019 in generalized pustular psoriasis

Spark Therapeutics Inc ONCE 1.04% – additional Phase 1/2 data for SPK-8011 in hemophilia A

Earnings

Monday, Aug. 5

• Acceleron Pharma Inc XLRN 0.39% (after the close)
• Insulet Corporation PODD 1.36% (after the close)
• Shockwave Medical Inc SWAV 0.77% (after the close)
• Galmed Pharmaceuticals Ltd GLMD 0.35%

Tuesday, Aug. 6

• Gamida Cell Ltd GMDA 1.89% (before the market open)
• Karyopharm Therapeutics Inc KPTI 5.9% (before the market open)
• GW Pharmaceuticals PLC- ADR GWPH 1.25% (after the close)
• HTG Molecular Diagnostics Inc HTGM 2.26% (after the close)
• Jazz Pharmaceuticals PLC JAZZ 1.3% (after the close)

Wednesday, Aug. 7

• Jounce Therapeutics Inc JNCE 9.34% (before the market open)
• PDL BioPharma Inc PDLI 2.11% (after the close)
• Cara Therapeutics Inc CARA 1.14% (after the close)
• Sarepta Therapeutics Inc SRPT 1.27% (after the close)
• Dynavax Technologies Corporation DVAX 1.08% (after the close)

Thursday, Aug. 8

• Axsome Therapeutics Inc AXSM 0.96% (before the market open)
• Achieve Life Sciences Inc ACHV 1.65% (before the market open)
• Adamas Pharmaceuticals Inc ADMS 1.5% (after the close)
• Nektar Therapeutics NKTR 0.32% (after the close)
• Puma Biotechnology Inc PBYI 4.56% (after the close)

Friday, Aug. 9

• Avadel Pharmaceuticals PLC AVDL 2.23% (before the market open)
• Diplomat Pharmacy Inc DPLO 4.19% (before the market open)
• PLx Pharma Inc PLXP 0.33% (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.

https://www.benzinga.com/general/biotech/19/08/14177111/the-week-ahead-in-biotech-focus-on-earnings-deluge-mid-year-clinical-trial-readouts