The Week Ahead In Biotech: ASCO Presentations Pick Up The Pace

Biotech stocks came under pressure this week ahead of the ASCO 2019 presentations. Headlines on legal woes related to the opioid crisis and drug price manipulation led to weakness in some stocks.

The unfolding week is all about the presentations at one of the largest educational and scientific events for the oncology community.

Here are the key events/catalysts to look forward to:

Conferences

• The American Society of Clinical Oncology, or ASCO, 2019 Annual Meeting – May 31–June 4, in Chicago, Illinois
• The European Academy of Allergy and Clinical Immunology 2019 Annual Congress – June 1-5, in Lisbon, Portugal
• 20th Global Nephrologists Annual Meeting - June 3-4, in London
• Jefferies 2019 Healthcare Conference – June 4-7, in New York City
• European Society for Pediatric Gastroenterology, Hepatology and Nutrition 2019 Annual Meeting – June 5-8, in Glasgow, Scotland
• HBV Cure Meeting – June 7-8, in Singapore
• The American Diabetes Association's 79th Scientific Sessions – June 7-11, in San Francisco, California

PDUFA Dates

The FDA is scheduled to rule Monday on Merck & Co., Inc. MRK's sNDA for Zerbaxa (ceftolozone and tazobactam) in treating adult patients with ventilated nosocomial (hospital-acquired) pneumonia

ASCO Presentations On Sunday, June 2

• Aduro BioTech Inc ADRO – Phase 1b data for ADU-S100 and Spartalozumab (solid tumors or lymphomas)
• Celgene Corporation CELG – Phase 1/2 data on CC-220 (relapsed and/or refractory multiple myeloma)
• CAN-FITE BIOPHA/S ADR CANF – already-released Phase 2 data for Namodenoson (second-line treatment of advanced liver cancer)
• Amgen, Inc. AMGN – Phase 1 data for AMG 420 (relapsed, refractory multiple myeloma)
• ZIOPHARM Oncology Inc. ZIOP – Phase 1 data for Ad-RTS-Hil-12 (recurrent glioblastoma) as well as initial Phase 1 data for Ad-RTS-Hil-12 plus veledimex in combination with Bristol-Myers Squibb Co BMY's Opdivo (refractory glioblastoma multiforme)
• VBI Vaccines Inc VBIV – Phase 1/2a expanded Part A data for VBI-1901 in recurrent glioblastoma multiforme
• Puma Biotechnology Inc PBYI – additional Phase 2 data for Neratinib monotherapy with high dose loperamide prophylaxis (extended adjuvant treatment of early-stage HER-2 positive breast cancer)
• AstraZeneca plc AZN and Merck – already-released Phase 3 data for Lynparza (pancreatic cancer)

ASCO Presentations On Monday, June 3

• Blueprint Medicines Corp BPMC – updated Phase 1 data for BLU-667 (RET-altered solid tumors)
• Actinium Pharmaceuticals Inc ATNM – Phase 3 data for Iomab-B (hematopoietic stem cell transplantation)
• Amgen – Phase 1 data for AMG510 (solid tumors)
• Agios Pharmaceuticals Inc AGIO – updated Phase 1 data for Ivosidenib (IDH1 mutant newly diagnosed AML ineligible for standard therapoes) as well as updated Phase 1 data for Ivosidenib in combination with Vidaza for newly diagnosed AML with an IDH1 mutation) and Phase 1 data for Ivosidenib and Vorasidenib (IDHm low-grade glioma)
• Incyte Corporation INCY and Novartis AG NVS – already-released Phase 2 data for INC280 (non-small cell lung cancer)
• Forty Seven Inc FTSV – Phase 1b data for 5F9 in AML as well as Phase 1b data for 5F9 + Azacitidine in AML
• Incyte – Poster presentation of Phase 2 data for INCB54828 (cholangiocarcinoma)
• Corcept Therapeutics Incorporated CORT – Phase 1/2 data for relacorilant plus Arbaxane (solid tumors)
• Seattle Genetics, Inc. SGEN – full Phase 2 data for enfortumab vedotin (urothelial cancer)
• MEI Pharma Inc MEIP – Phase 1b data for ME-401 (relapsed/refractory follicular lymphoma/chronic lymphocytic leukemia)
• Constellation Pharmaceuticals Inc CNST – interim Phase 2 data for CPI-060 and ruxolitinib (myelofibrosis)
• Stemline Therapeutics Inc STML – Phase 2 data for SL-401 (chronic myelomonocytic leukemia)
• Nektar Therapeutics NKTR – Phase 2 data for NKTR-214 and Opdivo (sarcomas)
• Stemline Therapeutics & Epizyme Inc EPZM - updated Phase 2 data for Tazemetostat (epithelial sarcoma)

ASCO Presentations On Tuesday, June 4

• Roche Holdings AG Basel ADR RHHBY – Phase 3 overall survival data for Tecentriq plus nab-paclitaxel (triple-negative breast cancer)
• MacroGenics Inc MGNX – detailed Phase 3 data for Margetuximab (metastatic breast cancer)
• Roche & AbbVie Inc ABBV - Phase 3 data for Venclexta plus Gazyva (chronic lympocytic leukemia)
• Celgene – updated Phase 1 data for Liso-cel (chronic lymphocytic leukemia)
• Puma Biotech – already-released Phase 3 data for Neratinib (third-line HER2-positive metastatic breast cancer)
• Atara Biotherapeutics Inc ATRA – Phase 1 data for autologous T cells (malignant pleural disease)
• TG Therapeutics Inc TGTX – Phase 2/3 MZL cohort data for TG-1101 and TGR-1202 (non-Hodgkin lymphoma)

Other Presentations

AnaptysBio Inc ANAB is due to present on Wednesday Phase 2a data for ANB020 in severe adult eosinophilic asthma at the European Society for Pediatric Gastroenterology, Hepatology and Nutrition 2019 annual meeting.

Spring Bank Pharmaceuticals Inc SBPH will present full data for Inarigivir 400mg in healthy volunteers at the HBV Cure Meeting

Opko Health Inc. OPK is scheduled to present already-released Phase 2b topline data for OPK88003 in obesity and diabetes at the American Diabetes Association's 79th Scientific Sessions.

Albireo Pharma Inc ALBO is set to present on June 7 Phase 2 data for Odevixibat in biliary atresia at the European Society for Pediatric Gastroenterology, Hepatology and Nutrition 2019 annual meeting

IPO Quiet Period Expiry

Axcella Health Inc AXLA

Cortexyme Inc CRTX

NextCure Inc NXTC

Milestone Pharmaceuticals Inc MIST

Applied Therapeutics Inc APLT