The Week Ahead In Biotech: Pending Clinical Readouts In Focus

Biotech stocks headed south last week, reversing decent gains made in the previous week. Unfavorable FDA decisions, botched trials and weaker broader market sentiment all weighed down on the sector.

Here are the key catalysts of the unfolding week.

Conferences

• European Cardiology Congress - July 1-2, in Prague, Czech Republic
• 11th International Virology Summit - July 1-2, in Valencia, Spain
• ESMO 21st World Congress on Gastrointestinal Cancer – July 3-6, in Barcelona, Spain
• 12th World Congress on Diabetes & Endocrinology - July 5-6, in Columbus, Ohio
• 27th Congress of the International Society of Thrombosis and Haemostasis – July 6-10, in Melbourne, Australia

PDUFA Dates

Retrophin Inc RTRX awaits FDA decision for a new formulation of Thiola in cystinuria on Sunday, June 30.

The FDA is set to rule on Karyopharm Therapeutics Inc KPTI's NDA for selinexor in combination with dexamethasone for treating patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody. The PDUFA date is scheduled for Saturday, July 6.

Clinical Trial Readouts

CELYAD SA/ADR CYAD will present at the ESMO conference Phase 1 data for its CYAD-1 and FOLFOX in colorectal cancer

Uniqure NV QURE is due to present at the ISTH conference July 5 nine-month data from the Phase 2b study of AMT-061 in hemophilia B

Sangamo Therapeutics Inc SGMO is scheduled to present at the ISTH conference July 5 initial Phase 1/2 data for SB-525 in hemophilia A.

Catalyst Biosciences Inc CBIO will release at the ISTH conference final Phase 2 data for marzeptaacog alfa in hemophilia.

Related Link: FDA Type A Meetings: What You Need To Know

Pending Data Releases

(expected in Q2 or the first half of 2019)

Novo Nordisk A/S NVO – Phase 2 data for anti-interlukin 21 monoclonal antibody glucagon-like peptide-1 receptor (Type 1 diabetes)

Reata Pharmaceuticals Inc RETA – initial Phase 1 data from healthy volunteers for RTA 1701 (autoimmune and inflammatory disorders)

Vertex Pharmaceuticals Incorporated VRTX – Phase 2b data for VX-150 (acute pain following bunionectomy surgery)

Bellicum Pharmaceuticals Inc BLCM – Phase 2 pediatric top-line data for BPX-501 (adjunct T-cell therapy administered after allogeneic hematopoietic stem cell transplantation)

Gilead Sciences, Inc. GILD – Phase 2 data for GS-9688 (hepatitis B virus)

Jaguar Health Inc JAGX and Roche Holdings AG Basel ADRRHHBY – interim Phase 2 data for Mytesi (cancer-related diarrhoea)

TRACON Pharmaceuticals Inc TCON – Phase 1 data for TRC253 (prostate cancer)

FibroGen Inc FGEN – initial Phase 2 data for FG-3019 in Duchenne muscular dystrophy

ASLAN PHARMACEU/ADR ASLN – Part 1 data from the Phase 1 study of ASLAN003 in acute myeloid leukemia

Obseva SA OBSV – interim analysis of Part B data from a Phase 2a trial of OBE022 in pre-term labor

Sorrento Therapeutics Inc SRNE - Phase 2 repeat dose data from a Phase 2/3 study of SP-102 (lumbosacral radicular pain)