The Week Ahead In Biotech: Viela FDA Decision, Hematology Conference Take Center Stage

The biotech space saw a flurry of activity last week, with coronavirus-related news, conference presentations and IPOs.

Negative clinical readouts led to some strong selling in stocks such as Iterum Therapeutics PLC ITRM and Novus Therapeutics Inc NVUS. On a positive note, Merck & Co., Inc. MRK snagged another approval for its triple combo antibiotic.

Here are are the key catalysts for the unfolding week.

Conferences

• Bio Digital: June 8-12
• 41st Annual Goldman Sachs Global Healthcare Conference, held as a virtual event: June 9-11
• The Endocrine Society's ENDO Online 2020: June 8-22
• 25th Edition of the European Hematology Association, or EHA, Annual Congress held in virtual format: June 11-21
• American Academy of Dermatology, or AAD, Virtual Meeting Experience: June 12-14
• The American Diabetes Association, or ADA, 80th Scientific Sessions – Virtual: June 12-16

Related Link: Revisiting The Coronavirus Vaccine Race: Updates On The 10 Candidates In Clinics

PDUFA Dates

The FDA is set to rule on Viela Bio Inc's VIE BLA for inebilizumab in treating neuromyelitis optica spectrum disorder, a rare autoimmune disorder. (Thursday)

Clinical Readouts

ENDO Online Presentations

Opko Health Inc. OPK: results from the global Phase 3 pediatric trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency (Monday)

Neurocrine Biosciences, Inc. NBIX: Results of the Phase 2 proof-of-concept study of crinecerfont in adult patients with congenital adrenal hyperplasia (Monday)

EHA Presentations

bluebird bio Inc BLUE: data from its gene therapy programs for sickle cell disease, transfusion-dependent β-thalassemia and its cell therapy program for relapsed and refractory multiple myeloma

Merus NV MRUS: interim data from the Phase 1 MCLA-117 acute myeloid leukemia trial and an analysis of an extensive, proprietary panel of CD3 bispecific antibodies

Blueprint Medicines Corp BPMC: results from Phase 2 PIONEER study of avapritinib in patients with indolent systemic mastocytosis and updated Phase 1 data for avapritinib in patients with advanced systemic mastocytosis, regardless of prior midostaurin therapy

Autolus Therapeutics Ltd – ADR AUTL: updated data using AUTO1 in relapsed/refractory B-Acute lymphoblastic leukemia, and Phase 1 data for AUTO3 with Merck's Keytruda in patients with relapsed/refractory diffuse large B cell lymphoma

Vertex Pharmaceuticals Incorporated VRTX and Crispr Therapeutics AG CRSP: 12 months of follow-up data for the first patient treated in the ongoing Phase 1/2 CLIMB-111 trial in transfusion-dependent beta thalassemia and six months of follow-up data for the first patient treated in the ongoing Phase 1/2 CLIMB-121 trial in severe sickle cell disease

Takeda Pharmaceutical Co Ltd TAK: interim analysis from the Phase 2 OPTIC study of ponatinib in chronic-phase chronic myeloid leukemia patients who are resistant or intolerant to prior tyrosine kinase inhibitor therapy.

Imara Inc IMRA: interim data from the ongoing Phase 2a study of IMR-687 in patients with sickle cell disease

Principia Biopharma Inc PRNB: updates on efficacy and safety, including durability of effect, from the ongoing open-label Phase 1/2 clinical trial in patients with immune thrombocytopenia

Constellation Pharmaceuticals Inc CNST: updated preliminary data from the MANIFEST clinical trial of CPI-0610 in myelofibrosis

Protagonist Therapeutics Inc PTGX: data from its Phase 2 trial of PTG-300 for the treatment of beta-thalassemia

Agios Pharmaceuticals Inc AGIO: updated clinical proof-of-concept data from the Phase 2 study of mitapivat in in adults with non-transfusion-dependent thalassemia

AAD Presentations

Principia Biopharma: full data set presentation from the Phase 2 Part B pemphigus trial with its investigational drug rilzabrutinib (Friday)

ADA Presentations

Oramed Pharmaceuticals, Inc. ORMP: poster presentations of oral insulin ORMD-0801's effects on glucose parameters in uncontrolled Type 2 diabetes, oral insulin-induced reduction in liver fat content in Type 2 diabetic patients with non-alcoholic steatohepatitis and evening oral insulin glycemic effects in uncontrolled Type 2 diabetes patients (Friday)

vTv Therapeutics Inc. VTVT: full clinical study results from the positive Phase 2 Simplici-T1 Study of TTP399 as an oral adjunctive therapy in type 1 diabetes (Saturday)

Earnings

Enzo Biochem, Inc. ENZ (Monday, after the close)

Advaxis, Inc. ADXS (Thursday, before the market opens)

IPO

Dallas, Texas-based clinical-stage biotech Lantern Pharma, which uses AI, machine language and genomic data to develop drugs and identify patients who can benefit from targeted oncology therapies, has filed to offer 1.563 million shares of its common stock at an estimated price range of $15-$17. The shares of the company have been approved for listing on the Nasdaq under the ticker symbol "LTRN."

IPO Quiet Period Expiry

ADC Therapeutics SA ADCT