The Week Ahead In Biotech: ASH 2018, PDUFA Dates, Clinical Trials And Earnings

Notwithstanding the scanty news flow, biotech stocks came under intense selling pressure last week, pushing the iShares NASDAQ Biotechnology Index IBB further into the red.

Here's a list of key biotech events that could move the space in the upcoming week.

Conferences

• 26th International Diabetes and Healthcare Conference – Nov. 26-27, in Helsinki, Finland
• 13th European Diabetes and Endocrinology Congress – Nov. 26-27, in Dublin, Ireland
• World Neuron Congress – Nov. 26-27, in Helsinki, Finland
• 3rd International Conference on Autoimmunity – Nov. 26-27, in Dublin
• 8th International Conference on Cell & Gene Therapy – Nov. 27-28, in Athens, Greece
• Evercore ISI HealthConX, - Nov. 27-29, at the Boston Harbor Hotel in Boston, Massachusetts
• Piper Jaffray 30th Annual Healthcare Conference – Nov. 27-29, in New York
• 2018 American Epilepsy Society, or AES, annual meeting – Nov. 30-Dec. 4, in New Orleans, Louisiana
• 2018 American Society of Hematology, or ASH, annual meeting – Dec. 1-4, in San Diego, California

PDUFA Dates

The FDA is set to rule Monday, Nov. 26 on Loxo Oncology Inc LOXO's Larotrectinib (LOXO-101) that is being evaluated for treating adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

The FDA will also decide on Catalyst Pharmaceuticals Inc CPRX's NDA for Firdapse, its pipeline candidate for Lambert-Eaton myasthenic syndrome. The PDUFA date has been set for Wednesday, Nov. 28.

Clinical Trial Results

Spark Therapeutics Inc ONCE will release Phase 2 data for its melanoma treatment candidate OMS-100, Friday, Nov. 30.

Histogenics Corp HSGX is expected to present by the end of November an update on potential BLA filing for its NeoCart being tested as a treatment option for cartilage defects in the knee.

Xenon Pharmaceuticals Inc XENE is expected to present Phase 1 data for XEN1101, its epilepsy treatment, as well as final phase data for XEN901 tested in healthy volunteers, both at the 2018 AES annual meeting held between Nov. 30 and Dec. 4.

See Also: Canaccord Turns Bullish On Mallinckrodt: 4 Reasons Why

ASH Presentations On Saturday, Dec. 1

• Catalyst Biosciences Inc CBIO – Phase 2 data for hemophilia candidate Marzeptacog alfa
• Karyopharm Therapeutics Inc KPTI – top-line Phase 2b data for its Selinexor, evaluated for diffuse large B-cell lymphoma, or DLBCL
• Bio-Path Holdings Inc BPTH – Phase 2 data for acute myeloid leukemia candidate Prexigebersen
• Bellicum Pharmaceuticals Inc BLCM – Additional interim Phase 1/2 data for BPX-501, its adjunct T-cell therapy candidate for administration after allogeneic hematopoietic stem cell transplantation
• MORPHOSYS AG/S ADR MOR – final Phase 2 data for its multiple myeloma treatment candidate MOR202 as well as Phase 2 data for Lenalidomide + MOR208 combo in treating relapsed or refractory DLBCL.
• Unum Therapeutics Inc UMRX – initial Phase 1 data for its multiple myeloma treatment candidate ACTR087 in combination with Seattle Genetics, Inc. SGEN's SEA-BCMA
• Amgen, Inc. AMGN – Phase 1 data for AMG 330, its pipeline asset for relapsed/refractory acute myeloid leukemia
• Beigene Ltd BGNE – Phase 2 data for relapsed/refractory mantle cell lymphoma candidate Zanubrutinib
• Acceleron Pharma Inc XLRN and Celgene Corporation CELG – Presentation of already released Phase 3 data for Luspatercept to treat beta-thalassemia
• Onconova Therapeutics Inc ONTX – Phase 2 data for Oral Rigosertib and azacytidine, which is being evaluated for first-line high risk myelodysplastic syndromes
• ImmunoGen, Inc. IMGN – additional Phase 1 data for its relapsed/refractory acute myeloid leukemia treatment candidate IMGN779
• Affimed NV AFMD – Updated Phase 1b data for AFM13 in combination with Merck & Co., Inc. MRK's Keytruda in Hodgkin lymphoma
• Aileron Therapeutics Inc ALRN – Interim Phase 2a data for its peripheral T-cell lymphoma treatment candidate ALRN-6924
• Fate Therapeutics Inc FATE – Updated Phase 1 data for ProTmune, its pipeline candidate for acute graft-versus-host disease patients undergoing hematopoietic cell transplantation
• Stemline Therapeutics Inc STML – Phase 1/2 data for SL-401 that is being evaluated for high-risk myeloproliferative neoplasms
• argenx SE – ADR ARGX – Phase 2 data for its relapsed/refractory cutaneous T-cell lymphoma treatment candidate ARGX - 110
• Trillium Therapeutics Inc TRIL – Updated Phase 2 data for its solid tumor treatment candidate TTI-621-02

Earnings

Monday

• Enanta Pharmaceuticals Inc ENTA (after the close)
• Tuesday
• GW Pharmaceuticals PLC- ADR GWPH (after the close)
• Wednesday
• Ascendis Pharma A/S ASND (after the close)