The Week Ahead In Biotech: Focus Shifts To Year-End Clinical Trial Results

Biotech stocks extended losses for the third straight week amid the markedly negative sentiment blanketing the broader market. This is despite the announcement of a major deal in the pharma space and optimism over record new molecule approvals.

Here are the key catalysts that could sway stocks in the biotech space this week.

PDUFA Dates

Bristol-Myers Squibb Co BMY's sBLA for its Sprycel, in combination with chemotherapy, for treating pediatric patients with newly diagnosed Ph+ acute lymphoblastic leukemia is pending before the FDA for review (Saturday, Dec. 29).

Clinical Trial Results (Expected Q4, Year-End Releases)

• Marinus Pharmaceuticals Inc MRNS – Phase 2 data for Ganaxolone (refractory status epilepticus)
• Kamada Ltd. KMDA – Interim analysis of Phase 2 data for Alpha-1 antitrypsin (for preventing lung transplant rejection)
• Vistagen Therapeutics Inc VTGN – Phase 2 data for AV-101 (as monotherapy treatment for major depressive disorder)
• Gilead Sciences, Inc. GILD – 24-week endpoint of Phase 2 study of Tirabrutinib, codenamed GS-4059 (chronic lymphocytic leukemia)
• Merus NV MRUS – early activity data from the Phase 1 trial for MCLA-117 (acute myeloid leukemia, or AMLA)
• Dynavax Technologies Corporation DVAX – Phase 1 safety and biomarker data for DV281 (non-small cell lung cancer, or NSCLC)
• AC Immune SA ACIU – Interim Phase 1/2 data for ACI-24 vaccine (treating Alzheimer's disease-like characteristics in individuals with Down syndrome)
• Sesen Bio Inc SESN – 12-month data from Phase 3 study of Vicinium (non-muscle invasive bladder cancer)
• Sanofi SA SNY – Phase 3 data for influenza vaccine Fluzone quadrivalent (influenza)
• Heat Biologics Inc HTBX – Interim Phase 2 data for HS-110 in combination with Bristol-Myers Squibb Co BMY's Opdivo (NSCLC)
• Spark Therapeutics Inc ONCE – Updated Phase 1/2 for SPK-7001 (Choroideremia)
• Entera Bio Ltd ENTX – Phase 2 pharmacokinetic/pharmacodynamic data for EB612 (hypoparathyroidism)
• Celgene Corporation CELG – 1) Phase 3 for oral Azacitidine (post-induction AML maintenance), 2) Phase 3 data for Abraxane (adjuvant therapy in surgically resected pancreatic cancer), 3) Phase 3 data for Revlimid (first-line ABC diffuse large B-cell lymphoma, or DLBCL)
• Lexicon Pharmaceuticals, Inc. LXRX – Phase 1b data for LX2761 (Type 2 diabetes)
• ContraFect Corp CFRX – Phase 2 data for CF-301 (serious infections caused by Staph aureus including MRSA)
• Merck & Co., Inc. MRK – 1) Phase 3 data for Keytruda (classical Hodgkin Lymphoma), 2) Phase 3 data for Keytruda (triple-negative breast cancer)
• Deciphera Pharmaceuticals Inc DCPH – Updated Phase 1 data for DCC-3014 (solid tumors or hematological malignancies)
• Ultragenyx Pharmaceutical Inc RARE – low-dose cohort data from Phase 1/2 study of DTX401 (GSD1)
• Corcept Therapeutics Incorporated CORT – Phase 2 pancreatic data for Relacorilant (solid tumors)

Related Link: A Bull And Bear Review Positive Results For Puma Biotech's Late-Stage Breast Cancer Drug Trial

• Aeglea Bio Therapeutics Inc AGLE – top-line safety and clinical data for Pegzilarginase along with Merck's Keytruda (small cell lung cancer, or SCLC)
• FibroGen Inc FGEN & AstraZeneca plc AZN – Pooled MACE safety data for Roxadustat (anemia in chronic kidney disease)
• Portola Pharmaceuticals Inc PTLA – Prior Approval Supplement, or PAS for Andexxa, a factor Xa inhibitor reversal agent
• AstraZeneca – Phase 3 TULIP 3 data for Anifrolumab (lupus)
• Novo Nordisk A/S NVO – Phase 2 data from a study dubbed EXPLORER 4 for Concizumab (hemophilia A)
• Amgen, Inc. AMGN – Phase 2 data for AMG301 (migraine)
• Marker Therapeutics Inc MRKR – Interim Phase 2 data for TPIV200+durvalumab (platinum-sensitive ovarian cancer)
• ProQR Therapeutics NV PRQR – Interim Phase 1/2 data for QR-313 (epidermolysis bullosa)
• Aerpio Pharmaceuticals Inc ARPO – Phase 1 multiple ascending dose data for AKB-4924 (ulcerative colitis)
• SCYNEXIS Inc SCYX – Preliminary Phase 3 data for SCY-078 (invasive candidiasis)
• Flexion Therapeutics Inc FLXN – top-line Phase 2 data for Zilretta (osteoarthritis of the shoulder and hip)
• Cocrystal Pharma Inc COCP – Initial Phase 2a data for CC-31244 (hepatitis C)
• ASLAN PHARMACEUTICALS ADR REP 5 ORD ASLN – Phase 2 data for Varlitinib (gastric cancer)
• TRACON Pharmaceuticals Inc TCON - 1) Phase 1 data for TRC105 + Bristol-Myers Squibb's Opdivo (NSCLC), 2) top-line data from Phase 2 data for TRC105 + Inlyta (renal cell carcinoma)
• Palatin Technologies, Inc. PTN – Phase 1 data for PL-8177 (inflammatory bowel disease)
• Sienna Biopharmaceuticals Inc SNNA – top-line data from the Phase 1/2 trial of SNA-125 (atopic dermatitis)
• Aquestive Therapeutics Inc AQST – top-line data from the Phase 3 trial of AQST-117 (amyotropic lateral sclerosis)
• Cytori Therapeutics Inc CYTX – Phase 2 data for Scleradec 2 (Scleroderma)
• Pain Therapeutics, Inc. PTIE - Preliminary data from the first cohort for PTI-428+ PTI-801 + PTI-808 (cystic fibrosis)
• BioXcel Therapeutics Inc BTAI – Phase 1 data for BXCL501 (Schizophrenia and senile dementia of the Alzheimer's type)
• Savara Inc SVRA – Interim Phase 2a data for Molgradex (non-tuberculous mycobacteria)
• Pfizer Inc. PFE – Phase 3 data for Xtandi based on ARCHES study (Metastatic hormone sensitive prostate cancer)