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

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.


Bristol-Myers Squibb Co (NYSE: 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 (NASDAQ: MRNS) – Phase 2 data for Ganaxolone (refractory status epilepticus)
  • Kamada Ltd. (NASDAQ: KMDA) – Interim analysis of Phase 2 data for Alpha-1 antitrypsin (for preventing lung transplant rejection)
  • Vistagen Therapeutics Inc (NASDAQ: VTGN) – Phase 2 data for AV-101 (as monotherapy treatment for major depressive disorder)
  • Gilead Sciences, Inc. (NASDAQ: GILD) – 24-week endpoint of Phase 2 study of Tirabrutinib, codenamed GS-4059 (chronic lymphocytic leukemia)
  • Merus NV (NASDAQ: MRUS) – early activity data from the Phase 1 trial for MCLA-117 (acute myeloid leukemia, or AMLA)
  • Dynavax Technologies Corporation (NASDAQ: DVAX) – Phase 1 safety and biomarker data for DV281 (non-small cell lung cancer, or NSCLC)
  • AC Immune SA (NASDAQ: ACIU) – Interim Phase 1/2 data for ACI-24 vaccine (treating Alzheimer's disease-like characteristics in individuals with Down syndrome)
  • Sesen Bio Inc (NASDAQ: SESN) – 12-month data from Phase 3 study of Vicinium (non-muscle invasive bladder cancer)
  • Sanofi SA (NYSE: SNY) – Phase 3 data for influenza vaccine Fluzone quadrivalent (influenza)
  • Heat Biologics Inc (NASDAQ: HTBX) – Interim Phase 2 data for HS-110 in combination with Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo (NSCLC)
  • Spark Therapeutics Inc (NASDAQ: ONCE) – Updated Phase 1/2 for SPK-7001 (Choroideremia)
  • Entera Bio Ltd (NASDAQ: ENTX) – Phase 2 pharmacokinetic/pharmacodynamic data for EB612 (hypoparathyroidism)
  • Celgene Corporation (NASDAQ: 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. (NASDAQ: LXRX) – Phase 1b data for LX2761 (Type 2 diabetes)
  • ContraFect Corp (NASDAQ: CFRX) – Phase 2 data for CF-301 (serious infections caused by Staph aureus including MRSA)
  • Merck & Co., Inc. (NYSE: MRK) – 1) Phase 3 data for Keytruda (classical Hodgkin Lymphoma), 2) Phase 3 data for Keytruda (triple-negative breast cancer)
  • Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) – Updated Phase 1 data for DCC-3014 (solid tumors or hematological malignancies)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) – low-dose cohort data from Phase 1/2 study of DTX401 (GSD1)
  • Corcept Therapeutics Incorporated (NASDAQ: 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 (NASDAQ: AGLE) – top-line safety and clinical data for Pegzilarginase along with Merck's Keytruda (small cell lung cancer, or SCLC)
  • FibroGen Inc (NASDAQ: FGEN) & AstraZeneca plc (NYSE: AZN) – Pooled MACE safety data for Roxadustat (anemia in chronic kidney disease)
  • Portola Pharmaceuticals Inc (NASDAQ: 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 (NYSE: NVO) – Phase 2 data from a study dubbed EXPLORER 4 for Concizumab (hemophilia A)
  • Amgen, Inc. (NASDAQ: AMGN) – Phase 2 data for AMG301 (migraine)
  • Marker Therapeutics Inc (NASDAQ: MRKR) – Interim Phase 2 data for TPIV200+durvalumab (platinum-sensitive ovarian cancer)
  • ProQR Therapeutics NV (NASDAQ: PRQR) – Interim Phase 1/2 data for QR-313 (epidermolysis bullosa)
  • Aerpio Pharmaceuticals Inc (NASDAQ: ARPO) – Phase 1 multiple ascending dose data for AKB-4924 (ulcerative colitis)
  • SCYNEXIS Inc (NASDAQ: SCYX) – Preliminary Phase 3 data for SCY-078 (invasive candidiasis)
  • Flexion Therapeutics Inc (NASDAQ: FLXN) – top-line Phase 2 data for Zilretta (osteoarthritis of the shoulder and hip)
  • Cocrystal Pharma Inc (NASDAQ: COCP) – Initial Phase 2a data for CC-31244 (hepatitis C)
  • ASLAN PHARMACEUTICALS ADR REP 5 ORD (NASDAQ: ASLN) – Phase 2 data for Varlitinib (gastric cancer)
  • TRACON Pharmaceuticals Inc (NASDAQ: 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. (NYSE: PTN) – Phase 1 data for PL-8177 (inflammatory bowel disease)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA) – top-line data from the Phase 1/2 trial of SNA-125 (atopic dermatitis)
  • Aquestive Therapeutics Inc (NASDAQ: AQST) – top-line data from the Phase 3 trial of AQST-117 (amyotropic lateral sclerosis)
  • Cytori Therapeutics Inc (NASDAQ: CYTX) – Phase 2 data for Scleradec 2 (Scleroderma)
  • Pain Therapeutics, Inc. (NASDAQ: PTIE) - Preliminary data from the first cohort for PTI-428+ PTI-801 + PTI-808 (cystic fibrosis)
  • BioXcel Therapeutics Inc (NASDAQ: BTAI) – Phase 1 data for BXCL501 (Schizophrenia and senile dementia of the Alzheimer's type)
  • Savara Inc (NASDAQ: SVRA) – Interim Phase 2a data for Molgradex (non-tuberculous mycobacteria)
  • Pfizer Inc. (NYSE: PFE) – Phase 3 data for Xtandi based on ARCHES study (Metastatic hormone sensitive prostate cancer)

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