Biotech stocks advanced in the holiday-shortened week, with upside driven mainly by the broader market strength. Reflecting the extreme volatility in the space, a few stocks gyrated wildly in reaction to catalytic events.
ChemoCentryx Inc CCXI 1.92% nearly tripled in a single session in reaction to positive Phase 3 data for drug to treat rare inflammatory disease.
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The Medicines Company MDCO 0.18% was another standout gainer, adding about 22% Monday, on a deal to be bought by Novartis AG NVS 0.29%.
Here are the key catalysts for the unfolding week.
Conferences
- International Alliance of Amyotrophic Lateral Sclerosis/Motor Neurone Disease, or ALS/MND, Annual Meeting – Dec. 1-2 in Perth, Australia
- 34th World Cardiology Conference – Dec. 2-3 in Barcelona, Spain
- Annual Congress on Antibiotics and Antimicrobial Resistance – Dec. 2-3 in Paris, France
- 6th Annual Conference on Stroke and Neurological Disorders – Dec. 2-3 in Rome, Italy
- 10th International Conference on Immunology & Immunogenetics – Dec. 2-3 in London
- 12th Clinical Trials On Alzheimer’s Disease, or CTAD – Dec. 4-7 in San Diego, California
- Piper Jaffray 31st Annual Healthcare Conference – Dec. 3-5 in New York City
- Evercore ISI HealthCONx Conference – Dec. 3-5 in Boston, Massachusetts
- 2nd Global Conference on Cardiovascular Research and Clinical Cardiology – Dec. 6-7 in Montreal, Canada
- American Epilepsy Society, or AES, 2019 Annual Meeting – Dec. 6-10 in Baltimore, Maryland
- 61st American Society of Hematology, or ASH, Annual Meeting – Dec. 7-10 in Orlando, Florida
PDUFA Dates
The FDA is scheduled to give its verdict on Roche Holdings AG Basel ADR’s RHHBY 0.05% Tecentriq in combination with Bristol-Myers Squibb Co’s BMY 1.16% chemo medications Carboplatin and Abraxane in patients with metastatic non-squamous NSCLC, who do not have EGFR or ALK genomic tumor aberrations. The PDUFA action date is fixed for Monday.
Clinical Readouts
CTAD Presentations
ACADIA Pharmaceuticals Inc. ACAD 3.64% – detailed Phase 3 data for pimavanserin in dementia-related psychosis (Wednesday)
Biogen Inc BIIB 1.17% – Detailed data from the Phase 3 EMERGE study of aducanumab in Alzheimer’s disease (Thursday)
Cassava Sciences Inc SAVA 2.78% – Phase 2a data for PTI-125 in Alzheimer’s disease (Thursday)
Alector Inc ALEC 1.48% – Phase 1 data for AL002, a monoclonal antibody, in Alzheimer’s disease (Friday)
International Alliance of ALS/MND Annual Meeting Presentations
Cytokinetics, Inc. CYTK 1.04% – Responder and subgroup analyses of data from the Phase 2 study of Reldesemtiv in ALS (Thursday)
AES Annual Meeting Presentations
GW Pharmaceuticals PLC- ADR GWPH 1.67% – Phase 3 data for Epidiolex in tuberous sclerosis leukemia (Saturday)
ASH Presentations
(Scheduled for Saturday)
Magenta Therapeutics Inc MGTA 0.53% – initial Phase 1 data for MGTA-145 in healthy volunteers
Bristol-Myers Squibb – Phase 1 data for liso-cel, or JCAR017, in relapsed/refractory B cell non-Hodgkin lymphoma
Fortress Biotech FBIO 4.57% and Mustang Bio Inc MBIO 9.69% – Phase 1/2 data for MB-107 in X-linked severe combined immunodeficiency
Sierra Oncology Inc (NASDAQ: SRRA – Phase 3 data for momelotinib in myelofibrosis
Actinium Pharmaceuticals Inc ATNM 17.9% – Phase 3 data for lomab-B in acute myeloid luekemia
bluebird bio Inc BLUE 0.86% – Phase 1/2 data for LentiGlobin in sickle cell disease
Morphosys Ag MOR 0.2% – Phase 2 data for MOR208 and Gilead Sciences, Inc. GILD 0.18%‘s Zydelig in chronic lymphocytic leukemia Unum Therapeutics Inc UMRX 0.75% – Phase 1 data for ACTR707 with Roche’s Rituxan in CD20 positive non-Hodgkin lymphoma and Phase 1 data for ACTR087 plus Rituxan, also in non-Hodgkin lymphoma
Verastem Inc VSTM 3.79% – Phase 2 data for duvelisib in peripheral T-cell lymphoma
Autolus Therapeutics Ltd – ADR AUTL 4.97% – interim Phase 1 data for AUTO3 in relapsed/refractory diffuse large B-cell lymphoma and updated Phase 1 data for AUT01 in acute lymphoblastic leukemia
TrovaGene Inc TROV 1.42% – Phase 1/2 data for ovansertib in acute myeloid leukemia
Cyclacel Pharmaceuticals Inc CYCC 3.77% – initial Phase 1 data for CYC065 plus AbbVie Inc ABBV 0.66%‘s venetoclax in chronic lymphocytic leukemia
Oncternal Therapeutics Inc ONCT 6.67% – Phase 1/2 data for cirmtuzumab plus AbbVie’s ibrutinib in chronic lymphocytic leukemia and mantle cell lymphona
Sangamo Therapeutics Inc SGMO 0.37% – Phase 1/2 data for SB-525 in hemophilia A
Acceleron Pharma Inc XLRN 1.05% and Bristol-Myers Squibb – Phase 2 data for luspatercept in hemophilia A
IPO Quiet Period Expirations
Centogene N.V./EQ CNTG 2.82%
Galera Therapeutics Inc GRTX 0.32%
TELA Bio Inc TELA 15.19%
CNS Pharmaceuticals Inc CNSP 1.2%
89bio Inc ETNB 3.82%
Galera Therapeutics Inc GRTX 0.32%
TELA Bio Inc TELA 15.19%
CNS Pharmaceuticals Inc CNSP 1.2%
89bio Inc ETNB 3.82%
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