The Week Ahead In Biotech: ASH 2019 Gets Underway, Biogen's Aducanumab Data And More

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 nearly tripled in a single session in reaction to positive Phase 3 data for drug to treat rare inflammatory disease.

The Medicines Company MDCO was another standout gainer, adding about 22% Monday, on a deal to be bought by Novartis AG NVS.

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 Tecentriq in combination with Bristol-Myers Squibb Co's BMY 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 – detailed Phase 3 data for pimavanserin in dementia-related psychosis (Wednesday)

Biogen Inc BIIB – Detailed data from the Phase 3 EMERGE study of aducanumab in Alzheimer's disease (Thursday)

Cassava Sciences Inc SAVA – Phase 2a data for PTI-125 in Alzheimer's disease (Thursday)

Alector Inc ALEC – Phase 1 data for AL002, a monoclonal antibody, in Alzheimer's disease (Friday)

International Alliance of ALS/MND Annual Meeting Presentations

Cytokinetics, Inc. CYTK – Responder and subgroup analyses of data from the Phase 2 study of Reldesemtiv in ALS (Thursday)

See Also: A Deep Dive Into Aquestive Following The FDA's Approval Of Riluzole

AES Annual Meeting Presentations

GW Pharmaceuticals PLC- ADR GWPH – Phase 3 data for Epidiolex in tuberous sclerosis leukemia (Saturday)

ASH Presentations

(Scheduled for Saturday)

Magenta Therapeutics Inc MGTA – 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 and Mustang Bio Inc MBIO – 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 – Phase 3 data for lomab-B in acute myeloid luekemia

bluebird bio Inc BLUE – Phase 1/2 data for LentiGlobin in sickle cell disease

Morphosys Ag MOR – Phase 2 data for MOR208 and Gilead Sciences, Inc. GILD's Zydelig in chronic lymphocytic leukemia Unum Therapeutics Inc UMRX – 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 – Phase 2 data for duvelisib in peripheral T-cell lymphoma

Autolus Therapeutics Ltd – ADR AUTL – 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 – Phase 1/2 data for ovansertib in acute myeloid leukemia

Cyclacel Pharmaceuticals Inc CYCC – initial Phase 1 data for CYC065 plus AbbVie Inc ABBV's venetoclax in chronic lymphocytic leukemia

Oncternal Therapeutics Inc ONCT – Phase 1/2 data for cirmtuzumab plus AbbVie's ibrutinib in chronic lymphocytic leukemia and mantle cell lymphona

Sangamo Therapeutics Inc SGMO – Phase 1/2 data for SB-525 in hemophilia A

Acceleron Pharma Inc XLRN and Bristol-Myers Squibb – Phase 2 data for luspatercept in hemophilia A

IPO Quiet Period Expirations

Centogene N.V./EQ CNTG
Galera Therapeutics Inc GRTX
TELA Bio Inc TELA
CNS Pharmaceuticals Inc CNSP
89bio Inc ETNB