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

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsPreviewsFDAIPOsTop StoriesTrading Ideas
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!