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 ... Read More...

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="ChemoCentryx Inc (NASDAQ: CCXI) nearly tripled in a single session in reaction to positive Phase 3 data for drug to treat rare inflammatory disease.” data-reactid=”19″>ChemoCentryx Inc (NASDAQ: CCXI) nearly tripled in a single session in reaction to positive Phase 3 data for drug to treat rare inflammatory disease.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="The Medicines Company (NASDAQ: MDCO) was another standout gainer, adding about 22% Monday, on a deal to be bought by Novartis AG (NYSE: NVS).” data-reactid=”20″>The Medicines Company (NASDAQ: MDCO) was another standout gainer, adding about 22% Monday, on a deal to be bought by Novartis AG (NYSE: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="The FDA is scheduled to give its verdict on Roche Holdings AG Basel ADR’s (OTC: RHHBY) Tecentriq in combination with Bristol-Myers Squibb Co’s (NYSE: 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.” data-reactid=”36″>The FDA is scheduled to give its verdict on Roche Holdings AG Basel ADR’s (OTC: RHHBY) Tecentriq in combination with Bristol-Myers Squibb Co’s (NYSE: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) – detailed Phase 3 data for pimavanserin in dementia-related psychosis (Wednesday)” data-reactid=”38″>ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) – detailed Phase 3 data for pimavanserin in dementia-related psychosis (Wednesday)

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Biogen Inc (NASDAQ: BIIB) – Detailed data from the Phase 3 EMERGE study of aducanumab in Alzheimer’s disease (Thursday)” data-reactid=”39″>Biogen Inc (NASDAQ: BIIB) – Detailed data from the Phase 3 EMERGE study of aducanumab in Alzheimer’s disease (Thursday)

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Cassava Sciences Inc (NASDAQ: SAVA) – Phase 2a data for PTI-125 in Alzheimer’s disease (Thursday)” data-reactid=”40″>Cassava Sciences Inc (NASDAQ: SAVA) – Phase 2a data for PTI-125 in Alzheimer’s disease (Thursday)

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Alector Inc (NASDAQ: ALEC) – Phase 1 data for AL002, a monoclonal antibody, in Alzheimer’s disease (Friday)” data-reactid=”41″>Alector Inc (NASDAQ: ALEC) – Phase 1 data for AL002, a monoclonal antibody, in Alzheimer’s disease (Friday)

International Alliance of ALS/MND Annual Meeting Presentations

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Cytokinetics, Inc. (NASDAQ: CYTK) – Responder and subgroup analyses of data from the Phase 2 study of Reldesemtiv in ALS (Thursday)” data-reactid=”43″>Cytokinetics, Inc. (NASDAQ: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) – Phase 3 data for Epidiolex in tuberous sclerosis leukemia (Saturday)” data-reactid=”46″>GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) – Phase 3 data for Epidiolex in tuberous sclerosis leukemia (Saturday)

ASH Presentations

(Scheduled for Saturday)

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Magenta Therapeutics Inc (NASDAQ: MGTA) – initial Phase 1 data for MGTA-145 in healthy volunteers” data-reactid=”49″>Magenta Therapeutics Inc (NASDAQ: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Fortress Biotech (NASDAQ: FBIO) and Mustang Bio Inc (NASDAQ: MBIO) – Phase 1/2 data for MB-107 in X-linked severe combined immunodeficiency” data-reactid=”51″>Fortress Biotech (NASDAQ: FBIO) and Mustang Bio Inc (NASDAQ: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Actinium Pharmaceuticals Inc (NYSE: ATNM) – Phase 3 data for lomab-B in acute myeloid luekemia” data-reactid=”53″>Actinium Pharmaceuticals Inc (NYSE: ATNM) – Phase 3 data for lomab-B in acute myeloid luekemia

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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Morphosys Ag (NASDAQ: MOR) – Phase 2 data for MOR208 and Gilead Sciences, Inc. (NASDAQ: GILD)’s Zydelig in chronic lymphocytic leukemia Unum Therapeutics Inc (NASDAQ: 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” data-reactid=”55″>Morphosys Ag (NASDAQ: MOR) – Phase 2 data for MOR208 and Gilead Sciences, Inc. (NASDAQ: GILD)’s Zydelig in chronic lymphocytic leukemia Unum Therapeutics Inc (NASDAQ: 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 (NASDAQ: VSTM) – Phase 2 data for duvelisib in peripheral T-cell lymphoma

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Autolus Therapeutics Ltd – ADR (NASDAQ: 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” data-reactid=”57″>Autolus Therapeutics Ltd – ADR (NASDAQ: 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 (NASDAQ: TROV) – Phase 1/2 data for ovansertib in acute myeloid leukemia

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) – initial Phase 1 data for CYC065 plus AbbVie Inc (NYSE: ABBV)’s venetoclax in chronic lymphocytic leukemia” data-reactid=”59″>Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) – initial Phase 1 data for CYC065 plus AbbVie Inc (NYSE: ABBV)’s venetoclax in chronic lymphocytic leukemia

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Oncternal Therapeutics Inc (NASDAQ: ONCT) – Phase 1/2 data for cirmtuzumab plus AbbVie’s ibrutinib in chronic lymphocytic leukemia and mantle cell lymphona” data-reactid=”60″>Oncternal Therapeutics Inc (NASDAQ: ONCT) – Phase 1/2 data for cirmtuzumab plus AbbVie’s ibrutinib in chronic lymphocytic leukemia and mantle cell lymphona

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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Acceleron Pharma Inc (NASDAQ: XLRN) and Bristol-Myers Squibb – Phase 2 data for luspatercept in hemophilia A” data-reactid=”62″>Acceleron Pharma Inc (NASDAQ: XLRN) and Bristol-Myers Squibb – Phase 2 data for luspatercept in hemophilia A

IPO Quiet Period Expirations

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Centogene N.V./EQ (NASDAQ: CNTG)
Galera Therapeutics Inc (NASDAQ: GRTX)
TELA Bio Inc (NASDAQ: TELA)
CNS Pharmaceuticals Inc (NASDAQ: CNSP)
89bio Inc (NASDAQ: ETNB)” data-reactid=”64″>Centogene N.V./EQ (NASDAQ: CNTG)
Galera Therapeutics Inc (NASDAQ: GRTX)
TELA Bio Inc (NASDAQ: TELA)
CNS Pharmaceuticals Inc (NASDAQ: CNSP)
89bio Inc (NASDAQ: ETNB)