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The Week Ahead In Biotech: ASH Presentations Pick Up Steam, Correvio Awaits Adcom Ruling

Shanthi Rexaline

Biotech stocks went back and forth but managed to end the week with a gain. As usual, some stocks swung wildly in reaction to catalysts, primarily clinical readouts.

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) more than doubled in a single session after its lead drug aced a pivotal trial in lupus nephritis. Meanwhile, SAGE Therapeutics Inc (NASDAQ: SAGE) saw more than half of its market value wiped out due to disappointing late-stage data for its depression drug.

Here are the key catalysts for the unfolding week.

Conferences

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
San Antonio Breast Cancer Symposium, or SABCS, 2019 – Dec. 10-14 in San Antonio, Texas
European Society of Medical Oncology, or ESMO, Immuno-Oncology Congress – Dec. 11-14, in Geneva, Switzerland

PDUFA Dates

The FDA is set to rule on Amgen, Inc.'s (NASDAQ: AMGN) ABP 710, a biosimilar to Johnson & Johnson's (NYSE: JNJ) Remicade, which has been approved for multiple indications such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. The BsUFA date is set for Saturday.

Adcom Calendar

FDA's Cardiovascular and Renal Drugs Advisory Committee will discuss Tuesday Correvio Pharma Corp's (NASDAQ: CORV) NDA for Brinavess, or vernakalant HCl solution, ahead of the Dec. 24 PDUFA action date.

Clinical Readouts ASH Presentations Sunday

Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) – Phase 1/2 data for OTL-103 in Wiskott-Aldrich syndrome

TG Therapeutics Inc common stock (NASDAQ: TGTX) – Phase 1/2 data for umbralisib in combination of AbbVie Inc (NYSE: ABBV)'s Venclexta in chronic lymphocytic leukemia

GENMAB A/S/S ADR (NASDAQ: GMAB): initial Phase 1 data for HexaBody-DR5/DR5 in solid tumors

Morphosys Ag (NASDAQ: MOR): Phase 1 data for tafasitamab in diffuse large B-cell lymphoma

Uniqure NV (NASDAQ: QURE): Phase 2b data for AMT-061 in hemophilia B

Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL) – Phase 1 data for AUT02 in relapsed or refractory multiple myeloma

Bristol-Myers Squibb Co (NYSE: BMY): updated Phase 1 data for liso-cel in chronic lymphocytic leukemia

Actinium Pharmaceuticals Inc (NYSE: ATNM): Phase 1 data for actimab-A in combination with CLAG-M in relapsed or refractory acute myeloid leukemia

Portola Pharmaceuticals Inc (NASDAQ: PTLA): interim Phase 2a data for cerdulatinib in refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia

Rocket Pharmaceuticals Inc (NASDAQ: RCKT): Phase 1 data for RP-L102 in Fanconi anemia

Fortress Biotech (NASDAQ: FBIO) and Mustang Bio Inc (NASDAQ: MBIO): Phase 1 data for MB-106 in B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia

PDS Biotechnology Corp (NASDAQ: PDSB): Phase 1 data for PDS0101 in head and neck cancer/human papillomavirus 16 infection

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS): Phase 1/2 data for vecabrutinib in advanced B-cell malignancies

View more earnings on IBB

Alpine Immune Sciences Inc (NASDAQ: ALPN): Phase 1 data for ALPN-101 in healthy volunteers

Kura Oncology Inc (NASDAQ: KURA): Phase 2 data for tipifarnib in relapsed or refractory peripheral T-cell lymphoma

Beigene Ltd (NASDAQ: BGNE): Phase 3 data for zanubrutinib in first-line chronic lymphocytic leukemia or small lymphocytic leukemia

Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL): Phase 1 data for AUT03 in acute lymphoblastic leukemia

Blueprint Medicines Corp (NASDAQ: BPMC): initial Phase 2 data for avapritinib in indolent and smoldering systemic mastocytosis

Eli Lilly And Co (NYSE: LLY): Phase 1/2 data for LOXO-305 in refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, non-Hodgkin's lymphomas

Imv Inc (NASDAQ: IMV): Phase 2 data for DPX-Survivac and Merck & Co., Inc. (NYSE: MRK)'s Keytruda in diffuse large cell lymphoma

See Also: This Biotech Is On Track To End 2019 As The Best Performing Stock In The Sector

Monday

  • bluebird bio Inc (NASDAQ: BLUE): Phase 3 data for lentiglobin – HGB-212 in transfusion-dependent thalassemia and the β0/β0genotype and lentiglobin – HGB-207 in non-β0/β0 transfusion-dependent thalassemia

  • Magenta Therapeutics Inc (NASDAQ: MGTA): Phase 2 data for MGTA-456 in acute lymphoblastic leukemia

  • CELYAD SA/ADR (NASDAQ: CYAD): Phase 1 data for CYAD-01 in solid and hematologic cancers; Phase 1 data for CYAD-01 and chemotherapy in acute myeloid leukemia or myelodysplastic syndrome

  • Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) and Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN): danicopan in paroxysmal nocturnal hemoglobinuria

  • Seattle Genetics, Inc. (NASDAQ: SGEN): Phase 1/2 data for ST-400 in beta thalassemia

  • Agios Pharmaceuticals Inc (NASDAQ: AGIO): Phase 2 data for AG-348 in pyruvate deficiency; updated Phase 1 data for ivosidenib and Bristol-Myers Squibb's Vidaza in newly diagnosed acute myeloid leukemia with an IDH1 mutation

  • Orchard Therapeutics: Phase 1 data for OTL-203 in MPS 1

  • GENMAB: Phase 1/2 data for GEN3013 in B-cell lymphoma

  • Kadmon Holdings Inc (NYSE: KDMN): Phase 2 data for KD025-208 in chronic graft-versus-host disease

  • Aprea Therapeutics Inc (NASDAQ: APRE): Phase 2 data for APR-246 and Bristol-Myers Squibb's azacitidine in TP53 mutated myelodysplastic syndrome and acute myeloid leukemia; Phase 2 data for APR-246 in combination with azacitidine in myelodysplastic syndromes

  • Gamida Cell Ltd (NASDAQ: GMDA): additional Phase 1 data for NAM-NK in non-Hodgkin lymphoma and multiple myeloma

  • Bristol-Myers Squibb & bluebird bio: Phase 1 data for bb21217 in multiple myeloma

  • Onconova Therapeutics Inc (NASDAQ: ONTX)': Phase 2 data for oral rigosertib and azacitidine in first-line high-risk myelodysplastic syndromes

  • Forty Seven Inc (NASDAQ: FTSV)': Phase 1b data for 5F9 in combination with azacitidine for acute myeloid leukemia

  • ImmunoGen, Inc. (NASDAQ: IMGN)': updated Phase 1 data for IMGN632 in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm

  • Calithera Biosciences Inc (NASDAQ: CALA) – Phase 2 data for telaglenastat in combination with azacitidine in myelodysplastic syndrome

  • TG Therapeutics: Phase 1 data for TG-1701 in non-Hodgkin lymphoma and chronic lymphocytic leukemia

  • Curis, Inc. (NASDAQ: CRIS): updated Phase 1 data for CA-4948 in relapsed or refractory non-Hodgkin lymphoma

  • ArQule, Inc. (NASDAQ: ARQL): Phase 1 data for ARQL 531 in B-cell malignancies

  • Xencor Inc (NASDAQ: XNCR): initial Phase 1 data for XmAb1367 in chronic lymphocytic leukemia, small lymphocytic lymphoma

  • MacroGenics Inc (NASDAQ: MGNX): updated Phase 1 data for flotetuzumab in acute myeloid leukemia/myelodysplastic syndrome

  • Constellation Pharmaceuticals Inc (NASDAQ: CNST): additional Phase 2 data for CPI-0610 and Incyte Corporation (NASDAQ: INCY)'s ruxolitinib in myelofibrosis

  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN): updated Phase 1 data for REGN1979 in follicular lymphoma

  • Stemline Therapeutics Inc (NASDAQ: STML): Phase 1/2 data for SL-401 in myelofibrosis

  • CTI BioPharma Corp (NASDAQ: CTIC): Phase 2 dose-finding study of Pacritinib in myelofibrosis

  • Geron Corporation (NASDAQ: GERN): Phase 2/3 data for imetelstat in myelodysplastic syndromes

  • Precision BioSciences Inc (NASDAQ: DTIL): Interim Phase 1/2 data for PBCAR0191 in relapsed or refractory B-cell precursor acute lymphoblastic leukemia and R/R non-hodgkin lymphoma

Tuesday

Amgen, Inc. (NASDAQ: AMGN) & GENMAB: Phase 3 data for krypolis in multiple myeloma (late-breaker abstract)

Sanofi SA (NASDAQ: SNY): Phase 3 data for sutimlimab in cardinal cold agglutinin disease

Bristol-Myers Squibb: Phase 3 data for oral azacitidine for acute myeloid leukemia maintenance

SABCS Presentations

MacroGenics and Zai Lab Ltd (NASDAQ: ZLAB) – oral presentation of detailed results from the second interim overall survival analysis form the SOPHIA study of margetuximab in patients with HER2-positive metastatic breast cancer who have been previously treated with anti-HER2-targeted therapies (date not confirmed)

Seattle Genetics – already-released Phase 2 data for Tucatinib ONT-380 in combination with Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Herceptin and oral chemotherapy Xeloda in HER2+ metastatic breast cancer (Wednesday)

G1 Therapeutics Inc (NASDAQ: GTHX) – additional Phase 1b data for Lerociclib plus AstraZeneca plc (NYSE: AZN)'s Faslodex in ER+ breast cancer (Wednesday)

OncoSec Medical Inc (NASDAQ: ONCS): interim Phase 2 data for tavo in combination with Keytruda in triple-negative breast cancer (Thursday)

Oncternal Therapeutics Inc (NASDAQ: ONCT): Phase 1 data for cirmtuzumab, in combination with Bristol-Myers Squibb's Abraxane (Thursday)

Athenex Inc (NASDAQ: ATNX): Phase 3 data for oraxol in metastatic breast cancer (Friday)

ESMO-IO Presentations

Gritstone Oncology Inc (NASDAQ: GRTS) – initial safety data from the Phase 1 study of GRANITE-001 in solid tumors (date not confirmed) as well as initial safety data from the Phase 1 data for SLATE-001 in solid tumors

BIOLINERX LTD/S ADR (NASDAQ: BLRX) – Phase 2a data for BL-8040 in combination with Merck's Keytruda in pancreatic cancer (Friday)

Earnings

Twist Bioscience Corp (NASDAQ: TWST) (Wednesday, after the market close)
Veru Inc (NASDAQ: VERU) (Thursday, before the market open)
Applied DNA Sciences Inc (NASDAQ: APDN) (Thursday, after the market close)

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