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The Week Ahead In Biotech: ASH Presentations Pick Up Pace, PDUFA Dates, Clinical Trials And IPOs

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The Week Ahead In Biotech: ASH Presentations Pick Up Pace, PDUFA Dates, Clinical Trials And IPOs
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Large-cap pharma stocks are seeing some upward momentum and are on track to finish the year with handsome gains. As the year draws to a close, it remains to be seen if these stocks can sustain the ongoing momentum. Biotech stocks staged a good recovery in the week ended Nov. 30, snapping three consecutive weeks of losses.

The following are catalytic events for biotech investors to watch in the coming week. 

Conferences

  • American Epilepsy Society, or AES, annual meeting: Nov. 30-Dec. 4 in New Orleans, Louisiana.
  • 60th American Society of Hematology, or ASH, Annual Meeting & Exposition: Dec. 1-4 in San Diego, California.
  • 3rd World Biotechnology Congress: Dec 3-4 in Sao Paulo, Brazil.
  • 15th World Hematology & Immunology Congress: Dec. 5-6, in Lisbon, Portugal.
  • World Congress on Rare Diseases: Dec. 05-07, in Dubai, UAE.
  • World Brain Congress: Dec. 5-7 in Dubai.
  • Annual Congress on Antibiotics and Antimicrobial Resistance: Dec. 6-7, in Amsterdam, Netherlands.
  • Annual Congress on Nephrology & Hypertension: Dec. 6-7 in Amsterdam.
  • International Congress on Vaccines & Immunology: Dec. 6-7 in Amsterdam.
  • 27th American Dental Congress: Dec. 7-8 in Chicago, Illinois.
  • 10th International Conference on Dermatology & Cosmetology: Dec. 7-8 in Chicago.
  • 11th World Congress on Cell Science, Stem Cell Research & Regenerative Medicine: Dec. 7-8 in Chicago.
  • 27th World Oncologists Annual Conference on Medical Oncology, Radiation Oncology & Surgical Oncology: Dec. 7-8 in Chicago.

PDUFA Dates

The FDA is set to rule on Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s sBLA for Tecentriq in combination with Avastin, and chemotherapy regimen carboplatin and paclitaxel as a first-line treatment option for metastatic non-squamous non-small cell lung cancer, or NSCLC. The PDUFA date is set for Wednesday, Dec. 5.

See Also: Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates

Clinical Trial Results

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) is due to present Phase 2 data for its autism candidate GWP42006 at the AES annual meeting being Nov. 30-Dec. 4.

Zogenix, Inc. (NASDAQ: ZGNX) will present full Phase 3 data for its Dravet syndrome candidate ZX008 at the AES annual meeting. The presentation is scheduled for Monday, Dec. 3.

ASH 2018 Presentations

Sunday, Dec. 2

  • Syros Pharmaceuticals Inc (NASDAQ: SYRS): initial Phase 2 data from combination arms for SY-1425, its pipeline candidate for relapsed or refractory acute myeloid leukemia, or AML, and relapsed high-risk myelodysplastic syndrome, or MDS.
  • Magenta Therapeutics Inc (NASDAQ: MGTA): initial Phase 2 data for its inherited metabolic disorder drug MGTA-456.
  • Unum Therapeutics Inc (NASDAQ: UMRX): initial Phase 1 data for its combo treatment option ACTR707 and Rituxan for CD20 positive non-Hodgkin Lymphoma, or NHL.
  • Apellis Pharmaceuticals Inc (NASDAQ: APLS): updated Phase 1 data for APL-2 for treating paroxysmal nocturnal hemoglobinuria, or PNH; updated Phase 1b data for its paroxysmal nocturnal hemoglobinuria treatment candidate APL-2.
  • Incyte Corporation (NASDAQ: INCY): Phase 2 data for INCB50465 and ruxolitinib, a combo treatment option for myelofibrosis.
  • bluebird bio Inc (NASDAQ: BLUE) and Celgene Corporation (NASDAQ: CELG): initial Phase 1 data for multiple myeloma treatment candidate bb21217.
  • Celgene: presentation of already released Phase 3 data for its Revlimid that is being evaluated for relapsed or refractory follicular lymphoma; Phase 1 data for chronic lymphocytic leukemia, or CLL, treatment candidate Liso-cel.
  • Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL): Phase 1 data for AUTO3, its pipeline candidate for relapsed or refractory diffuse large B-cell lymphoma, or DLBCL.
  • Blueprint Medicines Corp (NASDAQ: BPMC): Additional update on Phase 1 data for its advanced systemic mastocytosis treatment candidate Avapritnib.
  • Acceleron Pharma Inc (NASDAQ: XLRN) and Celgene: Presentation of already released Phase 3 data for Luspatercept for treating MDS.
  • NewLink Genetics Corp (NASDAQ: NLNK): Phase 1b data for its AML treatment candidate indoximod along with standard-of-care chemotherapy.
  • ImmunoGen, Inc. (NASDAQ: IMGN): Additional Phase 2 data for IMGN632 that is being tested for AML and blastic plasmacytoid dendritic cell neoplasm.
  • Immune Design Corp (NASDAQ: IMDZ): Phase 2 long-term follow-up combo data for G100, a treatment candidate for follicular NHL.
  • ArQule, Inc. (NASDAQ: ARQL): Phase 1a data for B-cell malignancies treatment candidate ARQL531.
  • Affimed NV (NASDAQ: AFMD): Updated Phase 1b/2a data for AFM13 that is being tested for CD30-positive lymphoma.
  • MEI Pharma Inc (NASDAQ: MEIP): Updated Phase 1b data for ME-401 for treating relapsed/refractory follicular lymphoma/CLL.
  • Pluristem Therapeutics Inc. (NASDAQ: PSTI): First cohort data from the Phase 1 trial of PLX-R18 to treat incomplete hematopoietic recovery following hematopoietic cell transplantation.
  • Miragen Therapeutics Inc (NASDAQ: MGEN): Phase 1 data for its cobomarsen for treating varied cancers including CLL, DLBCL and cutaneous T-cell lymphoma, or CTCL.
  • Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS): Phase 1/2 safety and pharmacokinetic update for advanced B-cell malignancies treatment candidate SNS-062.
  • Spark Therapeutics Inc (NASDAQ: ONCE): Updated Phase 1/2 data for hemophilia A candidate SPK-8011.
  • Argenx SE – ADR (NASDAQ: ARGX): Phase 1/2 data for its AML treatment candidate ARGX-110.
  • Geron Corporation (NASDAQ: GERN) and Johnson & Johnson (NYSE: JNJ): Additional Phase 2 data for their MDS treatment candidate Imetelstat.
  • Kura Oncology Inc (NASDAQ: KURA): Preliminary Phase 2 data for relapsed or refractory peripheral T-cell lymphoma treatment candidate tipifarnib.
  • GlycoMimetics Inc (NASDAQ: GLYC): Phase 1/2 data for uproleselan, its treatment candidate for newly diagnosed and refractory AML.
  • Gilead Sciences, Inc. (NASDAQ: GILD): Two-year data for Yescarta that was approved in October 2017 for treating NHL.

See Also: Tonix Pharma Rips Higher After FDA OKs Study Design For PTSD Drug

Monday, Dec. 3

  • bluebird bio: Phase 3 data for Lentiglobin gene therapy to treat transfusion-dependent beta-thalassemia; Phase 1/2 data for LentiGlobin to treat sickle cell disease.
  • CELYAD SA/ADR (NASDAQ: CYAD): Updated Phase 1 data for CYAD-01, which is being tested for solid and hematologic cancers.
  • Cellectis SA (NASDAQ: CLLS) and Allogene Therapeutics Inc (NASDAQ: ALLO): Updated Phase 1 data for acute lymphoblastic leukemia candidate UCART19.
  • Beigene Ltd (NASDAQ: BGNE): Presentation of the previously released Phase 2 data for tiselizumab for treating relapsed or refractory classical Hodgkin lymphoma.
  • Actinium Pharmaceuticals Inc (NYSE: ATNM): initial readout of Phase 3 data for lomab-B that is being evaluated for use in hematopoietic stem cell transplant.
  • Global Blood Therapeutics Inc (NASDAQ: GBT): Additional Phase 3 data for GBT440 that is being evaluated for treating sickle cell disease in adults; Phase 2 data for GBT440, its treatment candidate for sickle cell disease in children ages 6-17.
  • MORPHOSYS AG/S ADR (NASDAQ: MOR): Phase 2 data for its MOR208 along with idelalisib for treating CLL.
  • Sierra Oncology Inc (NASDAQ: SRRA): Phase 2 data for myelofibrosis treatment candidate momelotinib.
  • Agios Pharmaceuticals Inc (NASDAQ: AGIO): Phase 1 data for ivosidenib, its AML treatment candidate; updated Phase 1 data for ivosidenib that is being tested for frontline AML with IDH1 or IDH2 mutation.
  • Amgen, Inc. (NASDAQ: AMGN): Phase 1 data for its relapsed, refractory multiple myeloma treatment candidate.
  • Kadmon Holdings Inc (NYSE: KDMN): Updated Phase 2 data for chronic graft-versus-host disease treatment candidate KD025.
  • TrovaGene Inc (NASDAQ: TROV): Updated Phase 1/2 data for AML treatment candidate onvansertib.
  • Incyte: Interim Phase 2 data for INCB54828, its treatment candidate for myeloproliferative neoplasms, or MPN.
  • Xencor Inc (NASDAQ: XNCR): Phase 1 data for AML treatment candidate XmAb14045.
  • Apellis: Phase 2 monotherapy data for APL-2 subcutaneous formulation meant to treat auto-immune hemolytic anemia, or AIAHA.
  • MacroGenics Inc (NASDAQ: MGNX): Interim Phase 1 data for AML/MDS treatment candidate flotetuzumab.
  • Portola Pharmaceuticals Inc (NASDAQ: PTLA): Updated Phase 2 data for cerdulatinib, which is being evaluated for treating refractory NHL and chronic lymphocytic leukemia.
  • Ionis Pharmaceuticals Inc (NASDAQ: IONS): Phase 1 data for IONIS-TMPRSS6-LRx, tested for beta-thalassemia.
  • Celgene: Phase 1 data for multiple myeloma candidate JCARJ125.
  • Aileron Therapeutics Inc (NASDAQ: ALRN): Interim Phase 1/1b data for ALRN-6924 in AML/MDS.
  • Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN): Presentation of data for ALXN1210, its treatment candidate for PNH.
  • Incyte and Novartis AG (NYSE: NVS): Presentation of data for ruxolitinib that is being evaluated for graft versus host disease.
  • Argenx: Full Phase 2 data for immune thrombocytopenia, or ITP, treatment candidate ARGX-113.
  • Geron Corporation (NASDAQ: GERN): Data for its Imetelstat, which is also being studied for myelofibrosis.
  • Atara Biotherapeutics Inc (NASDAQ: ATRA): Phase 2 data for ATA 129 to treat Epstein-Barr virus.
  • AbbVie Inc (NYSE: ABBV): Presentation of data for Imbruvica and Gazyva as a treatment option for CLL/SLL.
  • Gilead Sciences: Updated Phase 2 data for axicabtageme ciloleucel to treat adult patients with ALL.

IPOs

DiaMedica Therapeutics is due to offer 4 million shares in an initial public offering, with the price estimated between $4 and $5. The biotech company, which is developing therapies for ischemic stroke and chronic kidney disease, seeks to list its shares on the Nasdaq under the ticker symbol DMAC.

Moderna, which develops therapies based on its modified mRNA platform, is set to offer 21.74 million shares to the public. The company expects to price the offering in the range of $22-$24. The shares would be listed on the Nasdaq under the ticker symbol MRNA.

Synthorx, which develops immunotherapies for solid tumors and autoimmune disorders, will offer 9.1 million shares in an IPO priced between $10 and $12. The company is seeking a Nasdaq listing under the ticker symbol THOR.

IPO Quiet Period Expiry

Eton Pharmaceuticals, Inc. (NASDAQ: ETON)

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