The Week Ahead In Biotech: Spotlight On ESMO Conference

Shanthi Rexaline
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Biotech stocks put up a muted performance in the week ended Sept. 20 amid conference presentations and FDA approvals.

Johnson & Johnson (NYSE: JNJ)'s Janssen unit received an FDA nod for label expansion for its prostate cancer drug Erleada, and Eisai Co., Ltd (OTC: ESALY)'s Lenvantinib in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda was approved for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

Among the biotech IPOs, IGM Biosciences, Inc. (NASDAQ: IGMS) made a strong debut, closing its first session with a gain of about 46% from its IPO price of $16.

The following are key catalysts for biotech investors to keep an eye on in the unfolding week.

Conferences

  • 2nd World Summit on Liver Cirrhosis and Hepatitis – Sept. 23-24 in Tokyo

  • 11th Euro-Global Conference on Infectious Diseases – Sept. 23-24 in London

  • Ladenburg Thalmann 2019 Healthcare Conference – Sept. 24 in New York

  • 15th World Conference on Cosmetic Dermatology & Skin Diseases – Sept. 25-26 in Lisbon

  • World Cancer Research and Biomarkers Conference – Sept. 25-26 in Toronto

  • 6th International Conference on Hypertension & Healthcare – Sept. 26-28 in London

  • Cancer Therapy & Biomarkers - Sept. 27-28 in Lisbon

  • 6th European Rett Syndrome Conference – Sept. 27-28 in Tampere

  • European Society for Medical Oncology 2019 Conference – Sept. 27- Oct. 1 in Barcelona

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PDUFA Dates

The FDA is set to rule on Johnson & Johnson (NYSE: JNJ)'s sBLA for daratumumab in combination with bortezomib, thalidomide and dexamethasone in newly diagnosed multiple myeloma patients who are candidates for autologous stem cell transplant.

Genmab has licensed daratumumab to J&J's Janssen unit under a 2012 agreement. The PDUFA date has been fixed for Thursday.

J&J has another PDUFA goal date coming up on Friday. The FDA is scheduled to give its verdict on the company's Invokana for treating chronic kidney disease in Type 2 diabetes patients.

Clinical Trial Readouts

Urogen Pharma Ltd (NASDAQ: URGN) will present on Tuesday initial Phase 2b data for its UGN-102 in low grade, non-muscle invasive bladder cancer.

Rhythm Pharmaceuticals Inc (NASDAQ: RYTM) is due Wednesday to issue an update on Phase 2 data for setmelanotide, which is being evaluated for a basket of rare melanocortin-4 receptor, pathway-driven disorders, including POMC heterozygous deficiency obesity, Alstrom syndrome and POMC epigenetic disorders.

Anavex Life Sciences Corp (NASDAQ: AVXL) will present on Friday detailed preliminary Phase 2 data for AVANEX 2-73 in Rett syndrome at the 6th European Rett Syndrome Conference.

ESMO Presentations

Friday, Sept. 27

Aravive Inc (NASDAQ: ARAV) – Phase 1b data for AVB-S6-500 in ovarian cancer.

TrovaGene Inc (NASDAQ: TROV) – Phase 1/2 data for onvansertib in acute myeloid leukemia.

Incyte Corporation (NASDAQ: INCY) – Phase 2 data for pemigatinib in cholangiocarcinoma.

Saturday, Sept. 28

AstraZeneca plc (NYSE: AZN) and Merck – already-released Phase 3 data on lynparza and Roche Holdings AG Basel ADR (OTC: RHHBY)'s Avastin in first-line ovarian cancer.

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Amgen, Inc. (NASDAQ: AMGN) – Phase 1 data for AMG 510 in solid tumors.

ASLAN PHARMACEU/ADR (NASDAQ: ASLN) – Phase 1 data for varlitinib + mFOLFIRI in solid tumors.

GlaxoSmithKline plc (NYSE: GSK) and Zai Lab Ltd (NASDAQ: ZLAB) – Presentation of already-released Phase 3 data for Niraparib in first-line ovarian cancer.

G1 Therapeutics Inc (NASDAQ: GTHX) – Phase 2 data for trilaciclib in triple-negative breast cancer.

Calithera Biosciences Inc (NASDAQ: CALA) – Phase 2 data for CB-839 + Novartis AG (NYSE: NVS)'s everolimus in clear cell renal cell carcinoma.

Seattle Genetics, Inc. (NASDAQ: SGEN) – initial Phase 1b data for enfortumab vedotin and Merck's Keytruda in second-line urothelial cancer.

Immunomedics, Inc. (NASDAQ: IMMU) – interim Phase 1/2 data for sacituzumab govitecan in urotherlial cancer.

Checkpoint Therapeutics Inc (NASDAQ: CKPT) – updated Phase 1 data for cosibelimab in lung and other solid tumors.

Aileron Therapeutics Inc (NASDAQ: ALRN) – Preliminary Phase 2a data for ALRN-6924 and Pfizer Inc. (NYSE: PFE)'s Ibrance in solid tumors.

Genocea Biosciences Inc (NASDAQ: GNCA) – additional immunogenicity data from the Phase 1/2 study of GEN-009 vaccine in various cancers.

AbbVie Inc (NYSE: ABBV) – Phase 3 data for veliparib in ovarian cancer.

AstraZeneca and G1 Therapeutics – Poster presentation of Phase 1/2 data for Tagrisso and lerociclib in EGFR mutation-positive non-small cell lung cancer.

Zymeworks Inc (NYSE: ZYME) - updated Phase 1 data for ZW25 in HER2-expressing cancers such as breast, ovarian and gastric cancers.

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