The Week Ahead In Biotech: Spotlight On ESMO Conference

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

Johnson & Johnson JNJ's Janssen unit received an FDA nod for label expansion for its prostate cancer drug Erleada, and Eisai Co., Ltd ESALY's Lenvantinib in combination with Merck & Co., Inc. 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. 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 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 URGN will present on Tuesday initial Phase 2b data for its UGN-102 in low grade, non-muscle invasive bladder cancer.

Rhythm Pharmaceuticals Inc 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 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 ARAV – Phase 1b data for AVB-S6-500 in ovarian cancer.

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

Incyte Corporation INCY – Phase 2 data for pemigatinib in cholangiocarcinoma.

Saturday, Sept. 28

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

Amgen, Inc. AMGN – Phase 1 data for AMG 510 in solid tumors.

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

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

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

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

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

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

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

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

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

AbbVie Inc 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 ZYME - updated Phase 1 data for ZW25 in HER2-expressing cancers such as breast, ovarian and gastric cancers.