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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
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2nd World Summit on Liver Cirrhosis and Hepatitis – Sept. 23-24 in Tokyo
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11th Euro-Global Conference on Infectious Diseases – Sept. 23-24 in London
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Ladenburg Thalmann 2019 Healthcare Conference – Sept. 24 in New York
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15th World Conference on Cosmetic Dermatology & Skin Diseases – Sept. 25-26 in Lisbon
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World Cancer Research and Biomarkers Conference – Sept. 25-26 in Toronto
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6th International Conference on Hypertension & Healthcare – Sept. 26-28 in London
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Cancer Therapy & Biomarkers - Sept. 27-28 in Lisbon
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6th European Rett Syndrome Conference – Sept. 27-28 in Tampere
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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.