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The Week Ahead In Biotech: ASCO Presentations In The Spotlight

Shanthi Rexaline

Biotech shares put up a lackadaisical show this week, as reflected by the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB). With earnings season winding down, FDA decisions and data presentations at conferences served as catalysts for stocks in the week.

Here're are the key catalytic events in the upcoming week biotech investors need to be mindful about.

Medical/Healthcare/Biotech Conferences

  • European Society of Cardiology, or ESC, World Congress on Acute Heart Failure – May 26-May 29, in Vienna, Austria
  • 2018 American Society of Clinical Oncology Annual Meeting – June 1-5, McCormick Place, Chicago, Illinois

PDUFA Dates

Sunday, May 27

TherapeuticsMD Inc (NASDAQ: TXMD), which was mired in a controversy over a website error following an erroneous post about FDA approval for its vaginal pain treatment candidate TX-004HR, awaits the FDA ruling on May 27.

The candidate was handed a complete response letter, or CRL, on May 8, 2017, citing a lack of long-term endometrial safety. Following a resubmission and FDA's acceptance of the resubmission on Dec. 19, 2017, the new PDUFA action date was set.

Thursday, May 31

The FDA is set to announce its verdict on KITOV PHARMA LT/S ADR (NASDAQ: KTOV)'s osteoarthritis and hypertension treatment candidate KIT-302 on May 31.

Clinical Trial Outcomes

ABIOMED, Inc. (NASDAQ: ABMD) is due to make an oral presentation of the Phase 2b data for its chronic heart failure treatment candidate gencaro at the ESC World Congress on Acute Heart Failure on Sunday, May 27. The data released in February didn't show any benefit in overall population.

ASCO Presentations

Friday, June 1

Incyte Corporation (NASDAQ: INCY) – The company will make an oral presentation of the Phase 1 data for its relapsed/refractory multiple myeloma treatment candidate ruxolitinib at 3:45 p.m. ET.

bluebird bio Inc (NASDAQ: BLUE) – Celgene and bluebird bio will present additional Phase 1 data for their relapsed/multiple myeloma treatment candidate bb2121 at 3:45 p.m. ET. Preliminary Phase 1 data released at the American Society of Hematology 2017 meeting showed overall response rate of 94 percent and complete response of 56 percent.

Celgene Corporation (NASDAQ: CELG) – The company will present Phase 3 data for its refractory multiple myeloma treatment candidate MM-007. Data released in Febraury showed that the study, dubbed OPTIMISMM, met the primary endpoint of progression free survival.

See Also: Cara Therapeutics Shares Jump On Licensing Deal For Pruritis Treatment

Saturday, June 2

View more earnings on IBB

Syndax Pharmaceuticals Inc (NASDAQ: SNDX) – The company will make a poster presentation of its solid tumor pipeline candidate entinostat.

Loxo Oncology Inc (NASDAQ: LOXO) – The company is set to present Phase 1 data for its LOXO-292, for treating RET-fusion non-small cell lung cancer, or NSCLC, medullary thyroid cancer and other tumors.

Exelixis, Inc. (NASDAQ: EXEL) – Exelixis will present Phase 1 data on its urothelial carcinoma treatment combo cabometyx and nivolumab-ipilimumab combined.

Karyopharm Therapeutics Inc (NASDAQ: KPTI) is due to release Phase 2/3 data for selinexsor for treating dedifferentiated liposarcoma.

Endocyte, Inc. (NASDAQ: ECYT) – The company will present Phase 3 data for its metastatic castration-resistant prostate cancer treatment candidate Lu-PSMA-617.

Celldex Therapeutics, Inc. (NASDAQ: CLDX - 2) – The company will present a poster of the Phase 2 data for its recurrent/metastatic head and neck squamous cell cancer candidate CDX-3379 at 1:15 pm CT. The company is also scheduled to make a oral presentation of Phase 2 data for its combo solid tumor treatment candidate varlilumab and nivolumab.

Jounce Therapeutics Inc (NASDAQ: JNCEO) – The company will present preliminary Phase 1/2 data for its solid tumor candidate JTX-2011. When the abstract data was publish on May 17, the stock slumped about 35 percent, with analyst attributing the stock decline to underwhelming objective response rate shown by the study.

Nektar Therapeutics (NASDAQ: NKTR) & Bristol-Myers Squibb Co (NYSE: BMY) – The companies will present preliminary Phase 1/2 data on NKTR-214-Opdivo combo from a study dubbed PIVOT-02. The combo is being evaluated for treating a variety of cancers, including melanoma, renal cell carcinoma and NSCLC.

Earnings

Wednesday, May 30

  • Ascendis Pharma A/S (NASDAQ: ASND)

Thursday, May 31

  • Organovo Holdings Inc (NASDAQ: ONVO)

IPOs

Quiet Period Expirations

Inspire Medical Systems Inc (NYSE: INSP) – Priced at $15 on May 3

Unity Biotechnology Inc (NASDAQ: UBX) – Priced at $17 on May 3

Aslan Pharmaceuticals (NASDAQ: ASLN) – Priced at $7.03 on May 4

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