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
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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