Biotech stocks held steady in the recent week as earnings
from the sector continue to trickle in. The week also saw presentations of clinical trial readouts at a couple of conferences.
The following are key catalysts that could move biotech stocks in the upcoming week.
Conferences
- International Conference on Biomarkers and Cancer Targets: Feb. 14-15 in Dubai, UAE
- 18th Global Ophthalmology, Optometry and Glaucoma Conference: Feb. 14-15, in Dubai
- ASCO Genitourinary Cancers Symposium: Feb. 14-16, in San Francisco, California
PDUFA Dates
MOTIF BIO PLC/S ADR (NASDAQ: MTFB)'s
NDA for iclaprim to treat acute bacterial skin and skin structure infections awaits FDA clearance. The PDUFA date for the NDA is
set for Wednesday, Feb. 13.
The FDA is set to rule on Bausch Health Companies Inc (NYSE: BHC)'s NDA for Duobrii, which is being evaluated for plaque psoriasis, on
Friday, Feb. 15. The application was handed a CRL in June 2018 after which the company made a resubmission in
August.
Merck & Co., Inc. (NYSE: MRK) awaits the
FDA verdict on its sBLA for Keytruda as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma.
The due date is Saturday, Feb. 16.
Adcom Meeting
A Feb. 12 joint meeting of FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory
Committee is set to deliberate on Johnson & Johnson (NYSE: JNJ) unit Janssen's NDA for an esketamine 28 mg single-use nasal spray device
for treatment-resistant depression.
See Also: Attention
Biotech Investors: Mark Your Calendar For These February PDUFA Dates
Clinical Trial Results
ASCO GU Cancers Symposium Presentations
Veru Inc (NASDAQ: VERU) is scheduled to
make a poster presentation of Phase 2 data on its hot flashes treatment candidate zuclomiphene citrate Feb. 14.
Pfizer Inc. (NYSE: PFE) will present Feb.
14 a poster on Phase 3 data for Xtandi, its metastatic hormone-sensitive prostate cancer candidate.
Merck
and Pfizer are due to present Feb.16 with Phase 3 data on Keytruda in combination with Inlyta for treating renal cell
carcinoma.
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) is set to present Feb.16 an abstract of Phase 3 data for tivozanib, which is
being evaluated as a third-line treatment for patients with renal cell carcinoma.
Calithera Biosciences Inc (NASDAQ: CALA) is due to make a poster presentation Feb. 16 on the Phase 2 study of CB-839
and cabozantinib for renal cell carcinoma.
Earnings
Wednesday, Feb. 13
-
Exelixis, Inc. (NASDAQ: EXEL) (after
the market close)
-
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) (before the market open)
-
Natus Medical Inc (NASDAQ: BABY)
(before the market open)
-
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the market close)
Thursday, Feb. 14
-
Agios Pharmaceuticals Inc (NASDAQ: AGIO) (before the market open)
-
Incyte Corporation (NASDAQ: INCY)
(before the market open)
-
Zoetis Inc (NYSE: ZTS) (before the market
open)
-
Prothena Corporation PLC (NASDAQ: PRTA) (after the market close)
-
Acorda Therapeutics Inc (NASDAQ: ACOR)
(after the market close)
IPOs
Anchiano Therapeutics is set to offer 2.4 million shares in an IPO priced at $14.55 each. The biotech that
develops therapies for early stage bladder cancer seeks to list its shares on the Nasdaq under the ticker symbol ANCN.
Stealth Biotherapeutics, which focuses on therapies for mitochondrial dysfunction, will offer 6.2 million
shares priced between $12 and $14. The shares are to be listed on the Nasdaq under the ticker symbol MITO.
TCR2 Therapeutics will offer 5 million shares in an IPO with an estimated price range of $14-$16. This
immuno-oncology biotech is looking to list its shares on the Nasdaq under the ticker symbol TCRR.
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