Biotech stocks continued to languish for a third straight week.
Negative broader market sentiment and company-specific weakness weighed
down on the sector.
Pfenex Inc PFNX 3.62% received
FDA approval for its biosimilar to
Amgen, Inc. AMGN 1.07%‘s Forteo, and Australian biotech
Clinuvel Pharmaceuticals Ltd CLVLY 0.44%‘s Scenesse to treat erythropoietic protoporphyria was also given the go-ahead by the regulatory agency.
The week also saw the listing of two biotechs following their initial public offerings.
The following are some of the key catalysts for biotech stocks in the upcoming week.
Conferences
- American Academy of Ophthalmology (AAO) 2019: Oct. 12-15 in San Francisco, California
- International Congress And Exhibition on Endocrine And Diabetic Complications: Oct. 14-15 in Sydney, Australia
- International Conference on Molecular Markers and Cancer Therapeutics: Oct. 14-15 in Abu Dhabi, UAE
- Annual meeting of Neuro Critical Care Society: Oct. 15-18, in Vancouver
- 10th Annual Congress on Rare Diseases and Orphan Drugs: Oct. 16-17 in Tokyo, Japan
- 14th Annual Conference on Nephrology & Renal Care: Oct. 16-17 in Singapore City
- 2nd International conference on blood disorders: Oct. 17-18 in Osaka, Japan
PDUFA Dates
Sunday
The FDA is expected to rule on
Johnson & Johnson JNJ 1.83%‘s Janssen unit’s sNDA for Xarelto for the expanded indication of venous thromboembolism in medically ill patients.
Monday
Flexion Therapeutics Inc FLXN 0.91%
awaits FDA verdict on its sNDA for Zilretta, which seeks approval of
the drug for repeat administration to treat osteoarthritis of the knee.
Tuesday
The regulatory body will rule on
Novartis AG NVS 0.83%‘s BLA for brolucizumab to treat wet-age related macular degeneration.
Friday
The FDA is likely to rule on
Amgen, Inc. AMGN 1.07%‘s Nplate, which is being evaluated for treating adult patients with immune thrombocytopenia for 12 months or less.
Saturday
Clearside Biomedical Inc CLSD 6.21% awaits an FDA decision on Xipere to treat macular edema associated with uveitis. The company in August said it
expects a complete response letter around the PDUFA date and also gave a schedule for the resubmission of the NDA.
Assertio Therapeutics Inc ASRT 1.64%‘s
NDA for Cosyntropin that’s being evaluated as a diagnostic drug for
detecting adrenocortical insufficiency is pending before the FDA, with a
decision likely on Oct. 19.
The FDA will also rule on
Alexion Pharmaceuticals, Inc. ALXN 0.92%‘s sBLA for ultomiris to treat atypical hemolytic uremic syndrome.
Clinical Trial Readouts
Aldeyra Therapeutics Inc ALDX 1.52% is scheduled to present Phase 3 data for reproxalap in allergic conjunctivitis at the AAO meeting Monday.
Lineage Cell Therapeutics Inc LCTX 0.08% on Monday will present updated Phase 1/2 data for OpRegen in dry age-related macular degeneration at the AAO meeting.
IMMUTEP LTD/S ADR IMMP 1.19% is due to present Tuesday with Phase 1 data for eftilagimod alpha and
Merck & Co., Inc. MRK 0.64%‘s Keytruda in melanoma.
Marinus Pharmaceuticals Inc MRNS 2.86% will present already released Phase 2 data for
ganaxolone in refractory status epilepticus on Wednesday.
Earnings
- Johnson & Johnson: Tuesday before the market open.
- Abbott Laboratories ABT 0.67%: Wednesday before the market open.
- Intuitive Surgical, Inc. ISRG 1.33%: Thursday after the close.
IPOs
Innate Pharma, which develops antibody therapies for
cancer, is proposing a 10.67-million-share IPO, with the offering
expected to be priced at $7.50. The company seeks to list its shares on
the Nasdaq under the ticker symbol “IPHA.”
IPO Quiet Period Expiry
IGM Biosciences Inc IGMS 1.03%
Exagen Inc XGN 3.3%
https://www.benzinga.com/general/biotech/19/10/14575481/the-week-ahead-in-biotech-fda-decisions-johnson-johnson-among-big-pharma-earnings
