The Week Ahead In Biotech: FDA Decisions, Johnson & Johnson Among Big Pharma Earnings

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 received FDA approval for its biosimilar to Amgen, Inc. AMGN's Forteo, and Australian biotech Clinuvel Pharmaceuticals Ltd CLVLY'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

See Also: Attention Biotech Investors: Mark Your Calendar For These October PDUFA Dates

PDUFA Dates

Sunday

The FDA is expected to rule on Johnson & Johnson JNJ's Janssen unit's sNDA for Xarelto for the expanded indication of venous thromboembolism in medically ill patients.

Monday

Flexion Therapeutics Inc FLXN 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's BLA for brolucizumab to treat wet-age related macular degeneration.

Friday

The FDA is likely to rule on Amgen, Inc. AMGN's Nplate, which is being evaluated for treating adult patients with immune thrombocytopenia for 12 months or less.

Saturday

Clearside Biomedical Inc CLSD 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'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's sBLA for ultomiris to treat atypical hemolytic uremic syndrome.

Clinical Trial Readouts

Aldeyra Therapeutics Inc ALDX is scheduled to present Phase 3 data for reproxalap in allergic conjunctivitis at the AAO meeting Monday.

Lineage Cell Therapeutics Inc LCTX 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 is due to present Tuesday with Phase 1 data for eftilagimod alpha and Merck & Co., Inc. MRK's Keytruda in melanoma.

Marinus Pharmaceuticals Inc MRNS 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: Wednesday before the market open.
  • Intuitive Surgical, Inc. ISRG: 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

Exagen Inc XGN

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