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The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials And Earnings

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The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials And Earnings

Biotech stocks came under modest selling pressure in the shortened trading week, which saw the release of earnings by some large-cap pharma stocks including Johnson & Johnson (NYSE: JNJ) and Bristol-Myers Squibb Co (NYSE: BMY).

As the earnings season reaches full throttle, here are a few catalysts that could impact the performance of biotech stocks in the unfolding week.

Conferences

  • 16th World Congress On Gastroenterology & Therapeutics – Jan. 30-31 in Bangkok, Thailand
  • World Congress On Pancreatic Cancer and Liver Diseases – Jan. 30-31 in Tokyo, Japan
  • 13th World Congress On Hematology and Oncology – Jan. 30-31 in Tokyo
  • 4th World Kidney Congress – Jan. 30-31 in Abu Dhabi, UAE
  • 15th International Conference On Nephrology and Hypertension – Jan. 30-31 in Abu Dhabi
  • World Congress on Advances in Neurology and Neuromuscular Diseases – Jan. 28-29 in Singapore City, Singapore
  • 4th World Congress On Sleep Disorders, Medicine and Neuropsychiatry – Jan. 30-31 in Tokyo

PDUFA Dates

The FDA is set to rule on Sanofi SA (NYSE: SNY)'s sBLA for its Fluzone Quadrivalent influenza vaccine, 0.5 ml dose, for which the company is seeking to expand the label to include children aged six to 35 months. The decision day is Monday, Jan. 28. Sanofi's Fluzone has already been approved for patients over 35 months and a 0.25-ml strength vaccine has already been approved for children between six and 35 months of age.

Aquestive Therapeutics Inc (NASDAQ: AQST)'s NDA for APL-130277 has a PDUFA date of Tuesday, Jan. 29. The pipeline candidate is being evaluated for motor fluctuations, or OFF episodes, experienced by people living with Parkinson's disease, when medications stop working. Aquestive is partnering with Sunovian Pharma, which is the sponsor of APL-130277, chemically apomorphine sublingual film.

Alkermes Plc (NASDAQ: ALKS) awaits the FDA decision on its NDA for ALKS 5461, which is being evaluated as an adjunctive treatment for major depressive disorder, or MDD, with an inadequate response to standard antidepressant therapies. The PDUFA date has been set for Thursday, Jan. 31. FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which met jointly to discuss the NDA Nov. 1, voted 2-21 against approval of the drug, citing the inadequate benefit-risk profile.

Evolus Inc (NASDAQ: EOLS) has set up its tryst with the FDA Sunday, Feb. 2 regarding its BLA for DWP-450, its treatment candidate for Glabellar lines, also known as frown lines, in adult patients. The BLA was issued a complete response letter in May 2018, citing issues with chemistry, manufacturing and controls processes. The FDA accepted a resubmission of the application in late August 2018.

See Also: Searching For A Treatment: NASH Investigational Drugs With Catalysts This Year

Clinical Trial Results

Sienna Biopharmaceuticals Inc (NASDAQ: SNNA) is due to release Phase 3 data for SNA-001, its investigational therapy used for the reduction of light-pigmented hair, in late January/early February.

Earnings

Tuesday, Jan. 29

  • Allergan plc (NYSE: AGN) (before the market open)
  • Biogen Inc (NASDAQ: BIIB) (before the market open)
  • Pfizer Inc. (NYSE: PFE) (before the market open)
  • Amgen, Inc. (NASDAQ: AMGN) (after the market close)
  • Illumina, Inc. (NASDAQ: ILMN) (after the market close)

Wednesday, Jan. 30

  • Hologic, Inc. (NASDAQ: HOLX) (after the market close)
  • SurModics, Inc. (NASDAQ: SRDX) (after the market close)

Thursday, Jan. 31

  • Celgene Corporation (NASDAQ: CELG)

Friday, Feb. 1

  • Merck & Co., Inc. (NYSE: MRK) (before the market open)

IPO Quiet Period Expiry

China SXT Pharmaceuticals Inc (NASDAQ: SXTC) – IPO priced Jan. 4 at $4.

Posted-In: Biotech Earnings News FDA IPOs Top Stories Trading Ideas Best of Benzinga

 

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