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

Biotech stocks came under pressure last week despite two FDA approvals coming through. The FDA approved SAGE Therapeutics Inc SAGE's drug to treat postpartum depression and Jazz Pharmaceuticals PLC JAZZ's sleep disorder drug.
Biogen Inc BIIB's Alzheimer's drug disappointment contributed to some of the negativity.

Looking ahead to the unfolding week, here are a few catalysts a biotech investor needs to be mindful about.

Conferences

  • Endo 2019 – March 23-26, in New Orleans, Lousisana
  • 2nd Annual Congress on Diabetes and its Complications - March 25-26, in Hong Kong
  • 11th World Congress and Expo on Cell & Stem Cell Research - March 25-26, in Orlando, Florida
  • 14th International Conference on Alzheimers and Parkinson's Diseases - March 26-31, in Lisbon, Portugal
  • KBC Securities Biotech and Healthcare Conference – March 26-27, in New York
  • 3rd Annual Gene Therapy For Rare Disorders – March 26-28, in Boston, Massachusetts
  • 5th World Heart Congress - March 27-28, in Sydney, Australia
  • Cold Spring Harbor Conference on RNA and Oligonucleotide Therapeutics -March 27-30, in Cold Spring Harbor, New York

See Also: Analysts Digest Biogen's Alzheimer's Disappointment: 'There Isn't Much To Be Excited About'

PDUFA Dates

The FDA is set to rule Sunday on Recro Pharma Inc REPH's NDA intravenous (IV) meloxicam, which is being evaluated for the management of moderate to severe pain.

Novartis AG NVS's NDA for oral, once-daily siponimod, or BAF312, for secondary progressive multiple sclerosis, or SPMS, in adults.

Clinical Trial Results

Ascendis Pharma A/S ASND will present the already-released Phase 3 data for TransCon hGH, its treatment candidate for growth hormone deficiency in children Sunday at ENDO 2019.

Eiger Biopharmaceuticals Inc EIGR is scheduled to present Monday already-released Phase 2 data for its post-bariatric hypoglycemia treatment candidate Avexitide at ENDO 2019.

Fibrocell Science Inc FCSC will release updated Phase 1/2 data for FCX-007, its treatment candidate for recessive dystrophic epidermolysis bullosa.

Companies With Q1 Release Schedules

Proteostasis Therapeutics Inc PTI – full Phase 1 data for PTI-428 + PTI-801 + PTI-808, Phase 1 data for the fourth cohort (PTI-801 and PTI-808) and Phase 1 data for PTI-801 + Symdeko (all combos are evaluated for cystic fibrosis)

Supernus Pharmaceuticals Inc SUPN – final trial data from a Phase 3 study of SPN-812 (ADHD)

FibroGen Inc FGEN – initial Phase 2 data for FG-3019 (Duchenne muscular dystrophy)

Insys Therapeutics Inc INSY – Phase 2 data for Cannabidiol (refractory childhood absence epilepsy)

(Note: This is not a complete list.)

See Also: Nevro's C-Suite, Board Changes Should 'Mark The Turnaround Of The Organization,' BMO Says In Upgrade

Earnings

Monday, March 25

  • Yield10 Bioscience Inc YTEN (after the market close)
  • Cesca Therapeutics Inc KOOL (after the market close)
  • aTyr Pharma Inc LIFE (after the market close)

Tuesday, March 26

  • Onconova Therapeutics Inc ONTX (before the market open)
  • PhaseBio Pharmaceuticals Inc PHAS (after the market close)

Wednesday, March 27

  • Affimed NV AFMD (before the market open)
  • Eyenovia Inc EYEN (before the market open)
  • Fibrocell Science Inc FCSC (before the market open)
  • Cyclacel Pharmaceuticals Inc CYCC (after the market close)

Thursday, March 28

  • Tricida Inc TCDA (before the market open)
  • Achaogen Inc AKAO (after the market close)
  • Biocept Inc BIOC (after the market close)
  • Vermillion, Inc. VRML (after the market close)
  • Capricor Therapeutics Inc CAPR (after the market close)

IPO

Genfit, a biopharma company focusing on developing therapies and diagnostic solutions for metabolic and liver-related diseases, is set to offer 5 million shares in an IPO. The shares are to be listed on the Nasdaq under the ticker symbol GNFT.

Precision Biosciences, a genome editing biotech, has filed to offer 7.9 million shares in an IPO, with an estimated price range of $15-$17. The shares of the company will be listed on the Nasdaq under the ticker symbol DTIL.

IPO Quiet Period Expiry

Kaleido Biosciences Inc KLDO

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