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

AFMD, BIIB, CYCC, IBB, JAZZ, ATYR, MRK | March 23, 2019

Biotech stocks came under pressure last week despite two FDA approvals coming through. The FDA approved SAGE Therapeutics Inc (NASDAQ: SAGE)'s drug to treat postpartum depression and Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)'s sleep disorder drug.
Biogen Inc (NASDAQ: 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

PDUFA Dates

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

Novartis AG (NYSE: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: SUPN) – final trial data from a Phase 3 study of SPN-812 (ADHD)

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

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

(Note: This is not a complete list.)

Earnings

Monday, March 25

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

Tuesday, March 26

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

Wednesday, March 27

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

Thursday, March 28

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