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
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 (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.)
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 (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.
IPO Quiet Period Expiry
Kaleido Biosciences Inc (NASDAQ: KLDO)
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