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The Week Ahead In Biotech: Bausch Health, Fennec Pharma FDA Decisions And Smid-cap Earnings

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The Week Ahead In Biotech: Bausch Health, Fennec Pharma FDA Decisions And Smid-cap Earnings

Biotech stocks advanced in the week ended Aug. 7, buoyed by multiple catalysts. Aside from the broader market strength, mostly positive earnings and continuing coronavirus treatment/vaccine news flow supported the move to the upside.

Novavax, Inc.'s (NASDAQ: NVAX) stretched valuation got further stretched as the shares added about 20% for the week in the wake of its interim Phase 1 readout for its coronavirus vaccine candidate.

Bristol-Myers Squibb Co (NYSE: BMY) reported a beat-and-raise quarter, with the shares receiving further support from a win in the patent lawsuit over its blood thinner Eliquis.

The week also saw a medical technology and two biotechs debuting on the Wall Street.

Here are the key catalysts for the unfolding week.

Conferences

BTIG Virtual Biotechnology Conference: Aug. 10-11
Wedbush PacGrow Healthcare Virtual Conference: Aug. 11-12

PDUFA Dates

The FDA is said to rule on the NDA filed by Bausch Health Companies Inc (NYSE: BHC) for EM-100, an investigational therapy for allergic conjunctivitis. The company had licensed this preservative-free ophthalmic solution from Eton Pharmaceuticals Inc (NASDAQ: ETON). (Monday)

The agency is also due to announce its decision on Fennec Pharmaceuticals Inc's (NASDAQ: FENC) NDA for Pedmark, which is being evaluated as a treatment option for chemotherapy-induced ototoxicity. (Monday)

FDA's decision on label expansion for Roche Holdings AG's Basel ADR Common Stock (OTC: RHHBY) Xolair for the treatment of nasal polyps could come Tuesday, based on 10 months from the submission of the sBLA.

Adcom Calendar

FDA' Oncology Drug Advisory Committee will discuss Thursday Mesoblast limited's (NASDAQ: MESO) BLA for remestemcel-L for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.

Earnings

Monday

  • Rubius Therapeutics Inc (NASDAQ: RUBY) (before the market open)
  • Reata Pharmaceuticals Inc (NASDAQ: RETA) (before the market open)
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) (before the market open)
  • Paratek Pharmaceuticals Inc (NASDAQ: PRTK) (before the market open)
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT) (before the market open)
  • TG Therapeutics Inc common stock (NASDAQ: TGTX) (before the market open)
  • Recro Pharma Inc (NASDAQ: REPH) (before the market open)
  • Radius Health Inc (NASDAQ: RDUS) (before the market open)
  • Voyager Therapeutics Inc (NASDAQ: VYGR) (before the market open)
  • Chimerix Inc (NASDAQ: CMRX) (before the market open)
  • Eagle Pharmaceuticals Inc (NASDAQ: EGRX) (before the market open)
  • SAGE Therapeutics Inc (NASDAQ: SAGE) (before the market open)
  • Neos Therapeutics Inc (NASDAQ: NEOS) (before the market open)
  • Pieris Pharmaceuticals Inc (NASDAQ: PIRS) (before the market open)
  • Protalix BioTherapeutics, Inc. (NASDAQ: PLX) (before the market open)
  • Intra-Cellular Therapies Inc (NASDAQ: ITCI) (before the market open)
  • Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) (before the market open)
  • Axsome Therapeutics Inc (NASDAQ: AXSM) (before the market open)
  • Amicus Therapeutics, Inc. (NASDAQ: FOLD) (before the market open)
  • Apyx Medical Corp (NASDAQ: APYX) (before the market open)
  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL) (before the market open)
  • Akebia Therapeutics Inc (NASDAQ: AKBA) (before the market open)
  • AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) (after the market close)
  • Athersys Inc (NASDAQ: ATHX) (after the market close)
  • Adverum Biotechnologies Inc (NASDAQ: ADVM) (after the market close)
  • Adaptive Biotechnologies Corp (NASDAQ: ADPT) (after the market close)
  • Clearside Biomedical Inc (NASDAQ: CLSD) (after the market close)
  • Pulse Biosciences Inc (NASDAQ: PLSE) (after the market close)
  • Calithera Biosciences Inc (NASDAQ: CALA) (after the market close)
  • Castle Biosciences Inc (NASDAQ: CSTL) (after the market close)
  • Matinas BioPharma Holdings Inc (NYSE: MTNB) (after the market close)
  • Catabasis Pharmaceuticals Inc (NASDAQ: CATB) (after the market close)
  • CASI Pharmaceuticals Inc (NASDAQ: CASI) (after the market close)
  • Celcuity Inc (NASDAQ: CELC) (after the market close)
  • CorMedix Inc. (NYSE: CRMD) (after the market close)
  • Integra Lifesciences Holdings Corp (NASDAQ: IART) (after the market close)
  • Cara Therapeutics Inc (NASDAQ: CARA) (after the market close)
  • Inovio Pharmaceuticals Inc (NASDAQ: INO) (after the market close)
  • Precigen Inc NASDAQ: (PGEN) (after the market close)
  • Rockwell Medical Inc (NASDAQ: RMTI) (after the market close)
  • Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) (after the market close)
  • ICU Medical Inc (NASDAQ: ICUI) (after the market close)
  • Plus Therapeutics Inc (NASDAQ: PSTV) (after the market close)
  • Liquidia Technologies Inc (NASDAQ: LQDA) (after the market close)
  • Novavax
  • Wave Life Sciences Ltd (NASDAQ: WVE) (after the market close)
  • Urogen Pharma Ltd (NASDAQ: URGN) (after the market close)
  • CymaBay Therapeutics Inc (NASDAQ: CBAY) (after the market close)
  • ChemoCentryx Inc (NASDAQ: CCXI) (after the market close)
  • Chiasma Inc (NASDAQ: CHMA) (after the market close)
  • Organogenesis Holdings Inc (NASDAQ: ORGO) (after the market close)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO) (after the market close)
  • Esperion Therapeutics Inc (NASDAQ: ESPR) (after the market close)
  • Evolus Inc (NASDAQ: EOLS) (after the market close)

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

Tuesday

  • BioNTech SE – ADR (NASDAQ: BNTX) (before the market open)
  • STRATA Skin Sciences Inc (NASDAQ: SSKN) (before the market open)
  • Fulcrum Therapeutics Inc (NASDAQ: FULC) (before the market open)
  • Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) (before the market open)
  • Affimed NV (NASDAQ: AFMD) (before the market open)
  • Burning Rock Biotech Ltd (NASDAQ: BNR) (before the market open)
  • Gamida Cell Ltd (NASDAQ: GMDA) (before the market open)
  • 10X Genomics Inc (NASDAQ: TXG) (after the market close)
  • Agile Therapeutics Inc (NASDAQ: AGRX) (after the market close)
  • Aethlon Medical, Inc. (NASDAQ: AEMD) (after the market close)
  • T2 Biosystems Inc (NASDAQ: TTOO) (after the market close)
  • Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the market close)
  • DiaMedica Therapeutics Inc (NASDAQ: DMAC) (after the market close)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM) (after the market close)
  • Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) (after the market close)
  • Shockwave Medical Inc (NASDAQ: SWAV) (after the market close)
  • RA Medical Systems Inc (NYSE: RMED) (after the market close)
  • Inari Medical Inc (NASDAQ: NARI) (after the market close)

Wednesday

  • Royalty Pharma plc (NASDAQ: RPRX) (before the market open)
  • Altimmune Inc (NASDAQ: ALT) (before the market open)
  • TELA Bio Inc (NASDAQ: TELA) (after the market close)
  • Brickell Biotech Inc (NASDAQ: BBI) (after the market close)
  • Dare Bioscience Inc (NASDAQ: DARE) (after the market close)
  • Biocept Inc (NASDAQ: BIOC) (after the market close)
  • ImmuCell Corporation (NASDAQ: ICCC) (after the market close)
  • Eyenovia Inc (NASDAQ: EYEN) (after the market close)
  • Eton Pharmaceuticals Inc (NASDAQ: ETON) (after the market close)
  • Thermogenesis Holdings Inc (NASDAQ: THMO) (after the market close)
  • OpGen Inc (NASDAQ: OPGN) (after the market close)
  • KemPharm Inc (OTC: KMPH) (after the market close)
  • Neoleukin Therapeutics Inc (NASDAQ: NLTX) (after the market close)
  • Salarius Pharmaceuticals Inc (NASDAQ: SLRX) (after the market close)

Thursday

  • Vascular Biogenics Ltd (NASDAQ: VBLT) (before the market open)
  • PDS Biotechnology Corp (NASDAQ: PDSB) (before the market open)
  • Zai Lab Ltd (NASDAQ: ZLAB) (before the market open)
  • Veru Inc (NASDAQ: VERU) (before the market open)
  • aTyr Pharma Inc (NASDAQ: LIFE) (after the market close)
  • Caladrius Biosciences Inc (NASDAQ: CLBS) (after the market close)
  • Dyadic International, Inc. (NASDAQ: DYAI) (after the market close)
  • Myriad Genetics, Inc. (NASDAQ: MYGN) (after the market close)
  • Histogen Inc (NASDAQ: HSTO) (after the market close)
  • Lumos Pharma Inc (NASDAQ: LUMO) (after the market close)
  • Viveve Medical Inc (NASDAQ: VIVE) (after the market close)
  • Urovant Sciences Ltd (NASDAQ: UROV) (after the market close)

Friday

  • PLx Pharma Inc (NASDAQ: PLXP) (before the market open)
  • Ocugen Inc (NASDAQ: OCGN) (before the market open)

IPO Quiet Period Expiry

Relay Therapeutics Inc (NASDAQ: RLAY)
Pandion Therapeutics Inc (NASDAQ: PAND)
ALX Oncology Holdings Inc (NASDAQ: ALXO)
Renalytix AI PLC (NASDAQ: RNLX)

 

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