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 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 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 BHC for EM-100, an investigational therapy for allergic conjunctivitis. The company had licensed this preservative-free ophthalmic solution from Eton Pharmaceuticals Inc ETON. (Monday)

The agency is also due to announce its decision on Fennec Pharmaceuticals Inc's 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 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 MESO BLA for remestemcel-L for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.

Earnings

Monday

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

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

Tuesday

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

Wednesday

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

Thursday

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

Friday

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

IPO Quiet Period Expiry

Relay Therapeutics Inc RLAY
Pandion Therapeutics Inc PAND
ALX Oncology Holdings Inc ALXO
Renalytix AI PLC RNLX