The Week Ahead In Biotech: Bristol-Myers, Rockwell Medical Await FDA Decisions, COVID-19 Updates In Focus

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Biotech stocks went on a roller coaster ride in the week ended March 20 amid the market-wide COVID-19 sell-off. Activity remained light amid the cancellation of many medical meetings.

The COVID-19 treatment and vaccine development news flow was front and center, as biopharma and diagnostics companies scrambled to capitalize on the need presented by the pandemic.

This news flow is likely to continue into the unfolding week, with companies already in the fray providing updates and new entrants making announcements.

Related Link: 8 Biotechs With Coronavirus Vaccines In Development

The following are other catalysts that could move stocks in the biotech space: 

PDUFA Dates

The FDA is scheduled to announced its verdict on Bristol-Myers Squibb Co's BMY NDA for ozanimod as a treatment option for patients with relapsing forms of multiple sclerosis. (Wednesday)

IntelGenx Technologies Corp. OTCMKTS: (IGXT)'s NDA for rizaport versafilm for the treatment of acute migraine is pending before the FDA, with the target action day fixed for Thursday. The company has faced three rejections for the investigational drug in the past.

The FDA is also expected to rule on Rockwell Medical Inc's RMTI sNDA for intravenous formulation of anemia drug Triferic. (Saturday)

Earnings

Monday

• DiaMedica Therapeutics Inc DMAC (after the close)
• Tuesday
• Thermogenesis Holdings Inc THMO (after the close)
• OpGen Inc OPGN (after the close)
• Onconova Therapeutics Inc ONTX (after the close)

Wednesday

• Viela Bio Inc VIE (after the close)
• Biocept Inc BIOC (after the close)
• OncoCyte Corp OCX (after the close)
• HTG Molecular Diagnostics Inc HTGM (after the close)
• Eyenovia Inc EYEN (after the close)
• Exagen Inc XGN (after the close)

Thursday

• Celsion Corporation CLSN
• Entera Bio Ltd ENTX (before the market open)
• TFF Pharmaceuticals Inc TFFP (before the market open)
• IGM Biosciences Inc IGMS (after the close)
• NovaBay Pharmaceuticals, Inc. NBY (after the close)
• Vermillion, Inc. VRML (after the close)

Friday

• TELA Bio Inc TELA (before the market open)
• Zyla Life Sciences ZCOR (before the market open)

IPO Quiet Period Expiry

Passage Bio Inc PASG