The Week Ahead In Biotech: Vanda Awaits FDA Decision, BioVie Plans IPO

Biotech stocks came under pressure this week along with the broader market amid an earnings spate. The biggest news break was an FDA probe into data integrity issues with Novartis AG NVS's regulatory submission for its recently approved gene therapy Zolgensma.

The following are key biotech catalysts for the unfolding week.

Conferences

2nd International Conference on Cardiovascular Diseases and Therapeutics: Aug. 12-13 in Amsterdam, Netherlands

International Conference on Tuberculosis and Respiratory Diseases: Aug. 12-13 in London

Wedbush PacGrow Healthcare Conference: Aug. 13-14 in New York City

PDUFA Dates

Vanda Pharmaceuticals Inc. VNDA awaits an FDA decision on its sNDA for Hetlioz, with the D-date fixed for Friday, Aug. 16. Hetlioz is being evaluated for jet lag disorder. Hetlioz received its first approval in January 2014 for non-24-hour sleep-wake disorder in blind people. 

KemPharm Inc KMPH is expected to submit its NDA for KP415, which is being evaluated for attention deficit hyperactivity disorder, in the early third quarter.

Earnings

Monday, Aug. 12

• Aptinyx Inc APTX (before the market open)
• Evolus Inc EOLS (before the market open)
• ImmuCell Corporation ICCC (after the market close)
• Eyenovia Inc EYEN (after the market close)
• OptiNose Inc OPTN (after the market close)
• Unum Therapeutics Inc UMRX (after the market close)

See Also: Biotech Stock On The Radar: Veru, A Catalyst-Rich Biopharma

Tuesday, Aug. 13

• Biostage Inc BSTG (before the market open)
• Rubius Therapeutics Inc RUBY (before the market open)
• Brainstorm Cell Therapeutics Inc BCLI (before the market open)
• Vascular Biogenics Ltd VBLT (before the market open)
• Matinas BioPharma Holdings Inc MTNB (before the market open)
• Cyclacel Pharmaceuticals Inc CYCC (after the close)
• Cesca Therapeutics Inc KOOL (after the close)
• Myriad Genetics, Inc. MYGN (after the close)
• PhaseBio Pharmaceuticals Inc PHAS

Wednesday, Aug. 14

• Altimmune Inc ALT (before the market open)
• Onconova Therapeutics Inc ONTX (before the market open)
• VolitionRX Ltd VNRX (before the market open)
• aTyr Pharma Inc LIFE (after the close)
• Aethlon Medical, Inc. AEMD (after the close)
• Dare Bioscience Inc DARE (after the close)
• Zosano Pharma Corp ZSAN (after the close)
• Y-mAbs Therapeutics, Inc YMAB (after the close)
• Misonix, Inc. MSON (after the close)
• Zyla Life Sciences ZCOR (after the close)
• Urovant Sciences Ltd UROV (after the close)

IPOs

BioVie, a biopharma company developing drug therapies for liver diseases, is proposing to offer 1.3 million shares in an IPO, likely to be priced at $11.44 each. The company intends to list its shares on the Nasdaq under the ticker symbol "BIVI."

IPO Quiet Period Expiry

GENMAB A/S/S ADR GMAB

Fulcrum Therapeutics Inc FULC

Mirum Pharmaceuticals Inc MIRM