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

Shanthi Rexaline

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

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

Tuesday, Aug. 13

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

Wednesday, Aug. 14

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

Fulcrum Therapeutics Inc (NASDAQ: FULC)

Mirum Pharmaceuticals Inc (NASDAQ: MIRM)

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