Jazz Awaits FDA Nod For Sleep Disorder Drug, Earnings Trickle In, ACell IPO

Biotech stocks advanced in the week ended July 17 thanks to positive broader market sentiment, encouraging news flow on the COVID-19 front, and fairly positive results reported by pharma giant Johnson & Johnson (JNJ).

Equillium Inc. (EQ) was among the biggest gainers of the week after a drug that it licensed from Biocon (BIOCON) was granted emergency use authorization in India for treating cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome.

Moderna Inc. (MRNA) advanced in all five sessions of the week, with detailed interim Phase 1 data publication, positive sell-side commentary, and news of inclusion in the Nasdaq 100 Index all serving as catalysts.

The following are key catalysts in the unfolding week.

PDUFA Dates

The FDA is set to rule on Jazz Pharmaceuticals PLC's (JAZZ) NDA for JZP-258, which is being evaluated as a treatment option for cataplexy — excessive daytime sleepiness — in patients seven years and older with narcolepsy.

Earnings

  • Biogen Inc. (BIIB) is to report earnings Wednesday, July 22, before the market open.
  • Quest Diagnostics Inc. (DQX) is to report earnings Thursday, July 23, before the market open.
  • West Pharmaceutical Services Inc. (WST) is to report earnings Thursday, July 23, before the market open.
  • Edwards Lifesciences Corp. (EW) is to report earnings Thursday, July 23, after the close.
  • LeMaitre Vascular Inc. (LMAT) is to report earnings Thursday, July 23, after the close. 

IPOs

ACell, a regenerative medicines company that develops products designed to facilitate the body's ability to repair and remodel tissue, is planning a 5-million-share IPO at an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol "ACLL."

IPO Quiet Period Expirations

  • Polypid Ltd. (PYPD).
  • Akouos Inc. (AKUS).
  • Fusion Pharmaceuticals Inc. (FUSN)
  • ADiTx Therapeutics Inc. (ADTX).
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