The Week Ahead In Biotech (Aug. 24-29): Lipocine Binary Event, Liver Congress In The Spotlight

After seeing some strength earlier on, biotech stocks came under pressure in the week ended August 21. With the earnings season tapering and not much noise on the coronavirus front, the sector reacted to some clinical readouts, two M&A announcements, and a couple of adverse rulings handed down by the FDA.

Three biotech issues IPOed this week, collecting a cumulative $404.1 in gross proceeds. This apart, Israeli medical imaging startup Nano-X Imaging Ltd. (NNOX) raised $165.2 million. Here are the key catalysts for the unfolding week:

Conferences

  • Virtual World Orphan Drug Congress USA 2020: August 24-27.
  • European Association for the Study of the Liver, or EASL, Digital International Liver Congress 2020: August 27-29.
  • European Society of Cardiology, ESC, Congress 2020: August 29 – September 1.
  • 46th Annual Meeting of the European Society for Blood and Marrow Transplantation: August 29 – September 1.

PDUFA Dates

Lipocine Inc. (LPCN) is knocking at FDA's doors for the fourth time on Friday, August 28 with respect to its Tlando, an oral prodrug of testosterone containing testosterone undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. The FDA has set a PDUFA action date of January 28.

Clinical Readouts

Odonate Therapeutics Inc. (ODT) announced it will hold a conference call on Monday, August 24 at 8:30 a.m. ET. Although the company has not given details, it is scheduled to report top-line results from the CONTESSA Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer in the third quarter.

EASL Presentations

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