The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Readouts And IPOs

Biotech stocks came under pressure this week along with the broader market, which succumbed to the negative sentiment generated by U.S.-China trade tensions. However, they recouped some of these losses, courtesy of  ASCO abstracts that were made available online late Wednesday.

Among other notable events, Insys Therapeutics Inc INSY warned of a possible bankruptcy filing, weighed down by legal woes; and the FDA finalized guidelines regarding interchangeable biosimilars.

The following are some of the key biotech catalysts ahead in the unfolding week.

Conferences

• 2019 World Advanced Therapies and Regenerative Medicine Congress: May 15-17 in London, U.K.
• American Thoracic Society 2019 International Conference: May 17-22 in Dallas, Texas.
• Digestive Disease Week 2019 Meeting: May 18-21 in San Diego, California.
• 2019 TReg Directed Therapies Summit: May 20-22 in Boston, Massachusetts.
• UBS Global Healthcare Conference: May 20-22 in New York City.
• Antibodies and Complement 2019 Conference: May 20-25 in Girona, Spain.
• RBC Capital Markets 2019 Healthcare Conference: May 21-22 in New York City.
• 28th World Congress on Neurology & Neuroscience: May 23-24 in Zurich, Switzerland.
• 2nd World Obesity and Diabetes Care Congress: May 23-24 in Paris, France.

See Also: FDA Issues Final Guidelines To Make Interchangeable Biosimilars More Easily Available

PDUFA Date

Incyte Corporation INCY and Novartis AG NVS await the FDA verdict on their sNDA for Jakafi in patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids. The PDUFA date is set for Friday, May 24.

Clinical Trial Readouts

American Thoracic Society 2019 International Conference Presentations

Athersys, Inc. ATHX: already released Phase 2a data for MultiStem therapy for acute respiratory distress syndrome.

resTORbio, Inc. TORC: Phase 2b data for RTB101 and Everolimus, evaluated for respiratory tract infections.

Bellerophon Therapeutics Inc BLPH: additional cohort one data for the INOpulse delivery device in pulmonary hypertension associated with interstitial lung disease.

Digestive Disease Week 2019 Meeting Presentations

Eli Lilly And Co LLY: Phase 2 data for mirikizumab in Crohn's disease.

CymaBay Therapeutics Inc CBAY: Phase 2 data for seladelpar in primary biliary cholangitis.

IPOs

Bicycle Therapeutics, a biotech company developing new therapeutics based on its proprietary bicyclic peptide product platform, is set to offer 4.33 million shares in an IPO, with the price per share estimated in the range of $14-$16. Shares are to be listed on the Nasdaq under the ticker symbol BCYC.

IDEAYA Biosciences, an oncology-focused precision medicine company, is planning a 5-million-share IPO, with the price estimated between $13 and $15 per share. The stock is slated for listing on the Nasdaq under the ticker symbol IDYA.

Peloton Therapeutics is set to offer 9.375 million shares, to be priced between $15 and $17. The biotech company working on cancer and other debilitating or life-threatening conditions seeks to list shares on the Nasdaq under the ticker symbol PLTX.