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

Biotech stocks ended higher for the second straight week, with the presentations at the American Association of Cancer Research annual meeting taking the spotlight. Additionally, there were clinical trial readouts from companies that carried a fourth-quarter timeframe.

ADMA Biologics Inc ADMA shares rallied sharply after the  FDA nod for its immunodeficiency therapy. But Evoke Pharma Inc EVOK's NDA for diabetic gastroparesis drug Gimoti received a thumbs-down from the regulatory agency, sending its shares down about 50% Tuesday.

Looking ahead to the unfolding week, the following are some key catalytic events biotech investors will be focusing on. 

Conferences

• Society for Inherited Metabolic Disorders 2019 annual meeting: April 6-9 in Bellevue, Washington.
• H.C. Wainwright Global Life Sciences Conference: April 8-9 in London.
• 13th International Conference on Endocrinology, Diabetes and Metabolism: April 8-9 in Wellington, New Zealand.
• 12th World Conference on Human Genomics and Genomic Medicine: April 8-9, in Abu Dhabi, UAE.
• 18th Annual Needham Healthcare Conference: April 9-10 in New York City.
• 3rd International Conference on Influenza and Emerging Infectious Diseases: April 10-11 in Toronto, Canada.
• 2019 Congress of the Schizophrenia International Research Society: April 10-14 in Orlando, Florida.
• The European Association for the Study of the Liver, or EASL, International Liver Congress 2019:  April 10-14 in Vienna, Austria.
• 12th World Congress on Dementia and Alzheimer Rehabilitation: April 11-12 in Stockholm, Sweden.
• 29th European Congress of Clinical Microbiology & Infectious Diseases: April 13-16 in Amsterdam, Netherlands.

PDUFA Dates

The FDA is set to rule on Merck & Co., Inc. MRK's sBLA for Keytruda as a monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations. The FDA decision is due Thursday, April 11.

See also: Biotech Winners, Losers In Q1

Clinical Trial Readouts

Alkermes Plc ALKS is due to release new Phase 3 data for ALKS 3831, which is being evaluated in a study dubbed ENLIGHTEN-2 for schizophrenia, at the 2019 Congress of the Schizophrenia International Research Society on Thursday, April 11.

The EASL International Liver Congress 2019 Presentations

Thursday, April 11

• Eiger Biopharmaceuticals Inc EIGR: Late-breaker presentation of already released Phase 2 data for pegylated interferon lambda (hepatitis delta virus).
• Assembly Biosciences Inc ASMB: Poster presentation of Phase 1a data for ABI-H2158 (hepatitis B virus).
• Intercept Pharmaceuticals Inc ICPT): Full Phase 3 data for Ocaliva from the REGENERATE study (non-alcoholic steatohepatitis).
• Viking Therapeutics Inc VKTX and Ligand Pharmaceuticals Inc. LGND: additional Phase 2 data for VK2809 (hypercholesterolemia and non-alcoholic fatty liver disease, or NAFLD).

Friday, April 12

• Spring Bank Pharmaceuticals Inc SBPH: full Phase 2 data for inarigivir and vemlidy (hepatitis B virus).
• Albireo Pharma Inc ALBO: Phase 2 data for A4250 (liver disease).
• Altimmune Inc ALT: Phase 1 data for HepTCell (hepatitis B).

Saturday, April 13

• Assembly Biosciences: Interim Phase 2a data for AB-H0731 (hepatitis B virus).
• Conatus Pharmaceuticals Inc CNAT: Late-breaker presentation of Phase 2b data for emricasan (NASH cirrhosis).

29th European Congress of Clinical Microbiology & Infectious Diseases Presentations

Saturday, April 13

• SCYNEXIS Inc SCYX: Phase 3 data for oral SCY-078 (candida auris).
• Cidara Therapeutics Inc CDTX: new analysis from Phase 2 STRIVE B for Rezafungin (candidemia).

Related Link: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates