Hyperion Therapeutics, Inc (NASDAQ:HPTX) – Initial public offering July 2012.
- PDUFA date October 23, 2012 for urea cycle disorders.
- Phase 2 trial completed for hepatic encephalopathy, or HE. End of Phase 2 meeting with the FDA planned for 4Q 2012.
Durata Therapeutics Inc (NASDAQ:DRTX) – Initial public offering July 2012.
- Phase 3 trial for the treatment of patients with acute bacterial skin and skin structure infections, or abSSSI. Topline data due in the beginning of 2013, and pending positive data, filing of their New Drug Application (NDA) in 1H 2013 and a marketing authorization application (MAA) to the EMA in 2H 2013.
TESARO Inc (NASDAQ:TSRO) – Initial public offering July 2012.
- Phase 3 trials for the prevention of chemotherapy induced nausea and vomiting, or CINV are ongoing.
- Phase 2 trial planned for the treatment of solid tumors.
Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) - Initial public offering April 2012.
- Phase 2 trial in patients with ovarian cancer initiated 1Q 2012.
- Phase 2 trial in patients with non-small cell lung cancer is ongoing.
- Phase 2 trial in patients with breast cancer is ongoing.
- Phase 3 trial in patients with second line pancreatic cancer initiated 1Q 2012.
- Phase 2 trial in combination with 5-FU and leucovorin in patients with metastatic colorectal cancer.
- Phase 3 trial in patients with moderate-to-severe Crohn’s disease is ongoing.
- Phase 2 trial in type 2 diabetics completed.
- Phase 2 trial for the treatment of diabetic nephropathy is ongoing.
- Phase 2 trial for the treatment of rheumatoid arthritis completed.
- Phase 2 trial for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis is ongoing.
Cempra Inc (NASDAQ:CEMP) – Initial public offering February 2012.
CEM-101 (solithromycin ) for CABP:
- Phase 3 trial with oral solithromycin due to commence in 2H 2012.
- Phase 2 trial initiated July 2012 for the treatment of uncomplicated urogenital gonococcal infections. Top-line results are due by the end of 2012.
- Phase 2 trials in ABSSSI patients completed. Partner required for Phase 3 trials.
- Phase 2 trial for the treatment of prosthetic joint infection (PJI) to commence during 4Q 2012.