This new column, “Your Biotech Calendar,” will offer a weekly glance at notable filings essential to your investment portfolio. Here you will see a compilation of upcoming events in our niche — the under-covered smallcap public markets. This aggregated calendar should help you take the temperature of the industry each week.
Clinical Development Announcements:
Wisconson-based Novelos Therapeutics announced development of CLR1502 (GLOW2), a preclinical cancer-targeted optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging. The company expects to file IND in Q3/Q4 2013.
Cachexia is a complex metabolic syndrome associated with underlying illness common in patients with cancer. Cachexia can cause diminished appetite, food intake and insulin sensitivity, which contributes to a decreaseon patients’ quality of life and survival rate. There are currently no approved treatments for cancer-related cachexia.
Q2 Earnings Releases: (all dates expected, are subject to change)
Ark Therapeutics Group plc [LSE: AKT]: 8/29. London and Finnish gene-based medicine company focused on vascular disease and cancer.
MDxHealth [OTC BB: MXDHF]: 8/30. Belgian biotech with headquarters in Irvine, CA developing molecular diagnostics for advanced epigenetic tests for cancer.
Innate Pharma [BE: IDD]: 9/6. Biopharmaceutical company developing first-in-class immunotherapy drugs for cancer and inflammatory diseases. Diverse pipeline in pre-clinical and clinical phase, with licensed technology to Bristol-Myers Squibb and Novo Novardisk.
PDUFA Dates: (all dates expected, are subject to change)
8/28: Humira, Abbott Laboratories – Moderately to severely active ulcerative colitis.
9/5: Tobramycin inhalation powder, Novartis AG – Pseudomonas aeruginosa, a common bacteria in the development of sepsis and inflammation.
Bacterin International Holdings Inc. develops anti-microbial, anti-infective coatings for revolutionary bone graft material and also processes and markets innovative, biologic allografts for transplantation. Bacterin’s products have various applications in orthopedic, neurological, trauma, oral/maxillofacial and reconstructive procedures. The allograft market is valued at $1 billion and is growing at 15-20% annually.