Your Biotech Calendar, August 28: PDUFA Dates, SEC Filings, Financings

At OneMedPlace, our goal is to be your eyes and ears to the biotech and life sciences sector: putting into perspective what we’ve seen so far, and providing you with snapshots of and what’s upcoming.

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:

Novelos Therapeutics Developing Cancer-Targeted Optical Imaging Agent

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.

Aeterna Zentaris Announces First Patient Recruited for Phase 2A Trial in Cancer Cachexia

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: Stribild/Quad, Gilead Sciences Inc – Four-drug combination pill to treat HIV. U.S. health regulators on Monday approved Gilead Sciences Inc’s four-drug combination pill to treat HIV.

8/28: Humira, Abbott Laboratories – Moderately to severely active ulcerative colitis.

9/5: Provir, Salix Pharmaceuticals Ltd – Control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy.

9/5: Tobramycin inhalation powder, Novartis AG – Pseudomonas aeruginosa, a common bacteria in the development of sepsis and inflammation.


Bacterin Secures $25 Million Financing with OrbiMed

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.

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