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Tuesday, June 30, 2015

ADMA Biologics Shares Possibly Worth A Triple On FDA Approval Of RI-002

By Jason Napodano, CFA & Nisha Hirani, MD

We are initiating coverage of ADMA Biologics, Inc. (ADMA) with a "Buy" rating and a $20 price target. ADMA recently announced positive Phase 3 data for lead product candidate RI-002, a plasma-derived intravenous immunoglobulin (IVIG) for the treatment and prevention of certain infectious diseases in Primary Immunodeficiency Disease (PIDD) patients. RI-002 contains high levels of standardized RSV antibody titers via a selective and proprietary donor screening process that differentiates the drug from other commercially available IVIG products. We believe that RI-002 will offer a superior treatment option for a subset of patients with PIDD, and other immunocompromised or immunosuppressed patient groups at high-risk for infections.

ADMA is currently assembling its Biologics License Application (BLA) for planned submission to the U.S. FDA at some point during the middle of 2015. We believe that if all goes well, FDA approval should take place during the second half of 2016. Management believes that first commercial sales could potentially occur as early as the second half of 2016. We think utilizing standardized high levels of anti-RSV neutralizing antibodies is a unique approach, and we view this as an area of unmet medical need for immunocompromised patients. At the current price, we view ADMA shares as meaningfully undervalued, and offer significant long-term upside potential.

Please read the article on Seeking-Alpha: LINK

Lipocine Is An Attractive Specialty Pharma Story

By Jason Napodano, CFA & Nisha Hirani, MD

We have remained big proponents of Lipocine Inc. (LPCN) over the past year. As a reminder to investors, in January 2015, we called the name one of our "top ideas" in the specialty pharmaceutical industry. Our article from March 2015 outlines the case for why we believe LPCN 1021, the company's oral testosterone replacement therapy, has significant potential for commercial success, while our article from early June 2015 provides a background on preterm birth and highlights how newly designated orphan drug LPCN 1107 further improves the fundamental outlook for the company. For the purpose of this article, we would like to offer a review and an update regarding Lipocine's assets, and why we continue to remain optimistic regarding the Lipocine story.

Please read the article on Seeking-Alpha: LINK

An Overview Of Immune Pharmaceuticals As Bertilimumab Enters The Clinic

By David Bautz, PhD

Immune Pharmaceuticals (IMNP) is a biopharmaceutical company developing therapeutics for the treatment of inflammatory diseases and cancer. The company recently announced the initiation of Phase 2 clinical trials for the company's lead product, bertilimumab, a monoclonal antibody targeting eotaxin-1. The Phase 2 trials are testing bertilimumab as a treatment for bullous pemphigoid (BP) and ulcerative colitis (UC). In addition, the company is developing NanomAbs®, a technology platform that allows for the targeted delivery of chemotherapeutic agents directly to cancer cells; Amiket™, which will be entering Phase 3 clinical testing for the treatment of post-herpetic neuralgia (PHN) in late 2015; and topical nano-formulated Cyclosporin A, which will be developed for treating psoriasis and atopic dermatitis. Below, we discuss Immune's pipeline in greater detail, with an emphasis on bertilimumab, which we believe has blockbuster potential.

Please read the article on Seeking-Alpha: LINK

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