Venaxis (APPY) is a diagnostic company focused on the development (U.S.) and commercialization (Europe) of a blood-based appendicitis test (APPY1) designed for use in children and young adults to identify patients presenting to an emergency room at low risk for acute appendicitis to avoid more extensive testing (i.e., the expense and radiation exposure associated with CT scans).

From the company's April presentation, the estimated market for APPY1 includes: 10.4 million (U.S.) and 11.8M (EU) emergency room visits each year for abdominal pain, resulting in 1M (U.S.) and 2M (EU) blood tests performed in patients age 2-20, which represents the initial target market.

The company has modeled for potential revenue of $2.7-$4.2M in 2014, $10.6-$17M in 2015 and $37.6-$59.6M in 2016 based on an estimated average sales price of $50-75/test in the U.S. and $30-50/test in Europe (the lower price in Europe represents sales of the test at a lower

Many traders were able to make solid gains trading Titan Pharma (TTNP.OB) before its FDA panel. In the course of about a week, shares of TTNP ran up from $1.40s to a high of $2.53, representing a gain of over 80%. One of the benefits we have as run-up traders is the opportunity to trade multiple catalysts for the same company, even for the same drug.

Titan is now offering us this opportunity, as we are expecting shares to run-up in anticipation of the FDA's decision (PDUFA date) on April 30, 2013. The FDA panel was completed on March 21, 2013, and resulted in the recommendation for approval -- with 10 yes votes and four no votes -- ultimately supporting approval for Probuphine. The FDA raised some serious concerns in their briefing documents and shares traded wildly, swinging to a low of $1.00 during the FDA presentation and hitting a

Nymox Pharma (NYMX) is developing a new treatment (NX-1207) for prostate disease with ongoing pivotal Phase III clinical trials for benign prostatic hyperplasia (BPH) and a Phase II clinical trial for low-risk, localized prostate cancer.

NX-1207 (click here for a published medical journal overview of the drug from late 2011) is an injection (classified as a therapeutic protein which triggers the process of programmed cell death or apoptosis) administered by a urologist in an office procedure that takes a few minutes and results in a smaller prostate with the goal of relieving BPH symptoms such as trouble urinating or removing cancerous prostate tissue.

NX-1207 has been well tolerated in previous clinical trials with a strong safety record to date and does not require any type of numbing agent (anesthesia) or catheterization in an office procedure that involves little in the way of pain or discomfort to patients. Previous

Rockwell Medical (RMTI) is a fully integrated provider of products and services for patients with end-stage renal disease (ESRD) and chronic kidney disease (CKD) that require dialysis. Below is a summary of the company's pipeline and marketed products.

Soluble Ferric Pyrophosphate (SFP) (continuous dialysate iron replacement therapy) is currently being evaluated in a pair of pivotal Phase III (CRUISE 1&2) clinical trials (ClinicalTrials.gov IDs NCT01320202 and NCT01322347). Last month, RMTI announced positive Phase II (PRIME) clinical trial results, including a 37% reduction in the use of erythropoietin stimulating agents (ESA) (e.g., EPOGEN, PROCRIT, ARANESP) in dialysis patients while maintaining iron balance.

The company recently provided guidance (click here for Q4 2012 conference call, Seeking Alpha transcript) to report top-line results for the CRUISE-1 study in July and CRUISE-2 in October. In addition, the PRIME results suggest a high probability of success in the upcoming

Flamel Technologies (FLML) is a French drug delivery company (click here for pdf of investor presentation) with pending FDA and clinical trial catalysts outlined below that also receives royalties from GlaxoSmithKline (GSK) for an approved drug, Coreg CR (a once-daily formulation of a beta blocker cardiovascular drug).

While Coreg CR is not a big seller (i.e. royalties from Glaxo were $1.7M during 4Q12, which decreased from $2.2M in the year-ago period), the product validates the Company's drug delivery technology platform and a recent acquisition provides Flamel with an approved product and multiple late-stage pipeline compounds including a near-term PDUFA date and recently filed NDA.

SUMMARY OF UPCOMING FDA & CLINICAL TRIAL CATALYSTS:

During Q4 2012, Flamel received a PDUFA decision goal date of 5/31/13 under a standard 10-month review seeking approval for an undisclosed (for competitive reasons) hospital-based product w/ projected sales potential of $25-35M based on

Delcath Systems (DCTH) is a cancer biotech focused on the development and commercialization of a medical device/drug combo product designed for the local delivery of high-dose chemo drugs to the liver with a goal of improving treatment outcomes while minimizing side effects typically associated with systemic/whole body exposure.

FDA CATALYST SUMMARY:

Delcath has a PDUFA decision goal date of 6/15/13 under a standard 10-month review period for a 505(b)(2) New Drug Application (NDA) seeking approval for MELBLEZ KIT (consisting of the approved chemo drug Melphalan for use with Delcath Hepatic Delivery System) to treat a rare form of skin cancer that cannot be removed by surgery (unresectable metastatic ocular melanoma) that has spread to the liver (the proposed indication was narrowed in December 2012 to provide the lowest risk pathway to a potential initial FDA approval with additional clinical trials planned for other indications).

A FDA advisory panel meeting

Durata Therapeutics (DRTX) develops new treatments for infectious disease. Here is a summary of the company's lead product candidate, which is currently being evaluated in the second of two pivotal Phase III clinical trials, with results expected this quarter to support a planned NDA filing by mid-2013.

The Company is currently evaluating Dalbavancin as a once-weekly intravenous, or IV, antibiotic in the second of two pivotal Phase III clinical trials (DISCOVER-2) under a Special Protocol Assessment (SPA) agreement with the FDA.

The once-weekly dosing regimen is a major improvement over vancomycin, which is typically dosed once or twice daily and requires regular monitoring of drug levels and kidney function, in addition to potential infusion-related reactions as a widely used IV antibiotic in the home healthcare environment that I deal with on a regular basis in my pharmacy job at a home health IV infusion pharmacy.

Vancomycin results in

AcelRx Pharmaceuticals (ACRX) is a pain drug developer with lead product candidate Sufentanil NanoTab PCA System (ARX-01) (sublingual patient-controlled pain relief in a hospital setting) that is being evaluated in a pair of ongoing pivotal Phase III clinical trials (ClinicalTrials.gov IDs NCT01539642 and NCT01660763) as outlined below.

Last month, ACRX reported that the first of three pivotal Phase III clinical trials met the primary endpoint of non-inferiority vs. patient-controlled analgesia or PCA morphine (IV pump system) for patient-directed, post-operative pain control. The less invasive and less complex route of sublingual pain drug delivery in the hospital setting would be a major improvement over the current use of IV-based pain pumps that must be programmed and are more invasive to the patient as an IV line must be kept open and free of infection.

The Company expects to report results from the remaining two pivotal Phase III clinical

Chembio Diagnostics (CEMI) (link to November presentation PDF) specializes in the development, manufacture and commercialization of rapid diagnostic tests for infectious disease that are designed for use at the point of care (POC) by healthcare professionals.

The Company's product portfolio includes several rapid (15-minute), blood-based HIV tests which are distributed exclusively in the US by Alere (ALR) and by CEMI outside of the US. Alere markets the tests in the US under the Clearview Complete HIV 1/2 (barrel format) and Clearview HIV 1/2 STAT PAK (cassette format) while CEMI markets ex-US as Chembio Sure Check HIV 1/2 and Chembio HIV 1/2 STAT PAK.

As of the most recent guidance with the Company's quarterly SEC 10-Q filing last month (top of page 14), CEMI expects to receive a CE Mark (Europe) for the FDA approved HIV screening tests during the current quarter. CEMI has a another key

BioLineRx (BLRX) is an Israel-based biotech incubator which receives government funding support (i.e. Office of Chief Scientist, Israeli Trade Ministry) to identify and develop compounds at an early (preclinical) stage. The Company develops these compounds through early-stage, proof-of-concept Phase II clinical trials and then seeks to partner with larger pharmaceutical companies for late stage development and potential commercialization.

Below is a summary of the Company's clinical development pipeline and financials from the most recent corporate presentation in December 2012, which is relatively large and diversified for a Company trading at a market cap of only $50 million that includes no debt and approximately $26 million in cash.

The Company's lead product candidate is BL-1020 (GABA-enhanced dopamine antagonist anti-psychotic agent) which is being evaluated in a Phase IIb / III (CLARITY) Clinical Trial (ClinicalTrials.gov ID NCT01363349) in Romania and India with a planned interim analysis during Q1 2013

Anika Therapeutics (ANIK) develops and markets biopolymer (based on the naturally occurring polymer hyaluronic acid or HA) joint health and tissue repair products with a pending FDA decision for a key pipeline product, MONOVISC (single-injection, six-month biopolymer arthritis product), expected by year-end.

On the Q3 2012 conference call in late October, the Company provided guidance for an expected FDA decision by year-end-reporting that during the quarter additional data was submitted to FDA analyzing the clinical benefits of MONOVISC, including clinical trial data in a new format. The FDA accepted the additional information and responded with follow-up clarification questions which the Company subsequently addresses and classified as being straightforward in nature-resulting in optimism over the potential FDA approval by year-end for MONOVISC (pages 3, 5 and 6 of Q3 2012 earnings call transcript).

The Company also reported (page 3 of transcript) that a patent infringement lawsuit filed

Anacor Pharma (ANAC) is focused on the clinical development of anti-fungal, antibiotic and anti-inflammatory product candidates including lead product candidate, Tavaborole (formerly AN2690) (topical anti-fungal product), which is currently being evaluated in two fully-enrolled pivotal Phase III clinical trials (ClinicalTrials.gov IDs NCT01270971 and NCT01302119) with results from the first trial expected in January and results from the second trial expected approximately six weeks later to support a planned New Drug Application (NDA) to the FDA in mid-2013 based on guidance from the most recent quarterly update in early November.

Tavaborole is a boron-based topical solution being developed to treat fungal infections of the nails and nail bed (onychomycosis) on a localized basis through a novel mode of action compared to current treatments such as PENLAC and LAMISIL to greatly minimize the risk of any systemic side effects while achieving similar or greater efficacy compared to marketed

Amicus Therapeutics (FOLD) is focused on the development of new treatments for rare metabolic/genetic disorders, including lead product candidate AMIGAL (migalastat HCl). This is summarized below, with pivotal Phase III results expected in December as part of a recently expanded collaboration with GlaxoSmithKline (GSK) that includes full U.S. rights to the drug for FOLD and a cost-sharing agreement for continued clinical development expenses.

Shares of FOLD have pulled back significantly from a run-up into the mid-$6s about a month ago. Shares are currently trading nearly $1 below the 50-day and 200-day moving averages in the low to mid-$4s.

Aside from the recent market pullback (especially in small-cap biotech stocks), there is no fundamental reason for the decline in shares of FOLD, which recently reported Q3 2012 results (click here for a transcript of the most recent conference call and updated timeline for Phase III results next month). FOLD

Lannett (LCI) is a generic and specialty pharmaceutical company that reported its fourth-quarter and full-year fiscal year 2012 results last week for the three and 12 months ended June 30, 2012, including the financial and operational highlights summarized below.

• LCI reported net sales rose 40% to $35.7 million during Q4 FY 2012 compared to $25.5 million in the year-ago period.
• LCI reported net income of $1.4 million compared to a net loss of ($1.9 million) in the year-ago period.
• As of June 30, 2012, LCI reported 28.4 million shares of common stock outstanding with $7.2 million in total debt (including primarily long-term debt of $6.5 million).
• As of June 30, 2012, LCI reported $29.2 million in cash plus investments.
• LCI reported FY 2012 net sales increased by 15.2% to $123 million vs. $106.8 million during FY 2011.
• LCI reported FY 2012 net income was $3.9 million, or $0.14 per diluted

Alexza Pharmaceuticals (ALXA) is developing lead product candidate ADASUVE (Staccato loxapine) (formerly AZ-004) as an inhaled version of the approved anti-psychotic drug loxapine. The Staccato system is designed to vaporize drugs into an aerosol for a rapid onset of action that is similar to intravenous (IV) administration with much better ease of use.

Pending catalysts for Alexza include a PDUFA decision goal date of 12/21/12 under a six-month Class 2 review for a New Drug Application (NDA) resubmission in response to a second Complete Response Letter (CRL) issued by the FDA earlier this year in May (the first CRL was issued in October 2010). In addition, the Company expects to receive a CHMP (Europe) Day 210 approval opinion in December and has partnered with Grupo Ferrer in Europe with ongoing partnership discussions for other regions including the United States.

In December 2011, the ADASUVE NDA was reviewed

Unilife (UNIS) is a proprietary medical device company that develops and commercializes advanced drug delivery systems through collaborations with bio-pharmaceutical companies to deliver injectable drugs and biological products such as vaccines and blood thinners.

The company's flagship product is the Unifill syringe, which is the only available prefilled syringe that includes fully integrated safety features, in addition to other proprietary technologies for drug reconstitution delivery systems, auto-injectors, auto-infusion pump systems and specialized devices for targeted organ delivery (i.e. drug/device combinations delivered directly into the eye for long-acting release of drugs for conditions such as macular degeneration).

More than two billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000). Key differentiating features of Unilife's fully integrated (within the barrel of the

Rigel Pharma (RIGL) is focused on the development of new treatments for auto-immune and inflammatory conditions with a key ongoing pivotal Phase 3 program for the company's late-stage pipeline drug candidate, Fostamatinib disodium (oral spleen tyrosine kinase or SYK inhibitor), which is currently being evaluated in Pivotal Phase 3 (OSKIRA-1,2,3) Clinical Trials, a Phase 2b (OSKIRA-4) Clinical Trial and a Phase 3 Long-Term Extension Clinical Trial (OSKIRA-X).

Partner AstraZeneca (AZN) expects to report pivotal Phase 3 clinical trial results from OSIRA-1,2,3 trials during 1H13 along w/ Phase 2b (OSKIRA-4) mono-therapy study in late 2012 to support a planned New Drug Application (NDA) filing during 2H13. AZN is also conducting a long-term extension study through early 2015 to evaluate both safety and effectiveness on a long-term basis in addition to a randomized, double-blind Phase 2 clinical trial in patients w/ relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that is evaluating

Intellipharmaceutics (IPCI) is focused on the development of generic and specialty drugs based on the Company's patented Rexista abuse-deterrent and Hypermatrix controlled-release drug delivery technology platforms. IPCI currently has six abbreviated New Drug Applications (ANDAs) pending at FDA for a targeted list of generic drugs in addition to a novel abuse-deterrent formulation of the widely used opiate pain drug OxyContin.

Below is a summary of the Company's six pending ANDAs (#1-6) referenced by the brand drug name (with the potential for two additional ANDA filings by year-end) and one proprietary drug candidate (#7):

1.) Focalin XR -- IPCI has a strategic alliance (10-year profit sharing agreement that begins with first sales of the drug) with Par Pharma (PRX), which agreed to a buyout by private equity firm TPG last month in a $1.9 billion deal. IPCI has settled patent litigation with Novartis, Elan and Celgene for an expected product launch

Cornerstone Therapeutics (CRTX) is a specialty pharmaceutical company focused on hospital products in addition to other generic and specialty niche market opportunities.

The company has a near-term catalyst for Lixivaptan (CRTX 080) -- a selective vasopressin 2 receptor antagonist -- in the form of an FDA advisory panel meeting on Sept. 13, 2012, for a new drug application seeking approval for the treatment of low sodium levels (hyponatremia). The PDUFA decision goal date is Oct. 29, 2012, under a standard 10-month review period and Lixivaptan was acquired as part of the company's acquisition of privately held Cardiokine last December.

In early August, Cornerstone reported Q2 2012 financial results, including the following highlights:

• As of June 30, 2012, Cornerstone reported $38.6 million in cash and equivalents vs. $74 million at year-end 2011, which primarily reflects cash usage to fund the EKR Therapeutics acquisition in a deal that also included the issuance

Ironwood Pharma (IRWD) is developing lead product candidate (Linaclotide) for the treatment of gastrointestinal (GI) disorders with pending near-term US and EU approval decisions.

Along with US partner Forest Labs (FRX), Ironwood has an upcoming PDUFA decision goal date of 9/8/12 under a standard 10-month review for a NDA seeking approval of Linaclotide for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The companies are co-developing the drug and plan to co-promote in the US with a planned launch in 2012 if approved by the FDA decision date next month and patent protection in the US through 2025.

In addition, Ironwood will receive $85 million from Forest Labs if the drug receives FDA approval in addition to $100M in potential sales-based milestone payments. Linaclotide is also partnered with Almirall in Europe with a MAA / EMA regulatory approval filing submitted in SEP11 (2H12 estimate