The actively managed HavRx Regulatory Catalyst Index tracks the performance of select companies which meet any of the following requirements: (1) pending new drug, biological agent, medical device, or diagnostic product applications at the FDA; (2) pending pivotal clinical trial results that are designed to support a new filing or resubmission for FDA marketing clearance; and (3) pending early stage clinical study results. Categories (1) and (2) will comprise two-third (67%) or greater of all index components while companies with pending early stage clinical trial results will comprise one-third (33%) or less of all index components.
As of 3/15/10, statistics for the <font> Regulatory Catalyst Index </font> are outlined below and includes daily updates in the evening (between 6-8pm ET) on regular market days which are available to view, download, and print at the subscriber home page. The daily Regulatory Catalyst Index Updates are available in four versions, sorted by company name (A-Z), stock price (low-high), expected binary event catalyst date (oldest-newest), and the date each entry was last updated (newest-oldest).
(1) 255 total entries to track select pending binary event data (FDA decisions, clinical trials)
(2) 170 companies tracked with 92 active index components
(3) 130 companies under $10 per share and 95 companies under $5 per share
1.) AP Pharma (NASDAQ: APPA) ($1.50, $59 million) has a pending FDA decision for a novel, long-acting formulation of already approved ingredient (granisetron is currently marketed as Kytril), known as APF530 (long-acting granisetron) with a FDA decision expected 3/18/10 for this Section 505(b)(2) NDA
2.) Somaxon Pharma (NASDAQ: SOMX) ($4.11, $97 million): Silenor (doxepin) NDA is seeking approval for the treatment of insomnia. FDA has accepted its response as a Class I resubmission (60-day review period) for expected decision by 3/21/10.
3.) Cell Therapeutics (NASDAQ: CTIC) ($1.01, $580 million): Pixuvri (pixantrone) Injection has a PDUFA action goal date of 4/23/10 and advisory panel meeting scheduled for 3/22/10. This NDA is seeking approval of pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL), expects to file MAA in EU mid-2010, NerPharMa manufctg facility was approved by FDA 3/8/10.
4.) Ariad Pharma (NASDAQ: ARIA) ($3.32, $362 million): Pivotal, Phase 3 SUCCEED trial for oral ridaforolimus has an expected interim analysis around the end of 1Q10 with final data analysis expected 2H10 in patients with metastatic soft-tissue and bone sarcomas.
5.) AspenBio Pharma (NASDAQ: APPY) ($2.26, $85 million): AppyScore (blood-based diagnostic test appendicitis) clinical trial expected to complete enrollment in March and support a new 510(k) submission that may occur 2H10, contingent upon results in this study.
mikehavRx.com Index Updates is a premium service that provides investors with time-saving information and updates on unique global baskets of stocks that are organized and managed within the 18 HavRx Stock Indexes outlined below that are being tracked at the Investars YOU website since June 2009. Please visit <font> www.mikehavRx.com </font> for more details on my new publishing company, website, and premium service.
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