As a follow-up to my most recent article
on the buyout binge among bio-pharma and diagnostic companies, below is a basket of 20 stocks (listed randomly) to consider from the ETF Innovators Indexes of 250 companies which represent a mix of pending catalysts in the form of clinical trials or FDA decisions, innovative patent portfolios or drug discovery technology platforms, promising compounds in clinical development, and marketed therapeutic or diagnostic products. Click on any of the company names for links to all of my previous articles for those I have mentioned previously. Emerging Diagnostic Index
: Average loss of 63.2%, including 39 companies with average market cap of $50M
Emerging Bio-Pharma Index: Top 40 Rated Companies
Emerging Bio-Pharma Index: 36 Additional Companies Micro-Cap Bio-Pharma Index
: 130 companies with an average loss of 43.6% in past year and average market cap of $58M AspenBio Pharma
(APPY) – APPY has pending results for the world's first blood-based appendicitis screening test, AppyScore, which will support a 510(k) filing with the FDA for marketing clearance if positive. BioDelivery Sciences
(BDSI) – Onsolis approval is possible by mid-2009 and the Company recently raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + a $3M advance of the $30M milestone payment upon FDA approval. Momenta Pharma
(MNTA) – MNTA represents a pure-play on the future of bio-generics and is developing a mix of proprietary compounds, follow-on-biologics, and has pending ANDAs for blockbuster, complex products including Lovenox and Copaxone in partnership with Sandoz division of Novartis (NVS). Electro-Optical Sciences
(MELA) – MELA has pending clinical trial results for MelaFind diagnostic screening test for melanoma, which will support a FDA application if positive.
OraSure Technologies (OSUR) – OSUR is a leader in oral fluid diagnostic testing, with a pending FDA application for its hepatitis C (HCV) test with Schering-Plough (SGP) and is also developing an over-the-counter oral fluid test for HIV. Discovery Labs
(DSCO) – DSCO has a mid-April PDUFA decision date for Surfaxin after several previous delays due to manufacturing issues raised by the FDA. Cytori Therapeutics
(CYTX) – An innovator in the field of regenerative medicine which is already marketing its products in Asia and Europe based on the Celution System for breast reconstruction procedures and stem cell banking applications from a patient's own fat tissue. Caraco Pharma
(CPD) – CPD has more than doubled from its low around 3 bucks, but is still cheap at current levels and is poised to return into double digits once resolving the manufacturing issues outlined in a FDA warning letter last year.
Dendreon (DNDN) – DNDN represents the ultimate biotech binary trade for 2009 with Provenge clinical trial results expected around mid-year which will either send the stock soaring or tumbling. Javelin Pharma
(JAV) – JAV has surged nearly four-fold from a low of 40 cents late last year as the victim of forced liquidation and panic selling since reporting positive Phase 3 results for Dyloject, which will support an application for FDA approval in 2H09. Dyloject is already on the market in Europe and the Company is engaged in partnership discussions for the product, along with another late-stage pipeline candidate Ereska.
SuperGen (SUPG) – SUPG has more than doubled from its low of $1.11, driven down by disappointing data for cancer drug Dacogen compared to Celgene's rival drug Vidaza. However, SUPG boasts a robust, early-stage cancer drug pipeline + discovery platform and the current price around $2.50 includes zero debt and about $1.50 per share in cash.
Clarient (CLRT) – CLRT is a play on personalized medicine through its diagnostic and clinical lab services, which are focused on improving the treatment outcomes for cancer therapeutics. Nanosphere
(NSPH) – NSPH recently filed 510(k) applications with the FDA for two new diagnostic products, including a cystic fibrosis assay and an infectious disease panel for respiratory viruses (influenza + respiratory syncytial virus or RSV). Home Diagnostics
(HDIX) – HDIX manufactures value-priced blood glucose monitors and testing supplies, which are sold through a variety of channels, including mail order, retail pharmacies, and medical wholesalers. Osiris Therapeutics
(OSIR) – OSIR is a leader in regenerative medicine, which signed a major deal with Genzyme (GENZ) last year and has pending clinical trial results later this year for Prochymal. Cypress Bioscience
(CYPB) – CYPB has attracted the attention of stock and option investors lately in anticipation of a FDA decision for milnacipran in the treatment of fibromyalgia – with no clear indication of a decision date, but 1/18/09 represents a three-month delay from the original PDUFA date.
Vivus (VVUS) – VVUS has nearly 3 bucks per share in cash, negligible debt, and is trading around 5 bucks with pending data from two Phase 3 clinical trials of weight loss drug Qnexa expected in mid-2009.
Isis Pharma (ISIS) – ISIS is expected to report Phase 3 data around mid-year for mipomersen in the treatment of patients with a genetic disorder that leads to very high levels of LDL (bad) cholesterol. AMAG Pharma
(AMAG) – AMAG received a second complete response late last year for Feraheme, but it appears that no new issues were raised by the FDA and the Company may not be required to issue another response to the agency as it may only required more time for the FDA to review AMAG's original response last October.
Acorda Therapeutics (ACOR) – ACOR is expected to submit a NDA to the FDA during 1Q09 for fampridine SR in the treatment of walking disabilities due to multiple sclerosis.