GTXI is developing enobosarm (Ostarine®;GTx-024), a selective androgen receptor modulator, or SARM, for the prevention and treatment of muscle loss in patients with non-small cell lung cancer and for other muscle wasting diseases.
Monday, the company announced that as per protocol safety review of unblinded safety data on Friday April 12, 2013, by an independent Data Safety Monitoring Board (DSMB), resulted in a determination that GTx continue as planned its two pivotal Phase III clinical trials of enobosarm.
As everyone is aware, this is big news. Combined with the fact that the FDA, on January 8th, has granted Fast Track Designation to enobosarm. This expedites the FDA review process to 60 days and confirms that Enobosarm has the potential to fill an unmet medical need.
Citi is aware of the potential of this drug, and that is why Citi had raised its price target on GTXI from $8 to $19. Citi even estimated that positive results from the phase 3 data alone would be worth $11/share to potential biopharma company bidders. In the note, Citi stated that GTXI is "currently one of the most compelling small-cap biotech companies.
Topline data from the studies should be released during the third quarter of 2013. I believe that the recent Macro events has presented an unbelievable opportunity for investors. I anticipate an uptrend from now until phase 3 results, to around $8.00 per share and a share price of $12.00 per share upon positive results.
Trius Therapeutics (TSRX) is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious, life-threatening infections.
Tedizolid phosphate (TR-701) is an IV and orally administered second generation oxazolidinone for the treatment of serious gram-positive infections, including methicillin-resistance Staphylococcus aureus (MRSA).
Acute bacterial skin and skin structure infections (ABSSSI), a new FDA classification for complicated skin and skin structure infections (cSSSI), are a significant and growing problem throughout the world.
ABSSSI are infections that involve deeper tissue or require surgical intervention (e.g. cellulitis, major cutaneous abscesses, and infected wounds) or are associated with a significant underlying disease (e.g., diabetes or systemic immunosuppression) that complicates response to therapy. A variety of pathogens may be identified in ABSSSI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of MRSA in community as well as hospital acquired infections has resulted in a need for therapy of ABSSSI that is effective against MRSA.
The recent phase 3 results met primary and secondary endpoints. Now we await the company to file an NDA (New Drug Application), which should be in August- September.
Analysts have also recently weighed in on TSRX. Zacks reiterated an outperform rating on shares of Trius Therapeutics in a research note recently. They have a $12.00 price target on the stock. Also, analysts at Piper Jaffray reiterated an overweight rating on shares of Trius Therapeutics in a research note. They now have a $11.00 price target on the stock. Analysts at Aegis have their price target on shares of Trius Therapeutics at $14.00 in a research note to investors on Thursday, January 24th, with a buy rating on the stock.
Nine research analysts have rated the stock with a buy rating, and one has given an overweight rating to the company. TRSX presently has an average rating of buy and an average price target of $11.50.
For investor looking for big gains in the short term, GTXI and TSRX present compelling opportunities to more than double your money. The companies are attractive speculative picks for potentially high returns. These 2 stocks could be your biggest gainers for 2013.
Disclosure: I am long GTXI. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.