Biopharmaceutical Stocks: Possible Catalysts in December (Part I)
Jorge is a member of The Motley Fool Blog Network -- entries represent the personal opinion of the blogger and are not formally edited.
A good investment strategy is to anticipate future movements of biopharmaceutical companies. These companies are typically reevaluated weeks before presenting results of their studies or future meetings with the FDA.
The first company that present an important results of thier studies is Celldex Therapeutics (NASDAQ: CLDX). On Nov. 1, 2012 the company announced that present more mature data from the Emerge phase IIb study at the San Antonio Breast Cancer Symposium in December 2012. Emerge or CDX-011 is a study for metastatic breast, currently in Phase IIb. The conference of San Antonio Breast Cancer Symposium is from Dec. 4 to Dec. 8 in 2012.
The Emerge study (CDX-011 or glembatumumab vedotin compound) is an antibody drug conjugate that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin. The antibody drug conjugate technology, comprised of MMAE and a stable linker system for attaching it to CR011. The Emerge study (CDX-011) was licensed from Seattle Genetics.
The stock currently trades at $6.16, with a market capitalization of $381.58 million. The 52-week high is $6.71 and 52-week low is $2.53. A positive results on the Emerge study in phase IIb could catapult shares of Celldex to the 52-weeks high. Celldex Therapeutics like to Oppenheimer Analysts. On Oct. 2, 2012 Oppenheimer's analyst said:
As a reminder, interim results for the EMERGE study of CDX-011 were reported in May. Assuming that the final results in December are consistent with the interim data, we anticipate significant partner interest in this compound.
Oppenheimer analyst isn't the only one who likes Celldex; On Jun. 1, 2012 ThinkEquity announced that it initiated coverage on Celldex Therapeutics with a Buy. In those days, ThinkEquity marked a price target at $7.00.
Zogenix Inc (NASDAQ: ZGNX) is the second company that can be a catalyst in December. On Nov. 8, 2012 The company announced that the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) will review NDA for Zohydro ER.
The review NDA date is on December 7, 2012. Zohydro ER is a product candidate for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The stock currently trades at $2.46 with a market capitalization of $251.66 million. The 52-week high is $3.30 and 52-week low is $1.31, but the shares of this company could explode if the FDA approves the NDA for Zohydro ER.
Alexza Pharmaceuticals (NASDAQ: ALXA) is another company that can be a catalyst in December. It is a pharmaceutical company that engages in the research, development, and commercialization of novel proprietary products for the acute treatment of central nervous system conditions worldwide. The company announced on July. 5, 2012, that the FDA has accepted the Company's resubmitted Adasuve NDA as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of December 21, 2012. The stock currently trades at $5.61 with a market capitalization of $88.01 million. The 52-week high is $11.50 and 52-week low is $2.55. If the FDA approves NDA to Adasuve, the shares could soar above the 52-weeks high in $11.50.
The readers should know the risk of investing in these companies. For example, we can analyze the last similar case with the company Dynavax Technologies Corporation (NASDAQ: DVAX). It is a biopharmaceutical company, that discovers and develops novel products to prevent and treat infectious and inflammatory diseases. On Nov. 15, 2012 the company announced that the FDA Vaccines and Related Biological Products Advisory Committee voted 13 to 1 that Heplisav data adequately demonstrated immunogenicity. But, the same Committee voted 8 to 5 with 1 abstention that there was insufficient data to adequately support the safety of Heplisav.. For this last reason, the shares fell by more than 48% to $2.22 on Nov. 16 2012.
Jorge Aura has no positions in the stocks mentioned above. The Motley Fool has no positions in the stocks mentioned above. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. Is this post wrong? Click here. Think you can do better? Join us and write your own!
