Wednesday's Bio Pharma Drug Approval And Catalyst Watch List

 |  Includes: AMRN, IBIO, LXRX, MNOV, PLX
by: StockMatusow

Yesterday after the Bell, Protalix (NYSEMKT:PLX) received approval from the FDA for its drug Elelyso, (taliglucerase alfa) which is a proprietary plant cell expressed recombinant Glucocerebrosidase enzyme for the treatment of a rare genetic disorder called Gaucher disease. Gaucher disease is estimated to affects about 6,000 people in the U.S.

Shares of PLX rallied as high as $7.80, up $0.85 cents from Monday's close, and well over 1.00 from Tuesday's trading session intra-day lows. immediately after receiving the good news.

On a related note, shares of iBio (NYSEMKT:IBIO) rallied as high as $1.80, up 0.30 cents from Monday's close, and up nearly $0.50 cents from its intra-day low during the trading session on Tuesday.

In a full feature article I wrote on IBIO, I remarked how IBIO uses a similar technology to PLX, but focuses its platform called "iBioLaunch" more towards creating vaccines for potential pandemic and epidemic out breaks.

Because of the related technology platform, there exists a catalyst relation between both companies. The main difference between both of the company's technology is Protalix is producing proteins using plant cells, but in isolation. PLX uses poly bio reactors and derivative of carrot cells in isolation. IBIO uses no bio reactors as the plant is the reactor. IBIO has much less CAPEX and quicker growth from start to finish with higher yields due to the patented vectors delivering DNA to plants to grow the proteins.

In my opinion, IBIO has more upside percentage gain potential than PLX now and in the future, and should break over $2 dollars a share soon, if not higher.

Amarin Corporation (NASDAQ:AMRN) PDUFA date July 26, 2012 for AMR101 in patients with very high triglycerides. In another article I wrote, I misstated concerning AMR101, and compared it to Lipitor. This was erroneous on my behalf as Lipitor is used to mainly treat patients high cholesterol levels, while AMR101 is more in line to compete with Lovaza, which also focuses on patients with elevated triglyceride levels. AMR101 if approved should compete well in a market space well over 1 billion dollars.

I still maintain that Amarin is not a buy-out target for a larger pharma, and this is actually good news for long term investors in Amarin. It's my opinion the Amarin stock price in 3 years will be much higher than any buy out offer it might receive now, if AMR101 gains FDA approval, and I believe it will.

My only real negative with the company is that I am not thrilled with the CEO, but he seems competent enough in my opinion. However, the man just needs to stop advertising that his company may be for sale. This is a good way to lose leverage in any possible negotiation which a larger pharma could use to try to get a cheaper price, which in turn would hurt investors in the company. Translation; he needs to be quiet. It is my opinion that at $12.21 a share, Amarin is a good value.

MediciNova (NASDAQ:MNOV) is expecting Phase 2B preliminary data of MN-221 for treatment of acute exacerbations of asthma by the end of the current month. MN-221 is used to treat asthma when patients see little to no benefit from standard inhalers.

Chief Business Officer, Michael Coffee in an interview with, said that if the data comes in positive (and he hints at this) MNOV then plans to engage a Phase 3 pivotal trial by the end of this year. The 2006 global asthma market data showed 15 billion dollars in sales, so this is a rather large market space. I expect the data to confirm, and for MNOV to partner this drug with a large pharma afterwards.

Also expected in June is the data from a Phase Ib multi-dose trial in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). MNOV has double catalysts upcoming it appears.

Institutions as well have bought a decent amount of shares as of late with MNOV. I expect a run-up to start within the next 2 weeks before the data is revealed. I am also working on a feature article for 3 sites about MNOV for a Thursday-Friday release date. At $2.83 a share, no debt on the books, and a market cap under 50 million, MNOV is highly undervalued, and should be selling for near $4 a share. I would not be surprised to see a $4 a share price after the data on MN-221 is released.

Lexicon Pharma (NASDAQ:LXRX) Phase 2b top-line data of LX4211 in patients with Type 2 diabetes due by mid-2012. Data from its dose-ranging study of LX2931 in rheumatoid arthritis patients, due 2Q 2012

Also, in March of this year, the FDA granted Lexicon Orphan Drug designation for telotristat etiprate (LX1032) for the treatment of carcinoid syndrome. Carcinoid syndrome is a chronic condition caused by neuroendocrine tumors that usually originate from the gastrointestinal tract and is characterized by severe diarrhea and flushing episodes with long-term consequences that may include cardiac valve disease. $1.65 a share seems reachable with LXRX in the short term.

I have made a supplemental YouTube video for this article. Just click on the link to view my video.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in MNOV over the next 72 hours.