Three Biotech Stocks With Pending News Developments, Catalysts

by: M. E. Garza

As always, we are chasing several stories and hearing whispers that may be of interest to readers. The first of these involves Access Pharmaceuticals, Inc. (OTCQB:ACCP-OLD). The word on the street is that the company is getting ready to announce its first commercial order for MuGard. The order should bring the company close to $1 million in revenue and could come as part of that exclusive specialty distribution deal that Access signed with BioScrip (NASDAQ:BIOS) in July. Access has been given comprehensive access to BioScrip's nationwide distribution platform, which includes extensive physician relationships, over 100 specialty pharmacies, a mail distribution network and more. If the rumor is true, this will be a significant step for Access, because it will mark a new phase for the company.

Patients who have been waiting for this FDA-approved oral wound rinse will be the real winners, of course. MuGuard has been used by many very effectively for the management of oral mucositis, a painful inflammation and ulceration of the mucous membranes which is a debilitating side effect of radiation treatment and chemotherapy. Zacks Investment Research recently issued an update summarizing some of the recent positive developments at Access and they reiterated an 'Outperform' rating with a six-twelve month price target of $8.00. The stock closed Monday's session at $1.95 +0.02 (1.04%) and charts show a 52-week high of $3.70.

Don't forget that long-awaited good news may be coming for Cleveland BioLabs (NasdaqCM: CBLI). As you may remember, the company has been developing and getting ready to commercialize their products for human protection against radiation - which have applications not only in national defense, but in oncology as well. Those two big shots on goal with little or no competition make CBLI one of my favorite plays. The company is waiting for word on some significant government funding and as they pointed out during Monday's presentation at the Rodman & Renshaw 12th Annual Healthcare Conference. Throughout its funding history, the company has raised nearly as much money from capital markets ($56 million) as it has through federal grants and contracts ($50 million).

When the stock was at $3.61 last month, we told our readers that during the first quarter of this year, the company had submitted additional paperwork about Protectan CBLB502 (a radioprotectant molecule with multiple medical and defense applications for reducing injury from acute stresses, such as radiation and chemotherapy) to the U.S. Government's Department of Defense. The stock spiked up to $4.50 before closing at $4.36 Monday and the price rise will likely continue because Wall Street believes that the company has the best chance of not only getting significant funding via that the DoD initiative, but that CBLI will get an even bigger order from the Biomedical Advanced Research and Development Authority (BARDA), who is reportedly interested in acquiring doses of the drug for the Strategic National Stockpile. In addition, the stock could rise significantly higher due to subsequent developments and orders coming in from foreign government contracts. In fact, Israel is said to be waiting in line behind the U.S. If those catalysts start to take place, you will see this stock starting to trade at much higher levels going forward.

The stock reminds me of Human Genome Sciences' (NASDAQ:HGSI), which I covered before their big price spike in the fall of 2009- while it was trading at only $3.03. You can see CBLI's Rodman & Renshaw conference presentation here.

Remember also that Chelsea Therapeutics (Nasdaq: CHTP) is scheduled to present at the Rodman & Renshaw 12th Annual Healthcare Conference this Wednesday at 11:40 AM ET. As we first told our subscribers in late August when the stock was trading at around $3.50, investors are anxiously awaiting news from CHTP’s pivotal Phase 3 trial with results due sometime this month. CHTP is currently completing work on Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Their latest PR regarding the study points to a results announcement sometime this month. Remember also that Chelsea has said that Study 302 would have received FDA approval, if they'd been using the new endpoints. This reaffirms our belief that Study 301 will show significant results in NOH. The stock closed at $ 4.04 following Monday's session after spiking as high as $4.26 following our initial report.

Disclosure: Long CBLI, CHTP