While the broad markets opened with the Dow down a few points and the Nasdaq up a few points, Pharmaceutical SmallCaps Trubion Pharmaceuticals (TRBN) soared this morning on news of a partnership deal with Facet (FACT), Eurand N.V. (EURX) soared on news of an FDA okay and Allos Therapeutics (ALTH) dropped on questions from the FDA about a trail in progress.
BigCap Tech stocks had positive Intel (NASDAQ:INTC) earnings to encourage the Dow and the Finance sector had AIG (NYSE:AIG) rising to $50 yesterday, but lackluster traders kept the market mixed and uncertain this morning and a 4-Month low in a confidence report released mid-session didn't help much, but when there's new money and FDA approvals, it doesn't much matter what everyone else is doing.
Gaining 58.75% ($2.25) this morning is Trubion Pharmaceuticals (TRBN) http://www.trubion.com/ which is currently trading on the Nasdaq in the $6.08 range. TRBN set a new market cap of $110 million. TRBN trades a mere 12,151 shares in its 3-Month average daily trading volume, but new investors (on today's news) pushed the volume past 130,615 shares by 11 a.m. EST.
The huge jump in trading volume and the astronomical share gain came on news today that TRBN has formed a joint, worldwide development and commercialization agreement with Netherlands pharmaceutical powerhouse Facet (FACT) for TRBN drug candidate TRU-016, currently in phase 1 clinical development for chronic lymphocytic leukemia.
TRBN, through this collaboration, can leverage and extend its development of protein therapeutics. The deal includes TRBN receiving $20 million upfront and. TRBN will also have access to an additional $176 million as trial milestones are met. TRBN and FACT will share equally the costs of all development, commercialization and promotional activities and all global operating profits. Also, FACT will buy 2,243,649 shares of newly issued Trubion common stock for an aggregate purchase price of $10 million.
The TRBN Trial Pipeline
TRBN focuses on drugs for the treatment of autoimmune and inflammatory diseases and cancer. TRBN The company, in a collaboration with Wyeth (WYE), is conducting a phase IIb clinical trial for its lead product candidate, TRU-015, for the treatment of rheumatoid arthritis. The TRU-016 drug mentioned above in phase II/II clinical evaluation and a novel CD37 targeted therapy for the treatment of B-cell malignancies, such as chronic lymphocytic leukemia and certain autoimmune and inflammatory disease indications.
TRBN also has a collaboration agreement with Wyeth for the development and commercialization of SBI-087 for the treatment of rheumatoid arthritis and SBI-087 for the treatment of systemic lupus erythematosus, as well as other therapeutics directed to CD20, an antigen that is a validated clinical target present on B cells.
At $6.08, TRBN is above its 52-week high of $5.46 set on 07-28-09 and above its 52-week low of $1.00 set on 12-09-08. At $6.08, TRBN is ahead of both its 50-day and 200-day moving averages. TRBN is widely held by insiders. It shares out versus float ratio is lopsided 18m/9m and I would like to see more shares in the public float.
As a precursor to the news on toady's gains by Eurand N.V. (EURX), I'd like to make mention of how difficult and delicate the process is when any drug, in any phase of a trial, is undergoing FDA scrutiny. The best example is a real one.
Losing as much as 8.49% ($0.66) this morning is Allos Therapeutics Inc., (ALTH) http://www.allos.com/ currently trading in the $7.21 range on the Nasdaq. ALTH has a new market cap of $642 million. ALTH has a 3-Month average trading volume of 838,477 shares and in mid-session today, it had topped 4,620,597 shares traded.
The ALTH value tumble came on news that an FDA advisory panel had questions about the ALTH lymphoma drug currently in trials. ALTH management maintains the drug offers meaningful benefit.
FDA reviewers claimed to have issues with the ALTH application to sell the drug Folotyn based on: 1) 'the clinical significance of tumor response and duration of response' and 2) 'whether the benefit/risk ratio is favorable'. ALTH is seeking approval of Folotyn for previously treated patients with peripheral T-cell lymphoma. The FDA panel will meet next Wednesday to talk it over. ALTH management said separately that Folotyn will help patients who have failed to respond to other therapies were in desperate need of better treatment options.
Never Kick Anyone When They're Down
Next week, the FDA could stall out the trial and more value losses could follow (depending on the news) however, the FDA could turn around next week and agree with ALTH management (in whole or even in part) and the stock could gain back its losses from today and skyrocket on the news.
The ALTH Trial Pipeline
ALTH has Pralatrexate, an antifolate under Phase II trial, which accumulates preferentially in cancer cells and treats patients with relapsed or refractory peripheral T-cell lymphoma, RH1, a small molecule chemotherapeutic agent, which is under Phase I trial to treat patients with advanced solid tumors and non-Hodgkin's lymphoma and Pralatrexate in various Phases for the treatment of non-Hodgkin's Lymphoma and Hodgkin's disease, cutaneous T-cell lymphoma, non-small cell lung cancer, bladder cancer, and other solid tumor indications.
At $7.21, ALTH is below its 52-week high of $9.95 set on 09-03-08 and above its 52-week low of $3.82 set on 10-10-08. At $7.21, ALTH is below its 50-day moving average and above its 200-day moving average. ALTH is widely held by institutions. Its shares out versus float ratio is close enough not to cause any worries about stability.
Gaining 10.78% ($1.45) on the 'approval' side of the FDA coin this morning is Eurand N.V. (EURX) http://www.eurand.com/ which is currently trading in the $14.87 range on the Nasdaq. EURX has a new market cap of $680 million. EURX has a 3-Month average daily trading volume of just 43,848 shares and that volume shot up over 245,620 shares this morning on FDA approval news.
EURX received FDA approval today for the drug Zenpep, a pancreatic enzyme product that treats the inability to digest food due to a lack of enzymes made by the pancreas. Zenpep is the only approved treatment for exocrine pancreatic insufficiency.
Zenpep, which was delayed by the FDA for three months to complete its review, has been approved with a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of the drug outweigh its risks. They do.
EURX plans to deploy its own sales force to market the product and expects to launch Zenpep in the fourth quarter of this year. The drug would come in four doses to meet the requirements of infants, toddlers, adolescents and adults.
EURX has EUR-1037, as an over-the-counter sleep-aid; EUR-1025, an oral formulation of ondansetron, an anti-emetic prescribed to prevent nausea and vomiting; and EUR-1073, an enteric coated, controlled release formulation of beclomethasone diproprionate for the treatment of inflammatory bowel disease. EURX also has Amrix, a sustained release formulation of cyclobenzaprine hydrochloride, used as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute and painful musculoskeletal conditions; and products and services to the cystic fibrosis community.
At $14.87, EURX is below its 52-week high of $18.93 set on 09-03-08 and above its 52-week low of $6.17 set on 12-01-08. At $14.87, EURX is ahead of both its 50-day and 200-day moving averages. EURX is widely held by insiders. The EURX shares out versus float ratio is lopsided 45m/9m and I would like to see more shares in the public float for stability.