ATRS Hits A High, CNDO's TRUST Fails, KOOL Has Some Hot News, MNKD, PLX On Watch

(RTTNews) - Antares Pharma Inc. (ATRS) touched a new 52-week high of $5.15 on Monday before closing at $4.69, following FDA approval of the company's OTREXUP Injection for adults with rheumatoid arthritis, children with polyarticular idiopathic arthritis, and adults with psoriasis.

Coronado Biosciences Inc. (CNDO) fell nearly 70 percent to a new low of $1.73 on Monday before closing at $1.91 following the failure of its phase II clinical trial, evaluating TSO (Trichuris suis ova or CNDO-201), in patients with moderate-to-severe Crohn's disease.

According to the company, the trial, dubbed TRUST-I, neither met its primary endpoint of improving response, defined as a 100-point decrease in the Crohn's Disease Activity Index (CDAI), nor the key secondary endpoint of remission, defined as achieving CDAI < 150 points.

The results from a second interim analysis of another phase II trial of TSO, dubbed TRUST-II, are expected in the fourth quarter of 2013.

Covidien plc (COV) said that its EverFlex self-expanding stent, which is approved for use in the superficial femoral artery and/or the proximal popliteal artery, demonstrated a low need for repeat procedures (revascularization of treated lesions) as well as a low rate of stent breakage (fracture rate) in a post-approval study, dubbed DURABILITY II.

In another study, dubbed DEFINITIVE AR (Anti-Restenosis), designed to address the challenge of preventing restenosis (re-narrowing of a blood vessel following treatment), a common occurrence in patients with peripheral artery disease, early results showed that physicians are achieving better acute procedural success when treating patients with directional atherectomy plus anti-restenotic therapy (DAART) versus using a drug-coated balloon alone.

COV closed Monday's trading at $61.76, up 0.68%.

MannKind Corp. (MNKD) has resubmitted a new drug application to the FDA seeking approval of AFREZZA Inhalation Powder to improve glycemic control in adults with type 1 or type 2 diabetes.

MNKD closed Monday's trading at $5.29, up 3.52%. In after-hours, the stock gained another 0.38% to $5.31.

Portola Pharmaceuticals Inc. (PTLA) said that its investigational Factor Xa inhibitor antidote, Andexanet alfa, administered in healthy volunteers who received the Factor Xa inhibitor anticoagulant Eliquis demonstrated a rapid and nearly complete reversal of the anticoagulation effect in a phase 2 proof-of-concept study.

Currently, there is no antidote or reversal agent approved for use against Factor Xa inhibitors. The company plans to initiate pivotal studies of Andexanet alfa in 2014.

PTLA closed Monday's trading at $22.21, down 1.77%.

Protalix BioTherapeutics Inc. (PLX) said that its investigational oral glucocerebrosidase or Oral GCD (PRX-112) was well tolerated in patients with Gaucher disease in a phase I trial. In addition, the active enzyme was detected in patients' blood circulation.

Oral GCD is an orally available form of the plant cell-expressed enzyme, glucocerebrosidase or GCD, which is the same active substance as the company's approved enzyme replacement therapy, ELELYSO. Oral GCD is an active form of human glucocerebrosidase which is naturally encapsulated within the carrot cells in which it is produced.

The trial has been extended to enroll and evaluate additional Gaucher patients with low platelet counts, and the amended study is expected to conclude during the fourth quarter of 2013.

PLX closed Monday's trading at $4.38, up 2.58%.

After having conducted a rigorous assessment of all strategic options, Savient Pharmaceuticals Inc. (SVNT) has elected to file voluntary petitions under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware.

The company has also filed a motion seeking authorization to pursue a sale process under Section 363 of the U.S. Bankruptcy Code, and has entered into an acquisition agreement with a "stalking horse" bidder, Sloan Holdings C.V., a subsidiary of US WorldMeds LLC.

Savient expects a final sale approval hearing to take place shortly after the auction with the anticipated closing to occur by the end of 2013.

A clinical case study has shown that Acute Myocardial Infarction Rapid Stem Cell Therapy protocol, a combination product and procedure developed by TotipotentRX, incorporating ThermoGenesis Corp.'s (KOOL) cell processing technology, has achieved its primary safety and secondary efficacy endpoints by improving the patient's Left Ventricular Ejection Fraction ("LVEF") from 35% to 60.3% in 24 months while preventing further infarct scarring and undesirable remodeling.

KOOL closed Monday's trading at $1.12, up 8.21%.

Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time.

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