FDA Lifts Hold On FLXN Study, All's Well With CPXX Trial, COMET Woes For EXEL

(RTTNews) - Baxter International Inc. (BAX) has submitted a biologics license application to the FDA for the approval of BAX 855, an investigational extended half-life, recombinant factor VIII (rFVIII) treatment for hemophilia A.

The submission is based on positive results from a prospective, global, multi-center, open-label, two-arm phase III study of 137 previously treated patients.

BAC closed Monday's trading at $72.87, down 0.18%.

Celator Pharmaceuticals Inc. (CPXX) has been asked by the independent Data and Safety Monitoring Board to continue with the pivotal phase III study of CPX-351 in acute myeloid leukemia.

The decision was taken after safety analysis of the first 225 randomized patients, out of a total of 309 patients who were enrolled in the study.

The company expects induction response rate analysis and secondary endpoint data to be available in the second quarter of 2015 while overall survival data, the study's primary endpoint, are expected in the first quarter of 2016.

CPXX closed Monday's trading 4.12% higher at $1.77.

Exelixis Inc. (EXEL) slumped more than 10 percent on Monday as its phase III study of Cabozantinib in men with metastatic castration-resistant prostate cancer did not meet its primary endpoint of alleviation of bone pain.

The study, known as COMET-2, is the second phase III trial from the COMET program. The first phase III trial of Cabozantinib in men with metastatic castration-resistant prostate cancer, dubbed COMET-1, had also failed to meet its primary endpoint of demonstrating a statistically significant increase in overall survival.

Cabozantinib, marketed under the trade name Cometriq, is approved by the FDA for the treatment of progressive, metastatic medullary thyroid cancer.

EXEL closed Monday's trading at $1.49, down 10.24%. In after-hours, the stock lost another 2.01% to $1.46.

Flexion Therapeutics Inc. (FLXN) is all set to immediately resume recruitment and dosing in its pivotal phase 2b trial of FX006 in patients with osteoarthritis of the knee, now that the FDA has lifted the clinical hold on the drug candidate.

The FDA had placed a clinical hold on the phase 2b trial on September 16, 2014 due to a single occurrence of an infection in the injected knee joint of a patient in the trial.

The removal of the clinical fold follows the company's submission of sufficient information to support that the study drug was not contaminated and that there was no compromise of sterility when administering the injection.

A phase III trial of FX006 is planned for early 2015.

FLXN closed Monday's trading at $16.25, down 5.25%.

Masimo Corp. (MASI) has received FDA clearance for its Radius-7 for the Root patient monitoring and connectivity platform, the first and only wearable, wireless monitor, which can alert clinicians - at the bedside or remotely - of critical changes in a patient's oxygen saturation and pulse rate while they are in bed or out.

In October of this year, the company revised its 2014 total revenue outlook downward to approximately $585 million from its prior guidance range of $588 million to $593 million.

MASI closed Monday's trading at $25.79, down 1.75%.

OncoMed Pharmaceuticals Inc. (OMED) has begun dosing in a phase II trial of Tarextumab in small cell lung cancer patients. The study, dubbed PINNACLE, is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients.

Another phase II trial of Tarextumab, known as the ALPINE study, in advanced pancreatic cancer patients is also underway.

OMED closed Monday's trading at $21.01, down 4.63%.

Otonomy Inc. (OTIC) has achieved the target enrollment of 140 patients in its phase 2b clinical trial of OTO-104 in patients with Ménière's disease. Results from this trial are expected in the second quarter of 2015.

Ménière's disease is a disorder of the inner ear characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness.

The company went public on The NASDAQ Global Select Market on August 13, 2014, priced at $16 per share.

OTIC closed Monday's trading at $25.37, up 5.66%.

With less than a month to the FDA decision on PA8140/PA32540 for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers, POZEN Inc. (POZN) and Sanofi US have mutually agreed to terminate their commercialization agreement.

POZEN had signed an exclusive license agreement with Sanofi US for the commercialization of PA8140/PA32540 tablets in the U.S. last September.

The NDA for PA8140/PA32540 is under FDA review, with a decision date set for December 30, 2014. The company also announced that the regulatory agency has provided preliminary approval for trade name 'YOSPRALA' pending approval of the PA8140/PA32540 NDA.

Considering Sanofi's exit, POZEN said it will be fully engaged in the near term evaluating strategic options available to the company.

POZN dropped 14.17% on Monday to close at $7.63.

Regeneron Pharmaceuticals Inc.'s (REGN) supplemental biologics license application for EYLEA, seeking approval for the treatment of diabetic retinopathy in patients with diabetic macular edema, has been accepted for priority review by the FDA, with a decision scheduled for March 30, 2015.

EYLEA is approved in the U.S. for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema.

REGN closed Monday's trading at $408.72, down 1.78%.

TG Therapeutics Inc. (TGTX) has initiated a multi-center, phase I trial to evaluate the safety and efficacy of the combination of TGR-1202 and *Ibrutinib for patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).

Ibrutinib, marketed under the name Imbruvica, is an oral Bruton's tyrosine kinase (BTK) inhibitor approved for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.

TGTX slipped 9.38% on Monday to close at $13.52.

Thoratec Corp. (THOR) has completed enrollment in the HeartMate III CE Mark trial, reaching the target of 50 patients at ten sites across Europe, Canada, and Australia.

According to the company, the CE Mark trial will evaluate patient survival with a six-month follow up period, which will be reached in May 2015. Thoratec continues to expect regulatory submission of CE Mark data next year, with an approval and commercial launch in late 2015.

In the third quarter ended September 27, 2014, Thoratec reported revenues of $105.8 million, a 16 percent decrease from the comparable year-ago quarter.

Looking ahead, the company expects 2015 to be something of a transition year as it seeks to ultimately reaccelerate market growth.

THOR closed Monday's trading at $31.61, up 1.35%.

Vascular Solutions Inc. (VASC) has received FDA clearance for its Turnpike catheters for use in complex coronary and peripheral interventions. The company expects to launch the product next month.

VASC closed Monday's trading at $26.05, up 1.28%.