BEAT Upbeat, COLL Gets Final FDA Nod, CPRX Crushed

(RTTNews) - BioTelemetry Inc. (BEAT) has reported revenue of $48.6 million for the first quarter ended March 31, 2016, which is the highest quarterly revenue in the company's history, and a 12% increase over prior year.

The adjusted net income for the first quarter of 2016 is $5.76 million or $0.20 per share compared to adjusted net income of $1.79 million or $0.06 per share in the year-ago quarter.

The company's profit and revenue were well above analysts' consensus estimate of $0.10 per share and $46.54 million, respectively.

Looking ahead, BioTelemety has increased its 2016 EBITDA guidance to be in the range of $42 million to $44 million.

BEAT closed Tuesday's trading at $12.52, up 1.62%.

Shares of Catalyst Pharmaceuticals Inc. (CPRX) sank over 49% on Tuesday as there is going to be a delay in resubmission of the company's New Drug Application for Firdapse for the treatment of Lambert Eaton myasthenic syndrome and congenital myasthenic syndromes.

Lambert Eaton myasthenic syndrome and congenital myasthenic syndromes are ultra-rare diseases with prevalences in the United States believed to be approximately 3,000 and 1,000-1,500 patients, respectively.

The company was issued a "Refusal to File" letter for its New Drug Application for Firdapse in February of this year. The "Refusal to File" letter stated that the NDA submitted in December 2015, was not sufficiently complete, and required additional supporting information.

In order to obtain greater clarity regarding the additional information required for acceptance of the NDA filing, Catalyst recently met with the FDA to seek guidance. Accordingly, the company has been asked to conduct an additional clinical study for Firdapse.

The FDA has stated that it is open to discuss a study design that could efficiently accomplish the requirement with a small, short-term study. Additionally, there is a requirement for several more short-term toxicology studies, which are expected to start soon, noted the company.

CPRX closed Tuesday's trading at $0.63, down 49.19%.

Celsion Corp.'s (CLSN) ongoing global phase III study evaluating ThermoDox in combination with radiofrequency ablation standardized to 45 minutes (sRFA) versus sRFA alone to treat newly diagnosed patients with primary liver cancer has enrolled the first patient in China.

The study, dubbed OPTIMA, is expected to enroll up to 550 patients globally.

Celsion aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application, assuming positive clinical results.

CLSN closed Tuesday's trading at $1.53, down 1.29%.

Collegium Pharmaceutical Inc.'s (COLL) Xtampza ER, which was granted tentative approval by the FDA last November, for the management of pain severe enough to require daily, around the clock, long term opioid treatment and for which alternative treatment options are inadequate, has received the final regulatory approval.

The FDA granted tentative approval then because though Xtampza met the required quality, safety and efficacy standards for approval, it was subject, at that time, to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue in March 2015.

However, with the District Court of Massachusetts entering a judgment in Collegium's favor in February of this year, the automatic stay has expired resulting in final approval.

COLL closed Tuesday's trading at $18.43, down 2.18%. In after hours, the stock was up 13.67% to $20.95.

Pfizer Inc.'s (PFE) phase III cardiovascular outcome trial of its investigational agent Bococizumab, dubbed SPIRE-2, has completed patient enrollment.

SPIRE-2 is evaluating the efficacy and safety of Bococizumab compared to placebo in reducing the risk of major cardiovascular events among approximately 10,600 patients at high risk for cardiovascular disease - including those without a prior history of cardiovascular events - who are on highly-effective statins or with documented statin intolerance.

The SPIRE-2 study is expected to complete in the second half of 2017.

PFE closed Tuesday's trading at $33.05, down 0.48%.

Rockwell Medical Inc's (RMTI) iron maintenance drug Triferic has been approved by the FDA to be sold as Triferic Powder Packet to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.

Triferic, in liquid ampule formulation, was first approved by the FDA last January for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

Commenting on the new presentation, Robert Chioini, Founder, Chairman and CEO of Rockwell said, "The Triferic powder packet is similar to the size of a packet of sugar. It is much smaller and lighter than the current Triferic liquid ampule and it enables us to place three-times greater the number of units in an even smaller carton. This presentation is much more convenient for customers as it reduces storage space and requires fewer reorders to maintain inventory. We expect it to be commercially available shortly."

RMTI closed Tuesday's trading 6.59% higher at $9.71.