CRY Has A Reason To Smile, MDXG Lifts Outlook, MYL Rejects Teva Bid

(RTTNews) - BioMarin Pharmaceutical Inc. (BMRN) has completed the rolling submission of a New Drug Application to the FDA for Drisapersen for the treatment of Duchenne Muscular Dystrophy.

Drisapersen has been granted Orphan and Fast Track status, as well as Breakthrough Therapy designation by the FDA.

The company intends to also submit an application for registration in the European Union in summer 2015.

BMRN closed Monday's trading at $116.97, down 2.75%.

CryoLife Inc. (CRY) has resolved the FDA warning letter that was issued to the company in January 2013 related to its manufacturing facility and headquarters in Kennesaw, GA.

With the company successfully implementing corrective actions, the regulatory agency has now issued a close-out letter confirming that the company's remediation activities are effective and its quality management system is in substantial compliance.

CRY closed Monday's trading at $9.99, down 1.87%.

MannKind Corp. (MNKD) is all set to manufacture a 12 unit cartridge strength of AFREZZA (insulin human) Inhalation Powder to improve glycemic control in adult patients with diabetes. The 12 unit cartridge was approved by the FDA on April 17, 2015 and is expected to be launched by Sanofi (SNY) in the second half of 2015.

The new dosage strength complements the existing 4 unit and 8 unit cartridges and will provide patients with another option to receive their prescribed dose, MannKind noted. Approved by the FDA last June, AFREZZA was launched in the U.S. as recently as February of this year.

MNKD closed Monday's trading at $4.59, down 4.38%. In after-hours, the stock was up 0.65% to $4.62.

Shares of MiMedx Group Inc. (MDXG) were up more than 5% in after-hours trading on Monday after the company posted better-than-expected first-quarter earnings and raised its full-year revenue outlook above analysts' consensus.

For the first quarter of 2015, net income was $4.1 million or $0.04 per share on revenue of $40.8 million. This compares with a net loss of $922 thousand or $0.01 per share and revenue of $19.6 million in the year-ago quarter. Analysts polled by Thomson Reuters had projected earnings of $0.03 and revenue of $40.84 million.

Looking ahead to full year 2015, the company now expects revenue in the range of $180 million to $190 million compared to its previous forecast range of $175.0 million to $190.0 million. Wall Street is looking for revenue of $186.01 million for the year.

MDXG closed Monday's trading at $9.46, down 3.52%. In after-hours, the stock was up 5.60% at $9.99.

While Mylan N.V. (MYL) has spurned a cash-and-stock acquisition offer from Teva Pharmaceutical Industries Ltd. (TEVA) for $82.00 per share, Teva remains committed to complete the transaction. Teva said that the offer is compelling for both Teva and Mylan stockholders.

MYL closed Monday's trading at $71.72, down 5.71%.

RedHill Biopharma Ltd. (RDHL) has completed patient enrollment in the first phase III clinical study of RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection. Top-line results from the phase III study are expected in mid-end June 2015.

RDHL closed Monday's trading at $14.84, up 0.95%.

ZIOPHARM Oncology Inc. (ZIOP) has initiated a phase 1b/2 study of its gene therapy candidate Ad-RTS-hIL-12 in combination with another experimental drug Veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer.

The primary study objective is to evaluate the safety and tolerability of Ad-RTS-hIL-12 immunotherapy. Secondary objectives include overall response rate, disease control rate and impact of treatment on tumor and serum immune biomarkers.

ZIOP closed Monday's trading at $9.81, down 9.25%. In after-hours, the stock was up 1.83% at $9.99.