FPRX Gets High Five, CLRX Put On Notice, RNA Snapped Up, Natesto Changes Hands

(RTTNews) - Aastrom Biosciences Inc. (ASTM) has changed its name to Vericel Corp. and ticker to "VCEL", effective immediately. The company's common stock will begin trading under its new stock ticker symbol "VCEL" on November 25, 2014, at market open.

In conjunction with the change, the company has moved its headquarters to Cambridge, Massachusetts, site of its commercial manufacturing facility.

Cepheid (CPHD) has received FDA clearance to market its Xpert Flu/RSV XC, an on-demand molecular test for accurate and reliable determination of Flu A, Flu B, and differentiation of Respiratory syncytial virus infection.

The shipment of Xpert Flu/RSV XC is expected to begin in early December.

Last month, the company increased its forecast for the year. As per the revised guidance, total revenue is estimated to be in the range of $461 million to $465 million, net loss per share between $0.54 to $0.52 and non-GAAP net income to range between $0.11 and $0.13 per share.

CPHD closed Monday's trading at $54.25, up 2.77%.

CollabRx Inc. (CLRX) has been issued a notice of bid price deficiency by the NASDAQ as the company's stock for the last 30 consecutive business days had closed below the minimum $1.00 per share.

The company has been provided a grace period of 180-calendar days, or until May 18, 2015, to regain compliance with the minimum bid price requirement.

CLRX closed Monday's trading at $0.80, up 5.26%.

Endo International plc (ENDP) (ENL.TO) has acquired rights to Natesto testosterone nasal gel from Trimel BioPharma SRL, a wholly-owned subsidiary of Trimel Pharmaceuticals Corp. (TRL.TO) for an upfront payment of $25 million.

Natesto, approved by the FDA in May of 2014, is the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism.

Trimel, which will be responsible for the manufacture and supply of Natesto, is entitled to receive a tiered supply price for the product from Endo and additional payments upon the achievement of certain regulatory and sales milestones.

Endo expects the transaction to close in early 2015.

ENDP closed Monday's trading 3.28% higher at $72.50. TRL.TO closed at C$0.56, up 21.74%.

Shares of Five Prime Therapeutics Inc. (FPRX) rose more than 31 percent on Monday after the company announced that it has established a second collaboration with Bristol-Myers Squibb Co. (BMY) in the area of immuno-oncology.

Under the terms of the collaboration, a phase 1a/1b study will evaluate the combination of Bristol-Myers' drug candidate Opdivo and Five prime's investigational drug FPA008 as a potential treatment option for patients with non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.

Bristol-Myers will make a one-time payment of $30 million to Five Prime and will be responsible for study costs. Five Prime will conduct the clinical trial, which is expected to begin in 2015.

The first collaboration agreement between Five Prime and Bristol-Myers was signed in March of this year to discover novel immuno-oncology therapies for two immune checkpoint pathways.

FPRX closed Monday's trading 31.43% higher at $20.70.

IGI Laboratories Inc. (IG) has submitted an additional abbreviated new drug application to the FDA, which brings the company's total number of ANDA submissions in 2014 to seven.

The company now has eighteen ANDAs pending approval and on file with the FDA, in addition to four more ANDAs pending approval under joint development agreements with its partners.

IGI Labs plans to file another three to four ANDAs before the end of 2014.

IG closed Monday's trading at $9.47, up 0.96%.

Ocata Therapeutics Inc. (OCAT.OB) has been granted Advanced Therapy Medicinal Product designation for its RPE therapy for macular degeneration by the European Medicines Agency.

The RPE, or retinal pigment epithelium, is a highly specialized tissue that is located between the choroids and the neural retina.

Ocata reported positive results from phase 1/2 clinical trials of RPE cells for the treatment of Stargardt's macular degeneration and dry age-related macular degeneration last month.

The company is preparing to dose the first patient in a phase II trial for Stargardt's patients by the end of this year.

Formerly known as Advanced Cell Technology Inc., it was only as recently as November 14, 2014, did the company change its name to Ocata Therapeutics Inc.

OCAT.OB closed Monday's trading at $6.32, up 1.94%.

Shares of Prosensa Holding N.V. (RNA) surged more than 62 percent on Monday following news about the company's acquisition by BioMarin Pharmaceutical Inc. (BMRN).

BioMarin has offered to purchase all of the outstanding ordinary shares of Prosensa for $17.75 per share, for a total up front consideration of roughly $680 million. In addition, Prosena is entitled to receive two approximately $80 million contingent milestones for the approval of Drisapersen for Duchenne Muscular Dystrophy in the U.S. no later than May 15, 2016 and Europe no later than February 15, 2017, respectively.

Prosena has made progress with Drisapersen's rolling New Drug Application submission with the FDA, and the first module for the NDA regulatory filing was made on October 10, 2014.

BMRN touched an all-time high of $88.37 on Monday before closing at $87.94.