AMGN's Kyprolis Better Than Rival, KOOL Put On Notice, XON Inks Fruity Deal

(RTTNews) - Allergan Inc. (AGN) has received approval from the FDA to market NATRELLE INSPIRA round gel-filled smooth breast implants.

NATRELLE INSPIRA is different from other available breast implant styles as it has a higher fill ratio that provides an additional breast shaping option for women undergoing reconstruction, augmentation or revision surgery, according to the company.

Allergan, Mentor Worldwide LLC, a division of Johnson & Johnson, and Sientra Inc. are the key breast implant producers.

AGN closed Friday's trading at $232.74, up 0.15%.

Acceleron Pharma Inc. (XLRN), on Saturday, announced encouraging new preliminary data from part 1 of an ongoing phase 2 clinical trial of its drug candidate Dalantercept in patients with advanced renal cell carcinoma.

In the trial, dubbed the DART study, the patients treated with Dalantercept subcutaneously once every three weeks and Pfizer's kidney cancer drug Inlyta orally twice a day for each 21 day cycle, showed promising response rates and progression-free survival.

Part 1 of the DART study is a dose-escalation study of Dalantercept in combination with Inlyta to evaluate the safety and tolerability of the combination in patients whose disease has progressed following one to three lines of prior therapy. Part 2 is a randomized, double-blind study of 130 patients with advanced renal cell carcinoma who have progressed following treatment with a VEGF receptor tyrosine kinase inhibitor. Patients may have also received prior mTOR therapy and/or immunotherapy, according to the company.

XLRN closed Friday's trading at $40.63, down 0.90%.

Amgen's (AMGN) Kyprolis has demonstrated superiority over Takeda's Velcade in patients with relapsed multiple myeloma in a head-to-head clinical trial.

In the phase 3 head-to-head clinical trial, dubbed ENDEAVOR, patients with relapsed multiple myeloma treated with Kyprolis in combination with low-dose dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade in combination with low-dose dexamethasone.

The ENDEAVOR study is the first of two head-to-head studies for Kyprolis versus Velcade, an established proteasome inhibitor, currently approved to treat multiple myeloma.

Velcade is Takeda's top-selling drug and it raked in sales of 114.4 billions of Yen in the nine months ended December 31, 2014, up 12.8% compared to the year-ago period. Amgen's Kyprolis recorded sales of $331 million in the full year of 2014.

AMGN closed Friday's trading at $157.72, down 0.79%.

Bristol-Myers Squibb Co.'s (BMY) Biologics Licensing Application for Opdivo for the treatment of patients with advanced squamous non-small cell lung cancer after prior therapy has been accepted for Priority Review by the FDA. The regulatory agency's decision on Opdivo is scheduled for June 22, 2015.

BMY closed Friday's trading at $60.92, down 0.88%.

Cesca Therapeutics Inc. (KOOL) has received a notice of non-compliance with Nasdaq listing rule for failing to timely file its December 31, 2014 quarterly report with the Securities and Exchange Commission.

The company has 60 calendar days to submit a plan to regain compliance and has until August 24, 2015 to regain compliance if its plan is accepted by NASDAQ. Failure to meet these conditions may subject the company's common stock to delisting.

KOOL closed Friday's trading at $0.91, up 0.47%. In after-hours, the stock was down 7.03% at $0.85.

Shares of CEL-SCI Corp. (CVM) rose more than 8% on Friday after the company announced that it has completed a key milestone with clearance to conduct phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine in the planned 20 countries in addition to the United States.

The company has so far received clearance to conduct the trial in 21 countries, with Belarus being the latest addition.

CVM closed Friday's trading 8.79% higher at $1.04. In after-hours, the stock rose another 5.77% to $1.10.

Intrexon Corp. (XON) has signed an agreement to acquire privately-held Okanagan Specialty Fruits, a move that will help to expand its food programs to include trees yielding fruit that is more appetizing and convenient for consumers while providing economic benefit throughout the tree fruit supply chain.

Okanagan Specialty is the pioneering agricultural company behind the Arctic apple, the world's first non-browning apple.

Pursuant to the definitive agreement, Okanagan's stockholders will receive $31 million in Intrexon common stock and $10 million in upfront cash. The transaction, anticipated to close in the first half of 2015, is subject to customary closing conditions.

XON closed Friday's trading at $41.06, down 4.33%.

TRACON Pharmaceuticals (TCON), on Saturday, reported positive results from a phase 1b clinical trial combining its drug candidate TRC105 with Pfizer's kidney cancer drug Inlyta in patients with advanced or metastatic renal cell carcinoma.

The objective response rate was 29% and an additional 59% of patients achieved stable disease. The median progression-free survival (PFS) for all patients in the study was 8.4 months, while median PFS for the subset of clear cell RCC patients was 11.3 months, according to the trial results. Clear cell renal cell cancer is the most common type of kidney cancer in adults.

A phase 2b study comparing the combination of TRC105 with Inlyta to treatment with Inlyta alone in patients with advanced or metastatic renal cell carcinoma is enrolling participants.

TRACON went public on the NASDAQ on January 30, 2015, priced at $10 per share.

TCON closed Friday's trading at $13.43, down 7.19%.