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15.04.2016 04:59:29

D-Day Awaits CHMA, APHB Abandons XON Collaboration, More On The Way For Opdivo

(RTTNews) - Shares of AmpliPhi Biosciences Corp. (APHB) were down over 16% on Thursday after the company terminated its collaboration agreement with Intrexon Corp. (XON).

AmpliPhi and Intrexon formed exclusive channel collaboration in April 2013 to develop new bacteriophage-based therapies to target specific antibiotic resistant infections, some of the most widespread and deadly types of infections.

Scott Salka, CEO of AmpliPhi Biosciences, said, "We thank Intrexon for their financial support dating back to 2013. Terminating this exclusive collaboration with Intrexon allows us to take advantage of the rapid advancements being made in the field of synthetic biology and frees us to partner with best-in-class technologies for genetically modifying phages to further improve their ability to conquer pathogenic bacteria resistant to current antibiotics."

APHB closed Thursday's trading at $3.30, down 16.46%.

Bristol-Myers Squibb Co.'s (BMY) supplemental Biologics License Application, which seeks to expand the use of Opdivo to patients with classical Hodgkin lymphoma after prior therapies, has been accepted for priority review by the FDA.

Opdivo has potential to become the first PD-1 inhibitor approved for a hematological malignancy in United States, according to the company.

The drug is already approved for the treatment of advanced melanoma, non-small cell lung cancer and advanced renal cell carcinoma.

Opdivo raked in sales of $942 million in 2015, its first full year on the market.

BMY closed Thursday's trading at $67.87, up 0.44%.

If the FDA sticks to its deadline, it will be a make or break moment for Chiasma Inc. (CHMA) tomorrow when the decision on Mycapssa, the company's investigational new oral drug of Chiasma, proposed for the maintenance therapy of adult patients with acromegaly, is announced.

Mycapssa exhibits the effects of somatostatin, a naturally occurring hormone that reduces the production of GH by binding to receptors on specialized cells in the pituitary gland. If approved, Mycapssa will be the first oral somatostatin analog available to acromegaly patients.

Will Mycapssa get the FDA nod? Stay tuned...

CHMA closed Thursday's trading at $10.03, down 7.94%.

Relmada Therapeutics Inc. (RLMD.OB), which is seeking to be uplisted on the Nasdaq Capital Market, believes it satisfies all the applicable listing requirements, barring the $4.00 bid price requirement.

In accordance with the Nasdaq Listing Rules, the company's stock price must close at or above $4.00 per share for 30 of the most recent 60 trading days in order for the company to be eligible to list.

RLMD.OB closed Thursday's trading at $2.95, down 1.67%.

Shire plc (SHPG) is seeking approval for a new, alternate formulation of Vyvanse as a chewable tablet for patients who may have difficulty swallowing or opening a capsule.

Vyvanse in capsule formulation is an FDA-approved drug for the treatment of attention deficit hyperactivity disorder and binge-eating disorder. Vyvanse capsules can be swallowed whole or consumed by opening and mixing the entire contents into water, orange juice or yogurt.

Vyvanse chewable tablets will offer an additional administration option for patients, says the company.

SHPG closed Thursday's trading at $180.51, down 1.51%.

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Bristol-Myers Squibb Co. 56,04 0,39% Bristol-Myers Squibb Co.