Man(n)kind Loses A Visionary, FDA Expands Gazyva's Use, Binary Events Await PTLA

(RTTNews) - Biota Pharmaceuticals Inc. (BOTA) phase I multiple ascending dose trial of BTA585 for the treatment and prevention of respiratory syncytial virus infections, usually called RSV, has yielded positive results.

According to the trial results, BTA585 was generally well tolerated at all dose levels. There were no serious adverse events, and no drug-related clinically-significant adverse changes in ECGs or clinical laboratory values were observed, said the company.

BOTA closed Friday's trading at $1.61, up 5.92%.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Bristol-Myers Squibb Co.'s (BMY) Opdivo for two new indications namely, adults with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy, and adults with advanced renal cell carcinoma after prior therapy. In the U.S., Opdivo is already approved for the above two indications.

In the European Union, Opdivo is approved for advanced melanoma and previously treated advanced squamous non-small cell lung cancer.

Opdivo logged sales of $942 million in 2015, and according to DrugAnalyst, an independent Pharmaceuticals Equity Research provider, the drug is expected to garner sales of $2.84 billion in 2016.

BMY closed Friday's trading at $62.25, down 1.24%.

Roche Holding AG's (RHHBY.OB) leukemia drug Gazyva has received FDA approval for yet another indication. This time in combination with bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan-containing regimen, or whose follicular lymphoma returned after such treatment.

Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin's lymphoma, or NHL, and accounts for approximately one in five cases of NHL.

Gazyva in combination with chemotherapy drug Chlorambucil was approved in November 2013 for people with previously untreated chronic lymphocytic leukemia (CLL).

Gazyva is marketed as Gazyvaro in EU and Switzerland.

RHHBY.OB closed Friday's trading at $32.66, up 0.03%.

MannKind Corp.'s (MNKD) founder and Chairman Emeritus Alfred Mann, aged 90, passed away on February 25, 2016.

Mann founded 17 companies during his career spanning over 7 decades. Second Sight, Bioness, IncuMed and perQflo are some of the other companies founded by Mann, in addition to MannKind.

MNKD closed Friday's trading at $1.03, down 4.63%.

Portola Pharmaceuticals (PTLA) is scheduled to report topline results from its phase III study of Betrixaban for the prevention of venous thromboembolism in acute medically ill patients, dubbed APEX, in early April.

Another important catalyst that can make or break Portola is the FDA decision on Andexanet alfa for reversal of anticoagulation in patients treated with a Factor Xa inhibitor and who are admitted to the hospital with uncontrolled bleeding or need urgent surgery.

The regulatory agency's decision on Andexanet alfa is set for August 17, 2016.

PTLA touched a 52-week low of $26.10 on Friday, before closing the day's trading at $27.79, down 1.56%.

Michael Pearson is back at the helm as Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) CEO, following his recovery from severe pneumonia and other complications.

The company is rescheduling its previously announced call to discuss preliminary fourth quarter 2015 results and provide updated guidance for 2016.

VRX closed Friday's trading at $80.65, down 4.79%.