DVAX To Face FDA Panel, BMY's Opdivo Disappoints, MRK Scores Big With FDA Nod

(RTTNews) - Aurinia Pharmaceuticals Inc. (AUPH), (AUP.TO) awaits an important catalyst this month.

The company's phase 2b trial evaluating Voclosporin therapy against placebo to achieve remission in patients with lupus nephritis, dubbed AURA-LV, is underway - with the primary end-point results slated to be released prior to the end of August, 2016.

AUPH closed Friday's trading at $3.60, up 2.86%.

Shares of Bristol-Myers Squibb Co. (BMY) dropped over 15% on Friday as the company's cancer drug Opdivo as monotherapy in treatment-naïve patients with advanced non-small cell lung cancer failed to meet its primary endpoint.

The primary endpoint of the trial CheckMate -026 was progression-free survival in patients with previously untreated advanced non-small cell lung cancer whose tumors expressed PD-L1 at = 5%.

Opdivo received its first FDA approval in December 2014 for the indication of unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma which no longer responds to other drugs.

The FDA expanded the approved use of Opdivo as a single agent to treat lung cancer in March 2015; in combination with Yervoy to treat BRAF V600 wild-type unresectable or metastatic melanoma and as a single agent to treat advanced lung cancer in October 2015; as a single agent to treat advanced renal cell carcinoma, a form of kidney cancer, and as a single agent to treat BRAF V600 wild-type unresectable or metastatic melanoma in November 2015, and combination with Yervoy to treat BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma in January 2016, and for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after prior therapies like autologous stem cell transplant and Seattle Genetics' Adcetris in May 2016.

Opdivo generated global sales of $942 million in 2015.

BMY closed Friday's trading at $63.28, down 15.99%.

Dynavax Technologies Corp.'s (DVAX) Biologics License Application for HEPLISAV-B is all set to be reviewed by an FDA panel on November 16, 2016.

HEPLISAV-B is the company's vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults ages 18 years of age and older.

The FDA's final decision on HEPLISAV-B is set for December 15, 2016.

DVAX closed Friday's trading 4.89% higher at $16.73.

Merck's (MRK) cancer drug KEYTRUDA has been granted accelerated approval in the expanded indication for treating patients with recurrent or metastatic head and neck squamous cell carcinoma.

The approval is based on tumor response rate and durability of response. Continued approval depends upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is already approved for the treatment of metastatic melanoma and metastatic non-small cell lung cancer. The drug generated global sales of $566 million in 2015 - the first full year on market.

MRK touched a new 52-week high of $64 on Friday, before closing the day's trading at $63.86, up 10.41%.