All Well Says ADRO As Stock Slips, LLY Gets FDA Nod, BMRN, OCUL On Watch

(RTTNews) - Shares of Aduro BioTech Inc. (ADRO) were down 16% on Tuesday as investors were worried about a serious adverse event that was reported in the company's phase 2a clinical trial of CRS-207 and GVAX Pancreas in patients with metastatic pancreatic cancer.

Aduro licensed GVAX Pancreas from BioSante Pharmaceuticals Inc. (BPAX) in 2011.

In a recent SEC filing, the company has revealed that one patient who was treated with CRS-207 and GVAX Pancreas, with low-dose cyclophosphamide had developed listeriosis, a Grade 3 serious adverse event. However, the patient was administered intravenous antibiotics and follow-up cultures are now negative for Listeria and the patient continues to receive study treatment, according to the company.

Aduro Biotech has confirmed that all clinical trials are continuing unaltered and as planned.

ADRO closed Tuesday's trading at $27.05, down 16.07%.

The FDA panel, which reviewed BioMarin Pharmaceutical Inc.'s (BMRN) New Drug Application for Kyndrisa for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, has not provided a favorable feedback on many of the data supporting the efficacy and acceptability of the drug candidate's safety profile.

The FDA's final decision is set for December 27, 2015. The FDA takes the panel's guidance into consideration although it is not bound to do so.

An application for marketing approval of Kyndrisa is also pending in the European Union.

Trading was halted on Tuesday.

The FDA has approved Emergent BioSolutions Inc.'s (EBS) supplemental Biologics License Application to expand the label of BioThrax to include post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease.

The vaccine's new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment.

BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.

EBS touched a new high of $38.98 on Tuesday, before closing the day's trading at $38.62, up 2.33%.

Eli Lilly and Co.'s (LLY) Portrazza has received FDA approval to be used in combination with two forms of chemotherapy - Gemcitabine and Cisplatin - to treat patients with advanced squamous non-small cell lung cancer who have not previously received medication specifically for treating their advanced lung cancer.

Portrazza becomes the first biologic to be cleared by the regulatory agency for the first-line treatment of people with metastatic squamous non-small cell lung cancer. According to industry experts, Portrazza could generate sales of $567 million in 2020.

LLY closed Tuesday's trading at $83.88, down 1.01%.

Ocular Therapeutix Inc. (OCUL) has begun enrollment in its second phase III clinical trial of DEXTENZA for the treatment of allergic conjunctivitis.

Last month, the company reported results from its phase III clinical trial of DEXTENZA. The primary endpoint of reducing ocular itching associated with allergic conjunctivitis was successfully achieved in this trial but the co-primary goal of reducing redness, which is not required for approval, was not achieved.

OCUL closed Tuesday's trading at $8.74, up 5.17%.