SAGE On A High, JUNO Rockets As FDA Lifts Clinical Hold, FDA Panel Nod For AMGN

(RTTNews) - Agile Therapeutics Inc. (AGRX) is making preparations for an initial phase II clinical trial of a novel 28-day contraceptive patch regimen, designed to allow women to experience shorter, lighter periods. Dosing in this study is expected to be initiated in the first quarter of 2017.

The company's lead product candidate, Twirla, a once-weekly prescription contraceptive patch is currently in phase III clinical development.

AGRX closed Tuesday's trading at $7.27, down 3.71%.

An FDA panel has voted 26-0 recommending approval of Amgen's (AMGN) ABP 501, a biosimilar candidate to AbbVie's (ABBV) Humira.

The regulatory agency's final decision on ABP 501 is set for September 25, 2016. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

AbbVie's Humira is approved to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, moderate to severe polyarticular juvenile idiopathic arthritis in children 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate to severe Crohn's disease in adults and children, moderate to severe hidradenitis suppurativa in adults, moderate to severe ulcerative colitis and moderate to severe chronic plaque psoriasis in adults.

Humira raked in sales of $14 billion in 2015, and was the world's best-selling drug of the year.

AMGN closed Tuesday's trading at $161.96, up 1.11%.

Aviragen Therapeutics Inc. (AVIR) has resumed enrollment in its phase 2a challenge study of BTA585, an oral fusion inhibitor in development for the treatment and prevention of respiratory syncytial virus infections.

On May 26, 2016, the company announced that it voluntarily decided to delay further enrollment in its phase IIa trial of BTA585 for the treatment of RSV infections being conducted in the U.K. in the wake of lab report from one subject showing an increase of a cardiac enzyme level coupled with transient ECG changes, which led to a hospitalization of less than 24 hours.

The company plans to submit a complete response to the FDA for the written confirmation of the previously announced clinical hold on BTA585 by the first quarter of 2017, including requested data from additional rodent studies.

Now that enrollment has been resumed, the company expects the trial to be completed by the end of 2016.

AVIR closed Tuesday's trading at $1.43, unchanged from the previous day's close.

Shares of Juno Therapeutics Inc. (JUNO) rose over 24% in extended trading on Tuesday, following the removal of FDA clinical hold on the company's phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

Last week, the FDA had placed a clinical hold on the phase II study, dubbed "ROCKET "after two patient deaths. The company was asked to submit, as a Complete Response to the Clinical Hold - a revised patient informed consent form, a revised investigator brochure and a revised trial protocol.

Now that the clinical hold has been removed, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.

JUNO closed Tuesday's trading at $27.79, up 1.68%. In after-hours, the stock was up 24.15% to $34.50.

Pfizer Inc.'s (PFE) pneumonia vaccine Prevnar 13 has received FDA approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumonia serotypes.

Prevnar 13 received FDA approval in 2010 for use in infants and young children ages 6 weeks through 5 years for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumonia.

Prevnar 13 raked in sales of $1.51 billion in the first quarter of 2016, up 16% over the year-ago quarter.

Commenting on the expanded approval, Luis Jodar, Chief Medical and Scientific Affairs Officer, Pfizer Vaccines said, "This expanded age indication in adults 18 to 49 offers an important public health benefit as appropriate vaccination against S. pneumoniae is critical to reducing the risk of pneumococcal disease, including in those with immunocompromising conditions."

PFE closed Tuesday's trading at $36.24, up 0.25%.

Shares of Sage Therapeutics Inc. (SAGE) climbed over 37% on Tuesday, following positive top-line results from its phase 2 clinical trial of SAGE-547 for the treatment of severe postpartum depression.

The trial achieved the primary endpoint - with SAGE-547 demonstrating a significant reduction in the HAM-D score compared to placebo at 60 hours. HAM-D score is a measure of remission from depression. The higher the score, the more severe the depression.

Postpartum depression, or PPD, is an affective disorder impacting women after childbirth.

SAGE closed Tuesday's trading 37.33% higher at $46.21.