APDN Up On Revenue Growth, ATRA Pulls Plug On Kidney Drug, NEOT Falls Flat

(RTTNews) - Adamas Pharmaceuticals Inc. (ADMS) has completed enrollment in a phase III study evaluating its product candidate ADS-5102 for the treatment of levodopa-induced dyskinesia, a motor complication associated with the treatment of Parkinson's disease.

The phase III study, dubbed EASE LID 3, which is a 13-week multi-center trial, has enrolled 77 patients. The primary endpoint of EASE LID 3 is a reduction in dyskinesia assessed by changes in Unified Dyskinesia Rating Scale (UDysRS) from baseline to week 12.

ADMS closed Monday's trading at $15.03, up 1.21%.

Shares of Applied DNA Sciences Inc. (APDN) were up more than 16% in extended trading on Monday, following quarterly record revenue results and, for the first time in the company's history, positive adjusted quarterly EBITDA.

In the fourth quarter ended September 30, 2015, revenues increased 517% to a record $4.0 million from $646 thousand reported in the fourth quarter of fiscal 2014, and a 76% increase from the $2.3 million reported in the third fiscal quarter ended June 30, 2015.

The company expects further revenue growth in fiscal year 2016.

APDN closed Monday's trading at $3.62, up 7.74%. In after hours, the stock was up 16.30% at $4.21.

Shares of Atara Biotherapeutics Inc. (ATRA) cratered on Monday as the company's phase II proof-of-concept clinical trial for PINTA 745 for the treatment of protein energy wasting in patients with end stage renal disease failed to meet its primary endpoint.

The company has decided to pull the plug on PINTA 745, following the failed trial.

ATRA closed Monday's trading at $21, down 36.75%.

International Stem Cell Corp. (ISCO.OB) has received clearance in Australia to initiate a phase I/IIa dose escalation trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) in patients with moderate to severe Parkinson's disease.

The planned clinical trial will enroll a total of 12 participants with moderate to severe Parkinson's disease who will be intracranially transplanted with ISC-hpNSC, and they will be monitored for 12 months at specified intervals.

The study will be performed at Royal Melbourne Hospital in Melbourne, Australia.

According to preclinical study results announced last year, intracranial administration of ISC-hpNSC improved Parkinson's disease symptoms and increased brain dopamine levels.

ISCO.OB closed Monday's trading at $5.00, up 15.74%.

Neothetics Inc. (NEOT) plunged more than 76% in after-hours on Monday as phase III trials evaluating its product candidate LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat failed to meet the primary endpoints.

The trials, dubbed AbCONTOUR1 and AbCONTOUR2, enrolled a total of 1,584 patients randomized to LIPO-202 or placebo, and were conducted at approximately 80 clinical sites across the U.S.

NEOT closed Monday's trading at $7.13, down 3.65%. In after hours, the stock was down 75.88% to $1.72.

Novavax Inc. (NVAX) has completed enrollment in a pivotal phase III clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate in older adults.

The trial, known as Resolve, has enrolled 11,850 older adults, aged 60 years and more, at 60 sites in the United States. The primary efficacy objective of the Resolve trial is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms.

The top-line data from the Resolve trial are expected in the third quarter of 2016.

NVAX closed Monday's trading at $7.43, down 3.88%.

Seres Therapeutics Inc. (MCRB) has initiated a phase 1b clinical trial evaluating SER-287 in mild-to-moderate ulcerative colitis.

The study, which is being conducted in the United States, will enroll up to 55 subjects with active mild-to-moderate UC who are failing current therapies. The primary endpoint of the study will evaluate the change in the microbiome resulting from SER-287 treatment. The study will also evaluate clinical response, mucosal healing, as well as metabolomic, immunological and safety findings.

MCRB closed Monday's trading at $37.91, up 3.07%.