CYTR Awaits Data In June, GILD Gets FDA Nod, PGNX Will Have To Wait

(RTTNews) - Shares of ANI Pharmaceuticals Inc. (ANIP) rose more than 8% on Monday, following upwardly revised financial guidance for 2016.

The company now expects adjusted non-GAAP net income per share range of $3.54 to $3.91 on revenue of $119 million to $134 million for 2016. Earlier, the company had forecast non-GAAP net income per share range of $2.94 to $3.31 and revenue of $105 million to $120 million.

The revised financial guidance is the result of the close of the acquisition of Inderal LA assets from Cranford Pharmaceuticals.

ANIP closed Monday's trading at $36.91, up 8.75%.

The independent Data Safety Monitoring Board has recommended Capricor Therapeutics Inc.'s (CAPR) phase I/II study of CAP-1002 in boys with Duchenne muscular dystrophy-associated cardiomyopathy to continue as planned.

The study is designed to enroll 24 male patients, and top-line results are expected in the first quarter of 2017.

CAPR closed Monday's trading at $2.74, up 4.98%.

Shares of CytRx Corp. (CYTR) were up over 10% on Monday after the company announced that it has reached the target number of progression events of 191 in its pivotal, global phase III trial of Aldoxorubicin in second-line soft tissue sarcomas.

Consequently, the company expects to have top-line progression-free survival data in June 2016.

CYTR closed Monday's trading at $3.02, up 10.22%.

Gilead Sciences Inc.'s (GILD) F/TAF, known by the brand name Descovy, has been approved by the FDA for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Descovy, which is a combination of Emtricitabine and Tenofovir alafenamide, is Gilead's third *TAF-based HIV therapy to be green lighted by the FDA after Odefsey and Genvoya.

Descovy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.

(*Tenofovir alafenamide)

GILD closed Monday's trading at $94.24, up 0.13%.

A patent infringement complaint has been filed by Morphosys AG against Genmab A/S (GMXAY.OB) and Janssen Biotech Inc. with the US District Court of Delaware relating to manufacture, use and sale of DARZALEX.

DARZALEX is approved in the U.S. for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, and a marketing application has been submitted in the EU seeking approval for use in patients with relapsed and refractory multiple myeloma by Janssen.

GMXAY.OB closed Monday's trading at $70.74, up 0.67%.

Intec Pharma Ltd.'s (NTEC) pivotal phase III trial of AP-CDLD for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients has enrolled the first patient.

The study is expected to enroll approximately 460 participants across two arms - AP-CDLD or Sinemet IR, which is a conventional Levodopa medication for the treatment of Parkinson's disease symptoms that is currently on the market.

NTEC closed Monday's trading at $4.18, up 1.46%.

Shire plc's (SHPG) phase III trial of SHP465 in children and adolescents with Attention-Deficit/Hyperactivity Disorder has yielded positive results.

According to the study results, SHP465, administered as a daily morning dose, resulted in significant improvement in ADHD symptoms and was superior to placebo.

The company previously submitted the NDA for SHP465 in 2006 to support the use of SHP465 as a longer-acting, once-daily treatment for ADHD in adults.

A pharmacokinetic study and an additional safety and efficacy phase III trial of SHP465 in adults are currently under way, and they are scheduled for completion later this year. Shire plans to add these study results to its existing data set to submit a Class 2 resubmission for FDA approval of SHP465 for treatment of ADHD.

SHPG closed Monday's trading at $177.51, up 1.54%.

Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO) and Progenics Pharmaceuticals Inc. (PGNX) announced that the FDA's decision date on Oral RELISTOR has been postponed by three months to July 19, 2016.

The companies are seeking approval of Oral RELISTOR for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

The development and commercialization rights for RELISTOR have been licensed by Progenics to Salix Pharmaceuticals, Inc., a subsidiary of Valeant.

The subcutaneous injection formulation of RELISTOR has been approved by regulatory authorities in the U.S., countries in the E.U., Canada, Australia and elsewhere since 2008 for treatment of OIC in advanced-illness patients receiving palliative care when laxative therapy has not been sufficient and in the U.S. since 2014 for the treatment of OIC in patients with non-cancer pain.

Net sales of RELISTOR injection for full year 2015 totaled $43.8 million, up from $20.3 million in 2014.

PGNX fell 7.03% on Monday to close the day's trading at $4.10.