FLXN Flexes Muscles, FDA Approves Broader Use Of Harvoni, Headache For TNXP

(RTTNews) - Biota Pharmaceuticals Inc.'s (BOTA) antiviral compound, BTA585, has been granted Fast Track designation by FDA for the treatment of respiratory syncytial virus infections in infants, young children and adults.

BTA585 has successfully completed a phase I single ascending dose trial and has recently completed dosing in a multiple ascending dose trial with results expected to be reported this quarter. A phase II trial with BTA585 for treatment of respiratory syncytial virus infections is expected to begin in the second quarter of 2016.

BOTA closed Tuesday's trading at $1.38, up 4.55%.

Celator Pharmaceuticals Inc. (CPXX) expects to announce overall survival results from its phase III clinical trial of VYXEOS Liposome for Injection, also known as CPX-351, in patients with untreated high-risk acute myeloid leukemia later this quarter.

The study has enrolled 309 patients between the ages of 60 and 75 who had pathologically confirmed diagnosis of high-risk AML.

CPXX closed Tuesday's trading at $1.41, up 7.63%.

Shares of Flexion Therapeutics Inc. (FLXN) were up over 28% in extended trading on Tuesday, following positive results from a pivotal phase III trial of Zilretta in knee osteoarthritis.

According to the trial results, Zilretta, also known as FX006, met its primary endpoint at week 12, demonstrating highly significant, durable and clinically meaningful pain relief against placebo in patients with moderate to severe osteoarthritis knee pain. The drug candidate also achieved statistically significant analgesia against placebo at weeks 1 through 16 and demonstrated a 50% reduction in pain from baseline over weeks 1 through 12.

There were no drug-related serious adverse events and no patients treated with Zilretta were discontinued from the study due to a treatment-related side effect, according to the company.

Commenting on the encouraging results, the company's President and CEO Michael Clayman, said, "We believe that Zilretta has the potential to become an important new non-opioid treatment in a therapeutic area that hasn't seen meaningful innovation in many years".

FLXN closed Tuesday's trading 2.83% higher at $10.90. In after hours, the stock was up 28.44% at $14.00.

Galapagos NV (GLPG) has started its phase II exploratory program of GLPG1837 in patients with cystic fibrosis.

This phase II program, dubbed SAPHIRA, which includes two studies, will evaluate GLP1837 in cystic fibrosis patients with a G551D or S1251N Class III mutation. In each study, different doses of GLPG1837 tablets will be administered twice daily for a total duration of four weeks. Top line results from both the studies are expected in the fourth quarter of this year.

GLPG closed Tuesday's trading at $41.37, up 5.32%.

The FDA has approved Gilead Sciences Inc.'s (GILD) blockbuster hepatitis C drug, Harvoni, in combination with Ribavirin for 12 weeks, for use in chronic hepatitis C virus genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation.

Harvoni was first approved by FDA in 2014 to treat chronic hepatitis C virus genotype 1 infection, and in November 2015 for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV.

Harvoni, whose wholesale list price is reportedly $1,125 per pill, logged in sales of $13.86 billion in 2015.

GILD closed Tuesday's trading at $91.15, up 1.91%.

Lipocine Inc. (LPCN) has reported encouraging data from its multi-dose pharmacokinetic dose finding clinical study of LPCN 1107 for the prevention of preterm birth.

According to the trial results, relevant hydroxyprogesterone caproate levels were achieved following oral administration of LPCN 1107, and it was well tolerated with no serious adverse events or adverse drug reactions.

The study could potentially allow dose adjustments of LPCN 1107 during the course of therapy to optimize the clinical outcome, noted the company.

LPCN closed Tuesday's trading at $9.31, up 6.28%.

Ocular Therapeutix Inc. (OCUL) is all set to start the first of two planned phase III clinical trials of OTX-TP (sustained release travoprost) drug product candidate for the treatment of glaucoma and ocular hypertension in the third quarter of 2016.

The planned trial design for the two phase III clinical trials includes an OTX-TP treatment arm and a placebo-controlled comparator arm that would use a non-drug eluting hydrogel-based intracanalicular depot, noted the company.

OCUL closed Tuesday's trading at $6.26, up 11.99%.

Repros Therapeutics Inc. (RPRX) has fully randomized a phase II proof of concept study of Enclomiphene in conjunction with rigorous diet and exercise in the treatment of obese secondary hypogonadal men.

The study, which is of 15 months duration, consists of three phases.

During the first six month phase, men are randomized to either Enclomiphene or placebo and are provided a commercially available prepared diet along with enrollment in a trainer-based exercise program. At the end of the six month period the subjects will be assessed for changes in a variety of biochemical markers as well as anatomical markers such as waist circumference, lean body mass and BMI. Quality of life will also be assessed. Three and six month data are expected before the end of summer 2016.

During the second six month phase, men will continue treatment with Enclomiphene or placebo but will no longer be provided the commercial diet. Exercise will continue during this period and all parameters will be re-assessed. In the last three months of the study, the subjects will no longer receive treatment but will stay enrolled in the exercise program, noted the company.

RPRX closed Tuesday's trading at $0.85, up 0.90%.

Shares of Tonix Pharmaceuticals Holding Corp. (TNXP) plunged over 36% on Tuesday as a phase II proof-of-concept clinical study of TNX-201 in episodic tension-type headache failed to meet the primary endpoints.

The study failed to achieve its primary efficacy endpoint of participants achieving headache pain-free status at two hours after dosing and two other primary endpoints, which were the proportion of participants with at least a 70% reduction in pain from baseline on the Visual Analog Scale (VAS) at two hours after dosing, and an increase of the mean change from baseline to two hours post-dose in the VAS score.

The company's phase II study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in post-traumatic stress disorder, and a phase III trial of TNX-102 SL in fibromyalgia are underway. Data from these studies are expected to be reported in the second and third quarters this year, respectively.

TNXP closed Tuesday's trading at $2.57, down 36.39%.