Eagle's Flying High, Sunesis Plunges On FDA Feedback, There's No Stopping Inotek

(RTTNews) - Chimerix Inc. (CMRX) has announced positive top line results from a pivotal animal study of Brincidofovir for smallpox, with the data demonstrating statistically significant survival benefit.

Brincidofovir is also being studied in two phase III clinical trials for prevention of cytomegalovirus (CMV) and treatment of adenovirus infections in immunocompromised patients. The FDA has granted Fast Track status to Brincidofovir for smallpox, CMV, and adenovirus.

CMRX closed Thursday's trading at $52.35, down 1.11%.

Shares of Cara Therapeutics Inc. (CARA) touched a new high of $21.71 on Thursday after announcing statistically significant topline results from its phase II trial of its lead kappa opioid agonist, CR845, for the treatment of moderate to severe uremic pruritus.

According to the trial results, I.V. CR845 achieved the primary endpoint of reducing worst itch intensity and secondary endpoint of quality of life improvements with additional positive trend on itch-related sleep disturbances in dialysis patients.

Based on the encouraging data, the company plans to engage the FDA in a formal meeting to guide the structure of a potential phase III pivotal trial, which is expected to begin in 2016.

CARA touched a new high of $21.71 on Thursday before closing the day's trading at $18.99, up 19.89%.

Eagle Pharmaceuticals Inc.'s (EGRX) New Drug Application for its novel ready-to-use Bivalirudin product ("RTU Bivalirudin") filed under 505(b)(2) regulatory pathway has been accepted for review by the FDA.

The company is seeking approval of the RTU Bivalirudin product for the treatment of patients: (1) undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

The FDA's decision on the NDA is expected in March of 2016.

EGRX touched a lifetime high of $96.25 on Thursday before closing the day's trading at $94.17.

Heron Therapeutics Inc. (HRTX) has initiated a second phase II clinical trial of HTX-011 for the treatment of post-operative pain. The trial is designed to enroll approximately 60 patients undergoing inguinal hernia repair.

Another phase II trial of HTX-011 in patients undergoing bunionectomy is underway, and data from both the bunionectomy study and the hernia repair study are expected in the second half of 2015.

HRTX closed Thursday's trading at $33.03, down 2.54%.

Shares of Inotek Pharmaceuticals Corp. (ITEK) soared as much as 220% on Thursday after announcing that it is in final preparation stages to commence its first phase III trial of Trabodenoson, a novel treatment for glaucoma.

Based on feedback from a recent End of phase II meeting with the FDA, the company expects to commence the trial in the fourth quarter, with topline data expected in 2016.

ITEK touched a high of $16.75 on Thursday, before closing the day's trading 193.88% higher at $15.37.

IGI Laboratories Inc. (IG) made a steady progress in the second quarter ended June 30, 2015.

The company's total revenues were $8.9 million in the second quarter of 2015, an increase of 37% over the same quarter in 2014.

Looking ahead, IGI Labs expects total revenue between $35.0 and $40.0 million for the year ended December 31, 2015.

The company intends to submit up to 20 ANDAs with the FDA by the end of 2015.

IG closed Thursday's trading at $6.78, down 1.60%. In after hours, the stock was up 6.19% to $7.20.

Inovio Pharmaceuticals Inc. (INO) has teamed up with the European Organization for Research and Treatment of Cancer to evaluate its immunotherapy, INO-3112, in a phase II cervical cancer trial.

The trial, primarily funded by the EORTC, is expected to begin by the end of the year.

INO closed Thursday's trading at $7.23, down 1.23%.

Lpath Inc. (LPTN) has finally received the FDA nod to initiate a phase I clinical trial of Lpathomab.

In March of this year, the FDA had requested additional analysis of certain data submitted as part of the Investigational New Drug application for Lpathomab filed by Lpath.

Lpathomab is a novel antibody targeting Lysophosphatidic Acid, or LPA, a bioactive lipid that has been characterized in the scientific literature as playing a key role in nerve injury and neuropathic pain.

Lpath plans to begin the phase I trial upon investigational review board approvals and anticipates the first subject to be dosed within two months.

LPTN closed Thursday's trading at $0.31, up 20.34%.

Lupin Ltd. has entered into a definitive agreement to acquire privately held GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. in a transaction valued at $880 million, cash free and debt free.

The acquisition enhances Lupin's scale in the US generic market and also broadens its pipeline in dermatology, controlled substance products and other high-value and niche generics.

Shares of Sunesis Pharmaceuticals Inc. (SNSS) plunged more than 57% on Thursday after the company announced that at this stage, the FDA did not support the filing of NDA for Vosaroxin as a treatment for acute myeloid leukemia, and encouraged the company to provide additional clinical evidence to support a future NDA submission.

However, with respect to Europe, based on feedback from the regulators, the company is set to proceed expeditiously with Marketing Authorization Application for Vosaroxin in Europe for the indication of relapsed/refractory AML in patients age 60 years and older.

SNSS closed Thursday's trading at $3.47, down 1.42%. In after-hours, the stock plunged 57.93% to $1.46.

Theravance Biopharma Inc.'s (TBPH) antibiotic VIBATIV has been approved in Canada for the treatment of adult patients with hospital-acquired bacterial pneumonia (HAP) and ventilator-associated bacterial pneumonia (VAP) known or suspected to be caused by susceptible isolates of Staphylococcus aureus including methicillin-susceptible and methicillin-resistant S. aureus (MSSA and MRSA).

The antibiotic was approved in Canada for the treatment of patients with complicated skin and skin structure infections (cSSSI) caused by susceptible strains of Gram-positive microorganisms in 2009.

VIBATIV is also approved in the U.S. for the above 2 indications.

TBPH closed Thursday's trading at $12.53, up 0.56%.