PTN Surges On Trial Data, PFE Dumps Cholesterol Drug, Watch Out For PRTA

(RTTNews) - Chembio Diagnostics Inc.'s (CEMI) DPP Zika IgM/IgG Assay has been cleared for commercial use by the Brazilian health regulatory agency, Agência Nacional de Vigilância Sanitária.

DPP Zika IgM/IgG Assay detects antibodies using a tiny (10uL) drop of blood from the fingertip and provides semi-quantitative results in 15 minutes, according to the company.

It is estimated that 1.5 million people have been infected with Zika virus and 2,000 babies have been born with microcephaly, a devastating birth defect linked to the Zika virus in Brazil.

There are no FDA approved/cleared tests that can detect Zika virus in clinical specimens in the United States.

CEMI closed Tuesday's trading at $6.90, unchanged from the previous day's close.

Ionis Pharmaceuticals Inc.'s (IONS) phase II study of IONIS-FXIRx in patients with end-stage renal disease on hemodialysis has yielded positive results.

In the study, patients treated with IONIS-FXIRx achieved statistically significant, dose-dependent reductions in Factor XI activity.

The company has an exclusive license agreement with Bayer to develop and commercialize IONIS-FXIRx for the prevention of clotting disorders. Ionis will be eligible to receive a $55 million payment upon review of the phase II data and potential advancement of the program by Bayer.

IONS closed Tuesday's trading at $27.32, up 5.16%.

Oculus Innovative Sciences Inc. (OCLS) has sold its Latin American-related assets to Invekra S.A.P.I. de C.V. of Mexico for $19.5 million in cash.

Oculus is also entitled to receive a 3% payment on all Latin American revenues outside of Mexico, with a minimum payment of $250,000 per year for the next ten years, from Invekra that will be paid quarterly in Mexican pesos.

Commenting on the transaction, Jim Schutz, CEO of Oculus, said, "We genuinely see this as a strategic opportunity to focus on our growing dermatological business. We are selling a slower growing, lower-margin segment of our business in exchange for a significant influx of immediate cash, allowing us to further advance our higher-margin, fast growing U.S. dermatology business."

OCLS closed Tuesday's trading at $5.04, up 26.00%. In after-hours, the stock was down 2.78% to $4.90.

Shares of Palatin Technologies Inc. (PTN) were up over 57% in extended trading on Tuesday, following positive results from its two phase III trials of Bremelanotide in premenopausal women with hypoactive sexual desire disorder.

Hypoactive sexual desire disorder, or HSDD, is a persistent or recurrent decrease or lack of sexual desire.

The two trials, collectively called Reconnect Studies, met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments.

The company is planning to submit Bremelanotide New Drug Application to the FDA in the second half of 2017.

PTN closed Tuesday's trading at $0.483, down 7.06%. In after-hours, the stock was up an impressive 57.25% to $0.76.

Pfizer Inc. (PFE) has decided to discontinue the development of Bococizumab, which is under phase III testing, as the drug candidate is not likely to provide value to patients, physicians, or shareholders.

Bococizumab is a Proprotein Convertase Subtilisin Kexin type 9 inhibitor that was studied for its potential to lower LDL-C and improve cardiovascular outcomes.

The phase III Bococizumab program, known as SPIRE, included six lipid-lowering studies known as SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LDL and SPIRE-LL, as well as two cardiovascular outcome studies.

PFE closed Tuesday's trading at $31.07, down 2.02%.

Prothena Corp. plc (PRTA) has a couple of catalysts coming its way in the coming months.

A near-term event to watch out for is the announcement of topline results from its phase 1b multiple ascending dose study of PRX002 in patients with Parkinson's disease that is expected this month.

A phase 2b study of NEOD001 for the potential treatment of AL amyloidosis, dubbed PRONTO, is underway - with topline results slated for early 2018.

Another drug candidate in clinical testing is PRX003, which is under a phase 1b multiple ascending dose, proof-of-biology study in patients with psoriasis. Interim data from this trial are expected by mid-2017.

PRTA closed Tuesday's trading at $47.93, up 0.23%.

TESARO Inc. (TSRO) has completed the Niraparib rolling New Drug Application submission to the FDA for the maintenance treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy.

In clinical trials, Niraparib treatment significantly prolonged progression free survival compared to control.

Whether or not the FDA has accepted the NDA filing will be known within 60 days of submission.

TSRO closed Tuesday's trading at $121.14, up 0.22%.

T2 Biosystems Inc. (TTOO) has partnered with Allergan plc (AGN) to develop a novel diagnostic panel to detect Gram-negative bacteria and antibiotic resistance for patients with serious bacterial infections, including infections leading to sepsis.

As per the deal terms, Allergan will pay T2 Biosystems $4 million in milestone payments related to the development of the bacterial resistance panel and an expansion of the T2Bacteria Panel currently under development.

TTOO closed Tuesday's trading at $6.15, down 2.69%. In after-hours, the stock was up 13.82% to $7.00.