HEB Gets Some Respite, ITEK Awaits Data In Dec., NYMX Abuzz, FDA Snubs AMGN

(RTTNews) - The FDA has turned down Amgen Inc.'s (AMGN) Parsabiv, proposed for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.

Secondary hyperparathyroidism, or SHPT, is a common and serious condition that is often progressive among patients with chronic kidney disease, and it manifests as increased levels of parathyroid hormone as a result of increased production from the parathyroid glands.

Parsabiv, known by its generic name etelcalcetide, is a calcimimetic agent that works by suppressing the secretion of parathyroid hormone.

Amgen is reviewing the Complete Response Letter, and anticipates a post-action meeting with the FDA later this year to discuss the Complete Response.

AMGN closed Wednesday's trading at $170.84, down 2.04%.

Biomerica Inc. (BMRA.OB) is expected to commence trading on Nasdaq under the ticker symbol "BMRA" on August 26, 2016.

The company's common stock will continue to trade as "BMRA" on the OTCQB until the market close on August 25, 2016.

BMRA.OB closed Wednesday's trading at $3.11, down 2.81%.

BioPharmX Corp. (BPMX) has enrolled the first subject in its phase 2b clinical trial assessing the efficacy and safety of BPX-01 for the treatment of acne vulgaris.

The study, known as the OPAL, is designed to enroll 225 people, aged 9 to 40, who have moderate-to-severe inflammatory, non-nodular acne vulgaris. Results from the OPAL study are expected in the first half of 2017.

BPMX closed Wednesday's trading at $0.84, up 1.20%.

Hemispherx Biopharma Inc. (HEB), which even after nearly 10 years of filing the initial NDA for Ampligen failed to get FDA approval, has a reason to cheer now.

Ampligen, whose generic name is Rintatolimod has been approved for commercial sale in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Rintatolimod is the first drug to receive approval for this indication anywhere in the world.

The product will be marketed by GP Pharm, Hemispherx's commercial partner in Latin America.

HEB closed Wednesday's trading at $0.18, down 1.12%.

Inotek Pharmaceuticals Corp. (ITEK) has completed the recruitment phase of MATrX-1, the first pivotal phase III trial of trabodenoson for the treatment of glaucoma.

The study is designed to enroll about 335 patients suffering from primary open angle glaucoma, and its primary endpoint is reduction of intraocular pressure compared to the placebo treatment arm.

Top-line data from the MATrX-1 study are expected in December 2016.

ITEK closed Wednesday's trading 2.29% lower at $6.83.

Insys Therapeutics Inc.'s (INSY) phase III trial for Buprenorphine Sublingual Spray met its primary endpoint of Summed Pain Intensity Difference in subjects with moderate to severe postoperative pain after bunionectomy.

The company will be discussing the phase III results with the FDA by the end of the year and take subsequent next steps towards filing a New Drug Application.

INSY closed Wednesday's trading at $15.70, down 4.09%.

Shares of Nymox Pharmaceutical Corp. (NYMX) surged more than 83% on Wednesday, following successful results from a long-term crossover study with Fexapotide, the company's key compound in late stage development for enlarged prostate and for localized prostate cancer.

The study aimed at determining the clinical benefit Fexapotide can provide to men who initially were double blind randomized to and received placebo, remained blinded as to their placebo treatment, and who subsequently required additional medical and/or surgical treatment.

Results have now shown that there was 82-95% reduction in the number of patients who required surgery after they received crossover Fexapotide in the trial, compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments.

The company expects to seek approval of Fexapotide in the next 1-2 quarters.

NYMX closed Wednesday's trading at $4.45, up 83.13%.

More than two years after Pfizer Inc. (PFE) abandoned its $118 billion bid for AstraZeneca plc (AZN), it has now agreed to acquire the UK drugmaker's small molecule anti-infective business in a deal valued at over $1.5 billion.

The agreement entitles Pfizer with the development rights to the newly approved EU drug Zavicefta, the marketed agents Merrem/Meronem and Zinforo, and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL.

Pfizer will make an upfront payment of $550 million to AstraZeneca upon the close of the transaction and a deferred payment of $175 million in January 2019. In addition, AstraZeneca is eligible to receive up to $250 million in milestone payments, up to $600 million in sales-related payments, as well as tiered royalties on sales of Zavicefta and ATM-AVI in certain markets.

The transaction is expected to close in the fourth quarter of 2016.

PFE closed Wednesday's trading at $34.82, down 0.77%.

RegeneRx Biopharmaceuticals Inc.'s (RGRX.OB) U.S. joint venture, ReGenTree LLC, has received permission from the FDA to proceed with a second phase III clinical trial using RGN-259 to treat patients with dry eye syndrome.

The second phase III trial is expected to commence during the 3rd quarter of this year and is scheduled for completion by the 3rd quarter of 2017.

In May of this year, a 317-patient phase 2/3 trial of RGN-259 for the treatment of dry eye was successfully completed. This trial was also sponsored by ReGenTree LLC.

RGRX.OB closed Wednesday's trading at $0.38, up 1.35%.

TG Therapeutics Inc.'s (TGTX) drug candidate TGR-1202, for the treatment of patients with chronic lymphocytic leukemia, has been granted orphan drug designation by the FDA.

TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated chronic lymphocytic leukemia.

TGTX closed Wednesday's trading at $6.79, up 9.16%.