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OMED Disappoints, PBYI Soars, AMAG Seeks Expanded Approval For Makena

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AMAG Pharmaceuticals Inc. (AMAG) has submitted a supplemental new drug application to the FDA for subcutaneous version of Makena auto-injector, a drug-device combination product.

Makena, the first and only FDA-approved medicine to reduce the risk of preterm birth in women who are currently pregnant with one baby and who have unexpectedly delivered a baby preterm (before 37 weeks) in the past, is currently available as an intramuscular injection.

AMAG anticipates a six-month FDA review timeline for the Makena subcutaneous auto-injector, with the potential for approval and launch in the fourth quarter of 2017.

AMAG closed Monday's trading at $23.60, up 0.85%.

Aurinia Pharmaceuticals Inc. (AUPH) (AUP.TO) has granted Merck Animal Health worldwide rights to develop and commercialize Voclosporin ophthalmic solution for the treatment of dry eye syndrome in dogs.

Aurinia will receive an upfront payment and is eligible to receive further payments based on certain development and sales milestones. Furthermore, Aurinia will receive royalties based on global product sales.

However, the rights to all human uses of Voclosporin will be with Aurinia.

AUPH closed Monday's trading at $6.69, down 2.05%. In after-hours, the stock was up 3.74% to $6.94.

Shares of OncoMed Pharmaceuticals Inc. (OMED) slipped more than 17% on Monday, following the failure of its phase II trial of Tarextumab in Small Cell Lung Cancer to meet the endpoints.

The phase II trial, dubbed PINNACLE, evaluated Tarextumab in combination with etoposide and either cisplatin or carboplatin chemotherapy in previously untreated patients with extensive-stage small cell lung cancer.

The Company noted that results for the combination of Tarextumab plus chemotherapy were undifferentiated from those of chemotherapy plus placebo, and therefore the trial did not meet its primary endpoint of progression-free survival or secondary endpoints of overall survival.

OMED closed Monday's trading at $4.01, down 17.15%.

Puma Biotechnology Inc.'s (PBYI) New Drug Application for Neratinib is scheduled to be reviewed by an FDA panel on May 24, 2017.

Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab (Herceptin) containing regimen.

The NDA for Neratinib was accepted for review by the FDA on September 20, 2016. No specific PDUFA (decision) date has been notified. However, the U.S. regulatory agency's decision is expected to be announced in the third quarter of 2017.

PBYI closed Monday's trading at $39.60, up 11.08%.

Rigel Pharmaceuticals Inc. (RIGL) has submitted a New Drug Application to the FDA for Fostamatinib in patients with chronic and persistent immune thrombocytopenia.

The NDA submission was based on data from the Company's phase III program for Fostamatinib in ITP, which was comprised of three studies, two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension study.

In the Study 047, 18% of the patients in the Fostamatinib arm achieved stable platelet response of greater than 50,000 platelets per µL of blood on at least four of the last scheduled visits between weeks 14 and 24 of treatment and no patients on placebo met the stable platelet response criteria. The Study 048 also had an 18% responder rate for the Fostamatinib subjects, but did not achieve a statistically significant distinction between the treatment and placebo cohorts.

Whether or not the FDA accepts the NDA for review will be known in June 2017.

RIGL closed Monday's trading at $3.17, up 0.32%. In after-hours, the stock gained another 2.21% to $3.24.

Roche's (RHHBY.OB) Genentech has been granted accelerated approval by the FDA for Tecentriq to treat people with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.

It is not known if Tecentriq is safe and effective in children, noted the company.

Tecentriq was first approved in May 2016 by the FDA for treating people with previously treated advanced bladder cancer, and last October, it was approved for people with a specific type of metastatic lung cancer.

Analysts believe Tecentriq could reach peak annual sales, across all types of cancer, of $4 billion in 2021.

RHHBY.OB closed Monday's trading at $32.12, up 0.63%.

by RTT Staff Writer

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