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AMGN's Xgeva To Face FDA In Feb, Double Treat For LPCN, SGEN Drops Cascade

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Today's Daily Dose brings you news about Amgen's regulatory catalyst for next February; Axsome's new addition to its Board; Clovis' ARIEL3 results; Exelisis' CABOSUN study; Lipocine's study results of oral testosterone candidate LPCN 1021; FDA approval of Neos' ADHD medication and Seattle Genetics' CASCADE disappointment.

Read on...

Amgen's (AMGN) supplemental Biologics License Application for XGEVA, seeking to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma, has been accepted for review by the FDA - with a decision date set for February 3, 2018.

XGEVA was approved by the FDA in 2010 for the prevention of skeletal-related events in patients with bone metastases from solid tumors; in 2013, to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor, and in December, 2014 for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

XGEVA sales totaled $1.53 billion in 2016, up 9% over the prior year.

AMGN closed Monday's trading at $165.09, up 1.64%.

Axsome Therapeutics Inc. (AXSM) has appointed Myrtle Potter to its Board of Directors.

Potter is the Chief Executive Officer and Founder of Myrtle Potter & Company, a healthcare and life science advisory firm. She previously served as the President, Commercial Operations and Chief Operating Officer of Genentech, and held executive operating positions at Bristol-Myers Squibb and Merck.

AXSM closed Monday's trading at $4.60, up 12.20%.

Shares of Clovis Oncology Inc. (CLVS) soared more than 46% on Monday, following positive top line results from a confirmatory phase 3 trial of Rucaparib in ovarian cancer patients, dubbed ARIEL3.

The trial met the primary endpoint of improved progression-free survival or PFS by investigator review in all three primary efficacy analyses: tumor BRCA-mutant, HRD-positive and overall intent-to-treat populations.

Rucaparib received FDA approval last December as monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more prior chemotherapies.

The Company intends to submit a sNDA for Rucaparib as a second line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data within the next four months, and also file a Marketing Authorization Application (MAA) in Europe for the maintenance indication.

In other news, the Company announced that it has commenced an underwritten public offering of shares of its common stock to raise aggregate proceeds of approximately $250 million.

CLVS closed Monday's trading at $87.88, up 46.54%. In after-hours, the stock was up 1.34% at $86.70.

Exelixis Inc. (EXEL) rose 12.15% on Monday after a review by a blinded independent radiology review committee confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival from the CABOSUN study.

The CABOSUN study is a phase II trial of Cabozantinib comparing Sunitinib, also called Sutent, in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease.

On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint. The Company is on track to seek approval of Cabozantinib in the E.U. in the third quarter of this year.

EXEL closed Monday's trading at $21.60, up 12.15%.

Shares of Lipocine Inc. (LPCN) climbed more than 38% in extended trading on Monday, following positive results from both the Dosing Validation and the Dosing Flexibility studies evaluating efficacy and tolerability of oral testosterone candidate LPCN 1021.

In the DV study, LPCN 1021 successfully met the FDA primary efficacy guidelines where 81% of the subjects achieved average testosterone levels within the normal range with a lower bound confidence interval of 72%.

The Dosing Flexibility study restored 70% of the subjects' average testosterone levels within the normal range confirming that twice daily dosing is the appropriate dosing regimen for LPCN 1021 and will be the basis for resubmission, noted the Company.

The FDA had refused to approve LPCN 1021 last June, citing deficiencies related to the dosing algorithm for the label. The Company plans to resubmit New Drug Application for LPCN 1021 in the third quarter of 2017.

LPCN closed Monday's trading at $4.02, up 3.88%. In after-hours, the stock was up 38.06% to $5.55.

The FDA has approved Neos Therapeutics Inc.'s (NEOS) Cotempla XR-ODT for the treatment of attention-deficit/hyperactivity disorder in patients 6 to 17 years old.

Cotempla XR-ODT becomes the first and only methylphenidate extended-release orally disintegrating tablet to be approved for ADHD. The drug will be commercially available in a portable, child-resistant blister pack in the fall of 2017.

Commenting on the approval, Vipin Garg, President and CEO of Neos Therapeutics said, "With this approval, Neos will be the only company to have both a branded methylphenidate and a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form. We look forward to having Cotempla XR-ODT join our Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets on the market this fall."

Cotempla XR-ODT and Adzenys XR-ODT are Schedule II controlled substances.

A category of drugs considered to have a strong potential for abuse or addiction but with legitimate medical use are called Schedule II controlled substances. (Source: Mosby's Medical Dictionary).

NEOS closed Monday's trading at $9.00, up 4.05%.

Seattle Genetics Inc. (SGEN) has decided to pull the plug on its phase III clinical trial of Vadastuximab talirine in frontline older acute myeloid leukemia patients, dubbed CASCADE, due to a higher rate of deaths, including fatal infections in the treated patients.

Based on available data, the safety concerns in the CASCADE trial are not related to hepatotoxicity, according to the Company.

Seattle Genetics is suspending patient enrollment and treatment in all of its Vadastuximab talirine clinical trials including the ongoing phase 1/2 clinical trial in frontline high risk myelodysplastic syndrome (MDS).

SGEN closed Monday's trading at $61.88, down 4.09%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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