Today’s Daily Dose brings you news about Arena Pharma’s OASIS trial results; national reimbursement of Abbott’s MitraClip in Japan; Apellis Pharma’s upcoming clinical trial catalysts; aTyr Pharma’s near-term catalyst; PDUFA date for Pfizer’s Xtandi sNDA, and Pain Therapeutics’ regulatory catalyst in June.
Abbott’s (ABT) MitraClip therapy to treat people with mitral regurgitation has received national reimbursement in Japan.
Mitral regurgitation is a serious, progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward into the heart.
The reimbursement, which will come into effect in Japan beginning April 1, 2018, is important to local physicians and patients because it makes the MitraClip therapy more accessible for people through the country’s health insurance plans, added the Company.
MitraClip received CE mark approval in Europe in 2008 and was approved by the U.S. Food & Drug Administration (FDA) in 2013. To date, more than 50,000 people have been treated with the MitraClip system in nearly 50 countries.
ABT closed Monday’s trading at $62.26, down 1.46%.
Shares of Arena Pharmaceuticals Inc. (ARNA) were up more than 24% in extended trading on Monday, following positive results from its phase II trial of Etrasimod in ulcerative colitis.
In the trial, dubbed OASIS, patients receiving the 2 mg dose of Etrasimod achieved statistically significant improvements compared to placebo in the primary, all secondary, and clinical remission endpoints.
The Company intends to initiate a phase III program of Etrasimod in ulcerative colitis.
ARNA closed Monday’s trading at $30.89, down 1.97%. In after-hours, the stock was up 24.80% to $38.55.
Apellis Pharmaceuticals Inc. (APLS) has a couple of events to watch out for in the coming months.
The Company is on track to initiate a phase III trial of APL-2 for the treatment of patients with geographic atrophy associated with AMD (GA) in the second half of 2018.
A phase III trial of APL-2 in Paroxysmal Nocturnal Hemoglobinuria is expected to begin in the second half of 2018.
APL-2 is also under two phase Ib trials in paroxysmal nocturnal hemoglobinuria – one as monotherapy and the other as add-on to Soliris. Updates from these trials are expected in the first half of 2018.
A phase II proof of concept study of APL-2 as monotherapy in autoimmune hemolytic anemia (AIHA) is underway, and data are anticipated in the first half of 2018.
The phase II proof of concept monotherapy data for APL-2 in four types of complement-dependent nephropathies, including IgA nephropathy, C3 glomerulonephropathy, primary membranous nephropathy, and lupus nephritis, are expected in the second half of 2018.
APLS closed Monday’s trading at $25.64, down 1.46%.
aTyr Pharma Inc. (LIFE) expects to announce top-line results from a phase I trial of intravenous ATYR1923 in healthy volunteers in the second quarter of 2018.
ATYR1923 is an agonist of the Resokine pathway designed to temper immune engagement in interstitial lung diseases.
As of December 31, 2017, the Company had $85.1 million in cash, cash equivalents and investments.
LIFE closed Monday’s trading at $3.00, unchanged from the previous day’s close.
Endologix Inc. (ELGX) has reported the first positive results from ENCORE, a pooled, global analysis of several prospective clinical trials and registries studying polymer endovascular aneurysm repair (Polymer EVAR) using Ovation Abdominal Stent Graft Systems.
The trial encompassed 1,296 patients in the U.S., Europe and Latin America.
According to the Company, at five years, the ENCORE analysis demonstrated the following:
— 99.1% freedom from AAA-related mortality
— 99.0% freedom from reintervention for Type 1a endoleak
— 99.7% freedom from rupture
— 99.2% freedom from conversion
— 96.4% freedom from all device-related reintervention
ELGX closed Monday’s trading at $4.16, down 1.89%.
Pfizer Inc. (PFE) and Astellas Pharma Inc’s supplemental New Drug Application seeking expanded approval of XTANDI to include men with non-metastatic Castration-Resistant Prostate Cancer (CRPC) has been granted priority review, with a decision expected in July 2018.
XTANDI is currently indicated for the treatment of patients with metastatic CRPC.
For the first nine months of fiscal year 2017 ending March 31, 2018, sales of XTANDI increased 16.2% year-on-year to ¥219.9 billion.
PFE closed Monday’s trading at $36.33, down 1.22%.
pSivida Corp.’s (PSDV) New Drug Application for Durasert three-year treatment for posterior segment uveitis has been accepted for review by the FDA, with a decision expected on November 5, 2018.
Posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior segment uveitis affects between 80,000 – 100,000 people.
PSDV closed Monday’s trading at $1.16, down 5.69%.
Pain Therapeutics Inc.’s (PTIE) resubmitted New Drug Application for REMOXY is slated to be reviewed by an FDA panel on June 26, 2018.
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for “the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
REMOXY ER was issued a Complete Response Letter by the FDA in September 2016.
The FDA’s decision on REMOXY ER is expected on August 7, 2018.
If approved, REMOXY ER will be classified as a Schedule II drug, subject to strict prescribing and dispensing rules.
PTIE closed Monday’s trading at $6.99, down 2.24%.
Xencor Inc. (XNCR) has offered to sell 5 million shares of its common stock in an underwritten public offering.
The underwriters will be granted a 30-day option to purchase up to an additional 750,000 shares of common stock.
XNCR closed Monday’s trading at $31.73, up 2.75%.
by RTT Staff Writer
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