On Tuesday, Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY)’s shares declined -5.56% to $0.650, as Oncolytics Biotech®, declared that it has presented an application for Orphan Drug Designation to the U.S. Food and Drug Administration (“FDA”) for REOLYSIN® for the treatment of gastric cancer.
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, counting a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees.
Oncolytics Biotech Inc., a development stage biopharmaceutical corporation, focuses on the discovery and development of pharmaceutical products for the treatment of cancers. The corporation develops REOLYSIN, a cancer therapeutic that is in various clinical trials for human use. Its cancer product is a potential therapeutic for tumours possessing an activated Ras pathway.
Pep Boys-Manny Moe and Jack (NYSE:PBY)’s shares dropped -7.19% to $8.91, during the last trading session on Tuesday, as The Pep Boys – Manny, Moe & Jack, declared the following results for the thirteen (fourth quarter) and fifty-two (fiscal year) weeks ended January 31, 2015.
Fourth Quarter
Sales
Sales for the thirteen weeks ended January 31, 2015 raised by $6.7 million, or 1.3%, to $502.4 million from $495.7 million for the thirteen weeks ended February 1, 2014. Comparable sales raised 1.3%, comprising of a 5.1% comparable service proceed raise and a 0.2% comparable merchandise sales raise.
Earnings
Net loss for the fourth quarter of fiscal 2014 was $26.7 million ($0.50 per share) as contrast to a net loss of $3.3 million ($0.06 per share) for the fourth quarter of fiscal 2013. On a pre-tax basis, the 2014 results comprised of, a net charge of $12.4 million comprised of a $23.9 million goodwill impairment charge, a $2.3 million asset impairment charge and $0.5 million in severance, partially offset by a $14.3 million gain from the disposition of certain properties.
Fiscal Year
Sales
Sales for fiscal year 2014 raised by $18.0 million, or 0.9%, to $2,084.6 million from $2,066.6 million for fiscal year 2013. Comparable sales remained relatively flat, comprising of a 4.9% comparable service proceed raise and a 1.6% comparable merchandise sales decrease.
Earnings
Net loss for fiscal year 2014 was $27.3 million ($0.51 per share) as contrast to earnings of $6.9 million ($0.13 per share) for fiscal year 2013. On a pre-tax basis, the 2014 results comprised of, a net charge of $24.6 million comprised of a $23.9 million goodwill impairment charge, a $7.5 million asset impairment charge, $4.0 million in litigation expense and $2.9 million in severance, partially offset by a $13.8 million gain from the disposition of certain properties.
The Pep Boys Manny, Moe & Jack, together with its auxiliaries, is engaged in the automotive aftermarket service and retail business. It operates service locations that offer a range of automotive maintenance and repair services; and install tires, parts, and accessories.
At the end of Tuesday’s trade, Nymox Pharmaceutical Corporation (NASDAQ:NYMX)‘s shares dipped -8.70% to $1.05, as Nymox Pharmaceutical Corporation, declared that the Corporation is undertaking further analyses of its pivotal U.S. Phase 3 studies of NX-1207 for prostate enlargement (BPH). This will comprise new long-term data from Studies NX02-0017 and NX02-0018. The Corporation anticipates to provide these new pivotal Phase 3 study results in Q2 or early Q3 this year.
The pivotal U.S. studies NX02-0017 and NX02-0018 were initiated in 2009. Enrollment of NX02-0017 (499 patients randomized) was accomplished in 2012; enrollment of NX02-0018 (498 patients randomized) was accomplished in 2013. 973 patients were injected with either NX-1207 2.5 mg (n=582) or saline vehicle alone as control (n=391).
Nymox Pharmaceutical Corporation, a biopharmaceutical corporation, is engaged in the research and development of products for the aging population. It provides NicAlert and TobacAlert products that use urine or saliva to detect use of and exposure to tobacco products, in addition to AlzheimAlert, a proprietary urine assay that aid physicians in the diagnosis of Alzheimers disease.
MiMedx Group Inc (NASDAQ:MDXG), ended its Tuesday’s trading session with -6.18% loss, and closed at $10.18, as MiMedx Group, declared the updated status of the Corporation’s payer coverage from commercial health plans and state Medicaid programs.
First Quarter of 2015 Coverage Highlights comprise:
- 53 million covered lives added from 27 new plans during the quarter
- 10 Blue Cross/Blue Shield plans encompassing 20 states added during the quarter
- Commercial covered lives grow to about 150 million during the quarter
- Medicare Beneficiaries eligible for coverage totals 36 million
- 29 state Medicaid programs have now confirmed coverage
MiMedx Group, Inc. designs, manufactures, and markets products and tissue processing services in the United States. The corporation’s products comprise patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane.
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