Posts Tagged ‘healthcare’

Delcath Systems Inc. (DCTH) shares climb as cancer drug shows promise

Monday, August 22nd, 2011

Delcath Systems Inc. (Nasdaq: DCTH) shares rose 8.5% to $3.96 after it said its experimental cancer treatment showed promising results in a mid-stage trial. Volume for the stock approached 315,000 as noon ET closed in; its all-day average is around 861,000.

A Reuters article published Monday noted that the study included four patient cohorts — hepatobiliary cancers, and metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal origins — but responses to the treatment were most encouraging for hepatocellular carcinoma, the most common primary cancer of the liver.

“We believe these results show a strong signal of efficacy, and support our plan to initiate Phase III and Phase IV trials for HCC in the second half of 2012,” Chief Executive Eamonn Hobbs was quoted in the article as saying.

Delcath is developing a chemosaturation system that is designed to administer high dose chemotherapy drugs to only the diseased organs or regions of the body, thereby restricting the harsh effects of chemo drugs on other body organs.

Delcath, headquartered in midtown Manhattan, is a development-stage, specialty pharmaceutical and medical device company focused on oncology. We’re researching breakthroughs in regional chemotherapies with the goal of improving clinical outcomes and potentially reducing drug-related adverse events.

DARA Biosciences Inc. (DARA) prospers from new pain drug

Thursday, August 18th, 2011

DARA Biosciences Inc. (Nasdaq: DARA) shares climbed 23.3% to $2.81, on word of a fast-tracking for its new pain drug. Volume for the stock topped 835,000 shares Thursday morning, crushing its all-day average of 28,000.

A news release out August 18 revealed that the Raleigh, North Carolina-based DARA announced today that its investigational drug KRN5500 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address the unmet medical need (Fast Track Drugs). The purpose of the program is to get important drugs to the patient earlier.

New Drug Applications (NDA) for products in the Fast Track program normally receive priority review.

The same release quoted DARA CEO Richard Franco as saying, “the FDA Fast Track designation for KRN5500 is a significant positive step for the thousands of cancer patients who suffer this unremitting pain from a number of causes including from their chemotherapy.

“This is a most serious condition in need of new treatment options,” Franco continued. “Current estimates show as many as 40-50% of cancer patients receiving chemotherapy endure this condition and a certain portion of these patients endure relentless chronic pain requiring treatment even after they recover from their cancer. CIPN is also a dose limiting side effect of many commonly used chemotherapeutics. We are very encouraged by the initial clinical results, our partnership with the National Cancer Institute (NCI) and now the FDA Fast Track Drug status,” he added.

Unilife Corporation (UNIS) stock rockets on CEO buyback

Wednesday, August 17th, 2011

Unilife Corporation (NASDAQ: UNIS) shares zoomed 12.9% to $4.20, on word the company’s CEO plans to buy back up to $1 million in shares this week. Volume for the stock totaled 232,000 shares, lagging an all-day average of 258,000.

A news release out Wednesday announced that Unilife’s CEO, Alan Shortall, intends to purchase $500,000 in shares of the company’s common stock over the next week. Shortall intends to begin purchasing these shares this week at market prices within 48 hours.

Furthermore, Mr. Shortall has advised the Board of Directors of Unilife that he intends to purchase up to an additional U.S. $500,000 of the Company’s common stock between now and September 30, 2011. Mr. Shortall intends to provide twenty-four hours advance notice to U.S. markets before purchasing these additional Unilife shares.

Shortall is the largest shareholder in Unilife. These upcoming purchases by Shortall follow his most recent open market purchases of more than U.S. $500,000 in Unilife shares, which were completed in mid-March 2011 at an average price equivalent to $4.80 per share of common stock.

Shortall was quoted in the release as saying, “I believe that this is an excellent time to purchase shares in Unilife, and to further align my own personal interests to that of my fellow shareholders. In my opinion, Unilife has never had a brighter business future than what we see today. We remain on track with our strategic plan to become a global leader in advanced drug delivery systems. As such, I intend to increase my personal investment in the Company.”

Unilife Corporation is a U.S.-based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in York, Pennsylvania.

BIOLASE Technology, Inc. (BLTI) shares spike on bottom line

Wednesday, August 10th, 2011

BIOLASE Technology, Inc. (Nasdaq: BLTI) shares leaped 19.1% to $3.31, after reporting quarterly net revenue of $12.1 million, up 105% from $5.9 million in the same quarter for 2010. Volume for the stock was more than 717,000, already surpassing a daily average of around 636,000.

A news release issued August 10 also noted that Q2 GAAP loss was $753,000, or $0.03 per share, with Q2 Non-GAAP profits around $6,000, or $0.00 per Share. This was the third consecutive quarter of Non-GAAP profit, first time since the second quarter of 2004.

The release also said the percentage of net revenue in this year’s second quarter from the U.S. and international markets totaled approximately 71% and 29%, respectively, as compared to approximately 60% and 40% of net revenue in the prior-year comparable period.

Federico Pignatelli, Chairman and CEO, was quoted in the same release as saying, “The rate of revenue growth and operational progress at the Company continued to accelerate in the second quarter and our momentum going into the second half of the year is strong. Sales activities across our laser product platforms remained very active — especially in the case of the Waterlase iPlus, which we believe will become the most successful all-tissue dental laser in history. In addition, we are now taking orders and will soon be shipping the first units from our new BIOLASE DaVinci Imaging™ product line.”

BIOLASE Technology, Inc., the world’s leading dental laser company, based in Irvine, California, is a medical technology company that develops, manufactures and markets dental lasers and also distributes and markets dental imaging equipment, products that are focused on technologies that advance the practice of dentistry and medicine.

Questcor Pharmaceuticals Inc. (QCOR) perks on Q2 bottom line

Wednesday, July 27th, 2011

Questcor Pharmaceuticals Inc. (Nasdaq: QCOR) shares rallied 24.1% to $32.26 after the drug developer late Tuesday reported second-quarter income above expectations. Volume for the stock totaled 6.7 million shares, or nearly seven times its daily average.

An AP story quoted the Anaheim-based drug company as saying Tuesday that its profit jumped 49% in the second quarter as a strong pickup in prescriptions of the multiple sclerosis treatment H.P. Acthar Gel helped boost revenue to record levels.

The company reported net income of $13.9 million, or 21 cents a share, for the three months ended June 30. That compares with net income of $9.3 million, or 14 cents a share, in the same period last year.

Excluding certain non-cash expenses, the company’s earnings amounted to 23 cents a share, Questcor said.

Revenue grew by 62% to $46 million, versus $28.3 million a year earlier.

Analysts polled by FactSet were expecting, on average, net income of 20 cents a share on a profit of $42.1 million.

AP also said Questcor’s shipments of vials of Acthar rose 45% during the quarter versus a year earlier. They were up 21% from the first quarter’s tally.

The company said prescriptions for Acthar to treat multiple sclerosis more than doubled compared with the same quarter last year.

Prescriptions for the drug as a treatment for other conditions, including infantile spasms, also surged.

“Our focus on expanding the use of Acthar in the treatment of MS exacerbations drove our record second quarter financial performance,” AP piece quoted Don Bailey, Questcor’s president and Chief Executive, as saying.

As a result, the company is expanding its nephrology selling effort, he added.