Posts Tagged ‘Biotech Stocks’

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Cypress Bioscience, Inc. (CYPB) – Buzz Stock of the Day

Monday, July 19th, 2010

Shares of drug maker Cypress Bioscience, Inc. (Nasdaq: CYPB) rallied as much as 41 percent from Friday’s closing price, in morning trading on Monday after hedge fund, Ramius offered to buy the company for about $154 million, or $4.00 a share in cash.

Ramius currently owns 9.9 percent of Cypress’ common stock. The offer of $4.00 per share is a 60 percent premium over Friday’s closing price of $2.50.

[–quote–]

In addition to the all-cash offer, Ramius also stated  that it would consider an acquisition structure that would allow management to continue the development of the recently acquired antipsychotic drug, BL-1020 if they are able to fund the required financing for the Phase IIb trial themselves or from a third party financing source.

In late June, Cypress Bioscience, Inc. entered  into an exclusive North American license for the development and commercialization of BioLineRx’s novel antipsychotic, BL-1020, a treatment for schizophrenia. Specific terms of the transaction were not disclosed, but the total upfront payment to BioLineRx was $30 million, with total potential clinical and regulatory milestones of up to $160 million through to approval in the United States, potential commercial milestones of $85 million, and a potential additional $90 million associated with approval for additional indications in the United States or for approval in other countries in North America. Cypress also agreed to fund all continuing development activities and pay BioLineRx a royalty based on applicable sales.

Ramius said poor decisions by Cypress management has damaged its stock price and that the company should hold off on making any further acquisitions or licensing deals. Shares of Cypress Bioscience are down about 73 percent over the past 12 months.

In a letter to Cypress management, Ramius said it is “ready, willing, and able to close this transaction expeditiously and expect the board to retain a reputable investment bank to immediately engage in discussions with us and any other potential acquirers to maximize value for all shareholders.”

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Keryx Biopharmaceuticals, Inc. (KERX) – Hot Buzz Stock of the Day

Wednesday, July 14th, 2010

Shares of Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) climbed as much as 17 percent in morning trading Wednesday after the after the company announced its experimental childhood cancer drug, KRX-0401 (perifosine), had received Orphan Drug designation from U.S. Food and Drug Administration (FDA).

Commenting on receiving Orphan Drug designation, Ron Bentsur, Chief Executive Officer of Keryx stated, “We are currently exploring next steps for the development of perifosine in this indication which we hope, ultimately, could provide a new treatment option for children and infants suffering with neuroblastoma.

The FDA grants Orphan Drug status to new drugs that treat a rare disease afflicting fewer than 200,000 patients in the U.S. The benefits of Orphan Drug designation include seven-year marketing exclusivity if the drug is the first of its kind approved, tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

KRX-0401 is being developed for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants. Although it is a rare form of cancer, neuroblastoma accounts for approximately 7 percent of all cancer deaths among children.

[–quote–]

Clinical Phase 1 data was presented last month in the pediatric solid tumor poster discussion session held at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Investigators from the Memorial Sloan-Kettering Cancer Center concluded that perifosine was demonstrated to be safe and well tolerated in children with advanced solid tumors and that perifosine may have antitumor clinical activity as a single agent in neuroblastoma.

Additionally, the Nationaly Cancer Institute recently published a preclinical study that found perifosine showed a statistically significant reduction in neuroblastoma cell survival, slowed or regressed tumor growth, and increased survival in mice bearing neuroblastoma tumors.

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Vivus, Inc. (VVUS) – Buzz Stock of the Day

Tuesday, July 13th, 2010

Shares of weight loss drug maker, VIVUS, Inc. (Nasdaq: VVUS) surged as much as 13 percent from Monday’s closing price, in morning trading on Tuesday after the U.S. Food and Drug Administration released documents that showed FDA researchers believe that use of Vivus’ diet drug Qnexa can result in “significant” weight loss. However, the agency raised questions about the drug’s safety.

Vivus shares were up about 34% to $14.25 in Tuesday’s pre-market trading session.

[–quote–]

In the FDA’s review of Qnexa, posted online Tuesday as part of the briefing documents for Thursday’s advisory panel, pooled data from two large phase III studies demonstrated that patients treated with low, medium and high doses Qnexa lost between 3 percent, 7 percent and 9 percent of their body weight, respectively, adjusted for the weight-loss reported for patients treated with a placebo.

Qnexa’s safety and not the drug’s ability to help patients lose weight, was the major concern entering Thursday’s meeting. In its briefing document Tuesday, FDA’s safety review highlights five areas of “particular interest” related to Qnexa — pregnancy risk, psychiatric-related adverse events, cognitive-related adverse events, metabolic acidosis and cardiovascular events. Many of these concerns, however, were expected.

Vivus, in its own briefing documents, said research showing that 68 percent of adults in the U.S. are overweight indicate a clear medical need for Qnexa.

A panel of experts is scheduled to review the drug on Thursday, with the FDA making a regulatory decision in October.

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Buzz Stocks Week in Review – IDT, CWLZ, PEIX, ARNA

Friday, July 2nd, 2010

Average Weekly Gain: 37.3%


Monday: Our Buzz Stock of the Day on June 28, IDT Corp. (NYSE: IDT) had a great week. IDT, which blends a strange pairing of telecom and energy had positive momentumthroughout the week. Shares began their climb on Monday, after a CNBC interview in which CEO Howard Jonas outlined the company’s shale properties and oil extraction technology. IDT’s energy business, Genie Energy, holds IDT’s interests in the American Shale Oil, LLC (AMSO), a joint oil shale research and development venture in Colorado with Total, S.A.; and in Israel Energy Initiatives (IEI), which holds an exclusive shale oil exploration and production license in the Shfela region of Israel. According to Jonas, it costs IDT Corp. $25 per-barrel to extract oil from shale rock. This figure is about $10 less than ultra-deep water fuel extraction — the kind of extraction that was being used by British Petroleum (NYSE: BP) in the Gulf of Mexico.

Up as much as 57 percent since our post.

Tuesday: On Tuesday, we featured Cowlitz Bancorp. (Pink Sheets: CWLZ) as our Buzz Stock of the Day. Cowlitz shares were up about 25 percent from Monday’s close, in morning trading on Tuesday after the company announced that it presented an updated plan to regain compliance with two Nasdaq Listing Rules with which it is not in compliance and requested a 90-day exception to the continued listing standards. Unfortunately, Cowlitz was de-listed from the Nasdaq on Thursday, July 1. Cowlitz received a  delisting determination letter from Nasdaq due to the Company not being in compliance with the minimum 500,000 publicly held shares requirement set forth in Listing Rule 5550(a)(4), on May 12.

Wednesday: Shares of Pacific Ethanol, Inc. (Nasdaq: PEIX) surged almost 60 percent on Wednesday, after the company announced that four of its subsidiaries had emerged out of bankruptcy. The plant subsidiaries, which are now owned by a newly formed holding company, will continue to be staffed, managed and operated by Pacific Ethanol under a fee and profit-sharing arrangement negotiated with the owners of the newly formed holding company. Pacific Ethanol, Inc. eliminated approximately $290 million in debt and other liabilities from its balance sheet. The bankruptcy did not affect the Company’s ownership structure and the Company continues to be owned by its existing common and preferred stockholders.
Up as much as 31 percent since our post.

Thursday: Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) was up 20 percent from Wednesday’s close, in morning trading on Thursday after the company announced that Japanese drug maker, Eisai, Inc. will market Arena’s obesity treatment lorcaserin in the U.S. The U.S. Food and Drug Administration is already reviewing lorcaserin, and a decision is expected on Oct. 22. The main concern with lorcaserin is that patients treated with the drug in two pivotal phase III studies didn’t lose much weight — a little more than 3% on a placebo adjusted basis. The biggest plus in lorcaserin’s corner is the drug’s safety and tolerability, which appear better than competing drugs.
Up as much as 24 percent since our post.

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Arena Pharmaceuticals, Inc. (ARNA) – Buzz Stock of the Day

Thursday, July 1st, 2010

Shares of drug maker Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) surged 20 percent from Wednesday’s close, in morning trading on Thursday after it was announced that Japanese drug maker, Eisai, Inc. will market Arena’s obesity treatment lorcaserin in the U.S.

“Execution of this commercial agreement is a major milestone in our plans for lorcaserin,” said Jack Lief, Arena’s President and Chief Executive Officer. “We believe in Eisai’s human health care mission to satisfy unmet medical needs and increase benefits to patients and their families.”

Here are a few highlights from the deal:

  • $50 million initial upfront (kind of small when considering the potential of the drug)
  • $90 million upon FDA Approval (PDUFA October 22nd) bringing upfront for US marketing rights to $140 million
  • $1.16B in one-time purchase price adjustments after certain sales goals.
  • 31.5-36.5% of annual Lorcaserin sales

    • [–quote–]
    The U.S. Food and Drug Administration is already reviewing lorcaserin, and an decision is expected on Oct. 22. The main concern with lorcaserin is that patients treated with the drug in two pivotal phase III studies didn’t lose much weight — a little more than 3% on a placebo adjusted basis. The biggest plus in lorcaserin’s corner is the drug’s safety and tolerability, which appear better than competing drugs.

    “With Eisai, we have the right company to market lorcaserin in the United States, the right type of agreement to optimize lorcaserin’s medical and commercial potential and the shared recognition that it is the right time to enter into this agreement to prepare for launch following FDA approval,” Lief said.

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