Posts Tagged ‘Biotech Stocks’

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Amylin Pharmaceuticals, Inc. (AMLN) soars on news of rejection of Bristol-Myers takeover bid

Wednesday, March 28th, 2012

Shares of diabetes drug maker Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) were up more than 50 percent from Tuesday’s closing price in morning trading on Wednesday after Bloomberg reported that Amylin rebuffed an unsolicited takeover bid from pharma giant Bristol-Myers Squib Co. (NYSE: BMY) for $3.5 billion, or $22 a share.

According to data provided by Yahoo Finance, shares of AMLN touched a high of $23.50 on Wednesday, up from Tuesday’s closing price of $15.39.

Reuters reported that Amylin has been considered a possible takeover target for quite some time. Spokeswomen for Bristol-Myers and Amylin refused to comment, Reuters reported.

Bristol Myers Squibb BMY“Bristol as an acquirer makes sense,” Robyn Karnauskas, an analyst with Deutsche Bank in New York, wrote in a note to clients today, Bloomberg reported. “Amylin could be worth up to $31 a share based on expense synergies. However, Bristol is financially disciplined.”

There have been 16 acquisitions more than $1 billion of biotech companies in Amylin’s peer group in the past five years, according to data compiled by Bloomberg. The average disclosed size was $8 billion, with an average premium of 35 percent, the Bloomberg data show.

 

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Transcept Pharmaceuticals Inc. (TSPT) nearly doubles on drug review

Thursday, September 15th, 2011

Transcept Pharmaceuticals Inc. (Nasdaq: TSPT) shares rose 93.7% to $6.47 a day after the drug developer said U.S. regulators might finish a new review of its sleep drug within two months. Volume for the stock exceeded 3.8 million, towering above a daily average of only 235,000.

A news release out Sept. 14 noted that the company, headquartered in Point Richmond, Calif., plans to resubmit to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) seeking approval of Intermezzo® (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The plan to resubmit the Intermezzo® NDA results from a meeting today with the FDA during which the FDA generally agreed with a Transcept proposal to reduce the recommended Intermezzo® dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo® dose for men at 3.5 mg. The Transcept proposal also includes new instructions stating that Intermezzo® should only be taken if patients have at least four hours of bedtime remaining, and that patients should refrain from driving for at least one hour after arising and until five hours after dosing Intermezzo®.

In the same release, Transcept CEO Glenn A. Oclassen was quoted as saying “We are pleased that the FDA has expressed general agreement with our proposal to address the concerns expressed in the July 2011 Intermezzo® Complete Response Letter. We look forward to working with the FDA to complete the review of this important new treatment strategy for insomnia characterized by middle of the night awakening.”

Transcept is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience.

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Mela Sciences Inc. (MELA) wins Europe nod, stocks skyrocket

Wednesday, September 7th, 2011

Mela Sciences Inc. (Nasdaq: MELA) shares surged 56.9% to $3.52, a day after the developer’s diagnostic device to help detect skin cancer won European Union approval. Volume for the stock topped 4.8 million shares, towering over a daily average of 261,000.

A news release dated September 6 noted that the company, located in Irvington, N.Y., had received CE Mark approval for MelaFind®, allowing the company to market its MelaFind device to dermatologists across the E.U. The company intends to initially market MelaFind in Germany, which has the highest incidence of melanoma in Europe.

The CE (Conformité Européenne, or “European Conformity”) Mark approval allows the company to market MelaFind freely across the 27 nations that comprise the E.U. The EU is the world’s largest economic bloc with over 500 million residents and annual economic output of over $16 trillion.

The same release quoted CEO Joseph Gulfo as saying, “We’re extremely pleased to receive the CE Mark for MelaFind. With more than 81 million people, Germany represents a significant opportunity for the company and an ideal market to launch MelaFind in the E.U.

Gulfo continued, “Given the high rates of melanoma seen in the German population, we believe MelaFind has the potential to make a deep impact on the disease there. In order to achieve our initial goals for the commercial development phase of the launch, we plan to utilize a direct sales force that will focus on strategically placing MelaFind systems in the top dermatology practices in several key cities throughout the country.”

MELA Sciences is a medical technology company focused on developing MelaFind®, a non-invasive and objective multi-spectral computer vision system intended to aid in the detection of early melanoma.

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Pharmasset Inc. (VRUS) jumps on drug findings

Tuesday, September 6th, 2011

Pharmasset Inc. (Nasdaq: VRUS) shares rose 5.2% to $67.55 after the drug developer released preliminary findings from a study of its Hepatitis C treatment. Volume for the stock was 658,000 shares, or about half its daily average.

A news release out September 6 noted that the Princeton, New Jersey-based company announced today sustained virologic response (SVR) results from its phase 2b PROTON study with PSI-7977 400 mg dosed once daily in combination with peginterferon alfa 2a and ribavirin (Peg-IFN/RBV) in subjects with hepatitis C virus (HCV) genotype 1 who have not been treated previously.

In all, 95 treatment-naive patients with HCV genotype 1 were enrolled into two open-label arms of the PROTON trial, receiving either PSI-7977 200 mg QD (N=48) or 400 mg QD (N=47) for 12 weeks. Individuals in both arms received Peg-IFN/RBV for 24 weeks and were followed post-treatment to assess SVR12.

What’s more, 26 subjects were enrolled in a placebo control arm and are receiving 48 weeks of Peg-IFN/RBV. Results from this study through the SVR12 endpoint are scheduled to be presented as part of a Presidential Plenary Session at the American Association for the Study of Liver Diseases (AASLD) meeting on Tuesday, November 8, 2011.

“I am very pleased with the results of this study which clearly demonstrate the benefit of the 400 mg dose of PSI-7977 with only 24 weeks of interferon for all subjects,” Dr. Eric Lawitz, the study’s principal investigator, was quoted in the release as saying. “HCV therapy is becoming overly complex, and the elimination of 24 weeks of interferon and ribavirin as well as all response guided criteria for patients with HCV genotype 1 would be a welcomed simplification.”

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections.

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Response Genetics, Inc. (RGDX) wins new assignment, stock soars

Wednesday, August 31st, 2011

Response Genetics, Inc. (Nasdaq: RGDX) shares hiked 10.6% to $2.40, on word of a new contract. Volume for the stock was a mere 500 shares, in contrast to a daily average of 12,000.

A news release out August 31 declared that XIFIN Inc., the company revolutionizing revenue cycle management for diagnostic service providers, announced today that Response Genetics had implemented XIFIN’s revenue cycle management system to optimize billing and claims management and help manage cash collections.

The release quoted David O’Toole, Vice President and CFO at Response Genetics as saying, “We believe XIFIN’s expertise in molecular diagnostic billing best positioned us to effectively manage RGI’s cash flow while bringing billing and collections in-house during a period of tremendous company growth and also to meet the stringent regulatory requirements for public companies.”

The Los Angeles-based Response Genetics, Inc., a leading developer of molecular diagnostic tests for cancer including ResponseDX: Lung(TM), ResponseDX: Colon(TM) and ResponseDX: Gastric(TM), has implemented XIFIN’s revenue cycle management system to optimize billing and claims management and help manage cash collections.

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