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A Busy Month For Immunogen (Part II)

Thu, 03 Dec 2009 21:03:11 GMT

At ASH 2009, Immunogen (IMGN) and its partners will present clinical data on three compounds: Sanofi-Aventis’ (SNY) SAR3419, Immunogen’s IMGN901 and Biotest’s BT-062.[More...]

BioMed Research Reports: Clinical Data (NASDAQ: CLDA), Lpath (OTC: LPTN.OB)

Fri, 27 Nov 2009 15:32:46 GMT

The BioMedReports.com research download section has been updated to include PDFs for two recent research reports written by Griffin Securities for Clinical Data (NASDAQ: CLDA) and Lpath, Inc. (OTC: LPTN.OB). Lpath received a buy rating with a $5 per share 12-month price target while CLDA was rated a buy with a 12-month price target of $38 per share. Below is a summary of both companies from their respective reports.[More...]

Celldex Therapeutics (NASDAQ: CLDX): Plenty of Cash and Pending Clinical Catalysts

Tue, 20 Oct 2009 02:19:35 GMT

At the beginning of the month, Celldex Therapeutics (NASDAQ: CLDX) announced the successful completion of its acquisition of CuraGen (formerly CRGN), which strengthens the balance sheet (approx. $85 million in cash / equivalents) while expanding the pipeline and increasing the expected news flow of clinical data catalysts for the combined entity[More...]

FDA Calendar Extreme Trades: 85 Single Digit Stocks

Tue, 13 Oct 2009 16:29:25 GMT

The BioMedReports.com FDA Calendar database includes over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.[More...]

10 Extreme Trades On Pending Clinical Trial Results

Thu, 14 May 2009 15:37:15 GMT

As a follow-up to my recent article on nine extreme FDA trades of pending new product decisions among small and micro-cap companies, I have examined the BioMedReports.com Clinical Trial Calendar database to find companies with market caps below $250M which have pending Phase 2 or 3 clinical trial results expected before the end of 2009. Below is a sample of 10 stocks meeting this criteria from the database of 111 entries included in the BioMedReports.com Clinical Trial Calendar, which is in addi (...)[More...]

How One Reader Found Dendreon (DNDN)

Tue, 21 Apr 2009 14:39:10 GMT

Lost in the multitude of "junk" stocks rising 30-50% in single sessions last week as speculative fever hit a high pitch, the story of Dendreon (DNDN) was somewhat lost in the mix. (Apr 14: Dendreon Cancer Vaccine Appears to be a Success; Analysts Miss It) Most weeks Dendreon's performance would stick out like a sore thumb but many Tom, Dick, and Harry $2 stocks were surging for no good reason... [More...]

Healthcare Product And Supplies, Short And Long Term Outlook

Mon, 06 Apr 2009 07:54:00 GMT

Healthcare Products and Supplies is a unique sub sector of healthcare that holds the potential for great growth opportunities in the coming years. The sub sector is extremely vast, with companies providing products and supplies to a variety of medical areas such as cosmetic surgery, eye care, cardiology, orthopedics, and diabetes to list just a few. Within these major areas, HCP&S ’s products are further divided into higher tech products such as drug eluting stents (DESs) and lower tech products such as hypodermic needles and scalpels. In[More...]

Spicing Up The Biotech Portfolio - Curagen and Curis

Tue, 24 Feb 2009 23:55:00 GMT

The past six months have not been kind to microcap biotech stocks, as it is hard to find a lot of love in today’s market for tiny, high risk, cash burning biotech companies. Honestly, who can blame investors for throwing stocks that offer a distant dream with minimal success rates and heavy spending? Surprisingly (or not), the negative sentiment also presents unprecedented opportunities in the microcap arena, as some microcaps are making tremendous progress, which is not yet reflected in their stock prices.

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AMAG Pharma: High Expectations - Analyst Blog

Tue, 20 Jan 2009 20:15:00 GMT

AMAG Pharmaceuticals Inc. (AMAG) develops superparamagnetic iron oxide nanoparticles for use in pharmaceutical products. The company's focus is on developing IV iron replacement therapy for anemia in chronic kidney disease and imaging agent to aid in diagnosis. The company filed the NDA (New Drug Application) for its lead drug, Ferumoxytol, in December 2007, and we expect FDA approval to come in 1H09. Clinical data in over 1,700 patients indicate an excellent safety profile for the drug with lower incidents of heart problems. Clinical results, and eventual approval for additional indications, should ensure strong growth in the coming years. We maintain our Buy rating on the shares of AMAG with a target price of $55. Read the full[More...]

Cytori Therapeutics' Big Upside - Analyst Blog

Tue, 11 Nov 2008 22:15:00 GMT

This is clearly an exciting time for Cytori Therapeutics Inc. (CYTX), as the company has begun to record product sales revenues from early-adopter Celution System placements in Europe and Asia. Additionally, sales of StemSource cell banking are also now beginning to ramp. Ultimately, the clinical data will determine the pace at which the ramp continues in the next several years. We have been encouraged by the small clinical data seen so far using Cytori's technology. We think the company is in store to report a solid fourth quarter, and the Street has yet to take notice of the upside that exists over the next few years. Today's price represents a very attractive entry point in our view. We are maintaining our Buy rating. We see $12 as fair-value based on $189.0 million in revenues in 2012[More...]

Beckman Coulter to Acquire Cogenics Division from Clinical Data

Wed, 01 Apr 2009 20:28:25 GMT

California-based biomedical testing instrument manufacturer Beckman Coulter has signed a definitive agreement to acquire Cogenics division from Clinical Data, a biotechnology company, for approximately $17 million.[More...]

Clinical Data, Inc. Reports Second Quarter Fiscal 2010 Results

Mon, 09 Nov 2009 11:47:00 GMT

Completed a public offering which generated approximately $47.4 million in gross proceeds
"The majority of our resources remain focused on driving our late-stage products toward key development milestones, several of which we anticipate over the next few quarters," said Drew Fromkin, Clinical Data's President and Chief Executive Officer.
Financial Results for the Three Months Ended September 30, 2009

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Clinical Data, Inc. Reports First Quarter Fiscal 2009 Results

Mon, 10 Aug 2009 11:46:00 GMT

Clinical Data, Inc. (NASDAQ: CLDA) today announced operational and financial results for the first fiscal quarter ended June 30, 2009.
The positive results from the second Phase III trial of vilazodone will contribute to a comprehensive new drug application (NDA) anticipated to be submitted to the U.S. Food and Drug Administration (FDA) by year end.
The Company also reported that gross revenue for Clinical Data's PGxHealth FAMILION® genetic testing business grew $1.7 million or 81% to $3.7 million compared to the same period a year ago.

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Clinical Data, Inc. to Present at BMO Capital Markets’ Ninth Annual Focus on Healthcare Conference August 5th

Wed, 29 Jul 2009 20:19:00 GMT

Clinical Data, Inc. (NASDAQ: CLDA), today announced that Drew Fromkin, President and Chief Executive Officer, and Dr. Carol Reed, Executive Vice President and Chief Medical Officer, will be presenting a corporate overview at the Ninth Annual BMO Capital Markets’ Focus on Healthcare Conference. The presentation will include updates on vilazodone, in development for major depressive disorder and Stedivaze™, a vasodilator in development for use in cardiac stress testing. Clinical Data's presentation will take place at 8:30 a.m. EDT. on Wednesday, August 5, 2009 at the Millennium Broadway Hotel, New York, NY.[More...]

Clinical Data, Inc. Announces Approval of Generic Name Vilazodone, First in a New Class of Experimental Treatments for Depression

Fri, 19 Jun 2009 20:24:00 GMT

Clinical Data, Inc. (NASDAQ: CLDA) announced today that the United States Adopted Name Council (USAN) has approved the generic name vilazodone hydrochloride. Vilazodone, if approved, would represent a first-in-class drug for the treatment of depression, due to its novel dual mechanism of action as both a potent and selective serotonin reuptake inhibitor (SSRI) and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Thus, vilazodone combines first-line therapy for depression with 5-HT1A partial agonism, an accepted adjunctive treatment for depression and a first-line therapy for anxiety disorders. Clinical Data has recently completed the second of two positive Phase III registration studies. Results of these studies will form the basis of a new drug application (NDA) that the Company intends to submit with the U.S. Food and Drug Administration (FDA) by the end of 2009.[More...]

Clinical Data, Inc. Reports Fourth Quarter and Fiscal Year 2009 Results

Mon, 15 Jun 2009 11:47:00 GMT

Clinical Data, Inc. (NASDAQ: CLDA) today announced financial results for the fourth quarter and fiscal year ended March 31, 2009, reporting strong revenue growth and continued achievement of key business and clinical program objectives for the periods.
"Foremost, our internal drug development expertise has successfully driven the vilazodone clinical program through two consecutive, successful Phase III registration trials for depression and we intend to file a new drug application for submission to the FDA by the end of this calendar year.
Importantly, to continue the momentum in our clinical development pipeline, we are moving our next promising drug candidate, Stedivaze, a vasodilator used for cardiac stress testing, into a Phase III clinical program."

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Clinical Data, Inc. to Present at Noble Financial’s Fifth Annual Equity Conference

Thu, 04 Jun 2009 21:15:00 GMT

Clinical Data, Inc. (NASDAQ: CLDA), today announced that Drew Fromkin, President and Chief Executive Officer, will be presenting a corporate overview at the Fifth Annual Noble Financial Equity Conference on Tuesday, June 9, 2009 at the Seminole Hard Rock Hotel, Hollywood, FL. Clinical Data's presentation will take place at 8:05 a.m. EDT.[More...]

Clinical Data, Inc. Announces Positive Results from Second Phase III Trial of Vilazodone for Depression

Tue, 02 Jun 2009 09:58:00 GMT

Clinical Data, Inc. (NASDAQ: CLDA) today announced positive top-line results from the second of two Phase III trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase III trial. In addition, study findings corroborate that effects of vilazodone on sexual function were comparable to placebo, an important finding since many antidepressants have been associated with causing or exacerbating sexual dysfunction. A statistically significant improvement in the symptoms of anxiety associated with MDD was also observed. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of MDD by the end of 2009.[More...]

Clinical Data Completes Acquisition of Avalon Pharmaceuticals

Thu, 28 May 2009 20:05:00 GMT

Clinical Data, Inc. (Nasdaq: CLDA) today announced the completion of its acquisition of Avalon Pharmaceuticals, Inc. Clinical Data acquired Avalon through an all-stock transaction valued at approximately $10 million, based upon the 15-day volume weighted average price of $12.49 for Clinical Data’s common stock through Monday, October 27, 2008, the date of the definitive merger agreement. As a result of the acquisition, the common stock of Avalon ceased trading at market close on May 28, 2009.[More...]

Clinical Data, Inc. and Dana-Farber Cancer Institute Form Research Collaboration to Study Role of FCGR3A Gene Variants for Predicting Clinical Outcomes in Breast Cancer Treatment

Mon, 18 May 2009 12:26:00 GMT

PGxHealth, a division of Clinical Data, Inc. (NASDAQ: CLDA), today announced that it has established a research collaboration with the Dana-Farber Cancer Institute (DCFI) to validate the use of genetic variants in Fc gamma receptors (FCGRs), including FCGR3A, in predicting response to trastuzumab (Herceptin) therapy in patients with breast cancer. The research, directed by Karen S. Anderson, M.D., Ph.D. at Dana-Farber, complements other studies underway to further demonstrate the contribution of genetic variants in the FCGR family to monoclonal antibody (mAb) response in cancer treatment. Importantly, the collaboration includes a large-scale effort to discover new genetic variants influencing response to Herceptin that may also predict response to other mAbs of the IgG1 class. The collaboration expands PGxHealth’s FCGR program, which includes its PGxPredict®:RITUXIMAB test for a gene variant used to determine response to rituximab monotherapy in follicular non-Hodgkin’s lymphoma. Fc gamma receptors are antibody receptors found on immune-regulatory white blood cells, such as T-cells.[More...]

Clinical Data, Inc. to Present at the Eighth Annual JMP Securities Research Conference

Thu, 14 May 2009 12:13:00 GMT

Clinical Data, Inc. (NASDAQ: CLDA), today announced that Drew Fromkin, President and Chief Executive Officer, will be presenting a corporate overview at the Eighth Annual JMP Securities Research Conference on Tuesday, May 19, 2009 at the Ritz-Carlton Hotel, San Francisco. Clinical Data’s presentation will take place at 8:30 a.m. PDT.[More...]