Drug stocks cling to the flat line in morning activity while shares of Inovio Biomedical soar on positive clinical data for its new DNA-based flu vaccine.
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Allergan and Medicis Pharmaceutical Corp. lead drug stocks lower in morning activity as shares of the dermatology-products makers fall on news that the health-care reform bill put forth by Senate Democrats would levy a 5% tax on elective cosmetic procedures.
Canaccord Adams gave the Biotechnology industry some bad news as it announced a downgrade on one of its stocks.
Poniard Pharmaceuticals, Inc. (PARD) [Chart - News - Analysis] was downgraded from Buy » Hold on 11/18/2009---a negative sign for the stock that investors will have to endure. FYI, Canaccord Adams uses the following rating scale when analyzing stocks: Buy, Hold, Sell.
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Poniard Pharmaceuticals, Inc. has an average analyst recommendation score of 1.5 and competes for investment dollars with Dendreon Corp. (DNDN) [Chart - News - Analysis] and Qiagen NV (QGEN) [Chart - News - Analysis]---two other stocks in the Biotechnology industry that have average analyst recommendation scores of 1.6 and 2.0 respectively.
Analyst recommendations are averaged and scored using the following rating scale:
- 1.0 = Strong Buy
- 2.0 = Buy
- 3.0 = Hold
- 4.0 = Sell
- 5.0 = Strong Sell
Why are Upgrades and Initiations Good and Downgrades Bad?
One event that is almost certain to get a reaction from Wall Street is an analyst upgrade or downgrade. Everyone is looking for an edge in the stock market, and quite often, traders turn to stock analysts to get that edge.
Upgrades and coverage initiations are typically good for stocks because they show that analysts either believe that the stock is going to perform better in the future or that the stock is worth covering and providing analysis on.
Downgrades are typically bad for stocks because they show that analysts believe that the stock is going to perform worse in the future.
A stock analysts is a person---typically employed by a large bank, investment firm or analysis company---who devotes his/her life to learning and making predictions about a company and its future performance.
Stock analysts sift through company reports and filings, talk to company management, probe customers and competitors and basically do whatever they can to find out if a company is healthy and growing or sick and shrinking. Because this is incredibly demanding work, stock analysts typically only monitor one or two companies at a time.
BloggingStocks: Analyst upgrades:
RBC Capital upgraded Fidelity National (FIS) to outperform from sector perform. The firm upgraded the stock due to valuation, and its belief that the company will clear up issues related to its merger on its Analyst Day, ... Read more
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, has been invited to present at the LD MICRO Growth Conference on Thursday, December 3, 2009 at 1:00 PM PST.AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it will release unaudited financial results for the quarter and fiscal year ended September 30, 2009 before market open on Tuesday, November 24, 2009.Conceptus, Inc. (Nasdaq: CPTS), developer of the Essure® procedure, the first proven non-incisional permanent birth control method available, today announced that Mark Sieczkarek, president and chief executive officer, will present at the Piper Jaffray 21st Annual Healthcare Conference on Tuesday December 1, 2009, at 2:00 p.m. ET. The conference will be held at the New York Palace Hotel.DARA BioSciences, Inc. (NASDAQ: DARA), a development-stage biopharmaceutical company, today announced that the Company will present at the New York Society of Security Analysts’ 13th Annual Biotech & Specialty Pharmaceuticals Industry investor conference to be held on December 1 in New York City.Exelixis, Inc. (Nasdaq:EXEL) today reported interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with paclitaxel and carboplatin in patients with advanced solid tumors.ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today reported encouraging clinical data with its IMGN901 product candidate in the treatment of Merkel cell carcinoma (MCC). Meaningful evidence of anticancer activity has been noted among the limited number of patients with MCC who have received IMGN901.ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company that is focused on the development of novel immune-based cancer therapies, announced today that Griffin Securities, a New York-based brokerage firm, has issued a research update summarizing some of the recent positive developments that the Company has been able to achieve which have led to reiteration of the ‘BUY’ rating on IMUC shares with an increase in the 12 month price target from $2.50, to $3.25, on the shares which are currently trading near $0.75.Neuralstem, Inc. (NYSE Amex: CUR) today provided a financial and business update for the third quarter ended September 30, 2009.Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) today announced that safety and potential efficacy parameters were demonstrated by the three month follow up data from the first patient ever to receive its placenta derived cell therapy product, PLX-PAD.PolyMedix Inc. (OTC BB: PYMX), an emerging biotechnology company developing acute care therapeutic drug products for infectious diseases and cardiovascular disorders, announced today that it has completed a public offering of units for aggregate gross proceeds of $20.7 million.Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC).Revolutions Medical Corporation ("RevMed" or the "Company") (OTCBB: RMCP), producers of the RevVac safety syringe, RevColor, RevDisplay and Rev3D MRI Technology, today announced that president and MRI industry pioneer Tom O'Brien has signed a 3-year employment commitment to the Company, giving RevMed leadership continuity and assured access to his unrivaled distribution relationships.
On 11/16/09, Cytori Therapeutics (NASDAQ: CYTX) completed enrollment in a 70-patient, international breast cancer reconstruction study, RESTORE 2. The study is evaluating the use of cell-enriched fat grafting to restore functional and cosmetic deformities in women who have undergone partial mastectomy for early breast cancer. Interim data on the first 32 patients who have reached the six-month follow-up will be presented as a poster at the San Antonio Breast Cancer Symposium on 12/12/0 at 7am (CT) by Mrs. Eva Weiler-Mithoff, MD, lead investigator at the Glasgow Royal Infirmary.[More...]
In a press release this morning, the company claims that the lawsuit is based upon the false claim that "...defendants failed to disclose that the FDA had requested several reports from the Company before the NDA could even be considered..." regarding the Ampligen(R) (Poly I : Poly C12U) investigational product. That claim is irrefutably false.You can read the complete press release here.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company’s Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.
“We have responded to all of FDA’s previous questions. We plan to address the current questions as well,” said Sally D. Bolmer, Ph.D., R.A.C, Senior Vice President, Development and Regulatory Affairs, HGS. “In certain respects, the Complete Response Letter appears to be inconsistent with the FDA’s published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible.”
James H. Davis, Ph.D., J.D., Executive Vice President and General Counsel, HGS, and leader of the Company’s raxibacumab program with the U.S. Government, said, “It is unfortunate that it was not possible to resolve these questions before the PDUFA date passed. However, HGS has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile under our contract with BARDA, so it is currently available in the Stockpile for use in the event of an emergency while we complete our discussions with the FDA.”
Raxibacumab represents a new way to address the anthrax threat.
Bad news for Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today. The company announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089.
"We are disappointed that the trial did not meet the primary endpoint. The data indicates that more patients on the best supportive care arm received chemotherapy following progression than those on the picoplatin arm, and we believe that this may have been a significant factor contributing to the trial outcome, as picoplatin appeared to demonstrate a trend toward a survival advantage. Based on these findings and other analyses, we are contacting the FDA today to request a meeting to discuss a regulatory path forward. We look forward to presenting the full SPEAR efficacy and safety data at an upcoming medical conference early next year," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We believe that the SPEAR data, coupled with efficacy and safety data from more than 1,100 cancer patients treated with picoplatin and the proof-of-concept data from our trials in colorectal, prostate and ovarian cancers, support our continued partnering effort. Our focus will be on the regulatory pathway for picoplatin, partnering activities, and realigning the use of resources for these objectives."
Novavax, Inc. (Nasdaq: NVAX) announced today that enrollment has been completed in the first stage of a two-stage clinical study of its novel 2009 H1N1 virus-like-particle (VLP) pandemic influenza unadjuvanted vaccine in the country of Mexico. An independent data and safety monitoring board has reviewed preliminary safety data from the first half of this cohort and recommended that this first stage continue as planned.
"We are encouraged by the recommendation of the data and safety monitoring board to continue the trial and plan to begin subjects' enrollment in the second phase of the study as soon as possible," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "This pivotal trial is advancing rapidly toward completion with the ability to evaluate results early next year. If our findings are positive, Novavax and our partners plan to seek immediate approval to market our VLP-based 2009 H1N1 VLP pandemic influenza vaccine in Mexico, which currently faces a critical shortage of H1N1 influenza vaccine."
The company has gone outside the country to look for ways to monetize their VLP vaccine technology after the CDC and other US regulators announced that they wanted to stay with older and proven technologies to continue making vaccines.
CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA). In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the Food, Drug and Cosmetic Act of 1938, as amended (FDCA).
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