|Vertex Soars on Promising Drug Data; Arena Awaits FDA Advisory Meeting|
|By Staff and Wire Reports|
|Monday, 07 May 2012 19:08|
Shares of Vertex Pharmaceuticals (NASDAQ: VRTX) rallied the most since it went public in 1991 on Monday. The company announced interim results from its phase 2 combination study of Kalydeco + VX809 in cystic fibrosis. The data revealed that the treatment demonstrated a statistically significant improvement in lung function. The promising data has sent shares of VRTX skyward, and at last check the stock was trading up 46% to $54.53 and trending up on an intra-day basis. Analysts at JP Morgan provided additional color on the data in a Monday morning report.
They wrote, "A FEV1 improvement of at least 5% was observed in 46% of patients and an improvement of at least 10% was observed in 30% of patients. Expectations were certainly not assuming an FEV-1 benefit, so obviously these subgroups performed well. Reductions in sweat chloride, the key objective of the study were not statistically significant. As such, we view the results as mixed with significant improvement in FEV1 for a subset of patients. We wouldn't be chasing VRTX shares here on the back of the data, but either way, Vertex anticipates initiating a pivotal study of this combination in CF patients with 2 copies of F508del following final discussion with regulators."
The analysts reiterated their Neutral rating on the stock based on their view that the sweat chloride data was mixed. Looking ahead, additional clinical trials of this drug combination could provide meaningful catalysts for VRTX. Despite today's huge move, VRTX is still trading below its 52-week high of $58.87, which was put in last May. This area may be a natural price target for the stock in the coming days and traders will want to see if VRTX can convincingly break this level to the upside.
In any event, today's data puts the company squarely on the radar of the investing community and the name should continue to be active this week. Volume has exploded with around 25 million VRTX shares already trading hands on the session compared to a 3-month daily average of 2.4 million. If the stock can continue to move higher in the coming days on significantly elevated volume, it would be an unmistakable bullish signal in light of today's news.
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it will hold an earnings call on Wednesday, May 9th, at 9 a.m. EDT during which it will discuss 2012 first quarter results for the period ended March 31, 2012 and provide a corporate update.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) is awaiting its opportunity to readdress the U.S. Federal Food and Drug Administration's Advisory Committee, as it continues to seek approval for its weight-loss drug Locaserin.
The meeting is scheduled for May 10, 2012. This will be the second attempt by Arena to gain the favor of the committee, after it submitted additional results in response to concerns expressed by the FDA, within its previous Complete Response Letter and with respect to the company's previous New Drug Application. The company is currently in a race with Vivus, Inc. (NASDAQ:VVUS) and Orexigen Therapeutics, Inc, (NASDAQ:OREX) to bring the first weight-loss drug to market in over a decade.
Affymax, Inc. (Nasdaq: AFFY) today reported financial results for the first quarter ended March 31, 2012.
BSD Medical Corporation (NASDAQ: BSDM) ("Company" or "BSD") (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, reported today that an important Phase III clinical study, hyperthermia in combination with chemotherapy for the treatment of pancreatic cancer patients, was the subject of a press release issued by The Society of Thermal Medicine (STM) (http://psfebus.allenpress.com/eBusSFTM/).
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the first quarter ended March 31, 2012.
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that the Company plans to release its financial results for the three months ended March 31, 2012, on Wednesday, May 9th after the close of market.
BioScrip, Inc. (NASDAQ: BIOS) (the “Company”) today announced that it has closed the sale of certain assets of its community specialty pharmacies and centralized specialty and mail service pharmacy businesses (the “Transferred Businesses”) to Walgreen Co. (NYSE, NASDAQ: WAG). The closing was effective at 11 pm CDT on May 4, 2012.
Celgene Corporation (NASDAQ: CELG) today announced the appointment of Thomas M. Moriarty as General Counsel and Corporate Secretary.
Codexis, Inc. (NASDAQ:CDXS), a developer of cost-advantaged processes for the production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced that the company will be participating in upcoming investor conferences.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that Robert Perez, EVP and COO of Cubist, will present on Tuesday May 15th, 2012, at 4:20 p.m. PT, at the Bank of America Merrill Lynch 2012 Health Care Conference being held at Encore at the Wynn in Las Vegas, Nevada.
CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced that complete data from the Company’s Phase 1b/2 clinical trial with its proprietary doxorubicin tumor-targeting conjugate INNO-206 in patients with advanced solid tumors (primarily soft tissue sarcomas) will be featured in a poster presentation at the 2012 annual meeting of the American Society of Clinical Oncology (ASCO) being held at McCormick Place in Chicago.
Dendreon Corporation (Nasdaq:DNDN) today reported results for the quarter ended March 31, 2012.
Exact Sciences Corp. (Nasdaq: EXAS) today announced that it will present at three investor conferences during May.
Flamel Technologies (NASDAQ: FLML) today announced its financial results for the first quarter of 2012.
Fluidigm Corporation (NASDAQ:FLDM) today announced that it can now offer unrestricted sales of its digital PCR and other advanced technology to customers interested in pursuing research and product development into the prenatal health and non-invasive prenatal diagnostics fields, as well as other fields.
IsoRay Inc. (AMEX: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a booth at the world brachytherapy meeting.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer will present at the Bank of America Merrill Lynch 2012 Health Care Conference on Thursday, May 17, 2012 at 8:00 a.m. Pacific (11:00 a.m. Eastern Time).
Maxygen, Inc. (Nasdaq:MAXY), a biopharmaceutical company, today announced financial and business results for the quarter ended March 31, 2012.
Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (Nasdaq: SGEN), today announced the initiation of an international pivotal phase 3 clinical trial evaluating ADCETRIS (brentuximab vedotin) in patients with CD30-expressing cutaneous T-cell lymphoma (CTCL) who received at least one prior systemic therapy.
NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that a fundamental patent, on which the nanoviricides® technology is based, is due to be issued in the USA on May 8, 2012.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced that it will release its first quarter 2012 financial results before the U.S. stock market opens on Tuesday, May 15, 2012 and has scheduled a conference call at 9:00 am EDT that day to discuss the financial results.
Pfizer Inc. (NYSE: PFE) announced new data presented at the 165th Annual Meeting of the American Psychiatric Association (APA) in Philadelphia on PRISTIQ® (desvenlafaxine) Extended Release Tablets 50 mg/day for the treatment of major depressive disorder (MDD) in adults,1 including a long-term relapse prevention study.
PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Michael J. Culotta, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the Deutsche Bank Securities 37th Annual Health Care Conference in Boston on Wednesday, May 9, 2012, at 8:40 a.m. Eastern Time.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) has granted marketing authorization for ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Repligen Corporation (NASDAQ:RGEN) today announced that it will support an amended stockholder proposal based upon an agreement with Ronald L. Chez, the proponent of the proposal.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced financial and operating results for the first quarter ended March 31, 2012 and other business updates.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today an interim analysis of data from an ongoing Phase 2 study of VX-809 and KALYDECO™ (ivacaftor) that showed significant improvements in lung function (FEV1) among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del.
Walgreen Co. (NYSE: WAG) (NASDAQ: WAG) today announced that it has completed its acquisition of certain assets of BioScrip, Inc.’s (NASDAQ: BIOS) community specialty pharmacies and centralized specialty and mail service pharmacy businesses.
Waters Corporation (NYSE:WAT) John Ornell, Chief Financial Officer, will speak to the investment community at the Baird 2012 Growth Stock Conference at the Four Seasons Hotel in Chicago, on Tuesday, May 8th, at 10:10 a.m. central time.