Below are extreme trades among 18 companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 232 entries as of 7/3/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA fili (...)[More...]
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response lette (...)[More...]
Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.
Savient Pharma (NASDAQ:SVNT) announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA action date by three months to 8/1/09.
BioDelivery Sciences (NASDAQ:BDSI) has a pending Onsolis (BEMA fentanyl) NDA resubmission for the proposed treatment of breakthrough cancer pain through a small, dissolving polymer delivery system for the opiate painkiller fentanyl designed for quick absorption through the cheek. On 12/15/08, BDSI announced in a press release that the FDA requested conversion of the originally submitted risk minimization action plan (RiskMAP) to a Risk Evaluation and Mitigation Strategy (REMS) and informed the Company that all other aspects of the NDA review were complete.
Given this information, the prospects for Onsolis approval appear excellent, with an approval decision possible as early as Friday 6/12/09 or the following Monday based on a Class II (six-month) review by the agency on the resubmission of the required REMS by BDSI. In the same press release, BDSI provided guidance for expected approval of the Onsolis approval during the first half of 2009.
Earlier this year, BDSI raised $6M in cash from partner Meda AB (STO:MEDAA) ($2.3B U.S. Dollar market cap) from a $3M expanded marketing agreement (which includes all countries except Taiwan and South Korea) and a $3M advance of the $30M milestone payment triggered by FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents about 22% of the Company's current market cap of $123M, in addition to double-digit royalties that will be received on product sales, an additional $30M possible in sales-related milestone payments, and a $5M milestone payment that is due upon EU approval/launch.
While I do not typically hold small and micro-cap bio-med stocks through binary events such as FDA decisions and clinical trial results, BDSI is an exception for me and the Company expects to generate positive operating cash flow this year if Onsolis is approved. Also, the Company is debt free with a promising mid-stage pipeline based on its drug delivery technology platform that can be funded through milestone payments and royalties from Meda AB (which expects peak sales exceeding $200M for Onsolis).
Osteotech (NASDAQ:OSTE) : On 6/10/09, OSTE announced that it has completed enrollment for the clinical trial of its DuraTech BioRegeneration Matrix. Based upon Osteotech's proprietary HCT (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures.
A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results from this trial to support its 510(k) filing for marketing clearance with the FDA during 3Q09 with expected marketing clearance before year-end.
Human Genome Sciences (NASDAQ:HGSI) : On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time.
HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. BENLYSTA is being developed by HGSI and GSK under a co-development and commercialization agreement entered into in August 2006.
Transcept Pharma (NASDAQ:TSPT) : On 6/11/09, TSPT announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09.
Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.
The ETF Innovators Global Stem Cell and Regenerative Medicine Index of 40 companies with market caps less than $1B at the index inception lost 9% of its value last week and is down 24.8% over the past year on an equal-weight basis, compared to losses of 21.6% for the Healthcare Sector SPDR (XLV), 8.4% for iShares Nasdaq Biotech (IBB), 4.5% for SPDR S&P Biotech (XBI), 19.9% for PowerShares Biotech & Genome (PBE), and 41.6% for the S&P 500 SPDR (SPY).
Click here for profiles and website links for all 40 companies and below are three companies to consider as long-term investments in regenerative medicine and stem cells based on their technology platforms, products + pipeline potential, and staying power – which is based on strategic partners for financing, nearing profitability, and strong balance sheet, respectively, for the three stocks listed below.
Cytori Therapeutics (CYTX) is a commercial-stage regenerative medicine company which is developing the Celution System to process a patient's own fat (adipose) tissue in about one hour for a variety of reconstructive and cosmetic medicine therapeutic applications.
CYTX also offers StemSource Cell Banking for a patient to preserve their own adipose-derived stem + regenerative cells (ADRCs) for use in the future as ongoing clinical trials establish the safety and effectiveness for cardiovascular disease, breast reconstruction/augmentation, liver disease, kidney failure, orthopedic/spinal disc regeneration, and gastrointestinal disorders.
CYTX currently offers its products and services in Japan and Europe along with two key strategic partners – Olympus Corp. (OCPNY.PK) (a strategic investor + medical device partner for Celution System) and Green Hospital Supply (GHSPF.PK) (a strategic investor + partner for StemSource Cell Banking, initially targeting hospitals in Japan).
ThermoGenesis (KOOL) is a commercial-stage provider of systems for the storage and processing of adult stem cells derived from cord blood and bone marrow. KOOL offers the AutoXpress Platform (AXP) (cord blood processing) as a family of automated devices which includes the MarrowXpress (bone marrow processing) and related disposables as a closed system to process and collect adult stem cells.
The CryoSeal FS System produces fibrin sealants from blood in about one hour for use in liver resection surgeries. KOOL also expects to enter the veterinary stem cell market under the Vantus brand and plans to launch Res-Q (a system for real-time processing of bone marrow and platelet rich plasma processing) during its fiscal 4Q09 as the Company hopes to achieve profitability during 2010.
Athersys (ATHX) recently received FDA clearance to begin a Phase 1 clinical trial for MultiStem as an "off-the-shelf" adult stem cell treatment for ischemic stroke to evaluate its safety and dosing parameters in as many as 48 patients. ATHX is in a unique position for stem cell companies as it trades at a market cap below its cash level of $33.5M with zero debt.
Intercytex Group (UK: ICX.L) (ICYXF.PK) is a regenerative medicine company which is developing cell-based therapies for commercialization as skin and hair repair + regeneration. Intercytex lost about three-quarters of its market value in the past five days after disappointing Phase 3 clinical trial results for Cyzact in the treatment of venous leg ulcers.
Intercytex illustrates the inherent risk of many companies in this index, but the three names mentioned earlier are trading at attractive entry points after losing all of their previous upside momentum and ahead of the expected move by President Obama to lift the ban on federal funding for stem cell research.
Join Me at BioMedReports.com
By Mike Havrilla – add date + logo/link – integrate into stem cell article at end index update
www.BioMedReports.com is a new website for healthcare investors and traders, featuring its own blog, discussion forum, news feeds, stock research reports, press release capability, videos, stock commentaries (with multiple contributors), and other unique content – including my FDA and Clinical Trial Calendars (with over 200 entries) plus a database that includes about 900 U.S. and foreign stocks + ETFs from the healthcare sector which are organized into nine new healthcare indexes (including a Global Stem Cell and Regenerative Medicine Index with 40 companies).
The indexes will be tracked at the site on daily basis and are meant to provide investors and traders with the ability to create their own specialized healthcare ETFs beyond current products such as the Healthcare Sector SPDR (XLV), iShares Nasdaq Biotech (IBB), Pharmaceutical HOLDRs (PPH), SPDR S&P Biotech (XBI), iShares S&P Global Healthcare (IXJ), etc.
Please note that my current blog site at www.ETFinnovators.com and the associated RSS Feed at http://feedproxy.google.com/etfi will continue to be available for a limited time during the transition, but all new content will be posted at BioMedReports.com in a variety of multimedia formats. Please contact me if you are interested in purchasing the ETFinnovators.com website domain name or the other five remaining business and investing domain names listed below.
