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up $1 to $2.41 with internal review:
1-7-13 PR: PPHM Provides Update on 2nd-Line NSCLC Trial Review
”Peregrine Pharmaceuticals Provides Update on the Internal Review of Its Phase II Second-Line Non-Small Cell Lung Cancer Trial”
• Preliminary Analysis Supports Advancing Bavituximab Into Phase III Development
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=731743
TUSTIN, 1/7/13: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today provided an update from its internal review of discrepancies from its Phase II randomized, double-blind placebo-controlled trial of bavituximab in second-line non-small cell lung cancer (NSCLC) in 121 patients. The review was prompted by the discovery of vial coding discrepancies while preparing for an end of Phase II meeting with the FDA. The internal review included a thorough operational review of multiple third-party vendor operations at sites worldwide, testing of investigational product used in the trial, additional patient sample testing to determine drug levels and a review of immunogenicity testing results from the trial. The results of the extensive internal review indicate that discrepancies are isolated to the placebo and 1 mg/kg treatment arms of the trial and that there was no evidence of discrepancies in the 3 mg/kg treatment arm of the trial.
"Our goal in undertaking such a comprehensive review was to understand every aspect of this clinical trial," said Jeffrey L. Masten, VP, Quality of Peregrine. "Due to the complex nature of this trial, this was an enormous effort involving multiple third-party vendors and thousands of product and patient samples obtained from three different continents. Specifically, we sought to determine the cause and the impact of any discrepancies within the trial and to verify every step within the drug product distribution process. We believe we have accomplished our goals in obtaining a more thorough understanding of the trial and we are very pleased with the outcome."
Based on the results of the internal review, Peregrine is taking a very conservative approach toward analyzing the results from the trial which included combining the placebo and 1mg/kg arms into one treatment arm (control arm), and comparing those results to the 3mg/kg arm. This analysis indicates that the 3 mg/kg arm continues to show favorable tumor response rates, progression-free survival and overall survival (OS) over the new combined control arm. Peregrine expects to announce more detailed results from the analysis in the near term when it is completed.
"The results from this comprehensive review have provided a better understanding of the outcome of this trial. We believe that these results of our internal review and subsequent data analysis support advancing bavituximab into Phase III development for the treatment of second-line non-small cell lung cancer," said Joseph S. Shan, VP, Clinical & Regulatory Affairs of Peregrine. "We are now preparing for discussions with the FDA and worldwide regulatory agencies."
"With the results of this review in hand, we are now in the process of updating potential partners and moving the program forward," said Steven W. King, president and CEO of Peregrine. "Looking ahead, we anticipate data from seven ongoing bavituximab trials in different indications as well as results from an imaging study based on the same novel target."
ABOUT BAVITUXIMAB
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. Bavituximab is the lead drug candidate from the company's PS technology platform and is currently being tested in eight clinical trials, including three randomized Phase II trials in front-line and second-line non-small cell lung cancer and front-line pancreatic cancer, and five investigator-sponsored trials (ISTs) in additional oncology indications. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Contact: Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
= = = = = = = = = = = =
F. LEAD IND: Phase IIb Bavi+Doce vs. 2nd-Line NSCLC (randomized, double-blinded, placebo-ctl'd, n=120, 'registrational')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 15 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 53 as of 8-12-11)
Enrolled Oct2010 - Oct2011 at 40 global sites (per J.Shan 9-7-12 webcast ( http://tinyurl.com/8cn87la )
8-2012: Compare Bavi+Doce's MOS=13.1mos (Bavi/3mg) to the 4 Curr-Approved 2Line/NSCLC Drugs http://tinyurl.com/cgnkvpa
• Taxotere/docetaxel => MOS=6.3mos (meta-analysis of 5 trials, 865 pts)
• Altima/pemetrexed => No diff. vs. Docetaxel (Ph.3 non-inferiority vs. Doce, 571 pts)
• Tarceva/erlotinib => MOS=5.3mos (TITAN Ph.III n=424 trial - see http://tinyurl.com/8w8lo93 )
• Iressa/gefitinib => "Iressa does not improve OS"
1-7-13: Review Update: “discrepancies are isolated to the placebo and 1 mg/kg arms; no evidence of discrepancies in the 3 mg/kg arm… Peregrine is taking a very conservative approach toward analyzing the results by combining the placebo & 1mg/kg arms into one treatment arm (control arm), and comparing to the 3mg/kg arm. This analysis indicates that the 3 mg/kg arm continues to show favorable TRR’s, PFS, and OS over the new combined control arm. Peregrine expects to announce more detailed results from the analysis in the near term when it is completed.” http://tinyurl.com/asup54d
9-24-12: Major Discrepancies found in 2nd-Line NSCLC Ph.2B Treatment Group Coding by Indep. Third-Party Vendor http://tinyurl.com/8r9zcqy
…"Investors should not rely on clinical data that the company disclosed on or before Sept. 7, 2012 from its Ph.2 Bavi trial in patients with 2nd-Line NSCLC or any presentations or other documents related to this Ph.2 trial."
...9-24-12: per iHub/GGrine, IR emailed, "There is an ongoing investigation into the events surrounding this incident. We are focused on ascertaining its full scope with the goal of getting clarity in weeks but not months. The company will not be furnishing any addl. comments until the investigation is complete."
9-24-12: Peregrine sues CSM Over Bavi Ph.2B 2nd-Line NSCLC Clinical Trial Mix-Up http://tinyurl.com/8fpgngu
…CSM=Clinical Supplies Management Inc., Fargo ND http://www.csmondemand.com
…9-10-12 CEO Steve King, QtlyCC ( http://tinyurl.com/8nkwrml )
……"These are truly remarkable results (statistically doubling MOS) that are not only great for the pgm… but also great news for the NSCLC patients in the trial…"
…9-10-12 Robert Garnick (Head/Reg), QtlyCC ( http://tinyurl.com/8nkwrml )
……"The NSCLC data we announced 9-7-12 has far exceeded our expectations, and I hope that you're as excited as I am with bavituximab's potential. I feel strongly that Peregrine should be recognized for having the corporate courage to conduct the rigorous, randomized placebo-controlled Phase II trial that provided these robust data and that provide the basis for us to plan for a pivotal Phase III program."
...9-7-12: PPHM Press Release about Dr. Gerber's plenary at ASTRO/Thoracic/Chicago: http://tinyurl.com/96wrrso
…"The interim data showed a statistically significant improvement in OS (Hazard Ratio 0.524, p-value .0154) and a doubling of MOS (12.1/13.1mos. vs. 5.6mos.) in the Bavituximab-containing arms compared to the [Docetaxel] ctl-arm."
......VP Joe Shan's 15min. Webcast & Slideshow recapping Dr. David Gerber's 9-7-12 ASTRO/Chicago Plenary: http://tinyurl.com/96wrrso
…8-15-12 CEO Steve King, Wedbush/NYC ( http://tinyurl.com/8mhrtld )
......"As we're sitting here today, we have still not reached the # of events for MOS in either of the Bavituximab arms - and, in fact, we still have patients that are on treatments." Q&A: "it's going to be a very positive MOS result, it's just a matter now of magnitude."
…7-16-12 CEO Steve King, QtlyCC ( http://tinyurl.com/cs7spbz )
......"The strength of this 2nd-Line NSCLC data (esp. MOS trends) in this large area of high unmet medical need has also sparked a surge in partnering discussions that has included over 15 in-person partnering meetings since that time with major players in oncology, with all discussions ongoing and addl. parties showing interest. Our goal for the program is to position ourselves, along with a potential partner, to initiate Ph3 by mid-2013, which means an EOP2 meeting by yr-end'12. It would be ideal to have a partner on board to participate in the EOP2 meeting, and we have communicated this to interested parties and they agree."
…7-16-12 Robert Garnick (Head/Reg), QtlyCC ( http://tinyurl.com/cs7spbz )
……"We've been working very hard and very actively on the next steps in our Bavi 2nd-Line NSCLC pgm, given the favorable data that we've seen. As you can imagine, with data like this, there are many things that we need to consider. One consideration is that, should the data continue to trend the way it is, particularly in survival, this opens a door for potential discussions around a pathway for Accelerated Approval. At this point, all options are being considered, with Peregrine working towards the most efficient path forward from a regulatory standpoint." Q&A: "…all in all, I think the data is extremely compelling and I think it makes a really good case. Certainly, I think, I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing a meeting with the FDA for Q4'12."
…7-12-12 CEO Steve King, JMP-Conf/NYC ( http://tinyurl.com/csdclwb )
……"Re: 2nd-Line/NSCLC trial, the most thrilling thing is the fact that, even though we'd reached MOS for the ctl-arm(Doce) at end of Apr'12 of LESS THAN 6MOS, the majority of patients are still alive (today) in both Bavi arms, and we expect that to continue for some period of time still. Ph3 planning is underway already; our goal is to start this Ph3 by mid'13, meaning an EOP2 meeting with the FDA in Q4'12; our goal is to bring a partner on board, ideally in time for that EOP2 meeting, certainly before the beg. of the Ph3 trial."
…5-21-12: TopLine data n=117 for Bavi/3mg+Doce arm: ORR=17.9%/PFS=4.5mos (vs. CTL 7.9%/3mos) http://tinyurl.com/73aeyxj
......Importantly, MOS for CTL-arm "< 6 mos", but not yet reached in both Bavi arms.
...10-6-11: Enrollment complete. http://tinyurl.com/3m9re39
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to ~45 sites, expect enroll. comp. "early in Q4/2011", data unblinding 1H'12. http://tinyurl.com/6k6y2as
…3-17-10/Roth, CEO S.King: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval."
...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk
……"up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid'11, topline data by y/e'11."
= = = = = = = = = = = =
10-1-12: Enhanced 9-7-12/Gerber K-M Graph from Sunstar:
NOTE: “Investors should not rely on clinical data that the company disclosed on or before Sept. 7, 2012 from its Ph.2 Bavi trial in patients with 2nd-Line NSCLC or any presentations or other documents related to this Ph.2 trial."
FHCO $7.14
1:30AM Female Health extends stock repurchase program until Dec 31, 2013 (FHCO) 7.14 : Co announces the extension of its stock repurchase program through December 31, 2013. The program was previously due to expire at the end of calendar year 2012 and has a repurchase cap of 3 mln shares of common stock. The co has repurchased ~2 mln shares under the program, and ~1 mln shares remain for potential repurchase.
MNOV UPDATED: $1.61 MediciNova provides development update (MNOV) 1.61 : Co provides a development update on its two lead programs, MN-221 and MN-166.
MN-221 Development Plan:
Co plans to conduct the MN-221 program according to the feedback from FDA following the end-of-phase 2 meeting in October 2012. The FDA identified the risk/benefit profile of MN-221 as a focal point for further development and advised that a clinical outcome, such as a reduction in hospitalizations, would need to be a pivotal trial primary endpoint. Previously completed Phase 2 studies have evaluated the potential for MN-221 to reduce hospitalizations due to AEA.
MN-166 Development Plan:
The co has been very successful in facilitating investigator-led, development funding to advance the diverse MN-166 program. The recent grants from the National Institute on Drug Abuse have accelerated the development of MN-166 in drug dependence. Currently ongoing are a Phase 2a clinical trial in opioid dependence led by investigators at Columbia University and the New York State Psychiatric Institute and a Phase 1b clinical trial in methamphetamine dependence that will lead to an already-funded Phase 2 trial in methamphetamine dependence, led by investigators at UCLA. The Phase 2 trial is expected to begin in the first half of 2013. These clinical trials are conducted by some of the country's leading experts in opioid and methamphetamine addiction. MediciNova's method-of-use patent for MN-166 in drug addiction expires no earlier than 2030 in the US.
1:30AM Female Health extends stock repurchase program until Dec 31, 2013 (FHCO) 7.14 : Co announces the extension of its stock repurchase program through December 31, 2013. The program was previously due to expire at the end of calendar year 2012 and has a repurchase cap of 3 mln shares of common stock. The co has repurchased ~2 mln shares under the program, and ~1 mln shares remain for potential repurchase.
$3 stock. "Navidea Biopharma reaches interim analysis point of Phase 3 head and neck cancer study of Lymphoseek (NAVB) 2.88 : Co announced that it has accrued sufficient subjects in its NEO3-06 study in patients with head and neck cancer to enable the Company to conduct a pre-planned interim analysis.
The interim analysis will compare the pathological analysis of the sentinel lymph nodes localized using Lymphoseek with that of all the lymph nodes removed during a full nodal dissection surgery of the head and neck.
A total of 82 subjects who underwent pre-planned, full dissection surgery were enrolled and represent the interim analysis cohort.
Results from the interim statistical analysis and reporting of the findings will be available upon completion of full site and data audits planned for later in 2013."
in Briefing
ARCA biopharma: Gencaro effect on reducing ventricular arrhythmias paper published in circulation: Arrhythmia and Electrophysiology (ABIO) 0.41 : The paper shows that patients in the BEST Trial who received Gencaro experienced a 58% reduction in the incidence of ventricular tachycardia or fibrillation. adjusted for the competing risk of mortality. In addition, the authors determined that Gencaro reduced the incidence of VT/VF by 74% (p = 0.00005) in patients with the beta-1 389 arginine homozygous genotype, believed to be present in about 50% of the U.S. population. The study also analyzed the effect of two other genotypes on Gencaro's effect on VT/VF. Based on a statistically significant test for interaction (p = 0.03), the three genotypes provide a potential method for identifying VT/VF patients for therapy. The first group is the approximately 50% of patients with the beta-1 389 arginine homozygous genotype, who had an enhanced response (event rate reduction by 74%); the next group is the approximately 40% of patients with a second genotype (beta-1 389 glycine carriers alpha-2C 322-325 wild type homozygous) who had an intermediate response (event rate reduction by 49%) to Gencaro; and the remaining group is the approximately 10% of patients with a third genotype (beta-1 389 glycine carriers + alpha-2C 322-325 Deletion carriers), that had no response. This pharmacogenetic approach therefore defines a target population for Gencaro that has a potentially enhanced response, as well as a small subpopulation that may not benefit from therapy; the genetic identification of such "outliers" in drug response is a major goal of pharmacogenetics.
A BIT OUTDATED BUT WORTH inserting details here: IPO priced @$8 over $12 already.
SolarCity Stock Pops In IPO Debut;
By Donna Howell, Investor's Business Daily
Posted 12/13/2012 02:34 PM ET
Email Print License Comment
SolarCity (SCTY) stock rocketed Thursday in its first day of trading Thursday, as investors shook off concerns about the company's worth in what's so far been a dicey market for solar energy.
Other solar energy stocks, however, widely fell a day after big gains on China subsidy news. Large sold stocks First Solar (FSLR), Sunpower (SPWR), GT Advanced Technologies (GTAT), Yingli Green Energy (YGE) and Trina Solar (TSL) were all down Thursday.
SolarCity, the biggest U.S. residential solar installer — it also puts up panels for businesses — priced at $8 a share and was trading near 12.10 in midafternoon, up more than 50%. The IPO raised $92 million.
Getty View Enlarged Image
The company, though, had expected to price its IPO at $13-$15 and raise more than $150 million, according to SEC filings, before cutting the price early Wednesday.
The company's chairman is serial entrepreneur and Tesla Motors (TSLA) CEO Elon Musk.
Thursday afternoon, the stocks in IBD's Energy-Solar industry group were down a collective 1.5% after rising 3% Wednesday, with ReneSola (SOL) down 9%, and JinkoSolar (JKS) off 5%. The group ranks No. 23 of 197 tracked — from near last place half a year ago amid the solar industry's struggles.
Solar stocks had risen broadly Wednesday on talk of China boosting its goal for domestic solar installations, and providing billions in backing for Chinese solar companies, as IBD reported
Cowen & Co. analysts Robert Stone and James Medvedeff called the Wednesday stock moves "a furious rally" but said in a research brief Thursday that they "remain cautious and see weak fundamentals."
Overall shipments of solar products worldwide fell 5% in Q3 from Q2, the analysts said. They added that while Q4 guidance suggests shipment growth, higher gross margins and inventory reduction, "we expect the cycle of overproduction, lower average selling prices, and inventory lag to continue."
Falling solar prices make life tough for manufacturers, especially in competition with low-cost-leader China. But in combination with government subsidies for solar, low prices make installing solar more attractive to end users comparing the benefits vs. fossil fuel energy costs.
Read More At IBD: http://news.investors.com/technology/121312-636956-scty-stock-jumps-in-ipo-solar-stocks-sink.htm#ixzz2GwC59Z7J
TC;
Should add few strong bids were in : One 301 000 shares at bid price of $0.75 got filled. Some still belive in Jany bounce effect may be at work it seems. In part it is year end tax loss sale by biggies.
JMFHO
GL
mlkr
Taxi Cat;
3m shares volume. Closed @0.75. I couldnt buy/average down @0.73. Any scenario is plausable. Just keep in mind Paramount capital owns this co along with several others . They dont have that great tract record. Just diversify. Check ANTH as well.
GL
mlkr
Patience!
Tower International sells Korean operations $8.50.
Tower International sells Korean ops
9:15am EST
Fri Dec 28, 2012 9:18am EST
(Reuters) - Automobile parts maker Tower International Inc (TOWR.N) sold its South Korean operations to Seco, a privately owned Korean auto parts supplier, for about $47 million in cash.
Livonia, Michigan-headquartered Tower said Seco will also assume debt of about $98 million, representing a deal enterprise value of about $145 million.
The operations being sold include five manufacturing plants, a tooling plant and a technical center.
Shares of Tower International closed at $7.44 on Thursday on the New York Stock Exchange. The company's stock has shed about a third of its value in the last one year.
(Reporting by Ritika Rai in Bangalore; Editing by Maju Samuel)
HarleyDavidson man;
Yes. Include me with LYG and IRE picks, since i own them and think will continue to come back in 2013.
Thnx in advance.
mlkr
Kudos. Great job PS Board. What are new picks for year 2013?
tia
mlkr
Year end tax loss sales: small cap microbiology names with possible january 2013 bounce effect: ANTH, CHTP, OLGC, PCRX,TZYM, ROSG, NGSX,PACB.
JMFHO
mlkr
received listing deficiency notice today. May be $0.44 is low cause of Year end tax loss and Jsnuary bounce effect may be at work .
What is your take? How can you be so sure?
PCRX board link:
http://www.investorvillage.com/smbd.asp?mb=17599
GL
one
Happy Holidays everyone. Best wishes for a great new year!
mlkr
deficiency letter $0.44 today. YOE tax sale?
Catalyst Pharma received Nasdaq Staff Deficiency Letter indicating that it is not in compliance with Minimum Bid Price requirement (CPRX) 0.45 :
0.62 with patent;
Oculus Innovative Sciences announces issuance of new U.S. patent for the use of Microcyn Technology in the treatment of skin ulcers (OCLS) 0.61 : In this application, Microcyn Technology can be delivered to skin ulcers via washing, irrigation and soaking or through application of a wound dressing saturated in the Microcyn Technology.
Easterntunder;
Good hearing from you. Hanging in there.
Good idea. Even Abott split itself. Why not keeping it simple board. Hope i could find new board.
Happy holidays.
tia
mlkr
Easternthunder: Great board,
tia
mlkr
Renren announces renewal of share repurchase program (RENN) 3.31 : Co announced that its board of directors has authorized the renewal of its share repurchase program dated Sep 29, 2011 for another 12 months from Jan 1, 2013 to Dec 31, 2013. During this 12-month period, Renren is authorized, but not obligated, to repurchase up to $48.2 mln of its ADSs, representing the remaining balance of its previously announced share repurchase plan that ended in Sep this year.
Eco;
What are the details?
tia
mlkr
Paragon Shipping announces that it has raised $10 million through a private placement (PRGN) 2.30 : Co announced that on December 24, 2012 it entered into an agreement to sell ~4.9 mln newly-issued shares of the Company's common stock to an entity affiliated with Mr. Michael Bodouroglou, the Company's Chairman and Chief Executive Officer, for total consideration of $10 million.
Transcept Pharmaceuticals announces that a Phase 2 clinical trial of TO-2061 as adjunctive therapy for obsessive compulsive disorder did not meet primary endpoint (TSPT) 5.16 : Co announced initial top-line results from its Phase 2 clinical trial evaluating the efficacy and safety of TO-2061 (ondansetron oral tablets 0.5 mg and 0.75 mg) in patients with obsessive compulsive disorder (OCD) who had not adequately responded to treatment with approved first-line therapies.
The data from the trial showed that TO-2061 did not meet the primary efficacy endpoint to demonstrate an improvement in OCD symptoms versus placebo. Transcept expects to complete the remaining protocol-specified analyses in early 2013 and will make a determination on any future development of TO-2061 after further review of the data.
"It is disappointing that the Phase 2 trial of TO-2061 did not meet its primary endpoint, in particular for those patients suffering from treatment resistant OCD," said Glenn Oclassen, President and Chief Executive Officer of Transcept. "Once we have reviewed the full data set, we will determine next steps, if any, in the clinical development program for TO-2061 for the adjunctive treatment of OCD."
... stock is halted.
Coronado Biosciences announces Phase 2 study evaluating TSO in Ulcerative Colitis (CNDO) 4.95 : Co announced the signing of a Clinical Trial Agreement between the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and Coronado Biosciences to evaluate TSO for the treatment of ulcerative colitis (UC) in a phase 2 clinical trial. This multi-center study will be conducted by the NIAID-funded Autoimmunity Centers of Excellence (ACE). The phase 2 trial is a randomized, double-blind, placebo-controlled clinical study designed to examine the safety and efficacy of TSO treatment in active left-sided ulcerative colitis and its effects on mucosal immune state and microbiota. The trial will randomize 120 people in a 1:1 ratio to receive either TSO 7500 or placebo. Participants will receive six doses of TSO 7500 or placebo orally every other week over a 12-week treatment period. The trial will evaluate the effect of TSO on clinical response of UC, intestinal mucosal immunological response, and inflammatory markers. The primary endpoint will be the percentage of patients who achieve response (reduction of UCDAI of = 3) by Week 12. The trial is planned to begin during the first quarter of 2013.
malc;
yep indeed.
ok.
I only have YOE tax loss sale and jany 2013 bounce possibility plays in biotech space.
approved $5.20 now
Chembio Diagnostics receives FDA approval for DPP Point-of-Care HIV 1/2 rapid test (CEMI) 4.60 : Co announces receipt of approval from the FDA to market the Company's Dual Path Platform HIV 1/2 assay for the rapid, point-of-care (POC) detection of HIV-1/2 antibodies in either oral fluid or blood samples. This determination follows a review of Chembio's Premarket Approval application and marks the first FDA approval of a diagnostic assay utilizing the Company's patented Dual Path Platform? technology. DPP enables samples to bind directly with target analytes before detection reagents are introduced to visualize the test results, and can improve accuracy compared with the current lateral flow HIV test technologies.
ShangPharma enters into definitive merger agreement for going private transaction (SHP) 8.07 : Co announced that it has entered into a definitive Agreement and Plan of Merger (the "Merger Agreement") with ShangPharma Holdings Limited ("Holdings"), ShangPharma Parent Limited ("Parent") and ShangPharma Merger Sub Limited, pursuant to which Parent will acquire the Company for US$0.50 per ordinary share or US$9.00 per American Depositary Share, each representing eighteen ordinary shares ("ADS").
This represents a 30.8% premium over the closing price of $6.88 per ADS as quoted by the New York Stock Exchange (on July 5, 2012, the last trading day prior to the Company's announcement on July 6, 2012 that it had received a "going private" proposal, and a 44.8% and 34.2% premium to the volume-weighted average closing price of the Company's ADSs during the 30 and 60 trading days prior to August 13, 2012, respectively. The consideration to be paid to holders of ordinary shares and ADSs implies an equity value of the co at ~US$173 million, on a fully diluted basis.
Initial IPO @ $12.50..
Then raised more capital @ $5 each.
CRESCENDO PHARMACEUTICALS CORP (CNDO) IPO
Company Name CRESCENDO PHARMACEUTICALS CORP
Company Address 1454 PAGE MILL RD
PALO ALTO, CA 94304
Company Phone 6504945600
Company Website --
CEO Dr. James W. Young
Employees --
State of Inc DE
Fiscal Year End 12/31
Status Priced (9/30/1997)
Proposed Symbol CNDO
Exchange Nasdaq National Market
Share Price $12.50
Shares Offered 4,965,470
Offer Amount $62,068,375.00
Total Expenses $3,140,000.00
Shares Over Alloted --
Shareholder Shares Offered --
Shares Outstanding 4,966,470
Lockup Period (days) 180
Lockup Expiration 3/30/1998
Quiet Period Expiration 10/27/1997
CIK 0001042138
Company Description
Crescendo was formed to select and develop human pharmaceutical products for
commercialization, most likely through licensing to ALZA. It is anticipated
that most of the products to be developed by Crescendo (including the
Identified Products) will be products combining ALZA's proprietary
source: Nazdog
Surf;
Very good piece.
mlkr
taxiCat;
How many shares sold? What are other major institutional and insider holders doing? Holding? Reducing, getting rid off?
Can u provide the link?
tia
mlkr
No sale: $9
Allscripts names new CEO to spearhead recovery
Wed, Dec 19 2012
Thu Dec 20, 2012 12:07pm EST
* New CEO Black sketches plans for role at Allscripts
* Chairman says strategic review process was rigorous
* Stock falls as much as 17 pct after announcement (Updates with background)
Dec 20 (Reuters) - Shares of Allscripts Healthcare Solutions Inc fell as much as 17 percent on Thursday after the company abandoned plans to sell itself and instead introduced new management to run the company as an independent entity.
Allscripts, which sells systems that enable hospitals and physicians to share patient records electronically, announced the changes late on Wednesday.
On Thursday the company's chairman, Dennis Chookaszian, told analysts on a conference call that the board had conducted a rigorous review of its options and ultimately decided that the best way to create value for shareholders was to exploit the company's long-term growth potential.
Allscripts named Paul Black, former chief operating officer at rival Cerner Corp and an Allscripts board member, to replace Glen Tullman, who led the company for 15 years.
Black, who addressed shareholders on the call, said his goals include freshening the company's product line, enhancing operating efficiencies and working to retain existing clients. He said he will spend time meeting with key constituents before laying out his plan in detail.
The company declined to provide a financial outlook except to say it was happy with the way the fourth quarter started. Black said he expects the company to benefit from having clarity now that the review process is over.
"There has been a lot of disruption in the marketplace," he said. "A lot of people were hesitant to make a decision until they knew who they would be working with."
Chookaszian declined to disclose whether the board's decision to remain independent was unanimous, saying the board "doesn't comment on its decisions."
The decision follows months of turmoil at Allscripts, which in June, under pressure, installed three board members nominated by the hedge fund HealthCor Management, which had lobbied intensively for the removal of Tullman.
Allscripts shares were down 14.6 percent at $9.13 on the Nasdaq at mid-day on Thursday.
Several private equity groups, including Blackstone Group LP , were apparently interested in Allscripts, but sources familiar with the situation told Reuters suitors had become concerned about Allscripts' declining earnings and market-share losses to larger rivals such as Cerner. (Reporting by Toni Clarke in Boston; Editing by Matthew Lewis and Steve Orlofsky)
Down to $9 with cancelling sale:Down to $9. No sale.
Idra up $0.20 to$0.97 with data updata.
MEI Pharma Announces Closing Of $27.5 Million Private Placement
Press Release: MEI Pharma, Inc. – 3 hours ago
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MEIP 7.89 -0.63
SAN DIEGO, Dec. 19, 2012 /PRNewswire/ -- MEI Pharma, Inc. (MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that it has completed its previously announced private placement of common stock and warrants in a financing led by new investors Vivo Ventures and New Leaf Venture Partners. Gross proceeds from the private placement were $27.5 million, before deducting fees and expenses. The Company intends to use the net proceeds primarily to advance the clinical development of its lead drug candidate, Pracinostat, an oral histone deacetylase (HDAC) inhibitor.
(Logo: http://photos.prnewswire.com/prnh/20120628/LA32362LOGO)
"The completion of this financing caps a pivotal year for our company and comes on the heels of exciting data presented last week at the American Society of Hematology Annual Meeting," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "These data from a pilot Phase II trial of Pracinostat in combination with azacitidine in patients with advanced myelodysplastic syndrome (MDS) showed that eight of the nine patients treated at the MD Anderson Cancer Center achieved a clinical response (CR, CRi, & PR). Combined with the results from an additional, previously unreported patient treated at the University of Wisconsin-Madison who achieved a complete response, the trial showed an overall response rate of 90% (nine out of 10).
"Now, with the proceeds from this financing," continued Dr. Gold, "we look forward to further evaluating the combination of Pracinostat and azacitidine in a larger, randomized, placebo-controlled Phase II trial in this high-risk MDS population. We are working diligently to initiate this trial and expect to begin enrolling patients by the second quarter of 2013."
The Company also announced that it has effected a 1-for-6 reverse stock split of its common stock, decreasing the number of shares issued and outstanding from approximately 27.2 million immediately prior to the reverse stock split to approximately 13.7 million after giving effect to the reverse stock split and the closing of the private placement.
The reverse split is another in a series of strategic actions the Company has undertaken to position itself for future growth and is intended to attract a broader range of institutional investors.
The Company's common stock will begin trading on a reverse stock split-adjusted basis when the market opens today, December 19, 2012. As a result of the reverse stock split, every six shares of issued and outstanding common stock were automatically converted into one issued and outstanding share of common stock. The new CUSIP number for the common stock following the reverse stock split is 55279B 202.
About MEI Pharma
MEI Pharma, Inc. (MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company's lead drug candidate is Pracinostat, a potential best-in-class, oral histone deacetylase (HDAC) inhibitor, which has been tested in multiple Phase I and pilot Phase II clinical trials, including advanced hematologic malignancies such as myelodysplastic syndrome (MDS), acute myeloid leukemia and myelofibrosis. The Company expects to initiate a randomized Phase II trial of Pracinostat in combination with azacitidine in patients with MDS by the second quarter of 2013. In addition, MEI Pharma is developing two drug candidates derived from its isoflavone-based technology platform, ME-143 and ME-344. For more information, go to www.meipharma.com.
Merck fell the most in seven months after the latest setback in an 11-year effort to develop L-BLP25, a drug originated by U.S. partner Oncothyreon Inc. (ONTY), into a marketable product. While Merck is implying that there may be some hope for the vaccine, it’s still too early to say that, and the company would probably have to conduct further trials, Edouard Aubery, an analyst with Equinet AG, said in a phone interview today.
“This could have been a potential blockbuster, but now it’s been taken off the table,” he said. Aubery had estimated peak annual sales at 1 billion euros ($1.32 billion), with only a 25 percent probability that the vaccine would make it to market after Merck signaled that L-BLP25 was a “high-risk project.”
Stock Drops
Merck fell as much as 4.1 percent to 97.50 euros, the steepest intraday drop since May 9, and was trading down 1.8 percent at 3:21 p.m. in Frankfurt. That pared the stock’s gain this year to 29 percent, valuing Merck at 21.7 billion euros. Oncothyreon plunged as much as 62 percent to $1.71 in Nasdaq trading, the biggest intraday decline since June 17, 2003, and was 59 percent lower at 10:22 p.m. in New York. That gave the company a market value of $106.9 million.
Oncothyreon licensed L-BLP25 to Merck in 2001. Success in the trial, known as Start, would have triggered a $90 million payment to the Seattle-based company, plus royalties on sales in the mid-teens in the U.S. and the high single digits in the rest of the world, the drugmaker said in 2011.
L-BLP25 is a therapeutic vaccine designed to stimulate a patient’s immune system to identify and target cancer cells where the MUC1 gene is present. GlaxoSmithKline Plc (GSK) is also developing a therapeutic cancer vaccine targeting the MAGE-A3 gene which is present in a number of cancers and expects data from late-stage trials next year.
Therapeutic Vaccines
Therapeutic cancer vaccines, which are not to be confused with preventative vaccines like flu shots, have been difficult to develop. Dendreon Corp. (DNDN)’s Provenge, a medicine that targets prostate tumors, is the only approved therapeutic cancer vaccine on the market, yet it has struggled to garner sales due to its $93,000 price tag and competition from existing drugs.
Merck’s Start trial enrolled patients with advanced, inoperable lung cancer whose disease was stable following chemoradiotherapy. The U.S. Food and Drug Administration put the program on hold in March 2010 after a patient developed a brain infection. Merck was allowed to resume two lung cancer trials in June 2010 and scrapped a test of the vaccine in breast cancer.
“It is disappointing” that the testing “did not meet its primary endpoint,” Frances Shepherd, a medical professor at the University of Toronto who coordinated the trial, said in the statement. “However, notable treatment effects were observed in certain subgroups of patients and warrant further investigation of L-BLP25.”
Publishing Data
Merck KGaA, which isn’t related to the U.S.-based Merck & Co. (MRK), plans to submit the results to a peer-reviewed journal for publication and present the data at an international scientific meeting. Stefan Oschmann, head of pharmaceuticals, and Annalisa Jenkins, head of global drug development and medical for Merck Serono, the company’s pharmaceutical unit, were unavailable for comment, Gangolf Schrimpf, a spokesman, said.
Merck is reorganizing with job cuts, factory closings and a review of its new-product pipeline in response to setbacks for some key medicines. Results of separate trials earlier this year showed that Merck’s Erbitux treatment for colorectal cancer and head and neck tumors failed to help patients with advanced cases of stomach cancer and colon cancer.
Merck scrapped development of the cladribine pill for multiple sclerosis in 2011. In September this year, the company withdrew an application to market Erbitux for use in a subgroup of patients with non-small cell lung cancer.
To contact the reporter on this story: Allison Connolly in Frankfurt at aconnolly4@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
The ECB will be the regulator of banks with assets of more than €30bn, or banks constituting at least one fifth of their home country’s GDP. The thresholds were chosen to include the three biggest banks in each country. The estimates last night range from a total number of 150 to 200 banks in the eurozone.
The ECB can intervene in smaller banks (under a procedure that has yet to be made known, or yet to be worked out)
The governance structure will consist of a separate supervisory body, the ECB governing council as final arbiter, and a steering committee to solve disagreement.
Agreement to be finalised in February 2013 – as this requires support from the European parliament. The single supervisory mechanism (SSM) kicks in March 2014.
The EBA will continue to be in charge of harmonising rules at EU-level, and there will be safeguards for the non-eurozone members through a double majority – one inside the banking union, one outside.
No direct bank recapitalisation by the ESM until at least 2014.
Offering of Common Stock and Warrants
Press Release: Galena Biopharma – 2 hours 14 minutes ago
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GALE 1.54 -0.33
LAKE OSWEGO, Ore., Dec. 18, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma (GALE) announced today the pricing of an underwritten public offering of 15,156,250 units at a public offering price of $1.60 per unit, or total gross proceeds of $24.25 million. Each unit consists of one share of common stock, and a warrant to purchase 0.5 share of common stock at an exercise price of $1.90 per share. The warrants are immediately exercisable and expire on the fifth anniversary of the date of issuance. The shares of common stock and warrants are immediately separable and will be issued separately. The offering is expected to close on December 21, 2012, subject to customary closing conditions.
Piper Jaffray & Co. is acting as the sole book-running manager for the offering, with JMP Securities LLC acting as a co-manager.
Galena intends to use the net proceeds from the offering to conduct its ongoing Phase 3 clinical trial for NeuVax(TM), its Phase 1/2 clinical trial for Folate Binding Protein-E39 (FBP), the planned Phase 2 clinical trial for NeuVax(TM) in combination with trastuzumab (Herceptin(R)), as well as for general corporate purposes.
Added @ intraday's lows.