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Both medicare reimbursement and secondary offer @ $6.80 news came out today!
Eco;
Numbers not bad but dividend cut. They will host an investors forum in NYC...They cant lie can they?
Any figures?
tia
mlkrborn
Smart;
I was late!
thnx for drawing my attention to it tho!
GL
PUMA (NYSE: PBYI), a development stage biopharmaceutical company, today announced top line results from the Phase II clinical trial of Puma's investigational drug PB272 (neratinib) for the neoadjuvant treatment of breast cancer (I-SPY 2 TRIAL).
The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) is a randomized Phase II clinical trial for women with newly diagnosed Stage 2 or higher (tumor size at least 2.5 cm) breast cancer that addresses whether adding investigational drugs to standard chemotherapy in the neoadjuvant setting is better than standard chemotherapy. The primary endpoint is pathological complete response (pCR) in the breast and the lymph nodes at the time of surgery. The goal of the trial is to match investigational regimens with patient subsets on the basis of molecular characteristics (referred to as biomarker signatures) that benefit from the regimen.
The I-SPY 2 TRIAL involves an adaptive trial design based on Bayesian predictive probability that a regimen will be shown to be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial. Regimens that have a high Bayesian predictive probability of showing superiority in at least one of 10 predefined signatures graduate from the trial. Regimens are dropped for futility if they show a low predictive probability of showing superiority over standard therapy in all 10 signatures. A maximum total of 120 patients can be assigned to each experimental regimen. A regimen can graduate early and at any time after having 60 patients assigned to it.
A good year end tax loss sale purchase with possible rebounding..
A good year end tax loss sale purchase with possible rebounding..
pre-split $0.25
new chjef
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced the appointment of Frederick W. Driscoll to its board of directors, effective January 1, 2014. Mr. Driscoll is a respected executive and financial management expert with more than 30 years of experience in the biotechnology and medical device industries. Mr. Driscoll will assume the role of Chairman of the OXiGENE board of directors and will also serve on the audit committee.
BSr Day dreamers today! No substance !
Short pricks cant lower today for sure!
AEZS
hurt longs!
SBsux
7-11
not my kind of growth story! what do you think?
hybrid; Probably in part.
News Alert: Unilife Signs Long-Term Supply Agreement with Hikma to Enhance Delivery of Generic Injectables $4
in one day dropped to $9.30
"Evoke Pharma Inc. fell 20.8 percent to $9.30."
Very strange to say the least!
A Co with Good earnings:
ANI Pharmaceuticals Reports Net Revenues of $7.8 million, adjusted Non-GAAP EBITDA of $1.7 Million, and EPS of $0.13 for the Third Quarter Ended September 30, 2013
PR Newswire
ANI Pharmaceuticals, Inc. November 7, 2013 8:00 AM
BAUDETTE, Minn., Nov. 7, 2013 /PRNewswire/ -- ANI Pharmaceuticals, Inc. (ANIP) today reported results for the three and nine months ended September 30, 2013.
Third quarter and year-to-date highlights include:
Third quarter net revenues of $7.8 million, reflecting an increase of 56% versus $5.0 million for the same period in 2012.
Third quarter net income from continuing operations of $1.0 million and third quarter EPS of $0.13.
Third quarter adjusted non-GAAP net income from continuing operations of $1.5 million and adjusted non-GAAP EPS from continuing operations of $0.16.
Third quarter adjusted non-GAAP EBITDA of $1.7 million, reflecting an increase of 539% versus the prior year period.
ANI announced an agreement for the development and marketing of an oral soft gel prescription product with Sofgen Pharmaceuticals.
Year-to-date net revenues of $19.5 million increased 30% versus $15.0 million in the first nine months of 2012.
Year-to-date adjusted non-GAAP EBITDA of $3.6 million increased 107% over the prior year period.
Net revenues and Adjusted Non-GAAP EBITDA
Three months ended
September 30,
Nine months ended
September 30,
2013
2012
2013
2012
Net revenues
$ 7,836,222
$ 5,036,024
$ 19,549,670
$ 15,049,619
Adjusted Non-GAAP EBITDA(a)
$ 1,692,667
$ 264,962
$ 3,579,067
$ 1,728,030
(a) See Table 2 for US GAAP reconciliation.
Arthur S. Przybyl, President and CEO, stated, "Our revenues continue to exhibit strong organic growth, increasing by 56% to $7.8 million in the third quarter. At the same time, our cost of sales decreased by 12 percentage points, from 46% to 34%, as we continue to grow sales in our higher margin products. We expect our fourth quarter 2013 revenues to exceed $9 million. ANI will begin to hold quarterly conference calls when we announce our fourth quarter and year end results."
Third Quarter Results
For the three months ended September 30, 2013, ANI Pharmaceuticals, Inc. ("ANI") reported net revenues of $7.8 million, an increase of 56% from $5.0 million for the same period last year. The increase in revenues was primarily due to a 93% increase in net prescription sales, from $3.3 million to $6.4 million. This was partially offset by a 16% decrease in contract sales and royalties from $1.7 million to $1.5 million.
Adjusted non-GAAP EBITDA was $1.7 million for the three months ended September 30, 2013, compared to $265,000 for the same period in the prior year, an increase of 539%.
Cost of sales decreased as a percentage of net sales to 34% from 46%, primarily due to a favorable shift in sales mix toward higher margin products.
Research and development costs increased by 205% to $454,000 for the three months ended September 30, 2013, from $149,000 in the prior year period, due to increased spending on development activities.
Selling, general and administrative ("SG&A") expenses and salaries and benefits increased to $3.5 million for the three months ended September 30, 2013 from $2.5 million in the prior year period. The increase was primarily due to merger-related expenses totaling $501,000, increases in personnel, as well as consulting, legal and other fees related to becoming a public company.
Operating income was $810,000 for the three months ended September 30, 2013, which included $501,000 of merger-related expenses.
Net income from continuing operations was $1.0 million for the three months ended September 30, 2013, which included $501,000 of merger-related expenses. Excluding those expenses, adjusted non-GAAP net income from continuing operations was $1.5 million and adjusted non-GAAP earnings per share from continuing operations was $0.16 (see Table 3 for US GAAP reconciliation) .
Results for Nine Months ended September 30, 2013
For the nine months ended September 30, 2013, ANI reported net revenues of $19.5 million, an increase of 30% from $15.0 million for the same period last year. The increase in revenues was primarily due to a 59% increase in net prescription sales, from $8.7 million to $13.8 million. This was partially offset by a 10% decrease in contract sales and royalties, from $6.3 million to $5.7 million.
Adjusted non-GAAP EBITDA was $3.6 million for the nine months ended September 30, 2013, compared to $1.7 million for the same period in the prior year, an increase of 107%.
Cost of sales decreased as a percentage of net sales to 36% from 42%, primarily due to a favorable shift in sales mix toward higher margin products.
Research and development costs increased by 87% to $1.2 million in the nine months ended September 30, 2013, from $637,000 in the prior year, due to increased spending on development activities. ANI filed one ANDA during the period.
SG&A expenses and salaries and benefits increased to $13.0 million from $6.5 million. The increase was primarily due to merger-related non-cash equity bonuses paid to ANI executives of $4.4 million, consistent with the Company's belief in employee ownership to further alignment with shareholders, and $1.1 million in merger-related expenses.
Operating loss was $2.6 million for the nine months ended September 30, 2013, which included $5.5 million of merger-related expenses.
Net loss from continuing operations was $3.3 million for the nine months ended September 30, 2013, which included $6.2 million of merger-related expenses.
Selected Balance Sheet Data
September 30,
December 31,
2013
2012
Cash
$ 10,929,806
$ 11,028
Restricted Cash
$ 2,260,100
$ -
Non-cash Current Assets
$ 12,904,853
$ 8,555,279
Total Current Assets
$ 26,094,759
$ 8,566,307
Current Liabilities
$ 6,597,023
$ 7,711,082
Current Ratio
4.0
1.1
As a result of the merger with BioSante, ANI's balance sheet strengthened considerably, with $10.9 million of unrestricted cash at September 30, 2013, increased from $11,000 at December 31, 2012. Additionally, as of September 30, 2013, ANI had retired all of its debt. ANI's non-cash current assets increased by $4.3 million due primarily to increases in accounts receivable, resulting from increased sales for the quarter. ANI's working capital ratio increased to 4.0 at September 30, 2013, from 1.1 at December 31, 2012.
Total shares issued and outstanding at September 30, 2013 were 9.5 million.
ANI Product Development Pipeline
Products
ANI
Partnered
Total
At FDA
5
1
6
Development
1
5
6
The pipeline includes extended-release products, narcotics, anti-cancers, oral solutions, suspensions and solid dosage forms. These twelve generic products address a total annual market size of approximately $771 million, based on data from IMS Health.
Non-GAAP Financial Measures
Adjusted Non-GAAP EBITDA
ANI considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI's operating performance, providing investors and analysts with a useful measure of continuing operation results unaffected by merger-related expenses and differences in capital structures, tax structures, capital investment cycles, ages of related assets and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as operating income/(loss) from continuing operations, excluding depreciation, amortization, and merger-related operating expenses. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided in Table 2.
Adjusted Non-GAAP Net Income and EPS from Continuing Operations
ANI uses adjusted non-GAAP net income and earnings per share from continuing operations to analyze the Company's performance and to provide investors and analysts with useful measures of continuing operations results unaffected by merger-related expenses.
Adjusted non-GAAP net income and earnings per share from continuing operations is defined as net income/(loss) from continuing operations excluding merger-related expenses. Adjusted non-GAAP net income and earnings per share from continuing operations should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP net income and earnings per share from continuing operations to the most directly comparable GAAP financial measure is provided in Table 3.
About ANI
ANI is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. In two facilities with combined manufacturing, packaging and laboratory capacity totaling 173,000 square feet, ANI manufactures oral solid dose products, as well as liquids and topicals, including narcotics and those that must be manufactured in a fully contained environment due to their potency and/or toxicity. ANI also performs contract manufacturing for other pharmaceutical companies. Over the last two years ANI has launched three new products and has eleven products in development. ANI's targeted areas of product development include narcotics, anti-cancers and hormones (potent compounds), and extended release niche generic product opportunities. ANI's other products include an FDA-approved testosterone gel, which is licensed to Teva Pharmaceuticals USA. For more information please visit our website www.anipharmaceuticals.com.
http://finance.yahoo.com/news/ani-pharmaceuticals-reports-net-revenues-130000228.html
good resuts $5.83 "MiMedx Group follow up study of DFU patients shows 94% of patients remained healed after nine to twelve months (MDXG) 5.70 +0.18 : Co announced that its study "Dehydrated Human Amnion/Chorion Membrane Allografts in Patients with Chronic Diabetic Foot Ulcers: A Long-term Follow-up Study" has been accepted for publication in Wound Medicine. This study is the long term follow-up from a previously completed randomized controlled trial (RCT) involving patients with diabetic foot ulcers (DFU). In this follow up study, the patients whose DFU wounds healed after treatment with EpiFix in the initial RCT and the subsequent crossover study were examined.
Eighteen of 22 eligible patients returned for follow-up examination, which was conducted 9 to 12 months after primary wound closure with EpiFix. Clinical record review was conducted with IRB approval and patient consent. Of the eighteen patients studied, only one patient had recurrent DFU during the follow-up period, while 17, or 94.4%, remained fully healed. These findings support the long-term effectiveness of dehydrated human amnion/chorion membrane ("dHACM") for treatment of DFU. The study concluded that dHACM is a clinically viable and economically feasible treatment option that should be considered by clinicians who treat diabetic pedal ulcers."
HISTORY
Initial Public Offering
On August 10, 2005, we consummated an initial public offering of 4.6 million shares of our common stock at $12.00 per share, which includes the underwriters exercise of their over-allotment option, on August 9, 2005, to purchase 600,000 shares of our common stock of which 450,000 shares were sold by selling shareholders and 150,000 shares were sold by us. We did not receive any proceeds from the sale of the 450,000 shares of common stock that were sold by selling shareholders. These share amounts reflect a 1-for-3.8 reverse split of our capital stock that was effected on July 27, 2005. Proceeds to us from the offering, after deducting underwriting discounts and commissions but before expenses, were $46.3 million. Expenses are estimated to be approximately $3.25 million.
15
AtriCure receives FDA approval for investigational study to evaluate stroke prevention in atrial fibrillation (ATRC) 14.35 : Co announces the FDA approval to begin enrollment in a clinical study of AtriCure's AtriClip Left Atrial Appendage Exclusion System. The study will evaluate the use of the AtriClip device to prevent stroke in patients with Afib. The feasibility study will enroll Afib patients at seven medical centers across the country. The study will focus on patients with risk factors that place them at significant risk of stroke as well as substantial bleeding risks that contraindicate them for anticoagulation therapy. Research suggests that up to 40% of patients are unable to take oral anticoagulants due to excessive risk of bleeding.
Celgene invests $6.0 mln in Alliqua at $3.59 per share (ALQA) 3.46"Alliqua announces transaction with Celgene (CELG); Celgene invests $6.0 mln in Alliqua at $3.59 per share (ALQA) 3.46 : Co entered into a licensing agreement with Celgene Cellular Therapeutics, a subsidiary of Celgene (CELG), whereby Alliqua received the right to develop and market the advanced wound care products Biovance and Extracellular Matrix (ECM). Concurrently with the license agreement, Alliqua entered into an agreement with Celgene to sell to Celgene 1,672,474 shares of common stock of Alliqua, at a purchase price of $3.59 per share and a five year warrant to purchase an additional 836,237 shares of common stock at an exercise price of $5.69, in exchange for $6.0 million. In connection with this agreement to invest in Alliqua's securities, Celgene received a right to appoint a director to Alliqua's Board of Directors. Concurrent to this transaction, several unrelated funds led by Broadfin Capital LLC and Perceptive Advisors LLC, invested an additional $7 million on comparable financial terms. Alere Financial Partners, a division of Summer Street Research Partners, acted as placement agent for the transaction with these investors. "
Looking good. Recent IPO @ $12 each. upped. up $3.23 today to $11.35
http://finance.yahoo.com/q/ud?s=EVOK
Evoke Pharma Announces Closing of Initial Public Offering of 2,100,000 Shares of Common Stock
GlobeNewswire
Evoke Pharma September 30, 2013 4:15 PM
SAN DIEGO, Sept. 30, 2013 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the closing of its previously announced initial public offering of common stock. The Company sold a total of 2,100,000 shares of its common stock, at an initial public offering price of $12.00 per share. The gross proceeds to Evoke Pharma from the initial public offering were $25,200,000, before underwriting discounts and commissions and estimated offering expenses. Evoke Pharma has granted the representative of the underwriters a 30 day option to purchase up to 315,000 additional shares of common stock from the Company to cover over-allotments, if any.
Aegis Capital Corp. acted as sole book-running manager for the offering.
Cantor Fitzgerald & Co. and Feltl and Company, Inc. acted as co-managers for the offering.
A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on September 24, 2013.
This offering was made only by means of a prospectus. Copies of the prospectus relating to this offering may be obtained by contacting Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY 10019, telephone: 212-813-1010, e-mail: prospectus@aegiscap.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Evoke Pharma, Inc.
Evoke Pharma is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through intranasal administration.
Approved and upped! Generic! $4.26 already!
"Intellipharmaceutics price target raised to $9 from $7 at Maxim
Maxim raised its price target for Intellipharmaceutics to $9 after the FDA approved the company’s generic version of Focalin. The firm keeps a Buy rating on the stock." The Fly on the Wall!
More pounding of short pricks!
Great short pricks pounding opportunity here! $70 m. financial backing
DRTX +8.39%
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PDL BioPharma Provides $70 Million in Financing to Durata Therapeutics
PR Newswire
PDL BioPharma, Inc. November 6, 2013 7:30 AM
INCLINE VILLAGE, Nev., Nov. 6, 2013 /PRNewswire/ -- PDL BioPharma, Inc. (PDL) (PDLI) announced today that it closed a financing transaction with Durata Therapeutics, Inc. (DRTX), a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Under the credit agreement, PDL will provide Durata with up to $70 million of debt financing with a five year term and will receive interest on the principal amount outstanding and a security interest in substantially all of Durata's assets.
(Logo: http://photos.prnewswire.com/prnh/20110822/SF55808LOGO)
Durata's lead product candidate, dalbavancin, is an intravenous antibiotic product candidate for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI), caused by Gram-positive bacteria, such as S. aureus, including methicillin-resistant and multi-drug resistant strains, and certain Streptococcal species. A second generation, semi-synthetic lipoglycopeptide designed for 30-minute intravenous dosing on days 1 and 8, dalbavancin is intended to facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, reducing the length of a patient's hospital stay or avoiding hospital admission altogether and, ultimately, lowering the overall cost of care for these patients.
On September 26, 2013, Durata announced that it had submitted a New Drug Application to the U.S Food and Drug Administration seeking approval for the marketing and sale of dalbavancin. The FDA has designated dalbavancin as a Qualified Infectious Disease Product (QIDP), a new initiative designed to increase the availability of any "new antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens…."
The total financing of up to $70 million was provided pursuant to a credit agreement that included an initial $25 million in cash funded to Durata on October 31, 2013, and provides up to $45 million in additional funds to Durata, with $15 million of funding upon U.S. regulatory approval of dalbavancin, and the remaining $30 million funded within nine months after regulatory approval of dalbavancin, at Durata's election.
"We are pleased to provide this non-dilutive financing to Durata. Based upon our extensive due diligence, we believe that dalbavancin will be a medically and commercially significant product," said John P. McLaughlin, president and chief executive officer of PDL. "This deal with Durata marks the fourth transaction we have closed in recent weeks and, in doing so, we believe that we are securing measurable value for PDL and our stockholders."
"We are very pleased to announce this debt financing with PDL, which we believe further validates the opportunity Durata has with dalbavancin. This structure provides Durata with operating capital now and the flexibility for future funding, without diluting our existing shareholders, something we find very valuable," said Paul R. Edick, chief executive officer of Durata. "With the strengthened balance sheet, we are able to enhance our existing pre-commercialization and planned launch activities," Mr. Edick continued.
About Durata Therapeutics, Inc.
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, dalbavancin, under investigation for the treatment of patients with acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria.
About PDL BioPharma, Inc.
PDL BioPharma manages a portfolio of patents and royalty assets, consisting primarily of its Queen et al. antibody humanization patents and license agreements with various biotechnology and pharmaceutical companies. PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases for which it receives significant royalty revenue. PDL is currently focused on intellectual property asset management, investing in new income generating assets, and maximizing value for its shareholders.
The company was formerly known as Protein Design Labs, Inc. and changed its name to PDL BioPharma, Inc. in 2006. PDL was founded in 1986 and is headquartered in Incline Village, Nevada.
In 2011, PDL initiated a strategy to bring in new income generating assets from the healthcare sector. To accomplish this goal, PDL seeks to provide non-dilutive growth capital and financing solutions to late stage public and private healthcare companies and offers immediate financial monetization of royalty streams to companies, academic institutions, and inventors. PDL successfully executed on this strategy by deploying over $125 million in 2012 and continues to pursue this strategic initiative. PDL is focused on the quality of the income generating assets and potential returns on investment.
For more information, please visit www.pdl.com.
Cyclacel Reports Third Quarter 2013 Financial Results
Conference Call Scheduled on November 12, 2013 at 4:30 p.m. Eastern Time
BERKELEY HEIGHTS, N.J., Nov. 12, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders today reported its financial results and business highlights for the third quarter ended September 30, 2013. The net loss for the third quarter of 2013 was $5.0 million versus a net loss for the third quarter of 2012 of $1.9 million. As of September 30, 2013, cash and cash equivalents totaled $34.5 million. The Company's net loss applicable to common shareholders for the third quarter of 2013 was $5.7 million, which includes $2.6 million of expense related to clinical trial drug supply, or $0.32 per basic and diluted share, compared to a net loss applicable to common shareholders of $2.1 million or $0.25 per basic and diluted share for the third quarter of 2012.
"We have been executing on our sapacitabine development plan by progressing enrollment in SEAMLESS, our pivotal, Phase 3 study in acute myeloid leukemia (AML) and our Phase 2 study in myelodysplastic syndromes (MDS). With approximately $35 million on our balance sheet, we have the resources to take us beyond the completion of SEAMLESS," stated Spiro Rombotis, Cyclacel's President and Chief Executive Officer. "SEAMLESS is close to the 50% enrollment mark from only US sites. In parallel we are expanding the study into Europe and expect to at least double the number of enrolling sites. Primary clinical outcomes from the MDS study will be reported at ASH 2013 with the aim of selecting a dosing schedule for Phase 3. We look forward to reporting the outcome of an upcoming DSMB review of SEAMLESS, MDS survival data at ASH 2013 and updates from other ongoing studies," added Mr. Rombotis.
Business Highlights
Announced that researchers will present new data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, the Company's lead product candidate, in older patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine and/or decitabine, at the 55th Annual Meeting of the American Society of Hematology (ASH) in December 2013. The data will include the primary endpoint of one year survival which will enable selection of a dosing schedule for Phase 3.
Reported that the US Patent and Trademark Office (USPTO) issued two patents extending the exclusivity of sapacitabine. The first patent claims, among others, methods of treating cancer comprising sapacitabine together with DNA methyltransferase inhibitors, including azacitidine and decitabine. The second patent claims methods of use for sapacitabine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), including the dosing regimen used in SEAMLESS, the Company's pivotal Phase 3 study in front-line elderly AML.
Announced updated data showing that sapacitabine has activity against a majority of ovarian cancer samples taken from patients, including resistant tumors. The data were reported at a poster presentation during the American Association of Cancer Research (AACR) conference "Advances in Ovarian Cancer from concept to clinic" held in September 2013.
Announced that seliciclib, the Company's oral CDK inhibitor, is to be evaluated in an investigator-initiated clinical study to treat rheumatoid arthritis (RA) supported by an approximately $1.5 million grant from the UK's Medical Research Council. Enabled by the clinical development experience in solid tumors, investigators believe that seliciclib's mechanism of action and oral administration route may be of benefit in treating patients with RA.
Issued 805,787 additional shares of common stock allowed under a Common Stock Purchase Agreement with Aspire Capital in consideration for aggregate proceeds of $3.2 million.
Converted 85,409 shares of preferred stock into 170,818 shares of common stock. As a result, 335,273 shares of preferred stock remain outstanding at September 30, 2013.
Third Quarter 2013 Financial Results
Research and Development Expenses
Research and development expenses in the third quarter of 2013 were $4.6 million compared to $1.5 million for the same period in 2012, with the increase of $3.1 million mainly attributable to clinical trial and manufacturing costs, including an expense of $2.6 million for clinical trial drug supply for the Company's pivotal, Phase 3 SEAMLESS trial.
General and Administrative Expenses
Total general and administrative expenses for the third quarter of 2013 were $1.5 million, compared to $2.0 million for the same period in 2012 with the decrease of $0.5 million primarily related to professional and consultancy costs, including legal fees.
Cash and Cash Equivalents
As of September 30, 2013, Cyclacel's cash and cash equivalents were $34.5 million compared to $16.4 million as of December 31, 2012. The increase in cash and cash equivalents was primarily due to net proceeds of $19.0 million from an underwritten public offering, proceeds of $6.6 million from the sale of common stock under a Common Stock Purchase Agreement, and $5.0 million, net of certain expenses, from the sale of four Cyclacel patents, partially offset by net spending on operating activities of $12.8 million.
Cyclacel's Key Goals for the next 12 Months
Continue US enrollment and expand into Europe the SEAMLESS Phase 3 study of sapacitabine in AML;
Report outcomes from upcoming DSMB periodic safety reviews of SEAMLESS every 100 patients and futility when 212 pooled events have been observed;
Report at ASH 2013 the primary endpoint of the Phase 2 sapacitabine study in MDS after treatment failure of hypomethylating agents;
Announce registration-directed, clinical development plan for sapacitabine in MDS after treatment failure of hypomethylating agents;
Report updated data from the Phase 1 study of sapacitabine and seliciclib in patients with advanced solid tumors, including BRCA carriers; and
Advance selected pipeline programs.
Conference call and Webcast Information:
Cyclacel will conduct a conference call on November 12, 2013 at 4:30 p.m. Eastern Time to review the third quarter results. Conference call and webcast details are as follows:
CPRX up a bit with reort $1.41
Catalyst Pharmaceutical Partners Announces Third Quarter 2013 Financial Results
GlobeNewswire
Catalyst Pharmaceutical Partners, Inc. 8 hours ago
CORAL GABLES, Fla., Nov. 14, 2013 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (CPRX), a specialty pharmaceutical company focused on developing safe and effective approved medicines targeting orphan neuromuscular and neurological diseases, today announced financial results for the third quarter and nine months period ended September 30, 2013.
"Significant progress has been made towards initiating new clinical trial sites and enrolling patients in our Phase 3 clinical trial for Firdapse(TM) to treat patients with Lambert-Eaton Myasthenic Syndrome (LEMS). We continue to believe that we will complete enrollment around the end of the year and be in a position to announce top-line data from the double-blind portion of our trial during the second quarter of 2014," said Patrick J. McEnany, Catalyst's Chief Executive Officer. "The Catalyst team is focused on all critical activities to successfully complete our Phase 3 registration trial and has begun its pre-commercialization efforts for Firdapse(TM)."
Third Quarter and Recent Business Activities
We closed a registered direct public offering with net proceeds of approximately $14.1 million.
Shareholder warrants were exercised resulting in approximately $4 million in additional capital.
Firdapse(TM) was granted "Breakthrough Therapy Designation" status by the FDA for the treatment of LEMS.
Nineteen trial sites are actively screening patients, with 7 in the United States (U.S.). Twelve trial sites in the U.S., Europe and Canada have been added by Catalyst to date, and we anticipate adding at least an additional 6 trial sites shortly.
The Data Monitoring Committee overseeing the Phase 3 trial met in October and recommended the continuation of the trial as planned.
We recently launched social media presence to better engage with LEMS patients and their families, shareholders and other stakeholders. Catalyst's blog and Twitter handle, can be found at CatalystPharmaBlog.com and @CatalystPharma respectively.
Financial Results
For the quarter ended September 30, 2013, Catalyst reported a GAAP net loss of $5,912,059, or $0.13 per basic and diluted share, compared to a GAAP net loss of $2,621,535, or $0.08 per basic and diluted share, for the same period in 2012. Excluding non-cash expense of $2,676,601 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $3,235,458 or $0.07 per share for the third quarter of 2013. In comparison, Non-GAAP1 net loss for the third quarter of 2012 was $1,280,969, or $0.04 per share, which excludes non-cash expense of $1,340,566 attributable to the change in fair value of liability-classified warrants.
For the nine months ended September 30, 2013, Catalyst reported a GAAP net loss of $10,799,938, or $0.25 per basic and diluted share, compared to a GAAP net loss of $3,999,801, or $0.14 per basic and diluted share, for the same period in 2012. Excluding non-cash expense of $3,220,514 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $7,579,424 or $0.18 per share for the nine months ended September 30, 2013. In comparison, Non-GAAP1 net loss for the nine months ended September 30, 2012 was $3,710,361, or $0.13 per share, which excludes non-cash expense of $289,440 attributable to the change in fair value of liability-classified warrants.
Research and development expenses for the third quarter of 2013 were $2,804,352, compared to $654,837 in the third quarter of 2012. For the nine months ended September 30, 2013, research and development expenses were $6,028,691, compared to $1,914,905 in the comparable period of 2012. Research and development expenses increased when compared to the same period in 2012 as Catalyst expanded its product development efforts and clinical trial activities related to the currently ongoing Phase 3 trial evaluating Firdapse(TM) for the treatment of LEMS. Catalyst expects that research and development expenses will continue to be substantial during the balance of 2013 and 2014, principally as a result of the ongoing development projects for Firdapse(TM).
General and administrative expenses for the third quarter of 2013 totaled $441,424, compared to $628,876 in the third quarter of 2012. For the nine months ended September 30, 2013, general and administrative expenses totaled $1,576,044, compared to $1,800,882 in the same period in 2012.
As a development-stage specialty pharmaceutical company, Catalyst had no revenues in either the third quarter of 2013 or the first nine months of 2013.
At September 30, 2013, Catalyst had cash and cash equivalents, certificates of deposit and short-term investments of $27.7 million and no debt. Catalyst believes that its existing capital resources will be sufficient to meet its currently anticipated working capital requirements through the end of 2014.
1 Statements made in this press release include a non-GAAP financial measure. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with generally accepted accounting principles (GAAP). This non-GAAP financial measure is intended to enhance an overall understanding of Catalyst's current financial performance. Catalyst believes that the non-GAAP financial measure presented in this press release provides investors and prospective investors with an alternative method for assessing Catalyst's operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. The non-GAAP financial measure in this press release excludes from the calculation of net loss the expense (or the income) associated with the change in fair value of the liability-classified warrants. Non-GAAP net loss per share is calculated by dividing non-GAAP net loss by the weighted average common shares outstanding.
TWA; good call. where else?
up a bit to 2.79
http://finance.yahoo.com/q?s=GFA
Shorties we will we will ruck you!
November 14, 2013
08:07 EDT EPZM Epizyme's EPZ-5676 DOT1L inhibitor for leukemia shows positive Phase 1 results
Epizyme announced initial findings from an ongoing Phase 1 study of EPZ-5676, an inhibitor of the DOT1L histone methyltransferase being developed for the treatment of acute leukemia with alterations in the MLL gene. In four completed dose cohorts, with a total of 16 patients dosed, EPZ-5676 has been well-tolerated. There have been no dose-limiting toxicities and only one adverse event-related treatment discontinuation. Some MLL-r patients experienced resolution of leukemia-related symptoms and manifestations, including fevers, cachexia, and leukemia cutis. The study is ongoing with a fifth dose cohort currently enrolling. Epizyme plans to start the Phase 1 MLL-r only expansion stage with an 80 mg/m2/day administration schedule without a drug holiday and with possible continued dose escalation.
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November 14, 2013
10:00 EDT EPZM Epizyme falls 26.2%
Epizyme is down 26.2%, or $8.30, to $23.41
09:07 EDT EPZM Epizyme hosted a conference call
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08:07 EDT EPZM Epizyme's EPZ-5676 DOT1L inhibitor for leukemia shows positive Phase 1 res
About Epizyme Inc (NasdaqGM:EPZM)
Epizyme, Inc., a clinical stage biopharmaceutical company, engages in the discovery, development, planning, and commercialization of various personalized therapeutics for the treatment of patients with genetically defined cancers. Its principal product candidates under development include EPZ-5676, an intravenously administered small molecule inhibitor of DOT1L that is in Phase I clinical trials for the treatment of mixed lineage rearranged leukemia (MLL-r); and EPZ-6438, an orally available small molecule inhibitor of EZH2 for the treatment of non-Hodgkin lymphoma patients caused by an oncogenic point mutation in EZH2. The company has strategic collaboration and license agreements with Celgene Corporation and Celgene International Sàrl, as well as Glaxo Group Limited to discover, develop, and commercialize small molecule HMT inhibitors; and Eisai Co., Ltd. (Eisai) to license its EZH2 program. It also has a companion diagnostic collaboration with Abbott Molecular Inc. for the development of a companion diagnostic to identify patients with the MLL-r genetic alteration targeted by EPZ-5676; and with Roche Molecular Systems, Inc., as well as with Eisai for the development and commercialization of a companion diagnostic for use with EPZ-6438 product candidate. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts.
Updated. But fell $10 to $21.. strange.
Epizyme's EPZ-5676 DOT1L Inhibitor Demonstrates Encouraging Initial Findings in an Ongoing Phase 1 Dose Escalation Study
Date : 11/14/2013 @ 8:00AM
Source : PR Newswire (US)
Stock : EPIZYME, INC. (EPZM)
Quote : 21.2 -10.51 (-33.14%) @ 2:51PM
Epizyme's EPZ-5676 DOT1L Inhibitor Demonstrates Encouraging Initial Findings in an Ongoing Phase 1 Dose Escalation Study
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CAMBRIDGE, Mass., Nov. 14, 2013 /PRNewswire/ --
Four dose cohorts (12, 24, 36 and 54 mg/m2/day) completed (16 patients, 8 with acute leukemia with MLL-r) with 21-day on/7-day off administration schedule
Observations to date include:
No dose-limiting toxicities; maximum tolerated dose (MTD) not reached
Treatment effects, consistent with genetically defined therapeutic mechanism of action, observed in 4 of 8 acute leukemia patients with MLL-rearrangement (MLL-r); no effects observed in non-MLL-r patients
Dose-proportional exposure
Dose- and time-dependent methyl mark inhibition
Plan to initiate Phase 1 MLL-r only expansion stage in December 2013 starting at an 80 mg/m2/day uninterrupted treatment schedule, continued dose escalation possible
Epizyme will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss these data; slides will be available on www.epizyme.com prior to call
Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced initial findings from an ongoing Phase 1 study of EPZ-5676, a potent and selective inhibitor of the DOT1L histone methyltransferase (HMT) being developed for the treatment of acute leukemia with alterations in the MLL gene.
"EPZ-5676 is a first-in-class inhibitor of the DOT1L HMT, and we are very pleased with the findings to date in the dose escalation stage of the ongoing two-stage Phase 1 study," said Robert J. Gould, Ph.D., chief executive officer, Epizyme. "The safety, pharmacokinetic, pharmacodynamic, and treatment effects observed in this study are consistent with our pre-clinical data. Based on these results, we plan to initiate the MLL-r only Phase 1 expansion stage in December 2013 and pediatric MLL-r and MLL-PTD studies in early 2014."
The dose escalation stage of the Phase 1 study, evaluating a 21-day on/7-day off administration schedule, is open to patients with heavily pre-treated advanced hematological malignancies, including but not limited to patients with acute leukemia with MLL-rearrangements (MLL-r). Study objectives are typical for a Phase 1 study, including determining safety and tolerability, identifying the maximum tolerated dose or recommended Phase 2 dose (RP2D) and schedule, and evaluating the relationship between dose, exposure and pharmacodynamic effects. In four completed dose cohorts, with a total of 16 patients dosed (including eight patients with acute leukemia with MLL-r), EPZ-5676 has been well-tolerated. There have been no dose-limiting toxicities and only one adverse event-related treatment discontinuation, which was not considered to be related to EPZ-5676. Exposure has been dose-proportional, and inhibition of the target methyl mark has been dose- and time-dependent. In four of the eight MLL-r acute leukemia patients, treatment effects consistent with the genetically defined therapeutic mechanism of action were observed, while no treatment effects were seen in the non-MLL-r patients. Treatment effects were consistent with leukemia cell differentiation and maturation, including treatment-related leukocytosis, maturation features in blood and bone marrow, and blood and bone marrow blast count reductions. Additionally, some MLL-r patients experienced resolution of leukemia-related symptoms and manifestations, including fevers, cachexia, and leukemia cutis. The study is ongoing with a fifth dose cohort (80 mg/m2/day) currently enrolling.
Based on these results, Epizyme plans to start the Phase 1 MLL-r only expansion stage with an 80 mg/m2/day administration schedule without a drug holiday and with possible continued dose escalation. This expansion stage is intended to provide an initial assessment of efficacy for EPZ-5676 in MLL-r patients.
"The observed safety and tolerability profile of EPZ-5676, along with the mechanistically consistent treatment effects in MLL-r patients, are strongly supportive of continued clinical development," said Eric Hedrick M.D., chief medical officer, Epizyme. "We believe these data warrant evaluation of an uninterrupted administration schedule of EPZ-5676 in the MLL-r only expansion stage of the ongoing Phase 1 adult trial, as well as in two additional clinical settings, both of which we plan to initiate in 2014: a Phase 1b trial in pediatric acute leukemia patients with MLL-r, and an expansion cohort in adult AML patients with the MLL-PTD genetic alteration."
About EPZ-5676
Epizyme is developing EPZ-5676, a small molecule inhibitor of DOT1L created with Epizyme's proprietary product platform, for the treatment of acute leukemias with alterations in the MLL gene. As a result of these alterations, DOT1L is misregulated and causes inappropriate methylation, resulting in the increased expression of genes causing leukemia. Additional information about this program, including clinical trial information, may be found here: http://clinicaltrials.gov/show/NCT01684150.
Epizyme retains all U.S. rights to EPZ-5676 and has granted Celgene an exclusive license to EPZ-5676 outside of the United States. Epizyme has partnered with Abbott to develop a companion diagnostic to identify MLL-r patients. Additional information about these partnerships may be found here: www.epizyme.com/about-us/partnerships/.
Conference Call Information
Epizyme will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss initial findings from the dose escalation stage of the ongoing Phase 1 study. To participate in the conference call, please dial 1-877-844-6886 (domestic) or 1-970-315-0315 (international) and refer to conference ID 10332364. The live webcast and accompanying slides that provide additional detail about the dose escalation stage of this study can be accessed under "Upcoming Events" in the Investor Center section of the Company's website at www.epizyme.com.
The archived webcast will be available on the Company's website beginning approximately 2 hours after the live conference call.
About Epizyme, Inc.
Epizyme, Inc. is a clinical stage biopharmaceutical company creating personalized therapeutics for patients with genetically defined cancers. Epizyme has built a proprietary product platform that the company uses to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs. HMTs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic (cancer-causing). By focusing on the genetic drivers of cancers, Epizyme's targeted science seeks to match the right medicines with the right patients for a personalized approach to cancer treatment.
For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
AH shorties working overtime to prevent them going over $3 resistance level.Once tru near history will be repeated.
GLLs
Hedgies pitch in to take over! No mo C only A+?
http://www.cnbc.com/id/101193820
UPDATE: Fannie, Freddie soar again; Carlyle upped to 'buy'
11:55a ET November 14, 2013 (MarketWatch)
UPDATE: Fannie, Freddie soar again; Carlyle upped to 'buy'
By Christina Rexrode
NEW YORK (MarketWatch) -- Mortgage-finance giants Fannie Mae and Freddie Mac soared again on Thursday, after a mutual fund company laid out a game plan for buying parts of the two bailed-out companies.
Fairholme Capital Management sent a letter to Fannie and Freddie's federal regulator late Wednesday, detailing its proposal. Both Fannie (FNMA) and Freddie (FMCC) were up more than 6% early Thursday.
It isn't clear if the proposal has legs, given the political entanglements: Fannie and Freddie were basically nationalized in 2008, and the government hasn't laid out a clear plan for them to earn their freedom. And Fairholme, which already owns preferred shares in Fannie and Freddie, sued the government this year, saying that it changed the terms of the bailout in a way that was unfair to private investors.
Michael Kao, founder of Akanthos Capital Management in Los Angeles, said the Fairholme proposal at least offers "a definable path" for Fannie and Freddie to earn their way out of government control and raises the debate to a public stage.
"I suspect this is going to be a back-and-forth process for some time to come," said Kao, whose hedge fund, which also owns shares in Fannie and Freddie, has advocated for a similar path out of conservatorship. "But at least there are some people forcing the issue now."
Blackstone Group L.P., (BX) which owns hedge funds that reportedly could get involved with the Fairholme proposal, was up 1%.
Thursday's performance was on top of big gains the day before. On Wednesday, when rumors first started leaking that some private investors wanted a bigger piece of the mortgage giants, Fannie soared more than 9%; Freddie, more than 8%; and Blackstone, more than 4%.
Pounding shrt pricks again! Discrepancy between FMCC and FNMA has to narrow down.
GLLs.
Pounding short pricks again!