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Yep. They settled some trades after markets closed.
Significant number of shares @ $3.15 AHs trades.. One wonders why pay a premium?
Short pricks' attack short lived. Opportunity to acquire funny and fredy men shares @ $2.00s for short term trade in addition to a long portfolio appreciation of low cost long term holdings.
GLLs
Still holding my YoE tax loss buys: TZYM, ANTH, CHTP. CBRX, etc.. Surf i read you treaemd those positions, right? Any charts for above?
tia
mlkr
Charts: Pieces of Arts. Hey Surf, Colors ?
Surf; Great board..Are you buying any of above? Any rebound candidates?
tia
mlkr
Looking good!
GLLs!
Dont get angry get even: Pounded short pricks few times.. Short squeeze underway. No cheap sales not even $0.30 cents ones!.
Holding large stake for long term.
Took a few very low cost ones off the table at intraday's low. Keeping longs!
POZEN: Presence of gastric erosions in patients taking low-dose aspirin for secondary cardiovascular prevention may result in a 2-fold increase in future gastric ulcers (POZN) 4.96 : Co presents data from a post-hoc analysis of Phase 3 data from the investigational compound PA32540. The analysis of patients screened for the Phase 3 studies demonstrated that at any time point, over 4% of subjects on low dose aspirin for cardiovascular and cerebrovascular disease have endoscopic gastric ulcers that go undetected. In addition, the analysis demonstrated that even the presence of small lesions known as endoscopic gastric erosions in aspirin-users was associated with a 2-fold increased risk of future development of endoscopic gastric ulcers.
Key Findings of Post-Hoc Analysis
The baseline rate of gastric ulcers in the screening of the general population of adults using ASA (325 mg) for =3 months for secondary cardiovascular prevention was 4.4%, and was 5.7% for both gastric or duodenal ulcers.
In the post-hoc analysis of subjects with and without gastric erosion at baseline endoscopy, the presence of gastric erosion at baseline was:
Predictive of a higher rate of subsequent gastric erosions for both EC-ASA (325 mg) and PA32540.
Associated with a significant propensity toward future gastric ulcer development in subjects treated with EC-ASA (325 mg), but not in those treated with PA32540.
In patients with baseline gastric erosions, a significantly higher percentage of patients taking EC-ASA (325 mg) developed a gastric ulcer over the six month study period than patients taking PA32540 (13% vs. 4.2%).
Co states these data highlight the need for physicians to identify aspirin patients at risk, and, where appropriate, prescribe gastroprotective agents. Based on American Heart Association and American College of Gastroenterology recommendations, the preferred gastroprotective agents are proton pump inhibitors.
$65 m credit line
Wells Fargo
SolarCity (SCTY) stock took off Friday, up 26% in afternoon trading at a new high, following word Thursday that Goldman Sachs (GS) will finance more than $500 million in solar panel system installations for SolarCity residential and business customers.
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Target raised:
May 17, 2013
07:37 EDT VNDA Vanda Pharmaceuticals price target raised to $17 from $11 at Lazard Capital
Lazard Capital raised its price target for Vanda Pharmaceuticals shares citing positive feedback on the company's sleep disorder drug tasimelteon. The firm keeps a Buy rating on the stock.
AMBI NEW BABY?
Ambit Biosciences Announces Pricing of Initial Public Offering
PR NewswirePress Release: Ambit Biosciences Corporation – Thu, May 16, 2013 8:00 AM EDT
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AMBI 6.75 -0.64
SAN DIEGO, May 16, 2013 /PRNewswire/ -- Ambit Biosciences Corporation today announced the pricing of its initial public offering of 8,125,000 shares of its common stock at $8.00 per share. Ambit has granted the underwriters a 30-day option to purchase up to an additional 1,218,750 shares at the initial public offering price to cover over-allotments, if any. Ambit's common stock is scheduled to begin trading on The NASDAQ Global Market on May 16, 2013, under the symbol "AMBI."
The joint book-running managers for the offering are Citigroup and Leerink Swann. In addition, BMO Capital Markets is acting as lead manager and Robert W. Baird & Co. Inc. is acting as co-manager.
This offering is being made by means of a prospectus, copies of which may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York, 11717, or by email at batprospectusdept@citi.com or by phone at 1-800-831-9146, and Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Mass., 02110, or by email at Syndicate@Leerink.com or by phone at 1-800-808-7525.
Tranzyme Pharma Announces First Quarter 2013 Financial Results
4:30p ET May 9, 2013 (GlobeNewswire)
Tranzyme Pharma (Nasdaq:TZYM) ("Tranzyme"), a biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics, today announced its financial results for the first quarter ended March 31, 2013.
Select First Quarter 2013 Financial Results
Total revenue for the first quarter of 2013 was $0.6 million compared to $2.6 million in the same period last year. The decrease in revenue was primarily due to completion of the amortization of deferred revenue from the upfront licensing fee received from our collaboration with Norgine B.V. Research and development expenses were $1.9 million in the first quarter 2013 as compared to $8.1 million for the same period in 2012. The decrease was primarily due to a reduction in Phase 3 clinical trial expenses for ulimorelin and our Phase 2b trial activities for TZP-102. General and administrative expenses were $2.1 million in the first quarter of 2013 versus $1.9 million in the same period last year, reflecting increased expenses relating to legal fees for our evaluation of strategic alternatives. The Company reported a consolidated net loss of $3.4 million for the three months ended March 31, 2013 as compared to a net loss of $8.4 million in the same period of 2012.
Recent Developments
In April 2013, Tranzyme and Ocera Therapeutics, Inc. ("Ocera") announced they have entered into a definitive agreement under which Ocera will merge with a subsidiary of Tranzyme in an all-stock transaction. The merger is expected to create a NASDAQ-listed company focused on the development of novel therapeutics for patients with acute and chronic decompensated liver disease, an area of high unmet medical need. Upon closing, the company will be named "Ocera Therapeutics, Inc." The merger is expected to close in the third quarter of 2013, subject to approval by a majority of Tranzyme stockholders, review by the Securities and Exchange Commission and customary closing conditions as detailed in the merger agreement.
About Tranzyme Pharma
Tranzyme Pharma is a biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics. All of Tranzyme's drug discovery activities are based on its proprietary small molecule macrocyclic template chemistry (MATCH(TM)) technology, which has also been successfully used to generate drug candidates in partnership with other pharmaceutical companies. MATCH enables the rapid construct of synthetic libraries of drug-like, macrocyclic compounds in a predictable and efficient manner. By leveraging MATCH, Tranzyme is committed to pursuing first-in-class medicines to address areas of significant unmet medical need and continues to pursue funded drug discovery partnerships. Additional information on Tranzyme can be found at www.tranzyme.com.
About Ocera Therapeutics
Ocera Therapeutics, based in San Diego, California, is a privately held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat acute and chronic liver diseases. Ocera's lead drug candidate OCR-002 (ornithine phenylacetate) is an ammonia scavenger designed to treat hyperammonemia and associated hepatic encephalopathy in patients with liver cirrhosis, acute liver failure and acute liver injury. OCR-002, through its dual mechanism of action, directly lowers circulating blood levels of ammonia by enabling alternate metabolic pathways in the muscle and kidney in patients with decompensated liver cirrhosis, and or liver failure from other causes. Planning is underway to initiate a Company-sponsored Phase 2b, randomized, double-blind, placebo-controlled, efficacy study of OCR-002 as a treatment for acute hepatic encephalopathy in hospitalized patients with liver cirrhosis. Enrollment is expected to begin in late 2013. OCR-002 also is the subject of two ongoing, externally-sponsored, Phase 2a studies in patients. Data from these studies are expected in 2014.
In addition to OCR-002, Ocera has developed Zysa(TM) (AST-120) a spherical carbon adsorbent, for the treatment of irritable bowel syndrome. Ocera has raised over $60 million dollars in venture financing from funds including Domain Associates, Sofinnova Ventures, Thomas, McNerney & Partners, Greenspring Associates and InterWest Partners. Additional information on Ocera can be found at www.ocerainc.com.
Forward-Looking Statements
Certain statements in this communication regarding the proposed merger (including statements relating to satisfaction of the conditions to and consummation of the proposed merger) constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.
Risks and uncertainties for Tranzyme and Ocera and of the combined company include, but are not limited to: inability to complete the proposed merger and other contemplated transactions; liquidity and trading market for shares prior to and following the consummation of the proposed merger and proposed financing; costs and potential litigation associated with the proposed merger; failure or delay in obtaining required approvals by the SEC or any other governmental or quasi-governmental entity necessary to consummate the proposed merger, including our ability to file an effective proxy statement in connection with the proposed merger and other contemplated transactions, which may also result in unexpected additional transaction expenses and operating cash expenditures on the parties; inability or the delay in obtaining required regulatory approvals for product candidates, and/or which may result in unexpected cost expenditures; failure to issue Tranzyme common stock in the proposed merger and other contemplated transactions exempt from registration or qualification requirements under applicable state securities laws; the price of the financing transaction in connection with the proposed merger and contemplated transactions being materially lower than the current weighted average trading price of Tranzyme's common stock, or the aggregate amount of cash received from such financing transaction being less than anticipated; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; failure to realize any value of certain product candidates developed and being developed, including with respect to OCR-002, in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing products; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for the combined company's products may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; loss of or diminished demand from one or more key customers or distributors; unexpected cost increases and pricing pressures; continuing or deepening economic recession and its negative impact on customers, vendors or suppliers; failure to obtain the necessary stockholder approvals or to satisfy other conditions to the closing of the proposed merger and the other contemplated transactions; a superior proposal being submitted to either party; uncertainties of cash flows and inability to meet working capital needs; cost reductions that may not result in anticipated level of cost savings or cost reductions prior to or after the consummation of the proposed merger; and risks associated with the possible failure to realize certain benefits of the proposed merger, including future financial, tax, accounting treatment, and operating results. Many of these factors that will determine actual results are beyond Tranzyme's, Ocera's, or the combined company's ability to control or predict.
Other risks and uncertainties are more fully described in our Annual Report on Form 10-K for the year ended December 31, 2012 filed with the SEC, and in other filings that Tranzyme makes and will make with the SEC in connection with the proposed merger and other contemplated transactions, including the proxy statement to be filed in connection with the proposed merger and other contemplated transactions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date after the date stated herein.
Important Information and Where to Find It
Tranzyme and Ocera and certain of their directors and executive officers may become participants in the solicitation of proxies from Tranzyme stockholders in connection with the proposed merger and related transactions. Additional information regarding persons who may, under the rules of the Securities and Exchange Commission, be deemed to be participants in the solicitation of the Tranzyme stockholders in connection with the proposed merger, and who have interests, whether as security holders, directors or employees of Tranzyme or Ocera or otherwise, which may be different from those of Tranzyme stockholders generally, can be found in the Form 8-K filed by Tranzyme on April 24, 2013, and will otherwise be provided in the proxy statement and other materials to be filed with the Securities and Exchange Commission.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. A definitive proxy statement and a proxy card will be filed with the Securities and Exchange Commission and will be mailed to Tranzyme's stockholders seeking any required stockholder approvals in connection with the proposed transactions. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT TRANZYME MAY FILE WITH THE SECURITIES AND EXCHANGE COMMISSION WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Stockholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by Tranzyme with the SEC in connection with the proposed transactions at the Securities and Exchange Commission's website (http://www.sec.gov), at Tranzyme's website (http://ir.tranzyme.com), or by writing to the Secretary, Tranzyme, Inc. at 5001 South Miami Boulevard, Suite 300, Durham, North Carolina 27703.
Financial Tables Follow
Tranzyme, Inc.
Consolidated Statements of Comprehensive Income
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended
March 31,
2013 2012
Licensing and royalty revenue $ 599 $ 1,443
Research revenue -- 1,165
Total revenue 599 2,608
Operating expenses:
Research and development 1,856 8,140
General and administrative 2,136 1,948
Total operating expenses 3,992 10,088
Operating loss (3,393) (7,480)
Interest expense, net (2) (432)
Other income (expense), net 2 (508)
Net income (loss) $ (3,393) $ (8,420)
Net income (loss) per share--basic and diluted $ (0.12) $ (0.34)
Shares used to compute net loss per share--basic and diluted 27,600,437 24,601,447
Other comprehensive income (loss):
Net income (loss) $ (3,393) $ (8,420)
Foreign currency translation adjustment (40) 20
Comprehensive income (loss) $ (3,433) $ (8,400)
Tranzyme, Inc.
Consolidated Balance Sheets
(Unaudited)
(In thousands, except share and per share amounts)
March 31, December 31,
2013 2012
Assets
Current assets:
Cash and cash equivalents $ 10,812 $ 15,319
Accounts receivable, net 390 152
Investment tax credits receivable 731 746
Prepaid expenses and other assets 134 369
Total current assets 12,067 16,586
Investment tax credits receivable 101 --
Furniture, fixtures and equipment, net 841 942
Total assets $ 13,009 $ 17,528
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 736 $ 1,678
Accrued liabilities 659 840
Current portion of deferred revenue 300 599
Total current liabilities 1,695 3,117
Other long-term liabilities 132 137
Total liabilities 1,827 3,254
Total stockholders' equity 11,182 14,274
Total liabilities and stockholders' equity $ 13,009 $ 17,528
CONTACT: Inquiries:
Susan Sharpe
Director, Corporate Communications
(919) 328-1109
ssharpe@tranzyme.com
http://www.globenewswire.com/newsroom/ti?nf=MTMjMTAwMzIyMzEjMTc0MDA=
Anacor Pharmaceuticals Reports First Quarter 2013 Financial Results $5.68
Business WirePress Release: Anacor Pharmaceuticals – Thu, May 9, 2013 4:01 PM EDT
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ANAC 5.68 -0.58
PALO ALTO, Calif.--(BUSINESS WIRE)--
Anacor Pharmaceuticals (ANAC) announced today its financial results for the first quarter ended March 31, 2013.
“It was an eventful first quarter. We reported positive data from our two Phase 3 trials of tavaborole in onychomycosis, and we are on track to file our NDA around the middle of this year. In addition, we reported successful results from our third Phase 2 trial of AN2728 in atopic dermatitis, which informed the most efficacious dosing regimen for our anticipated Phase 3 trials,” said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. “And most recently, we accomplished the goal of our previously scheduled preliminary injunction hearing as Valeant agreed not to launch efinaconazole, its topical product candidate for onychomycosis, if approved, until after our final arbitration hearing in September of this year.”
First Quarter 2013 Highlights and Recent Developments
Clinical
Tavaborole – our lead topical antifungal product candidate for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
In the first quarter of 2013, we announced the results from two Phase 3 clinical trials in which tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints.
AN2728 – our lead topical anti-inflammatory product candidate for the treatment of atopic dermatitis and psoriasis. Atopic dermatitis is a chronic rash characterized by inflammation and itching and affects an estimated 40 million people in the seven major pharmaceutical markets, including approximately 10% to 20% of infants and young children.
In March 2013, we announced positive results from a Phase 2 dose-ranging trial of AN2728 in adolescents (ages 12 – 17) with mild-to-moderate atopic dermatitis. This was our third Phase 2 study of AN2728 in atopic dermatitis. A clear dose response was demonstrated in this study, with AN2728 ointment, 2.0% BID yielding the greatest improvement, and AN2728 continued to demonstrate an excellent safety profile.
Research Agreement
On April 5, 2013, we entered into a research agreement with the Bill & Melinda Gates Foundation (the Gates Foundation) to discover drug candidates intended to treat two filarial worm diseases (onchocerciasis, or river blindness, and lymphatic filariasis, commonly known as elephantiasis) and tuberculosis. Under the agreement, the Gates Foundation will pay Anacor up to $17.7 million over a three-year term to conduct research activities directed at discovering potential drug candidates for these neglected diseases. In addition, the Gates Foundation purchased shares of Anacor’s common stock for net proceeds of approximately $5.0 million.
Corporate
In May 2013, we completed an underwritten public offering of 3,599,373 shares of our common stock, including the exercise of the overallotment option in full by the underwriters, for net proceeds of approximately $21.4 million.
In May 2013, Valeant Pharmaceuticals International, Inc. (Valeant) agreed that the launch of efinaconazole, its topical product candidate for the treatment of onychomycosis, will not occur, if at all, until after the September 2013 arbitration hearing to resolve the breach of contract dispute we initiated with them in October 2012. As a result, the preliminary injunction hearing, which was previously scheduled for May 6-8, 2013, was canceled.
Anticipated Milestones in the Next Twelve Months
Tavaborole, our lead product candidate for the treatment of onychomycosis:
We expect to file a New Drug Application with the FDA for tavaborole in mid-2013.
We currently have a final hearing for our arbitration with Valeant scheduled in September 2013 and anticipate the resolution of the arbitration in the second half of 2013.
We expect to choose a path for commercialization of tavaborole in the second half of 2013.
AN2728, our lead product candidate for the treatment of atopic dermatitis:
We expect to initiate the following two additional safety studies prior to initiating a Phase 3 study in atopic dermatitis:
1. MUSE (maximal use systemic exposure) study in ~ 30 children with atopic dermatitis to measure blood levels when AN2728 is applied under maximal use conditions.
2. TQT (thorough QT) study to assess the effects of AN2728 on electrocardiograms (ECGs) in ~180 healthy volunteers following multiple-dose administration.
We expect to initiate a Phase 3 study in atopic dermatitis in the fourth quarter of 2013 or the first quarter of 2014, with timing dependent on the completion of the MUSE study.
Selected First Quarter 2013 Financial Results
Revenues for the quarter ended March 31, 2013 were $1.7 million, compared to $2.4 million for the comparable period in 2012. The decrease in revenues from 2012 is primarily due to a decrease in research work performed under our research and development agreements, including agreements with not-for-profit organizations for neglected diseases. In addition, in the first quarter of 2013, we did not recognize any revenue from the upfront free received in 2011 under the agreement with Medicis relating to the discovery of potential treatments for acne.
Research and development expenses were $11.2 million for the first quarter of 2013, compared to $12.7 million for the same quarter in 2012. The decrease in research and development expenses from 2012 is comprised of a decrease in clinical expenses for tavaborole and a decrease in research and development related to the Medicis collaboration, partially offset by increases in expenses related to our Lilly animal health programs and other research activities.
General and administrative expenses for the first quarter of 2013 were $4.7 million, compared to $3.4 million for the comparable period in 2012. The increase from 2012 is primarily due to an increase in legal fees resulting from the legal proceedings for our disputes with Valeant.
Cash, cash equivalents and short-term investments totaled $32.4 million at March 31, 2013, compared to $45.5 million at December 31, 2012.
2013 Financial Outlook
We believe that our existing capital resources, including the net proceeds from the sale of our common stock in the Gates Foundation private placement offering in April 2013 and the public stock offering in May 2013, will be sufficient to meet our anticipated operating requirements until at least the end of 2013.
Conference Call and Webcast
Anacor will host a conference call at 5:00 p.m. ET / 2:00 p.m. PT today, during which management will discuss the Company’s financial results and recent developments. The call can be accessed by dialing (877) 291-1367 (domestic) and (914) 495-8534 (international) five minutes prior to the start of the call. The call will also be webcast live and can be accessed on the Events and Presentations page, under Investors, on the Company’s website at www.anacor.com and will be available for three months following the call.
About Anacor Pharmaceuticals
Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has discovered eight compounds that are currently in development. Its two lead product candidates are topically administered dermatologic compounds — tavaborole, an antifungal for the treatment of onychomycosis, and AN2728, an anti-inflammatory PDE-4 inhibitor for the treatment of atopic dermatitis and psoriasis. In addition to its two lead programs, Anacor has discovered three other wholly-owned clinical product candidates — AN2718 and AN2898, which are backup compounds to tavaborole and AN2728, respectively, and AN3365 (formerly referred to as GSK2251052, or GSK ‘052), an antibiotic for the treatment of infections caused by Gram-negative bacteria, which previously was licensed to GlaxoSmithKline LLC, or GSK. GSK has returned all rights to the compound to us and we are considering our options for further development, if any, of this compound. We have also discovered three other compounds that we have out-licensed for further development — two are licensed to Eli Lilly and Company for the treatment of animal health indications and the third compound, AN5568, also referred to as SCYX-7158, is licensed to Drugs for Neglected Diseases initiative, or DNDi, for human African trypanosomiasis (HAT, or sleeping sickness). We also have a pipeline of other internally discovered topical and systemic boron-based compounds in development. For more information, visit http://www.anacor.com.
REPORTED $6.50 today
LipoScience Reports First Quarter 2013 Financial Results
GlobeNewswirePress Release: LipoScience, Inc. – Thu, May 9, 2013 4:05 PM EDT
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LPDX 6.50 -1.96
First Quarter 2013 NMR LipoProfile(R) Test Volumes Up 8.7% from 2012 Period
Announces Mayo Clinic Preparation for "Go Live" of Clinical Reporting on Vantera(R) System and Inclusion in American Association of Clinical Endocrinologists Diabetes Management Algorithm
RALEIGH, N.C., May 9, 2013 (GLOBE NEWSWIRE) -- LipoScience, Inc. (LPDX), a diagnostic company pioneering a new field of personalized NMR diagnostics to advance the quality of patient care, today announced its financial results for the first quarter ended March 31, 2013.
First Quarter Results
During the first quarter of 2013, clinicians ordered approximately 518,000 NMR LipoProfile tests, representing an increase of 8.7% over the first quarter of 2012. Total revenue was $13.6 million for the first quarter ended March 31, 2013, a decline of 1.2% compared to the first quarter ended March 31, 2012.
"We are dissatisfied with our unit growth and revenue performance, and our responses are already underway," commented Richard Brajer, President and Chief Executive Officer. "Based on a comprehensive review, the four primary factors contributing to the first quarter 2013 revenue shortfall were 1) we were unable to get the needed number of new sales representatives up and running, 2) our direct business is converting to our lab partners at a faster rate than prior years, 3) managed care headwinds, and 4) Vantera system placement delays."
"Given these factors and our slow start, we are reducing our full year 2013 revenue guidance to $54 to $56 million," said Mr. Brajer. "Unfortunately, these issues cannot be fixed overnight. But I can assure you that we fully understand what the issues are, and we are assertively implementing our responses as we continue to drive toward becoming a clinical standard of care."
"Despite these operational challenges, we continue to make important progress in attracting the support and validation of leading institutions and medical societies," added Mr. Brajer. "LipoScience is pleased to report that Mayo Clinic has successfully completed its Vantera system testing, and we are working with them to achieve 'Go Live' with clinical reporting of test results in the very near future. Additionally, the American Association of Clinical Endocrinologists (AACE) recently recommended LDL particle number (LDL-P) in their cardiovascular disease (CVD) risk factor modifications algorithm for patients with diabetes. TMAO, the diagnostic test that LipoScience has exclusive rights to commercialize from the Cleveland Clinic, has recently received broad press coverage, with a recent publication in the New England Journal of Medicine and coverage on NBC News. Moreover, the National Institutes of Health has signed a contract for a Vantera system to be used for research and clinical purposes. With these strong endorsements for our test and our platform by leading institutions and medical societies, we believe that the NMR LipoProfile test and Vantera system will become an important clinical standard of care in the future."
Additional First Quarter Operating Results
For the first quarter ended March 31, 2013, gross profit was $10.8 million compared to $11.5 million in the prior year, a decrease of 6.1%. Gross margin for the first quarter of 2013 was 79.1%, as compared to 83.2% for the first quarter of 2012 due primarily to increased costs incurred in 2013 associated with the launch of the Vantera system at third-party customer sites.
The overall average selling price of NMR LipoProfile tests decreased 6.4% to $25.25 for the first quarter of 2013, compared to $26.99 for the prior year period. The decline was primarily the result of certain reductions in price for some clinical laboratory customers based on their achievement of higher test volumes set forth in their agreements as well as the continuing shift in channel mix toward high-volume clinical laboratory customers. The percentage of total NMR LipoProfile tests sold through the Company's direct distribution channel, whereby clinicians ordered the test directly from LipoScience, decreased from 6% for the first quarter ended March 31, 2012 to 3% for the first quarter ended March 31, 2013. This trend reflects the Company's strategy of increasing the proportion of its business conducted through clinical diagnostic laboratories, resulting in an overall increase in test volumes, but a decreasing average selling price due to the shift in channel mix.
During the first quarter of 2013, sales and marketing expenses of $6.7 million were up 19.6% compared to $5.6 million in the prior year period. Sales and marketing expenses represented 48.9% of total revenues for the first quarter of 2013 compared to 40.4% in the first quarter of 2012. The increase in sales and marketing expenses as a percentage of revenue for the first quarter of 2013 is due to the continued expansion of the Company's direct sales force, growing geographic presence and an expansion in the Health, Policy & Reimbursement organization. These increases were partially offset by lower marketing expenses experienced during the first quarter of 2013 as a result of the timing of various marketing programs and medical education initiatives to drive awareness and adoption of the NMR LipoProfile test.
For the first quarter ended March 31, 2013, research and development expenses of $3.1 million increased by 45.9% as compared to $2.1 million during the prior year period. As a percentage of total revenues, research and development expenses increased to 23.0% for the first quarter of 2013, compared to 15.6% for the first quarter of 2012. This increase over the prior year period primarily reflects higher personnel-related expenses due to increased headcount, higher consulting fees for external research and development studies in support for our publication efforts, and other engineering projects, as well as higher allocated information technology and facility charges.
General and administrative expenses in the first quarter of 2013 were $3.3 million, up 47.0% compared to $2.3 million in the first quarter of 2012.The increase versus the prior year period resulted primarily from higher fees associated with the expansion of our business operations, compliance obligations in connection with becoming a publicly traded company and increased salaries and benefits due to higher staffing levels. The Company also incurred $0.3 million in tax liability as a result of the new U.S. medical device tax that became effective in January 2013 and that applies to sales of the NMR LipoProfile test. These higher costs were partially offset by lower bad debt expense. General and administrative expenses represented 24.3% of total revenues for the first quarter of 2013 compared to 16.3% in the first quarter of 2012.
Net loss for the first quarter of 2013 was $2.8 million compared to net income of $1.3 million in the prior year period.
As of March 31, 2013, LipoScience had approximately $55.0 million of cash and cash equivalents and $15.7 million of long-term debt. In the initial public offering, or IPO, completed in January 2013, LipoScience raised net proceeds of $44.4 million after the underwriting discount and offering expenses. Contemporaneous with the closing of the IPO, the Company paid $5.2 million in accrued dividends to holders of the Company's Series F preferred stock, which converted into common stock upon the closing of the IPO. In the first quarter, LipoScience also paid off the outstanding balance of $5.0 million on the Company's revolving line of credit.
Full Year 2013 Revenue Outlook
Based on information available as of May 9, 2013, the Company expects that total revenue for the full year 2013 will range from approximately $54 to $56 million as compared to reported revenue of $54.8 million for the full year 2012.
Conference Call Information
LipoScience management will host a conference call today at 4:30 p.m. EDT to discuss the first quarter 2013 financial results. To participate in the call, please dial (877) 303-2523 (U.S. and Canada) or (253) 237-1755 (international). A live webcast will be available on the Investor Relations section of the corporate website at http://investor.liposcience.com.
A replay of the conference call will be available beginning May 9, 2013 at 7:30 p.m. EDT and ending on May 21, 2013 by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international), Conference ID Number: 60327831. A replay of the webcast will be available on the corporate website for two weeks, through May 21, 2013.
About LipoScience, Inc.
LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. Its first proprietary diagnostic test, the NMR LipoProfile test, measures the number of low density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. To date, over 9 million NMR LipoProfile tests have been ordered. LipoScience's automated clinical analyzer, the Vantera(R) system, has been cleared by the FDA. It requires no previous knowledge of NMR technology to operate and has been designed to significantly simplify complex technology through ease of use and walk-away automation. The Vantera system will be placed with national and regional clinical laboratories.
LipoScience is driving toward becoming a clinical standard of care by decentralizing its technology and expanding its menu of personalized diagnostic tests to address a broad range of cardiovascular, metabolic and other diseases. For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.
Wider-than-Expected Loss at Optimer
ZacksBy Zacks Equity Research | Zacks – 5 hours ago
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AZN 51.54 -0.04
CBST 48.00 1.49
OPTR 12.81 -2.11
ALPMY 56.15 -0.97
Optimer Pharmaceuticals Inc.’s (OPTR) first quarter 2013 net loss (excluding special items) of 65 cents per share was wider than the Zacks Consensus Estimate of a loss of 42 cents but narrower than the year-ago loss of 73 cents per share. Lower-than-expected revenues were primarily responsible for the wider-than-expected loss incurred by the company in the first quarter of 2013.
Revenues in the first quarter of 2013 came in at $19.4 million, up 35.1% from the year-ago quarter. The increase was primarily due to higher Dificid sales. Revenues, however, missed the Zacks Consensus Estimate of $21 million.
Quarter in Details
Revenues in the reported quarter included Dificid sales in the US and Canada along with contract revenue of $2.5 million under the company’s collaboration agreements with companies like Astellas Pharma, Inc. (ALPMY), AstraZeneca (AZN) and Specialized Therapeutics Australia, Pty. Ltd.
We remind investors that Dificid, Optimer’s sole marketed product, was launched in the US in Jul 2011 for treating patients suffering from clostridium difficile-associated diarrhea (:CDAD) -- the most common form of nosocomial, or hospital acquired, diarrhea. Dificid was launched in Canada in Jun 2012. Net sales of the drug shot up 16.7% to $16.8 million in the reported quarter. The increase was primarily attributable to higher demand along with a 5.6% price increase which was effective from Jan 2013.
Dificid was approved in the EU under the trade name, Dificlir, in Dec 2011. Last month the drug was also approved in Australia for the treatment of confirmed clostridium difficile infection (CDI) in adults. Dificid is expected to be launched in Australia shortly.
We note that Optimer has an exclusive two-year agreement (through Jul 2013) with Cubist Pharmaceuticals (CBST) to co-promote Dificid in the US for the treatment of CDAD. Co-promotion expenses amounted to $3.8 million during the first quarter of 2013, compared with $10.1 million in the year-ago quarter.
Optimer is planning to expand Dificid’s label. The company is currently running a phase IIIb study evaluating the prophylactic use of Dificid in patients undergoing bone marrow transplantation or hematopoietic stem cell transplant. Optimer expects an interim analysis on the study in the latter half of the year. Optimer is also conducting a phase IIa study evaluating the pharmacokinetics of Dificid in pediatrics.
Selling, general and administrative (SG&A) expenses during the reported quarter were up 33.2% to $34 million. However, research & development (R&D) expenses were down 10.7% to $9.9 million during the period.
Optimer currently carries a Zacks Rank #4 (Sell). Meanwhile, Cubist Pharma carries a Zacks Rank #2 (Buy).
BIOA new IPO : BioAmber prices 8 mln unit IPO consisting of 1 share of common stock and 1 warrant to purchase half of one share of common stock at $10 per unit, at low end of revised $10-12 expected range (BIOA) : The IPO price was orignally expected to be between $15 and $17 per unit.
BioAmber prices 8 mln unit IPO consisting of 1 share of common stock and 1 warrant to purchase half of one share of common stock at $10 per unit, at low end of revised $10-12 expected range (BIOA) : The IPO price was orignally expected to be between $15 and $17 per unit.
GL!
starbuxsux;
interesting one!
Oclaro Debuts 1060 nm DFB Seed Laser $1.05
Distributed Feedback Seed Laser delivers highest peak power at picosecond pulses, enabling shorter pulse generation and efficient frequency conversion of fiber and solid state lasers
PR NewswirePress Release: Oclaro, Inc. – 7 hours ago
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OCLR 1.05 -0.31
SAN JOSE, Calif., May 8, 2013 /PRNewswire/ -- Oclaro, Inc. (OCLR), a tier-one provider and innovator of optical communications and laser solutions today unveiled a Distributed Feedback (DFB) 1060 nm laser diode module as the latest addition to its seed laser portfolio, designed for the seeding of sub-nanosecond fiber and solid state lasers. Oclaro will showcase the new DFB seed laser modules, high power lasers, visible and near lasers, and VCSEL technology at the LASER World of PHOTONICS conference, May 13-16, 2013, at the Messe Munchen Trade Fair Center in Munich, Germany. Visit Oclaro at Hall C1, Booth 370.
(Logo: http://photos.prnewswire.com/prnh/20130129/SF49903LOGO)
The innovative 10xx nm DFB laser diode module, featuring a single-mode laser diode with an on-chip distributed feedback grating delivers high peak power for sub-nanosecond and picosecond pulse operation. Capable of peak powers up to 800 mW for a pulse width as short as150 ps, and a spectral line-width well below 100 pm, the 10xx seed laser enables highly efficient pulse amplification and improved frequency conversions to green and UV wavelengths. It allows customers to easily extend their current nanosecond lasers to the picosecond regime. Operating with these short pulses improves the quality of material processing and mitigates the common SBS (Stimulated Brillouin Scattering) problem with pulse fiber lasers that occurs above 10 ns. In CW mode, the seed laser module delivers 200 mW of optical power with a 3dB line-width of 150 kHz and 50 dB side mode suppression ratio.
"The market for picosecond material processing is growing fast as these systems enable higher precision in micromachining by reducing the affected heat zone," said Gunnar Stolze, VP of Sales and Marketing for the Global Industrial and Consumer business at Oclaro, Inc.. "We are partnering with our customers to leverage the exceptional performance of this DFB seed laser to drive innovation in shorter pulse generation for these applications."
The DFB seed module features a standard telecom butterfly type package that includes a thermistor and back-facet monitor photodiode. Reliability of the DFB chip has been demonstrated with over 8,000 hours of multi-cell life-testing at accelerated operating conditions with zero failures.
About Oclaro
Oclaro, Inc. (OCLR) is one of the largest providers of lasers and optical components, modules and subsystems for the optical communications, industrial, and consumer laser markets.
stox sale @ $8:
nsys Therapeutics Announces Pricing of Initial Public Offering
MarketwiredPress Release: Insys Therapeutics, Inc. – 8 hours ago
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INSY 9.43 -7.57
PHOENIX, AZ--(Marketwired - May 2, 2013) - Insys Therapeutics, Inc. (NASDAQ: INSY), a specialty pharmaceutical company that develops and commercializes innovative supportive care products, today announced the pricing of its initial public offering of four million shares of its common stock at a price to the public of $8.00 per share. The shares of Insys' common stock will trade on the NASDAQ Global Market under the symbol "INSY." All of the shares of common stock are being offered by Insys. In addition, the company has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of common stock at the initial public offering price to cover over-allotments, if any.
Wells Fargo Securities, LLC and JMP Securities LLC are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as co-manager.
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.
A registration statement relating to the offering has been filed with, and declared effective by, the Securities and Exchange Commission. The offering is being made only by means of a final prospectus, which is part of the effective registration statement. Copies of the final prospectus, when available, may be obtained by contacting Wells Fargo Securities, LLC, 1525 West W.T. Harris Boulevard, NC0675, Charlotte, NC 28262, Attn: Capital Markets Client Support, telephone: 1-800-326-5897 or email: cmclientsupport@wellsfargo.com; or JMP Securities, Attn: Prospectus Department, 600 Montgomery Street, 10th Floor, San Francisco, CA 94111 (415-835-8985).
About Insys Therapeutics, Inc.
Insys Therapeutics, Inc. is a commercial-stage specialty pharmaceutical company that develops and commercializes innovative supportive care products, with a focus on utilizing its proprietary formulation technologies to address the clinical shortcomings of existing commercial pharmaceutical products. We have two marketed products including Subsys, a proprietary sublingual fentanyl spray for breakthrough pain in opioid-tolerant cancer patients. We market Subsys through our incentive-based, cost-efficient commercial organization of approximately 67 sales professionals. Our lead product candidate is Dronabinol Oral Solution, a proprietary orally administered liquid formulation of dronabinol, which would be our second branded supportive care product, if approved.
Contact:
Investor
Darryl S. Baker
Chief Financial Officer
Insys Therapeutics, Inc.
(602) 910-2617
Great decision! Kudos.
pre-split level $0.80
Cool!
Ebix enters into merger agreement to be acquired by an affiliate of Goldman Sachs (GS) for $20 per share in cash (EBIX) 19.50 +0.89 : Co announced that it has entered into a definitive merger agreement to be acquired by an affiliate of Goldman, Sachs & Co. (GS) in a transaction valued at approximately $820 million, including the assumption of any outstanding debt. Under the terms of the agreement, Ebix shareholders will receive $20.00 per share in cash. This represents a premium of approximately 18% over Ebix's average daily closing price over the preceding 30 days. The merger agreement contains a "go-shop" provision under which Ebix may solicit alternative proposals from third parties during the next 45 calendar days on customary terms and conditions for transactions of this nature. Ebix's special committee, with the assistance of its advisors, will actively solicit acquisition proposals during this period.
Tianyin Pharma construction of QLF has been completed in mid April as previously projected (TPI) 0.58 0.00 : The Company targets mid June 2013 for the GMP certification process initiation for the QLF TCM pre-extraction facility.
oppps! Kudos.
preliminary data from a Phase 2 clinical trial: $4.87=$0.71 pre-split level (1 for 6)
Agenus announces preliminary data from a Phase 2 clinical trial showed that newly diagnosed glioblastoma multiforme patients treated with Prophage G-100 vaccine plus the standard of care showed a 146% increase in progression free survival and a 60% increase in overall survival as compared to the standard of care alone (AGEN) 5.23 +0.37 : Co announced that preliminary data from a Phase 2 clinical trial showed that newly diagnosed glioblastoma multiforme (GBM) patients treated with Prophage G-100 (Heat Shock Protein-Peptide Complex-96, HSPPC-96) vaccine plus the standard of care showed a 146% increase in progression free survival and a 60% increase in overall survival as compared to the standard of care alone. Results were presented today by Orin Bloch, M.D., of the Department of Neurological Surgery, University of California San Francisco, during Plenary Session III at the 81st American Association of Neurological Surgeons Annual Scientific Meeting in New Orleans, Louisiana.
The single-arm, Phase 2 trial of HSPPC-96 in patients with newly diagnosed GBM included a total of 46 patients treated at eight centers across the United States. Patients were treated with radiation and temozolomide as the standard of care in addition to receiving HSPPC-96 vaccination. Analyses of data collected to date show a median PFS of 17 months; these results compare favorably to the PFS reported with the standard of care of radiation and temozolomide alone, which is 6.9 months. A total of 32 patients enrolled and treated at UCSF also underwent testing for expression of B7-H1 in blood samples taken prior to surgery. Glioblastoma has been shown to induce systemic immunosuppression through stimulation of B7-H1 expression, which could affect the efficacy of immunotherapy. These exploratory analyses showed that patients with low expression of B7-H1 (53%) had better PFS (21.6 months) than those with high B7-H1 (47%) expression (11.4 months). This finding may have the potential to help identify a more responsive patient population for future trials.
Ambac began trading on the NASDAQ today after emerging from bankruptcy (AMBC) 20.35 +1.74 : Co announced the effectiveness of its Second Modified Fifth Amended Plan of Reorganization, which marks the completion of its financial restructuring and Ambac's emergence from Chapter 11 bankruptcy protection.
Under the terms of the restructuring, all allowed claims of Ambac's former creditors were discharged and such creditors received new common stock, and in certain instances, new warrants, issued by the reorganized co. All common stock of the co in existence prior to Ambac's emergence from bankruptcy has been cancelled. Holders of such existing stock have not, and will not, receive distributions under the Plan.
Co traded on the OTC markets under ABKFQ since going into bankruptcy in 2010.
Can you form a board? I dont know anything about it.
tia
mlklr
12:47PM GW Pharma prices 3.5 mln share IPO at $8.90/ADS (GWPH)
MGIC 1st-Quarter Loss Widened Sharply; Shares Down: $5.10 today
Last update: 4/30/2013 8:45:05 AM
By Tess Stynes
MGIC Investment Corp.'s (MTG) first-quarter loss widened sharply as the struggling mortgage insurer posted far lower investment gains, contributing to a broader decline in revenue.
Shares were down 7.7% at $5.06 in premarket trading as the loss was wider than feared and revenue missed expectations.
MGIC Investment--the largest mortgage insurer for Fannie Mae (FNMA) and Freddie Mac (FMCC)-- has been plagued by billions in losses in recent years and is looking to keep selling coverage in several key states under a complicated plan that involves its new unit, MGIC Indemnity Corp.
Mortgage insurers cover potential lender losses on loan given to borrowers that make a less than 20% downpayment on home purchases.
MGIC Investment reported a loss of $72.9 million, or 31 cents a share, compared with a year-earlier loss of $19.6 million, or 10 cents a share. Realized gains were $1.3 million, compared with prior-year gains of $77.6 million.
Revenue decreased 29% to $269.2 million as investment income dropped 51% and net premiums earned fell 5.8%. Realized gains were a penny a share, compared with 38 cents a share a year earlier.
Analysts polled by Thomson Reuters most recently projected a loss of 14 cents a share on revenue of $279.5 million.
Net premiums written declined 2.5% to $248.5 million,
Write to Tess Stynes at tess.stynes@dowjones.com
MGIC 1st-Quarter Loss Widened Sharply; Shares Down: $5.10 today
Last update: 4/30/2013 8:45:05 AM
By Tess Stynes
MGIC Investment Corp.'s (MTG) first-quarter loss widened sharply as the struggling mortgage insurer posted far lower investment gains, contributing to a broader decline in revenue.
Shares were down 7.7% at $5.06 in premarket trading as the loss was wider than feared and revenue missed expectations.
MGIC Investment--the largest mortgage insurer for Fannie Mae (FNMA) and Freddie Mac (FMCC)-- has been plagued by billions in losses in recent years and is looking to keep selling coverage in several key states under a complicated plan that involves its new unit, MGIC Indemnity Corp.
Mortgage insurers cover potential lender losses on loan given to borrowers that make a less than 20% downpayment on home purchases.
MGIC Investment reported a loss of $72.9 million, or 31 cents a share, compared with a year-earlier loss of $19.6 million, or 10 cents a share. Realized gains were $1.3 million, compared with prior-year gains of $77.6 million.
Revenue decreased 29% to $269.2 million as investment income dropped 51% and net premiums earned fell 5.8%. Realized gains were a penny a share, compared with 38 cents a share a year earlier.
Analysts polled by Thomson Reuters most recently projected a loss of 14 cents a share on revenue of $279.5 million.
Net premiums written declined 2.5% to $248.5 million,
Write to Tess Stynes at tess.stynes@dowjones.com
Symbol Price Change
OGEN 3.4999 0.44
TAMPA, Fla.--(BUSINESS WIRE)--
Oragenics, Inc. (OGEN) (the “Company”) announced today that its common stock has been approved for listing on the NYSE Euronext's NYSE MKT. Trading is expected to commence on the NYSE MKT on Wednesday, April 10, 2013 under the ticker symbol ‘OGEN’.
“We are pleased to begin trading on NYSE MKT,” said John N. Bonfiglio PhD, President and CEO of Oragenics. “This listing marks an important step in our Company’s development by giving us greater access to a broader investor base and by providing increased transparency and liquidity for the financial community.”
“We welcome Oragenics, Inc. to the NYSE MKT family of listed companies,” Scott Cutler, Executive Vice President, Global Listings at NYSE Euronext. “Oragenics will be joining other growth oriented companies in the U.S. taking advantage of the NYSE’s advanced and innovative market model to offer a premier value for listing and trading their stocks.”
The listing approval is contingent on the Company continuing to meet all of the initial listing requirements on the day it is scheduled to commence trading.
About Oragenics, Inc.
Oragenics, Inc. is focused on becoming the world leader in novel antibiotics against infectious disease and probiotics for oral health for humans and pets. Oragenics, Inc. has established an exclusive worldwide channel collaboration for lantibiotics, a novel class of broad spectrum antibiotics, with Intrexon Corporation Inc., a synthetic biology company. The collaboration will allow Oragenics access to Intrexon's proprietary technologies with the idea of accelerating the development of much needed new antibiotics that will work against resistant strains of bacteria. Oragenics also develops, markets and sells proprietary probiotics specifically designed to enhance oral health for humans and pets, under the brand names Evora and ProBiora in over 13 countries worldwide.
Phizer's comments lift DRRX $1.56 and PTIE $4
Pain Therapeutics, Durect shares soar on Pfizer's Remoxy comments:
Pain Therapeutics, Durect shares soar on Pfizer's Remoxy comments
Mon, Apr 15 2013
Tue Apr 30, 2013 12:32pm EDT
(Reuters) - Shares of Pain Therapeutics Inc (PTIE.O) and Durect Corp (DRRX.O) rose more than 40 percent after partner Pfizer Inc (PFE.N) said it is in talks with U.S. health regulators to find a way forward on the companies' painkiller, Remoxy.
The U.S. Food and Drug Administration twice declined to approve Remoxy, an abuse-resistant painkiller, on concerns about the drug's chemistry and production process.
Pain Therapeutics and Durect shares crashed in November when Pfizer called Remoxy "a challenging asset," raising fears that the pharmaceutical giant would not pursue development of the drug.
Pfizer owns marketing rights to the drug, developed by Pain Therapeutics using Durect's technology.
On a post-earnings call on Tuesday, Pfizer said it had a "productive meeting" with the regulator in March.
"We've had discussions with the FDA and have a clear understanding of what we need to do to meet FDA requirements," Pfizer Chief Executive Ian Read told Reuters.
Read declined to specify what the agency wants, or how Pfizer will satisfy the agency's requirements -- including whether new studies or new analyses of completed studies have been requested.
He had told Reuters in November that the drug would be evaluated in three more trials to be completed by March 2013.
Durect shares rose 48 percent to $1.85 in early trading, but pared some gains to be up at $1.57 around midday. Pain Therapeutics shares jumped about 40 percent to touch a high of $4.60, before easing back a little to $4.00.
(Reporting by Ransdell Pierson in New York and Pallavi Ail in Bangalore; Editing by Sriraj Kalluvila)