Discovery Laboratories Inc ...nach dem 1:15 R/S

Traders Gobbling Up Shares of Discovery Laboratories, Shares Up 6.9% (DSCO)

http://www.mysmartrend.com/news-briefs/...laboratories-shares-69-dsco

Discovery Labs Submits SURFAXIN® Complete Response to FDA

http://www.finanznachrichten.de/...n-complete-response-to-fda-008.htm

http://www.ariva.de/news/...l-2000-and-Russell-Global-Indexes-4147198

21:41 21.06.12

PR Newswire

WARRINGTON, Pa., June 21, 2012

WARRINGTON, Pa., June 21, 2012 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a biotechnology company dedicated to establishing a new standard in respiratory critical care, today announced that the company will be added to the Russell 2000® and Russell Global® Indexes when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes at the market close on June 22, 2012, this according to a preliminary list of new additions to the indexes from Russell.  Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies.  An industry-leading $3.9 trillion in institutional assets currently are benchmarked to them.  

"This year has marked a significant turning point for our company and inclusion in the Russell 2000 and Russell Global Indexes is a testament to the progress we continue to make," said W. Thomas Amick, Chief Executive Officer at Discovery Labs, "It is known that institutional investors rely on the Russell Indexes for true market representation and our inclusion in these indexes will help us gain more visibility with that important audience."

The Russell 2000 Index measures the performance of the small-cap segment of the U.S. equity universe. The Russell 2000 is a subset of the Russell 3000® Index representing approximately 10% of the total market capitalization of that index.  The Russell 2000 Index is constructed to provide a comprehensive and unbiased small-cap barometer and is completely reconstituted annually to ensure larger stocks do not distort the performance and characteristics of the true small-cap opportunity set. Membership in the Russell 2000 also means automatic inclusion in the appropriate growth and value style indexes.

The Russell Global Index measures the performance of the global equity market based on all investable equity securities.


...weiter siehe LINK  

 

Discovery Labs Receives $30 Million Funding Commitment from Deerfield Management22:05 13.02.13


PR Newswire

WARRINGTON, Pa., Feb. 13, 2013

WARRINGTON, Pa., Feb. 13, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that it has entered into a secured loan facility with Deerfield Management Company, L.P. (Deerfield) for up to $30.0 million in financing.  Deerfield is a leading healthcare investment firm with more than $3.5 billion of assets currently under management.  

"We are encouraged by Deerfield's confidence in the potential of our transformative technology and business strategy," commented John G. Cooper, President and Chief Executive Officer at Discovery Labs.  "After considering a variety of financing options, we worked with Deerfield to structure a facility that aligns with our near-and long-term strategy to achieve important commercial, development and strategic milestones."

"We believe that SURFAXIN® and AEROSURF® could represent meaningful improvements in the care of premature infants with respiratory distress syndrome," commented William Slattery, Partner at Deerfield Management.  "Our goal with this facility is to strengthen Discovery Labs' financial position in a minimally dilutive way, and build a long-term relationship that helps advance these important programs for neonatal medicine."

Under terms of the facility, Deerfield committed to advance $30 million in 2013: $10 million immediately following execution of the facility agreement and $20 million upon the first commercial sale of SURFAXIN.  The loan matures six years from the date of the facility agreement and may be prepaid in whole or in part without penalty at any time.  The principal amount of the loan is payable in three equal annual installments on the fourth, fifth and sixth anniversaries of the facility agreement, except that, if Discovery Labs achieves certain revenue or market capitalization targets, the principal payments due on the fourth and fifth anniversaries could be deferred for one year.  Accordingly, if the milestones are achieved, payment of the principal amount could be deferred until the maturity date of the loan in 2019.  The outstanding principal amount of the loan at any time will accrue interest at a rate of 8.75% per annum, payable quarterly in cash.  The facility agreement contains customary terms and conditions but does not require Discovery Labs to meet minimum financial and revenue performance covenants.  In connection with each advance, Deerfield will receive a transaction fee equal to 1.5% of the amount disbursed.  In connection with the initial advance, Deerfield will receive warrants to purchase 2.3 million shares of common stock, par value $.001 per share (Common Stock), at an exercise price of $2.81 per share, which represents a premium of 24% over the closing price of the Company's common stock preceding the execution of the facility agreement.  Upon disbursement of the $20 million advance, Deerfield will receive warrants to purchase an additional 4.7 million shares of Common Stock at the same exercise price per share of Common Stock.  All of the warrants will expire on the sixth anniversary date of the facility agreement.

Additional information about the facility and the terms of the related agreements is included in a Current Report on Form 8-K that is expected to be filed today with the Securities and Exchange Commission.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of the securities discussed herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any state.  

ABOUT DISCOVERY LABS

Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to advance a new standard in respiratory critical care.  Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant.  Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.  

Discovery Labs' strategy is initially focused on the development of its technologies to improve the management of respiratory distress syndrome (RDS) in premature infants.  SURFAXIN is the first synthetic, peptide-containing (KL4) surfactant approved by the FDA and the only alternative to animal-derived surfactants.  

AEROSURF is a drug/device combination product being developed to enable efficient delivery of aerosolized KL4 surfactant.  If approved, AEROSURF potentially will provide neonatologists with the ability to deliver surfactant therapy using a less-invasive method and thereby enable the treatment of premature infants who could benefit from surfactant therapy but who are currently not treated.  Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, to significantly expand the current worldwide RDS market.

For more information, please visit www.Discoverylabs.com.

ABOUT DEERFIELD

Deerfield is committed to advancing healthcare through investment, information and philanthropy.

For more information about Deerfield, please visit www.deerfield.com

IMPORTANT SAFETY INFORMATION

SURFAXIN (lucinactant) intratracheal suspension is intended for intratracheal use only.  The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance.  SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.

Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.  During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized.  SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).

For more information about SURFAXIN, please visit www.surfaxin.com

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including without limitation those related to the terms and conditions of the Deerfield agreements, including the security agreement, the warrants, the related registration rights agreement ("Transaction Documents"), Discovery Labs' ability to comply with the terms and conditions of the Transaction Documents, the anticipated U.S. commercial introduction of SURFAXIN, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.  Any forward-looking statement in this release speaks only as of the date on which it is made. The Company assumes no obligation to update or revise any forward-looking statements.

SOURCE Discovery Laboratories, Inc.


Quelle: PR Newswire  

Heute gehts wieder schön rauf!  

Mittel- bis langfristig klare Kaufkurse!  

Wird Zeit dass sich bald mal was tut!  

 

 

Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) Updated Product Specifications

Discovery labs (NASDAQ:DSCO)
Intraday Stock Chart
Heute : Freitag 4 Oktober 2013
WARRINGTON, Pa., Oct. 4, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the U.S. Food and Drug Administration (FDA) has agreed to the Company's updated product specifications for SURFAXIN® (lucinactant) Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.  The Company has initiated manufacturing of SURFAXIN for its planned commercial introduction in the fourth quarter of 2013.  SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of RDS in premature infants and the only approved alternative to animal-derived surfactants currently used today.
"We are pleased that the FDA has agreed with our updated product specifications and are appreciative of the process that has lead to this decision," said John G. Cooper, Chief Executive Officer of Discovery Labs. "SURFAXIN represents the first milestone in our goal of transforming the treatment of RDS and is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants for the prevention of RDS."
ABOUT SURFAXIN
The U.S. Food and Drug Administration (FDA) approved SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants who are at high risk for RDS.  SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants.
IMPORTANT SAFETY INFORMATION
SURFAXIN is intended for intratracheal use only.  The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance.  SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.  During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized.  
SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).
For more information about SURFAXIN, please visit www.surfaxin.com.
ABOUT DISCOVERY LABS
Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care.  Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant.  Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.  Discovery Labs' strategy is initially focused on neonatology and improving the management of respiratory distress syndrome (RDS) in premature infants.  Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, significantly expand the current worldwide RDS market.
For more information, please visit the Company's website at www.Discoverylabs.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties, including those related to Discovery Labs' plans to manufacture commercial lots of SURFAXIN and the timing of the commercial launch and market acceptance of SURFAXIN, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.  Any forward-looking statement in this release speaks only as of the date on which it is made.  The Company assumes no obligation to update or revise any forward-looking statements.
SOURCE Discovery Laboratories, Inc.

Copyright 2013 PR Newswire

 

Jetzt geht es aber ordentlich hoch... das sind mal locker 300% gegenüber dem Schlusskurs von Freitag.

UPDATE: Piper Jaffray Initiates Coverage on Discovery Laboratories on Emerging Respiratory Franchise at Breathtaking Value

Last update: 11/11/2013 9:05:32 am
In a report published Monday, Piper Jaffray analyst David Amsellem initiated coverage on Discovery Laboratories (NASDAQ: DSCO) with an Overweight rating and $6.00 price target.

In the report, Piper Jaffray noted, "We are initiating coverage of Discovery Labs with an Overweight rating and $6 price target. We believe that there is ample room for significant value creation, with DSCO now rolling out Surfaxin, a potentially best-in-class FDA-approved agent for the prevention of respiratory distress syndrome (RDS) in high-risk premature infants. With north of $100M in peak sales potential and a lean hospital-based U.S. sales organization focused on neonatologists, we believe DSCO can reach profitability on Surfaxin alone. That said, with the advancement of Aerosurf into Phase II, DSCO has a next-generation shot-on-goal in RDS that would target a far wider population of infants, translating into a transformative peak sales opportunity of north of $300M. With a market cap of under $170M in the context of two high-margin, novel, long-duration assets, we believe that the risk/reward for DSCO is compelling."

Discovery Laboratories closed on Friday at $2.01.  

Discovery Labs Announces U.S. Commercial Launch of SURFAXIN® (lucinactant)
By PR Newswire,  November 08, 2013, 08:00:00 AM EDT
Vote up


WARRINGTON, Pa., Nov. 8, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ:DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that it has initiated the U.S. commercial launch of SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.  SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant and the only alternative to animal-derived surfactants available in the U.S.

"The commercial launch of SURFAXIN marks a significant milestone for Discovery Labs, but more importantly represents a long-awaited therapeutic option for the neonatology community and the fragile premature infants in its care," said John G. Cooper, Chief Executive Officer of Discovery Labs.

Discovery Labs also announced today that, in accordance with the terms of its February 2013 $30 million secured loan facility with Deerfield Management Company, L.P. (Deerfield), it will be notifying Deerfield that it has now met the conditions to receive the final $20 million advance under the facility.  Upon receipt of the $20 million advance in early December 2013, the Company will issue warrants to Deerfield for approximately 4.7 million shares at an exercise price of $2.81 per share.

Read more: http://www.nasdaq.com/press-release/...t-20131108-00258#ixzz2kLhFuPer
 

Discovery Labs Receives FDA Clearance of IND to Initiate AEROSURF® Phase 2 Clinical Program

Discovery labs (NASDAQ:DSCO)
Intraday Stock Chart
Heute : Dienstag 12 November 2013
WARRINGTON, Pa., Nov. 12, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's investigational new drug (IND) application for AEROSURF® and the Company can initiate its phase 2 clinical program.  
The phase 2 clinical program is expected to include two studies.  The primary goal of the initial study, phase 2a, is to evaluate the safety and tolerability of a single exposure of aerosolized KL4 surfactant drug product.  This study is planned as an escalating dose study evaluating three dose levels of aerosolized KL4 surfactant.  The comparator is nCPAP alone.  The study will be conducted in three centers in the U.S. and is expected to be completed by mid-2014.  The design of the second study, phase 2b, will be informed by the results of the phase 2a study.  The primary objective of the phase 2b study will be to determine optimal dose and to estimate the efficacy margin. Results of the phase 2b study will inform the design of the phase 3 efficacy and safety study.  Phase 2b is expected to be conducted in multiple centers and completed by mid-2015.
About AEROSURF®
AEROSURF is a novel investigational drug-device combination product being developed to deliver Discovery Labs' KL4 surfactant in aerosolized form to premature infants with respiratory distress syndrome (RDS).  AEROSURF could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.
About Respiratory Distress Syndrome (RDS)
RDS is a condition in which premature infants are born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen.  Premature infants born prior to 37 weeks gestation have not fully developed their own natural lung surfactant and therefore need treatment to sustain life.  RDS is experienced in approximately half of the babies born between 26 and 32 weeks gestational age.  The incidence of RDS approaches 100 percent in babies born less than 26 weeks gestational age.  RDS can result in long-term respiratory problems and death.
Premature infants with RDS currently are treated with surfactants that can only be administered by endotracheal intubation supported with mechanical ventilation, both invasive procedures that may result in serious respiratory conditions and complications.  To avoid such adverse results, neonatologists generally provide surfactants as initial therapy only to premature infants with severe RDS where the potential benefits of surfactant therapy outweigh the risks associated with endotracheal intubation and mechanical ventilation.  For infants with less severe RDS, neonatologists will first attempt to provide respiratory support using a less invasive means, such as nasal continuous positive airway pressure (nCPAP).  Unfortunately, a significant number of these infants do not respond adequately to nCPAP, an outcome referred to as nCPAP failure, and require subsequent surfactant administration via intubation and mechanical ventilation.  As it is not possible to ascertain in advance which infants will experience nCPAP failure, neonatologists are faced with a dilemma, because the outcome for those infants who experience nCPAP failure and receive delayed surfactant therapy may not be as favorable as the outcome for those infants who receive surfactant therapy as initial therapy.
Discovery Labs estimates that, on an annual basis, approximately 160,000 premature infants in the U.S. could potentially benefit from early surfactant therapy to address surfactant deficiency or insufficiency.  However, only approximately 45,000 will receive surfactants as an initial therapy.  More than 70 percent of surfactant deficient infants (approximately 115,000) do not receive first-line surfactant therapy and instead receive nCPAP alone.
Discovery Labs believes that the neonatal medical community increasingly recognizes the potential of a synthetic, peptide-containing surfactant, such as SURFAXIN® and, importantly, a less-invasive method of delivering surfactant, such as AEROSURF, to treat premature infants at risk of suffering from respiratory disorders.  
About Discovery Labs
Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care.  Discovery Labs' technology platforms include a novel proprietary KL4 surfactant, a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant, and proprietary drug delivery technologies being developed to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.  Discovery Labs' strategy is initially focused on neonatology and improving the management of respiratory distress syndrome (RDS) in premature infants.  Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.
About SURFAXIN®
The U.S. Food and Drug Administration (FDA) approved SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants who are at high risk for RDS.  SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants.
IMPORTANT SAFETY INFORMATION
SURFAXIN is intended for intratracheal use only.  The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance.  SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting.  Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.  During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized.  SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).
For more information about SURFAXIN, please visit www.surfaxin.com.
Disclosure Note: The RDS population estimates and data included in the discussion above have been derived from the following sources, among others: IMS MIDAS data (MAT Sept 2008); CDC National Vital Statistics, 2005, Births by birth weight (CDC Website); "Annual Summary of Vital Statistics: 2006", Pediatrics, Martin et al.; Vermont Oxford Network (VON) data, 2006; UNICEF data, 2005 (website); and our primary market research (2010).  Discovery Labs' estimate of the number of premature infants that could potentially benefit from early surfactant therapy is derived from data from the foregoing sources, taking into account several factors, including without limitation, gestational age of premature infants, treatment rates for nCPAP, rates of nCPAP failure, and incidence of RDS.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties include those related to Discovery Labs' research and development activities generally and, in particular, Discovery Labs' AEROSURF development program, including, among other things, (i) time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or failure, and (ii) regulatory requirements relating to development and manufacture of the drug and aerosol delivery components of Discovery Labs' combination drug/device products, as well as those risks and uncertainties described in Discovery Labs' filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.  Any forward-looking statement in this release speaks only as of the date on which it is made.  Discovery Labs assumes no obligation to update or revise any forward-looking statements.

SOURCE Discovery Laboratories, Inc.

Copyright 2013 PR Newswire

 

demnächst eine stärkere Bewegung Richtung 3 Dollar an!  

 

Grund für den Absturz? Ist keiner mehr drinnen von Euch?  

zu dieser Firma?  

 

 

Studie soll diesen Monat enden. Nebenwirkungen sind nicht zu erwarten da Aerosurf nur eine aerosolierte Version einer bereits zugelassen Substanz ist.

Was die Effektivität anbetrifft: diesmal sind 2 Anwendungen zugelassen und schon eine Anwendung hat gute Resultate gezeigt(in den ersten 8 Stunden gab es keine Ausfälle (Corporate Presentation p.21), danach wurde warscheinlich die Substanz von der Lunge absorbiert/ausgeatmet, wiederholte Anwendung wird diese Zeitspanne wohl mehr als verdoppeln)