Kein Beinbruch für Discovery Laboratories - 500 Beiträge pro Seite

[Biotechspezialx]

Am Gestrigen Freitag kam das kleine
Biotechnologie-Unternehmen Discovery Laboratories unter die Räder!
Nach einem schreiben der FDA einen so genannten "Approvable letter" der FDA zu dem Wirkstoff Surfaxin.

Dessen Inhalt des Schreibens ist derzeitig nicht bekannt ...dies kann eine kurze Verzögerung bis hin zu einer neuen Testphase enthalten! Da die FDA die Inspektion des Unternehmens Fertigungsanlagen in Totowa, New Jersey positiv abgeschlossen hat ...darf man wohl ausgehen das die Verzögerung es sich nur um eine kleine Sache handelt!

Der Kurs wurde wohl ein Paar Prozent zu tief nach unten geprügelt!

Der jetzige Kurs (D) Frankfurt ca. um 0,95-1,10 EUR bietet ein interessantes neues Spiel..........
Das Unternehmen verfügt im Übrigen noch über 50 Millionen $...Cash!

30-40 Cent sollten hier Erholungspotential zu holen sein.


Good Look allen Mitstreitern.......

[Biotechspezialx]

Meinungen aus demn Ami Board!

Re: Shorts covered Fri @ < 50% > Off Fire $ale 3-May-08 02:38 pm
I agree with your sentiment--the bottom line is that Surfaxin will be approved within 60 days--Liklihood of a partnership during that timeframe is great.


Sentiment : Strong Buy

2-May-08 11:21 pm
Hey, I'm not pumping this stock, I don't care if you buy it or not. If you own it now is not the time to sell. All I know is that I pick up a lot of shares at $1.34/share. The share price was $2.90 at close yesterday and it opened at approx 1.20 today. Yesterday I paid $2900.00 for a 1000 shares. Today when I bought, I got it for $1340/share. NOW THAT IS A BIG DIFFERENCE.
You have been here for 10 years and they haven't approved it yet. One thing for sure they are much closer to approval now and it is not the time to sell.
Take that with with a grain of salt, it is just my opinion. I've been in for 2 days now and I see an approval coming soon.


Sentiment : Strong Buy

2-May-08 11:00 pm
OK now that I have your attention read this.

YOU FIGURE IT OUT.

DSCO is way way to OVER SOLD.
Lot of STOP LIMIT ORDERS TAKEN OUT.
shorts will be COVERING SOON to protect profits.
DSCO will RESOLVE FDA questions.
FDA will approve DSCO request.
DSCO SHARES WILL JUMP TO THE $6.00 TO $8.00 AREA.
I WILL BE ONE HAPPY SOB.

remember: PANIC SELLING TODAY AND I WAS PANIC BUYING.


Da müssen wohl Bald einige teuer zurück kaufen....

[ipollit]

Antwort auf Beitrag Nr.: 34.020.941 von Biotechspezialx am 03.05.08 10:42:55

der wievielte "approvable letter" war das jetzt für Surfaxin? der vierte, fünfte, sechste??? natürlich mit jeweils nur einer "kleinen" Verzögerung (bis zum nächsten approvable letter). Achja... und ein Approvable Letter ist natürlich keine entgültige Ablehnung der FDA.

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 34.020.941 von Biotechspezialx am 03.05.08 10:42:55

und 50 Mio USD Cash... ohne das jetzt im Detail zu kennen, laut yahoo-Zahlen sieht es so aus, dass den 53 Mio USD Cash Ende 2007 15 Mio USD Schulden gegenüberstehen. Das war Ende letzten Jahres, jetzt ist schon wieder ein Drittel vom Jahr rum, so dass die 53 Mio USD wieder ein Teil abgeschmolzen sein dürften. Im letzten Quartal 2007 gab es einen Cashburn von 8,6 Mio USD. Laut Yahoo hat DSCO in den 3 Jahren von 2005 bis 2007 insgesamt 154 Mio USD Cash aufgenommen, wovon nach den 3 Jahren noch ca. 8 Mio USD übrig waren...

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 34.022.934 von Biotechspezialx am 04.05.08 09:21:12

Surfaxin is a synthetic lung substance for premature babies who are born with insufficient natural surfactant in their lungs and are prone to life-threatening diseases. Surfactant is a critical substance that helps breathing and prevents tiny air sacs in the lungs from collapsing. Treatments for this disorder are limited.

"Obviously, it is disappointing news for the company -- a third approvable letter," said Kimberly Lee, analyst at Pacific Growth Equities in San Francisco. "There definitely is a need" for the product in premature infants.

"It could be a quick fix, in which case the company could hear back from the FDA in 60 days," said Lee. "A second scenario is that there are deeper issues, which would take some time to resolve, and could take as long as six months."

Lee said Discovery has enough cash to last until the fourth quarter this year. Depending on the delay, however, "they might not have enough cash" to take the drug to market.

In April 2007, Discovery eliminated its commercial staff and laid off 30 sales and marketing employees out of 160 employees.

Management also announced last year plans to look for "strategic partners" to commercialize the drug because of the need for operating cash.

Shares were down to $1.45 at the end of Nasdaq trading yesterday, half of the previous day's closing price of $2.90.

[Biotechspezialx]

Antwort auf Beitrag Nr.: 34.023.507 von ipollit am 04.05.08 13:06:59

Discovery Labs Reports Fourth Quarter 2007 Financial Results
Warrington, PA — February 14, 2008 — Discovery Laboratories, Inc.

As of December 31, 2007, the Company had cash and marketable securities of $53.0 million and
approximately 5.2 million shares available for

Die Bestrafung erfolgt für einen Brief approvable letter deren Inhalt derzeit niemand kennt! kein Analyst Niemand!
Oder kennen Sie Ihn schon...............???


Die Analysten kriegen ja nicht mal ihre Zeitungsartikel richtig hin............Peinlicher geht es nicht mehr... richtige Kenner der Branche.........

CORRECT: Discovery Labs gets FDA approvable letter
NEW YORK (MarketWatch) -- Discovery Laboratories (DSCO:
discovery laboratories inc n com
News, chart, profile, more

1.45, -1.45, -50.0%) said Friday that it has received an approvable letter from the U.S. Food and Drug Administration for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome in premature infants. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. (Corrects headline to reflect that the company received an approvable letter, not an approval letter.)

[kalabrienfan]

Antwort auf Beitrag Nr.: 34.020.941 von Biotechspezialx am 03.05.08 10:42:55

Das ganze ist ein schlechter Witz. Die Argumentation von "ist ja nur eine zeitliche Verzögerung" hat mich damals zum Kauf bewogen.
Meine dsco-Aktien hab ich gedanklich schon abgeschrieben und nachkaufen werd ich auf gar keinen Fall, auch wenn es jetzt verlockend scheint. Abwarten, was genau in dem Letter steht. Ich hoffe natürlich auch, daß es nur eine Kleinigkeit ist, aber Vertrauen in die Firma hab ich nicht mehr. Und dabei bräuchten wir
das Präparat so dringend. Schade

[StaatsKnecht]

Ich denke auf diesem Kursniveau kann man sich ein paar ins Depot legen .
In 4 Monaten könnte die Zulassung erfolgen .

http://biz.yahoo.com/pz/080505/141879.html

Discovery Labs believes that the steps required to file a response to the Approvable Letter may be completed in the upcoming 6 to 8 weeks and the response may potentially be designated by the FDA as a Class 1 resubmission with a review target of 60 days, rather than the longer 6 month review target

[Biotechspezialx]

Antwort auf Beitrag Nr.: 34.020.941 von Biotechspezialx am 03.05.08 10:42:55

30-40 Cent sollten hier Erholungspotential zu holen sein


Denke das ich nicht zu viel versprochen habe...

War nett das als Zugabe ....

[Bombenleger]

FDA Tussle Leaves Discovery Labs Huffing
Lisa LaMotta, 05.05.08, 4:35 PM ET

Discovery Laboratories

Tear Sheet Chart News




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The FDA asked for more and Discovery Labs plans to oblige. Yet, analysts are mixed about whether they can get it done in time.

Discovery Laboratories is having a tug-of-war with the U.S. Food and Drug Administration over how much discovery the lab has to do when researching the affects of its respiratory drug for infants, causing the company's stock to swing wildly.

Shares of Discovery Laboratories (nasdaq: DSCO - news - people ) jumped 31.0%, or 45 cents, to $1.90 on Monday at the close of the market after falling 50.0% on Friday to close at $1.45.

This hot and cold behavior from investors began early last week with hopes that Surfaxin, a preventive medication for respiratory distress syndrome in premature infants, was going to be approved by the FDA. Investors quickly soured on the stock when Discovery received an Approvable Letter from the FDA on Friday stating the conditions in which Surfaxin could be approved and requesting more information about the drug.

Discovery said on Monday that the FDA does not require anymore clinical trials for the drug and that it will likely respond to the letter in the six to eight week period given. The company then hopes for approval of Surfaxin within 60 days of receipt of the response by the FDA.

The FDA has already approved labeling for the drug and gave a successful inspection of the company's manufacturing facility in Totowa, N.J., but some analysts believe that investors should still be weary.

"Given the company's troubling regulatory track record thus far, we bluntly don't believe it is prudent for investors to accept management's description of the remaining steps at face value, particularly in light of the fact that the company still needs to meet with the agency to clarify these issues," said Janney Montgomery Scott analyst Brian D. Rye.

On Friday, Discovery Labs said it requested a meeting with the FDA to clarify certain items in the letter pertaining to biological testing dealing with stability and release-time of the drug. The FDA asked that Discovery do some further explaining of two of the 21 physical and chemical drug product acceptance criteria that were proposed in its October 2007 complete response, as well as summaries of equipment-related qualification reports.

Jefferies analyst Adam Walsh said he views the company's timeline for approval as a best-case scenario and optimistic, but he reinstated his "buy" rating because he believes that the company will be able to comply with the FDAs demands in the coming six to eight weeks.

Brean Murray, Carret analyst Jonathan Aschoff agrees and told Forbes.com that he even thinks Discovery is being conservative in its timeline estimates. "The requests from the FDA seem minor enough; all they are looking for are tightening up of measures of acceptability," said Aschoff. "Yes, that makes it more difficult, but I think the product is already in those ranges."

[Bombenleger]

Securities Class Action Against Discovery Labs is Dismissed
Tuesday May 13, 4:52 pm ET


WARRINGTON, Pa., May 13, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGMSCO - News), a biotechnology company developing its proprietary Surfactant Replacement Therapies (SRT) to address respiratory conditions, announced today that, on April 29, 2008, the U.S. Court of Appeals for the Third Circuit affirmed the dismissal of the Second Consolidated Amended Complaint that was filed against the Company and two of its executive officers in November 2006. The Court's order is now final and this matter is now concluded.
ADVERTISEMENT


The Second Consolidated Amended Complaint, like the First Consolidated Amended Complaint that was dismissed without prejudice in November 2006, alleged violations of Section 10(b) of the Securities Exchange Act of 1934 (Exchange Act), Rule 10b-5 and Section 20(a) of the Exchange Act in connection with various public statements made by the Company. The United States District Court for the Eastern District of Pennsylvania dismissed the complaint on March 15, 2007. The District Court, in May 2007, also dismissed a related shareholder derivative action brought against the Company and several of its officers and directors. Plaintiffs in that proceeding did not file an appeal and that matter is also finally concluded.

Mary B. Templeton, Esq., Deputy General Counsel of Discovery Labs commented, ``Discovery Labs is committed to full and prompt disclosure of all material information about our Company and our efforts to develop our SRT portfolio. Our counsel in this matter, Pepper Hamilton, LP has represented us effectively and both the Third Circuit Court of Appeals and the District Court have recognized the quality of our disclosures and finally dismissed with prejudice this class action.''

About Discovery Labs

Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to advance respiratory medicine and address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.

Discovery Labs' lead product candidate, SURFAXIN (r), is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. SURFAXIN(r) is also being developed for other neonatal and pediatric indications. AEROSURF(tm), Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at http://www.Discoverylabs.com.

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, including, without limitation, the risks that: Discovery Labs may be unable to timely respond, if at all, to the recent approvable letter; Discovery Labs may not succeed in the FDA or other regulatory agency review process, including that such regulatory authority may not approve the marketing and sale of a drug product or may withhold, delay and/or limit marketing of a drug product by indication or impose other label limitations; Discovery Labs may not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT); changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval of drug products; Discovery Labs may be unable to profitably develop and market its products; Discovery Labs' significant, time-consuming and costly research and development activities, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any products may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs may be unable to successfully manufacture or provide adequate supplies of drug substances on a timely basis; Discovery Labs may be unable to transfer its manufacturing technology to third-party contract manufacturers or its contract manufacturers or any of its materials suppliers may encounter problems manufacturing drug products or drug substances on a timely basis or manufacture in amounts sufficient to meet demand; Discovery Labs and its collaborators may be unable to develop, manufacture and successfully commercialize products that combine Discovery Labs' drug products with innovative aerosolization technologies; Discovery Labs may be unable to maintain and protect the patents and licenses related to its SRT; other companies may develop competing therapies and/or technologies or health care reform may adversely affect Discovery Labs; and Discovery Labs may become involved in securities, product liability and other litigation. The foregoing risks and others are further 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.



Contact:
Discovery Laboratories, Inc.
Investor Relations
Lisa Caperelli
215-488-9413


--------------------------------------------------------------------------------
Source: Discovery Laboratories

[Bombenleger]

Hat jemand schon informationen?

Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in SURFAXIN Approvable Letter

es müßte ja heute zumindest irgenswas dazu kommen!

[Bombenleger]

Discovery Labs and FDA Meet to Clarify Limited Items in SURFAXIN Approvable Letter
Thursday June 19, 8:30 am ET


WARRINGTON, Pa., June 19, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGMSCO - News) held a teleconference on June 18, 2008 with the U.S. Food and Drug Administration (FDA) to discuss Discovery Labs' approach to addressing key remaining items identified in the May 1, 2008 Approvable Letter to potentially gain U.S. marketing approval of SURFAXIN(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Discovery Labs received clarification on its proposals and, although timeline assessment is continuing, believes that it could submit its formal response to the Approvable Letter in September 2008. Discovery Labs also believes that this response may be designated by the FDA as a Class 1 resubmission with a target review period of 60 days.
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On May 1, 2008, Discovery Labs received an Approvable Letter from the FDA for SURFAXIN. Prior to receiving the Approvable Letter, Discovery Labs had made notable progress towards gaining FDA approval of SURFAXIN, including agreeing with the FDA on the form of the SURFAXIN package insert and successfully concluding a pre-approval inspection of Discovery Labs' manufacturing operations. The Approvable Letter did not require any additional clinical trials to gain SURFAXIN approval.

On May 14, Discovery Labs submitted a pre-meeting information package to the FDA that outlined Discovery Labs' proposals for responding to select items identified in the Approvable Letter. The purpose of the meeting was to clarify and reach agreement with the FDA on the remaining steps necessary to achieve SURFAXIN approval, prior to filing a formal response to the Approvable Letter. Importantly, the meeting confirmed Discovery Labs' approach to finalizing SURFAXIN drug product specifications. With the exception of two items, Discovery Labs can prepare its responses using readily available data. The FDA has requested that Discovery Labs provide additional preclinical data and related information for two items.

One of the two items requires additional SURFAXIN biological activity test data. These additional data will be correlated with results of previously conducted preclinical studies and also will be used to justify the acceptance criteria for this biological activity test. The other item involves justifying the proposed specifications for certain lipid-related impurities in the individual active pharmaceutical ingredients (APIs) that comprise SURFAXIN. Discovery Labs' approach to justifying the levels of these lipid-related API impurities was based, in part, on their being present in the human lung at levels equal to or greater than that in SURFAXIN. The FDA has requested additional information about the levels of these lipid-related API impurities in the neonatal lung. Discovery Labs believes that it will be able to develop this information based on existing scientific literature. Discovery Labs presently anticipates completing the activities related to finalizing these two items in order to submit its formal response to the Approvable Letter in September 2008.

DISCLOSURE NOTICE: The information in this press release includes certain ``forward-looking'' statements relating to, among other things, the remaining steps necessary for FDA approval of Surfaxin for the prevention of RDS in premature infants, including information about the outcome of Discovery Labs' June 18, 2008 meeting with the FDA and Discovery Labs' plans and expected timing to respond to the May 1, 2008 Approvable Letter. Although Discovery Labs believes that it has made significant progress towards gaining approval of Surfaxin, gaining approval of Surfaxin involves ongoing activities, the final results of which could vary materially from Discovery Labs' expectations and the results obtained to date. Discovery Labs currently believes that it will succeed in gaining approval of its NDA for Surfaxin for the prevention of RDS in premature infants within the timeline outlined above; however, these activities and the ultimate outcomes are subject to a variety of risks, including but not limited to risks that (i) even if Discovery Labs is able to generate the additional data requested by the FDA and file its formal response to the Approvable letter within the timeline indicated above, the FDA may not be satisfied with the new data and may require Discovery Labs to perform further studies or undertake other activities that are presently not contemplated by Discovery Labs, (ii) Discovery Labs may not succeed in adequately addressing other items identified in the Approvable Letter and be unable to gain approval of SURFAXIN within the timeline indicated above, and (iii) Discovery Labs, in the process of preparing its response to the Approvable Letter, may identify unforeseen problems that have not yet been discovered. Any failure to provide information requested by the FDA or to adequately address the items raised in the Approvable Letter in Discovery Labs' formal response to the Approvable Letter could significantly delay, or preclude outright, gaining approval of SURFAXIN, which could potentially prevent the approval of Discovery Labs' other products.

About Discovery Labs

Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to advance respiratory medicine and address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.

SURFAXIN(r), the Company's lead product from its SRT pipeline, is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. SURFAXIN is also being developed for other neonatal and pediatric indications. AEROSURF(tm), Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at http://www.Discoverylabs.com.

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, including, without limitation, the risks that: Discovery Labs may be unable to timely respond, if at all, to the recent approvable letter for Surfaxin; Discovery Labs may not succeed in the FDA or other regulatory agency review process, including that such regulatory authority may not approve the marketing and sale of Surfaxin or any other drug product that Discovery Labs may develop, or such regulatory agency may further delay and/or limit marketing of Surfaxin or any of Discovery Labs' drug products by indication or impose other label limitations; Discovery Labs may not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT); changes in the national or international political and regulatory environment may make it more difficult for Discovery Labs to gain FDA or other regulatory approval of its products; Discovery Labs may be unable to profitably develop and market its products; Discovery Labs' significant, time-consuming and costly research and development activities, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any of its products may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs may be unable to successfully manufacture or provide adequate supplies of drug substances on a timely basis; Discovery Labs may be unable to transfer its manufacturing technology to third-party contract manufacturers or its contract manufacturers or any of its materials suppliers may encounter problems manufacturing drug products or drug substances on a timely basis or manufacture in amounts sufficient to meet demand; Discovery Labs and its collaborators may be unable to develop, manufacture and successfully commercialize products that combine Discovery Labs' drug products with innovative aerosolization technologies; Discovery Labs may be unable to maintain and protect the patents and licenses related to its SRT; other companies may develop competing therapies and/or technologies or health care reform may adversely affect Discovery Labs; and Discovery Labs may become involved in securities, product liability and other litigation. The foregoing risks and others are further 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.



Contact:
Discovery Laboratories, Inc.
Investor Relations
Lisa Caperelli
215-488-9413
John Cooper, EVP & CFO
215-488-9490


--------------------------------------------------------------------------------
Source: Discovery Laboratories

[Bombenleger]

Mich würde einmal Eure Meinung dazu interessieren.
Wenn ich das richtig sehe verzögert es sich noch um 2 Monate.

[Bombenleger]

Analysts: Discovery Labs sell-off overdone
Thursday June 19, 1:42 pm ET
Discovery Labs plummets in wake of Surfaxin delay, but analysts remain bullish on prospects


NEW YORK (AP) -- Analysts said Thursday investors are overreacting to news that Discovery Laboratories Inc. will delay its response to the Food and Drug Administration's request for information about the company's Surfaxin drug by three months.
ADVERTISEMENT


Last month, the FDA requested more information on Surfaxin, a respiratory distress syndrome drug for premature infants, delaying regulatory approval. Discovery Labs said then it would respond to the FDA in six to eight weeks, but announced earlier Thursday that it now won't be able to file the information with the agency until September.

Shares dropped 46 cents, or 21.3 percent, to $1.70 in afternoon trading on heavy volume.

Brean Murray, Carret analyst Jonathan Aschoff said the stock reaction is "overdone."

"In our opinion, the FDA meeting provides better clarity to the route as well as a clearer timing for the potential approval of Surfaxin," he wrote in a note to clients. "Although additional preclinical data and information are requested, we believe the issues are easy to address and the company should be able to prepare a complete response within three months."

Aschoff continues to deem Surfaxin worthy of approval and thinks Discovery could assemble a salesforce in as little as two or three months, which could allow initial Surfaxin sales as soon as the 2009 first quarter. He reiterated a "Buy" rating and $5 price target on shares.

Jefferies & Co.'s Adam Walsh said the delay is disappointing, but he still expects the drug to be approved by the end of the year. He also reaffirmed a "Buy" rating.

[Bombenleger]

24-Jun-2008

Other Events, Financial Statements and Exhibits



Item 8.01. Other Events.
On June 19, 2008, Discovery Laboratories, Inc. (the "Company") issued a press release announcing that it held a teleconference on June 18, 2008 with the U.S. Food and Drug Administration (FDA). The purpose of the teleconference was to discuss the Company's approach to addressing key remaining items identified in the May 1, 2008 Approvable Letter that the Company received from the FDA in connection with its New Drug Application (NDA) for Surfaxin� (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The Company indicated its belief that, with the exception of two items, the Company can prepare its formal response to the Approvable Letter using readily available data. To respond to the remaining two items, the FDA has requested that the Company provide additional preclinical data and related information. The Company believes that (a) the activities related to finalizing these two items can be completed in a timeframe that will enable it to file a formal response to the Approvable Letter in September 2008, and (b) the Company's formal response may potentially be designated by the FDA as a Class 1 resubmission with a target review period of 60 days. The press release, dated June 19, 2008, is filed as Exhibit 99.1 to this report and is incorporated herein by reference.

Although the Company believes that it will succeed in filing its formal response to the Approvable Letter and in gaining approval of its NDA for Surfaxin for the prevention of RDS in premature infants within the timeline outlined above, the activities involved and the ultimate outcome are subject to a variety of risks and uncertainties, including without limitation that (i) the Company may be unable to generate the additional data requested by the FDA and file its formal response to the Approvable Letter within the timeline indicated above, (ii) the FDA may not be satisfied with the new data and may require the Company to perform further studies or undertake other activities that the Company does not presently contemplate, (iii) the Company may not succeed in adequately addressing other items identified in the Approvable Letter that were not discussed during the teleconference and be unable to gain approval of Surfaxin, if at all, within the timeline indicated above, and (iv) the Company may in the future identify unforeseen problems that have not yet been discovered. Any failure to provide information requested by the FDA or to adequately address in the Company's formal response to the Approvable Letter the items raised in the Approvable Letter could significantly delay, or preclude outright, gaining approval of Surfaxin, which would have a material adverse effect on its business and could potentially prevent the approval of the Company's other products.





Item 9.01. Financial Statements and Exhibits.
(d) Exhibits

99.1 Press release dated June 19, 2008



--------------------------------------------------------------------------------

Cautionary Note Regarding Forward-looking Statements:

To the extent that statements in this Current Report on Form 8-K are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's product development or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this Current Report are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Such risks and others are further described in the Company's 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.

[Bombenleger]

Discovery Labs to Present At the Jefferies Healthcare Conference
Tuesday June 24, 4:00 pm ET


WARRINGTON, Pa., June 24, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGMSCO - News) announced today that Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery Labs, will present an update on the Company's recent progress at the Jefferies 2nd Annual Healthcare Conference to be held in New York. The conference will be simultaneously webcast over the Internet.
Dr. Capetola is scheduled to present at 11:15 a.m. E.T. on Thursday, June 26, 2008. The presentation will be available through a live audio webcast at http://www.wsw.com/webcast/jeff26/dsco or Discovery Labs' web site, http://www.discoverylabs.com. A replay of the audio webcast will be available on both websites for thirty days.

ADVERTISEMENT


About Discovery Labs

Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to advance respiratory medicine and address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.

SURFAXIN(r), the Company's lead product from its SRT pipeline, is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. SURFAXIN is also being developed for other neonatal and pediatric indications. AEROSURF, Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at http://www.Discoverylabs.com.



Contact:
Discovery Laboratories, Inc.
Lisa Caperelli, Investor Relations
215-488-9413


--------------------------------------------------------------------------------
Source: Discovery Laboratories