SureTrader Advertisement Advertisement Advertisement
Home > Boards > US Listed > Biotechs >

Discovery Laboratories Inc (DSCO)

Add DSCO Price Alert      Hide Sticky   Hide Intro
Moderator: No Moderator
Search This Board:
Last Post: 11/25/2015 9:47:08 AM - Followers: 117 - Board type: Free - Posts Today: 0

The Big Day is Coming!!!!!!!!!!

 The FDA classified the review of the Complete Response as a Class 2 review and established March 6, 2012 as the target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant marketing approval for SURFAXIN.


Discovery Laboratories, Inc., a biotechnology company, engages in developing surfactant therapies to treat respiratory disorders and diseases based on its KL4 surfactant and capillary aerosol-generating technologies. Its development stage products include Surfaxin, a synthetic, peptide-containing surfactant in phase III clinical trial for the prevention of respiratory distress syndrome in premature infants; Surfaxin LS, a Phase III trial product to improve ease of use for healthcare practitioners; and Aerosurf, an aerosolized KL4 surfactant that has completed first pilot Phase II clinical trial for the treatment of respiratory distress syndrome in premature infants.

The company has a license agreement with Philip Morris USA Inc. to use its capillary aerosolization technology for use with pulmonary surfactants for the respiratory diseases and conditions; and a strategic alliance agreement with Laboratorios del Dr. Esteve, S.A. for the development, marketing, and sale of a portfolio of potential KL4 surfactant products in Andorra, Greece, Italy, Portugal, and Spain.

Discovery Laboratories, Inc. was founded in 1992 and is headquartered in Warrington, Pennsylvania.


MUST READ!!!!!!!!!!!!!!!!!

  On May 11, 2011, the Company issued a press release highlighting the results of operations for the quarter ended March 31, 2011, and providing an update on its pipeline development as follows:
Surfaxin® (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants: The Company is conducting a comprehensive preclinical program to validate its optimized biological activity test (BAT), a key remaining issue that must be addressed to potentially gain U.S. Food and Drug Administration (FDA) marketing approval for Surfaxin in the United States.  The Company has had several interactions with the FDA intended to ensure that the comprehensive preclinical program would ultimately satisfy the FDA.  In January 2011, the Company announced that the FDA had provided guidance to increase the sample size of a specific data set by testing additional Surfaxin batches.  To comply with the FDA's suggestion, the Company has successfully manufactured eight Surfaxin batches and presently plans to manufacture two additional Surfaxin batches for use in the comprehensive preclinical program. The Company presently plans to complete all related analytical testing and concordance studies, and be in a position to file a Surfaxin Complete Response in the third quarter of 2011.
Surfaxin LSTM (lyophilized lucinactant) for neonatal RDS :  The Company continues to advance this program. Its plans for 2011 include establishing a commercial-scale manufacturing capability at a cGMP-compliant contract manufacturer with expertise in lyophilized formulations and seeking regulatory guidance from the FDA and the European Medicines Agency (EMA) for the planned clinical development program.
Aerosolization Technology :  Recently, at the 2011 Pediatric Academic Societies Annual Meeting (PAS), new data was presented including: (i) a collaborative study indicating that aerosolized KL4 surfactant significantly improved lung function and survival when treating Acute Lung Injury in a well established preclinical model of this severe respiratory condition, (ii) a dose-ranging assessment of aerosolized KL4 surfactant in a widely recognized preclinical model of RDS, demonstrating significant improvement in lung function, lung structural integrity and pulmonary inflammatory mediator profile following treatment with aerosolized KL4 surfactant versus controls, and (iii) a study highlighting the Company's novel patient interface technology intended to increase the efficiency of pulmonary aerosol drug delivery to patients requiring positive pressure ventilatory support.


Regarding the Company's lead aerosolized KL4 surfactant program, Aerosurf® (aerosolized lucinactant for neonatal RDS), data from the preclinical dose ranging assessment study presented at PAS mentioned above suggests that, out of several doses tested, KL4 surfactant delivered via the Company's proprietary capillary aerosol generator during a 20 to 30 minute dosing interval results in the most favorable physiologic outcomes.  This study provides guidance for future clinical dosing strategies for this program. The Company's plans for 2011 include finalizing the clinical and potential commercial design of the capillary aerosol generator, finalizing the clinical and potential commercial design for the novel patient interface, and seeking regulatory guidance in the U.S. and Europe for the planned development program.
For the quarter ending June 30, 2011, the Company projects cash outflow of $5.8 million.



Investor Relations Contacts

John G. Cooper
Executive Vice President, Chief Financial Officer
Discovery Laboratories, Inc.
2600 Kelly Road, Suite 100
Warrington, PA 18976
Tel. 215.488.9490
Fax. 215.488.9391


As of November 8, 2011, 24,499,497 shares of the registrant's common stock, par value $0.001 per share, were outstanding

As of  May 2, 2011, 24,178,502 shares of the registrant's common stock, par value $0.001 per share, were outstanding.  AutAeeeeee

Authorized 50 Mill

85 BM's 5-15-11




2010-11 Press Releases


May 13, 2011 10-Q 

May 13, 2011       A Brighter Decade Ahead for Biotech - Equity Research on Discovery Laboratories and Mylan Inc   

May 11, 2011 8k     

May 19, 2010
Discovery Labs Achieves Key Milestone Towards Potential Surfaxin® Approval

May 17, 2010
Discovery Labs' KL4 Surfactant Demonstrates Potential Protective Role for Lung Transplantation in Established Preclinical Model

May 14, 2010
Discovery Labs' Phase 2a Aerosurf® Study Published in Journal of Aerosol Medicine and Pulmonary Drug Delivery

May 5, 2010
Surfaxin LSTM Improves Pulmonary Function and Reduces Lung Inflammation in Established Model of Respiratory Distress Syndrome

April 28, 2010
Discovery Labs' KL4 Surfactant Data to be Presented at Pediatric Academic Societies Annual Meeting and American Thoracic Society International Conference

April 27, 2010
Discovery Labs Provides Updates on Surfaxin®, Other Key Programs and First Quarter 2010 Financial Results

March 10, 2010
Discovery Labs Reports Fourth Quarter 2009 Financial Results and Provides Business Update

February 23, 2010
Discovery Labs Announces Completion of $16.5 Million Public Offering

February 18, 2010
Discovery Labs Prices $16.5 Million Public Offering of Common Stock and Warrants

February 17, 2010
Discovery Labs Announces Proposed Public Offering of Common Stock and Warrants

February 16, 2010
Discovery Labs Receives FDA Guidance Regarding Pathway to Potential SURFAXIN® Approval

January 19, 2010
POPG, a Key Component of Discovery Labs KL4 Surfactant, Identified as a Novel Anti-Viral Therapeutic Approach


Management Team View Bio

W. Thomas Amick, Interim CEO

Russell Clayton, D.O.
Vice President, Academic and Medical Affairs, Acting Head, Regulatory Affairs and Preclinical Research

Kathryn Cole
Senior Vice President, Human Resources

John G. Cooper
Executive Vice President, Chief Financial Officer

David L. Lopez, C.P.A., Esq.
Executive Vice President, General Counsel

Charles F. Katzer
Senior Vice President, Manufacturing Operations

Thomas F. Miller, Ph.D., MBA
Senior Vice President, Commercialization & Corporate Development

Gerald J. Orehostky
Senior Vice President, Quality Operations

Robert Segal, M.D., F.A.C.P.
Senior Vice President, Medical & Scientific Affairs, Chief Medical Officer

Mary B. Templeton, Esq.
Senior Vice President, Deputy General Counsel


Do your own DD & trade smart

(DSCO) Pre-Market Trading     (DSCO) After Hours Trading

(DSCO) Short

Technical Indicators (Barchart) 

Yahoo! Finance (i.e Real-Time)

Last update: June 03,2010

  • 1D
  • 1M
  • 2M
  • 3M
  • 6M
  • 1Y
  • 2Y
  • 3Y
  • 5Y
Current Price
Bid Ask Day's Range
DSCO News: Statement of Ownership (sc 13g) 11/19/2015 11:03:01 AM
DSCO News: Current Report Filing (8-k) 11/12/2015 07:18:23 AM
DSCO News: Discovery Labs Announces Top Line Results of AEROSURF® Phase 2a Clinical Program in Premature Infants 29 to 34 Weeks Gestati... 11/12/2015 07:00:00 AM
DSCO News: Discovery Labs to Announce Results from AEROSURF® Phase 2a Expansion Clinical Trial 11/06/2015 08:30:00 AM
DSCO News: Current Report Filing (8-k) 11/05/2015 04:34:22 PM
#2869   Big bid, nice buys so far today, maybe Klinsmann 11/25/15 09:47:07 AM
#2868   needs 3 - 4x volume baussman23 11/24/15 01:19:35 PM
#2867   It looks set to explode any minute juancarlos 11/24/15 12:41:09 PM
#2866   Most everything he's been entering lately has been bell345 11/20/15 09:01:56 AM
#2865   Who is Sheff? Tony888 11/20/15 05:25:41 AM
#2864   Been following Sheff on these small penny bio's...he's bell345 11/20/15 02:44:47 AM
#2863   DSCO PDT BUYING TOMORROW @ OPEN ||_2OUTS_|| 11/19/15 10:10:52 PM
#2862   Because sheff bought it Dollar Bill 11/19/15 06:31:53 PM
#2861   So why did volume massively influx around 3:30 valeriana 11/19/15 05:26:50 PM
#2860   new 52 week Low!!! Yayyyyyyyyyyyyyyyyyyyyy what a POS baussman23 11/16/15 02:03:50 PM
#2859 [SMART MONEY] 11/13/15 01:07:20 PM
#2858   Agree. ash111 11/13/15 11:11:37 AM
#2857   It's all relative. The news wasn't as king oil 11/13/15 11:07:28 AM
#2856   My guess is everyone anticipated this being positive. dmsrz8 11/13/15 07:43:40 AM
#2855   The news was not bad why the huge drop? ash111 11/13/15 01:54:15 AM
#2854   L Oh rockman_1892 11/12/15 09:32:05 PM
#2853   * * $DSCO Video Chart 11-12-15 * * ClayTrader 11/12/15 05:20:02 PM
#2852   the company has been pulling this stunt all king oil 11/12/15 03:37:37 PM
#2851   Flatlining here now....too bad. dmsrz8 11/12/15 02:17:14 PM
#2850   Yeah for sure. Might check out some far CalderQuacks 11/12/15 10:49:15 AM
#2849   Oh definitely I agree this is good news valeriana 11/12/15 10:41:17 AM
#2848   It was good news but not great news. CalderQuacks 11/12/15 10:36:41 AM
#2847   Because the results were nothing important. It told valeriana 11/12/15 10:19:03 AM
#2846   34% discount. GMONEY4 11/12/15 10:02:23 AM
#2845   .28 WHAT THE !@#$ [SMART MONEY] 11/12/15 09:48:35 AM
#2844   YOUR FEARS CAME TRUE [SMART MONEY] 11/12/15 09:46:35 AM
#2842   Abu Dhabi, citys amazing CalderQuacks 11/12/15 08:28:29 AM
#2841   Wow wheres all the big towersss?? Roadtojourney 11/12/15 08:16:57 AM
#2840   Yeah. According to FinViz, only 1.77% of the CalderQuacks 11/11/15 06:27:28 PM
#2839   So we are hoping the escalated and increased valeriana 11/11/15 06:08:33 PM
#2838   I'm just worried about a "sell-the-news" event, like kld2 11/11/15 04:27:58 PM
#2837   I posted in an earlier post that if CalderQuacks 11/11/15 04:17:39 PM
#2836   Never said negative. dmsrz8 11/11/15 04:00:58 PM
#2835   Besides that, it's totally the opposite: if bad, kld2 11/11/15 03:49:03 PM
#2834   They probably didn't have the results compiled yet CalderQuacks 11/11/15 02:36:25 PM
#2833   Why wait for a week to present the dmsrz8 11/11/15 02:21:06 PM
#2832   You couldn't find this? CalderQuacks 11/11/15 01:09:30 PM
#2831   What are we waiting on for this week dmsrz8 11/11/15 12:21:52 PM
#2830   What comes out tomorrow/this week? dmsrz8 11/11/15 11:11:28 AM
#2829   Calderquacks is locked and loaded for Thursday! I CalderQuacks 11/10/15 03:42:11 PM
#2828   or perhaps news has leaked and it's not king oil 11/10/15 11:03:31 AM
#2827   Looks like last try to scare before it Roadtojourney 11/10/15 09:22:17 AM
#2826   HUGE NEWS WILL BE RELEASED THIS WEEK!!!!!!! baseballfan 11/08/15 12:28:31 PM
#2825   The waiting game (Release Nov. 12): Purchaser 11/07/15 03:44:04 AM
#2824   Reminds me a little of the "aerotyne? aerodyne?" richrichrich 11/06/15 03:40:03 PM
#2823   Disco broke res.nice waking ash111 11/06/15 01:02:16 PM
#2822   Why DSCO is moving: freshy 11/06/15 10:59:40 AM
#2821   DSCO duck!! freshy 11/06/15 10:38:13 AM
#2820   DSCO...looks interesting over here! freshy 11/06/15 10:32:27 AM