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Posts Tagged ‘U.S. Securities and Exchange Commission’


Intravenous drug for the treatment of Acute Heart Failure (AHF) by Trevena, Inc. (Trevena) – Leader in the Discovery of G-protein coupled receptor (GPCR) biased ligands

Reporter: Aviva Lev-Ari, PhD, RN

Cardiovascular biotech Trevena files for a $86 million IPO

10/9/13

Trevena, a clinical-stage biotech developing a treatment for acute heart failure, filed on Wednesday with the SEC to raise up to $86 million in an initial public offering. The King of Prussia, PA-based company, which was founded in 2007 and booked $1 million in grant and collaboration revenue for the 12 months ended June 30, 2013, plans to list on the NASDAQ under the symbol TRVN. Trevena initially filed confidentially on September 6, 2013. Barclays and Jefferies are the joint bookrunners on the deal. No pricing terms were disclosed.

Keywords/Tickers: TRVN

Trevena (TRVN) Files $86.25M IPO

October 9, 2013 3:42 PM EDT   

Trevena, Inc. (Nasdaq: TRVN) filed a registration with the U.S. Securities and Exchange Commission for an Initial Public Offering of its Common Stock. The proposed maximum offering price is $86.25 million. The company plans to list on the NasdaqGlobal Market under the ticker, TRVN.The offering is being made via BarclaysJefferies, Canaccord Genuity, JMP Securities, and Needham & Company

Trevena a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs.

Heart Biotech Trevena, Inc. Files for a $86 Million IPO

10/10/2013 9:19:18 AM

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Trevena, Inc. (Nasdaq: TRVN) filed a registration with the U.S. Securities and Exchange Commission for an Initial Public Offering of its Common Stock. The proposed maximum offering price is $86.25 million. The company plans to list on the Nasdaq Global Market under the ticker, “TRVN.” The offering is being made via Barclays, Jefferies, Canaccord Genuity, JMP Securities, and Needham & Company.

http://www.biospace.com/news_story.aspx?NewsEntityId=311439&type=email&source=GP_101013

Journal of Clinical Pharmacology Publishes First Clinical Experience With Trevena, Inc.‘s Heart Failure Biased Ligand TRV027

7/8/2013 2:56:28 PM

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KING OF PRUSSIA, Pa., July 8, 2013 /PRNewswire/ — Trevena, Inc. (Trevena), a clinical stage pharmaceutical company and the leader in the discovery of G-protein coupled receptor (GPCR) biased ligands, today announced the electronic publication of Trevena’s manuscript, “First Clinical Experience with TRV027: Pharmacokinetics and Pharmacodynamics in Healthy Volunteers.” The manuscript can be viewed online at the Journal of Clinical Pharmacology’s website (http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1552-4604/ earlyview).

TRV027 is an experimental intravenous drug now in mid-stage clinical trials for the treatment of acute heart failure (AHF). The printed manuscript will appear in a future print issue of the journal. David G. Soergel, M.D., Trevena’s Senior Vice President of Clinical Development, Jonathan D. Violin, PhD, Director of Biology and Co-Founder of Trevena, and Michael W. Lark, PhD, Trevena’s Chief Scientific Officer and Senior Vice President of Research at Trevena, were among the publication’s authors.

The manuscript summarizes results from the first-in-human clinical study in which the compound was administered to healthy human subjects. In this study, the tolerability, pharmacokinetics and pharmacodynamics of multiple doses of TRV027 were explored. TRV027 was safe and well-tolerated, with a usefully short half-life and dose-proportional increases in systemic exposure. The compound showed a decrease in mean arterial pressure in subjects that had an elevation in their renin angiotensin aldosterone system, a common characteristic in AHF patients. TRV027’s activity, observed in the study, is consistent with its mechanism of action and previously published preclinical findings.

“In this phase 1 study, we successfully translated the unique activity profile of TRV027 from preclinical species into humans. These data supported our decision to progress TRV027 into Phase 2 studies in heart failure patients,” commented Dr. Soergel.

About TRV027 and AHF

TRV027 is a novel beta-arrestin biased ligand of the angiotensin II type 1 receptor (AT1R) that combines the proven benefits of angiotensin blockade with new beta-arrestin-mediated biology to preserve cardiac and renal function. TRV027 is being developed by Trevena under a recently announced collaborative licensing option agreement with Forest Laboratories Inc. For more details, please find a copy of the May 9, 2013 press release on the Trevena website, under the “News” tab (http://www.trevenainc.com/).

In March 2013, Trevena also presented the results of a Phase 2a study on the hemodynamic effects of TRV027 in patients with advanced systolic heart failure as a poster at the annual American College of Cardiology meeting. Completion of the ascending dose-titration Phase 2a study was announced in October 2012, in which the safety, tolerability, pharmacokinetics, and invasive hemodynamics of TRV027 (formally TRV120027) was measured (NCT01187836). The drug was generally well-tolerated and produced a beneficial set of hemodynamic effects in the study. A phase 2b clinical trial of TRV027 is expected to begin later this year.

The American Heart Association estimated that AHF hospitalization costs the U.S. healthcare system more than $20 billion each year in direct spending. AHF is already the leading reason for hospitalization of individuals over 65 years old in the United States, with over 1 million hospital admissions per year. AHF is also the most costly diagnosis for Medicare in the nation. Despite the significance of this problem, current therapies are not producing meaningful improvements in patient outcomes. AHF incidence is increasing globally, and both heart failure mortality and hospital re-admission following an AHF event remain extremely high.

About Trevena

Trevena, Inc. is dedicated to discovering and developing the next generation of GPCR targeted medicines. GPCRs are the targets for at least one-third of modern medicinal products, and remain the predominant class of targets under clinical evaluation. Trevena’s expertise lies in engineering “biased ligands” that activate only the beneficial signaling pathways downstream of a GPCR to unlock new biology and avoid drug adverse effects. In addition to TRV027, Trevena’s pipeline currently includes a clinical stage mu-opioid biased ligand for post-operative pain, and discovery-stage programs for chronic pain and Parkinson’s disease.

http://www.biospace.com/News/journal-of-clinical-pharmacology-publishes-first/302084

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Reporter: Aviva Lev-Ari, PhD, RN
Fluidigm Corporation (NASDAQ: FLDM) develops, manufactures and markets microfluidic systems for growth markets in the life science and agricultural biotechnology, or Ag-Bio, industries. Fluidigm’s proprietary microfluidic systems consist of instruments and consumables, including chips, assays and other reagents. These systems are designed to significantly simplify experimental workflow, increase throughput and reduce costs, while providing the excellent data quality demanded by customers. Fluidigm actively markets four microfluidic systems, including nine different commercial chips, to leading academic institutions, diagnostic laboratories, and pharmaceutical, biotechnology and Ag-Bio companies. Fluidigm products are marketed for research purposes only (not for diagnostic use).
Fluidigm Announces Exercise of Underwriters’ Over-Allotment Option and Closing of $60 million Public Offering of Common Stock

SOUTH SAN FRANCISCO, CALIFORNIA – August 21, 2012 – Fluidigm Corporation (NASDAQ: FLDM), a supplier of microfluidic systems for growth markets in the life science and agricultural biotechnology industries, today announced that it has closed the previously announced underwritten public offering of 4,209,000 shares of its common stock at a price to the public of $14.25 per share for gross proceeds of approximately $60 million. The shares include 549,000 shares of common stock sold pursuant to the over-allotment option granted by Fluidigm to the underwriters, which option was exercised in full. The net proceeds from the sale of the shares, after deducting the underwriters’ discounts and commissions and other estimated offering expenses payable by Fluidigm, will be approximately $56.1 million.
Fluidigm currently plans to use the net proceeds from this offering for research and development, commercialization of its products, working capital and other general corporate purposes.
Piper Jaffray & Co. and Cowen and Company, LLC acted as the joint book-running managers for the offering.  Leerink Swann LLC, Oppenheimer & Co. Inc. and Cantor Fitzgerald & Co. acted as the co-managers for the offering.

A shelf registration statement (File No. 333-180550) relating to these securities was filed on April 4, 2012, as amended on May 7, 2012, and declared effective by the Securities and Exchange Commission on May 10, 2012.  A final prospectus supplement and accompanying prospectus describing the terms of the offering was filed with the SEC on August 16, 2012.  Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402 or by telephone at 800-747-3924 or by email at prospectus@pjc.com, or from Cowen and Company, LLC (c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, Phone: 631-274-2806, Fax: 631-254-7140). An electronic copy of the prospectus supplement and accompanying prospectus relating to the offering is available on the website of the Securities and Exchange Commission at http://www.sec.gov/.
This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Fluidigm, and shall not constitute an offer, solicitation or sale of any security 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.

Forward-Looking Statements

In order to provide Fluidigm’s investors with an understanding of our current intentions and future prospects, this release may contain statements that are forward-looking.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include our expectations regarding the offering and the use of proceeds from such offering.
Forward-looking statements involve risks and uncertainties related to our business and the general economic environment, many beyond our control. These risks, uncertainties and other factors could cause our actual results to differ materially from those projected in forward-looking statements, including market risk and the risks we identify in reports filed with the SEC.
Although we believe that the forward-looking statements contained herein are reasonable, we can give no assurance that our expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of our risks and uncertainties, you are encouraged to review the official corporate documents filed with the SEC. Fluidigm does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

The C1™ Single-Cell Auto Prep System is a new approach to single-cell gene expression.

For the first time, extract, reverse transcribe, preamplify, and ultimately detect and analyze cell activity using just one technology:

  • Resolves individual cells 
  • Easy and intuitive 
  • Cell input to data in less than a day
  • Reduced technical noise for reliable results
  • qPCR profiling of gene expression

Applications

Learn about the advantages of Integrated Fluidic Circuits (IFCs) for your specific application.

Gene Expression
High throughput • Low cost • Compatibility with existing
reagents
a2.pngSingle-Cell Gene Expression
High sample throughput • More results faster • Assay
flexibility
a6.pngSNP Genotyping
Higher sample throughput • Outstanding data quality •
Dramatically lower costs
a5.pngTargeted Resequencing
Target enrichment • Sample barcoding for multiplexed
sequencing • Sequencing
library preparation using amplicon tagging
a1.pngSample Quantitation
Ability to amplify individual
molecules • Accurately and
reproducibly determine
library concentrations
a4.pngCopy Number Variation
High-resolution CNV studies using digital PCR •
Simple, fast, and reliable workflow • Standard
assays and reagents

Research Publications Featuring Fluidigm Products

Select from the Following Categories:

Gene Expression

Single-Cell Gene Expression

SNP Genotyping

Targeted Resequencing

Number Variation/Digital Quantification

Other

Gene Expression

 

Single-Cell Gene Expression

 

SNP Genotyping

 

Targeted Resequencing

 

Copy Number Variation/Digital Quantification/Digital PCR

Protein Crystallization

Products

Fluidigm develops and distributes life science systems based on our proprietary Integrated Fluidic Circuits (IFCs).  We currently offer the following complete systems and products:

b5.pngBioMark™ HD System
Reproducible results down to
a single cell • Fast PCR enabled •
Collect more data points per
day • Multiple reagents with different sample configurations
Granicus_Right_315.jpgC1™ System
Single-cell precision • Easy to use • Fast—cell input-to-data • All in one—comprehensive • Flexible—expandable
b3.pngAccess Array™ System
Target enrichment • Sample
barcoding for multiplexed
sequencing • Sequencing library prep using amplicon tagging
b4.pngEP1™ System
Accelerated workflow • Outstanding data Quality • Efficient high sample throughput SNP Genotyping
b2.pngDeltagene™ Assays
High quality—sensitivity and linearity
similar to probe-based assays •
MIQE* compliant—assay primer
sequences provided • Cost savings
—low startup and running costs
b6.pngChips & Kits
192.24 – 192 samples x 24
assays  • 48.48 – 48 samples x 48 assays • 96.96 – 96 samples x 96 assays
AA_TS_Primers_Image.jpgTarget-Specific Primers
Custom-designed primer sets •
multiplex capability allows up to 480 amplicons per sample • Amplicon tagging bypasses traditional library preparation
b1.pngSNPtype™ Assays 
Low start-up and running costs • Locus-specific primer sequences provided • Change targets on demand
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topazproduct.pngOther Products

 

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