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FDA Calendar Extreme Trades: 85 Single Digit Stocks
MNTA
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+14.06%
in
29 days
<> <> The <font> BioMedReports.com FDA Calendar database </font> includes over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. My FDA Calendar Extreme Trades article series highlights companies with market caps below $1 billion and / or single digit stock prices with pending catalysts in the form of FDA decisions, clinical trial res...
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Momenta Pharma: Timing Uncertain, Approval Likely for M-Enoxaparin
MNTA
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+0.85%
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7 days
(closed on 10/13/09)
Momenta Pharma (NASDAQ: MNTA) presented at the 2009 UBS Global Life Sciences Conference about two weeks ago and outlined several key developments for the Company, including an update on the FDA status for M-Enoxaparin. <o:p> </o:p> <o:p> </o:p> <> <> In late September, the Company raised net proceeds of approximately $46.7 million through a public offering of 4.6 million shares of common at $10.75 per share (compared to a current share price hovering around $9.50). Momenta provided guidance for ending the year with about $90-100 million in cash, providing adequate liquidi...
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BioMed News Bytes: Arena (NASDAQ: ARNA), Momenta (NASDAQ:MNTA), Vivus (NASDAQ: VVUS)
MNTA
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-18.08%
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18 days
(closed on 10/06/09)
<> On 9/18/09, Arena Pharma (NASDAQ: ARNA) ($5.32, +9%) (heavy, above-average volume) announced lorcaserin met all primary endpoints and FDA benchmark with 63% of patients who complied with the protocol losing at least 5% of their weight. ARNA plans to file a NDA with the FDA in December. However, patients who took lorcaserin 10 mg twice daily achieved an average weight loss of 5.9% of their body weight, compared to 2.8% for placebo, causing shares of ARNA to initially decline on the news (with a recent turnaround and uptick) based on concerns for the commercial prospects of lorcaserin compar...
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FDA Declines to Review Teva's Citizen Petition for Copaxone
MNTA
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+3.15%
in
160 days
(closed on 09/18/09)
Source: FDANews.com. The FDA has declined to review a citizen petition submitted by the neuroscience division of Teva Pharma (TEVA) asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment until certain conditions are met. The agency told Teva that it would be “premature and inappropriate” to review the Copaxone (glatiramer acetate) petition filed last September. In addition, the FDA didn’t address or take action on Teva’s requests in the petition, the company says in a statement. <> <> <>http://biomedreports.com/articles/la...
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BioMedReports.com Most Popular Links
MNTA
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-0.18%
in
2 days
(closed on 04/11/09)
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From the Blogosphere
Opinion: Pathway for FOBs Should Balance Need for Competition and Need for Innovation
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This story was written by James Bianco, M.D., prinicipal founder, CEO, and director of Cell Therapeutics (CTIC), which is a member of the ETF Innovators Emerging Bio-Pharma Index:
http://biomedreports.com/health-indexes.html
Related Article on Momenta Pharma (MNTA) by Mike Havrilla:
http://biomedreports.com/bloglist/599.html
President Obama's first budget calls for the creation of a regulatory pathway for the creation of follow-on, or biosmiliar, biologics. This is obviously now the most high-profile call yet to move forward with a system that will provide the benefit of biotech drugs to patien...
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Three Oversold Healthcare Catalyst Stocks
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With the S&P 500 SPDR ETF (SPY) trading about 8% below its 50-day moving average (DMA), I went in search of oversold healthcare stocks trading at least 16% below their 50 DMA which have potential catalysts within the next six months that may provide some very nice returns.
The Healthcare Sector SPDR (XLV) is trading about 12% below its 50 DMA amidst concerns of sweeping healthcare reform that would threaten the profits of health insurers, managed care companies, big pharma, and biotechs – although such concerns may be overblown given the failed attempts at large scale healthcare reform in < />< />< />< />< />< /><>< />< />< />< />< />< />< />< />< />< /><><><>< /><>< /><>< /><>< /><>< /><>< /><>< /><>< /><>< /><>< /><>< />< />...
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Biotech Competition Legislation Introduced
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NORTH WALES, Pa., March 11, 2009 /PRNewswire-USNewswire via COMTEX/ -- Teva Pharma (TEVA), the leading generic pharmaceutical company, today applauded the introduction of a landmark, bi-partisan bill that would bring safe and affordable generic biologics to all Americans.
Energy and Commerce Chairman Henry Waxman and Ranking Health Subcommittee Republican Nathan Deal, together with Representatives Frank Pallone and Jo Ann Emerson, introduced the Promoting Innovation and Access to Life Saving Medicines Act in the House of Representatives today following years of debate over the establishment ...
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Big Pharma Goes Generic
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Sanofi-Aventis (SNY) is now the 11th largest generic drug maker in the world following its successful acquisition of Czech generic drug company Zentiva. As $70B in brand drug patents are set to expire through 2012, big pharma companies are hedging their bets through generic drug divisions, including Pfizer (PFE) - Greenstone, Novartis (NVS) - Sandoz, and the recently announced Merck (MRK) BioVentures which will specialize in bio-generics.
Elsewhere in the industry, India-based Ranbaxy (RANBAXY.NS) lost about 20% of its market value today on word the FDA would not review new generic drug prod...
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Momenta Pharma's Three-Part Strategy
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Momenta Pharma (MNTA) is pursuing a three-part business model which includes complex generic equivalents in partnership with the Sandoz division of Novartis (NVS), proprietary compounds, and follow-on- biologics (FOB). <>
Momenta is partnered with Sandoz to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company is set to expire on 4/1/09 for Amphastar + partner Wat...
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