Sunday, January 10, 2010 10:59:12 PM
http://seekingalpha.com/article/180656-biotechs-2009-stealth-small-cap-rally
Gastrointestinal Disease: 3 Hits, 3 Misses
First, the good:
Both Salix Pharmaceuticals, Inc. (SLXP) and Santarus, Inc. (SNTS) appear in the list of top ten biotechnology gainers for 2009 with triple-digit returns due to favorable regulatory progress reported during the year [see Table 1]. In September, Salix announced the successful outcome of two Phase 3 trials to evaluate the efficacy and safety of Xifaxan® [rifaximin] for the treatment of non-constipation irritable bowel syndrome. Salix is planning an NDA submission for the first half of 2010. In December, Santarus announced that the FDA approved the company’s New Drug Application [NDA] for its prescription tablet product for all of the indications being sought, including for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease.
While not a member of either major biotechnology index, shares of Soligenix, Inc. (SNGX.OB) increased 317% during 2009. In January, the company reached agreement with the FDA on the design of a confirmatory, pivotal Phase 3 clinical trial evaluating its lead product orBec® for the treatment of acute gastrointestinal Graft-versus-Host Disease [GVHD]. The following month, Soligenix announced a potential $30 million North American partnership agreement with Sigma-Tau Pharmaceuticals for orBec and in October 2009 initiated patient enrollment in the confirmatory Phase 3 trial that is expected to complete with clinical data available in the first half of 2011.
Next, the bad:
As discussed in our December 2009 article “Graft Versus Host Disease: Failures and Future Opportunities,” Osiris Therapeutics, Inc. (OSIR) recently reported preliminary results from two Phase 3 trials evaluating its Prochymal product candidate for the treatment of acute GVHD. Unfortunately, neither trial reached its primary endpoint, sending shares from $14 to a 52-week low of $5.35 by November 2009, earning the company a spot in the top ten decliners for the year [see Table 2].
Recent SNGX News
- Soligenix Announces Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma • PR Newswire (US) • 06/25/2024 11:30:00 AM
- A Comparison of Vaccine Technologies to be Presented at the ASM Microbe Conference • PR Newswire (US) • 06/14/2024 11:30:00 AM
- Setting the Stage for Success: PRISM MarketView Highlights Soligenix's Promising HyBryte™ Replication Trial • GlobeNewswire Inc. • 06/05/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 12:00:25 PM
- Soligenix Announces Reverse Stock Split • PR Newswire (US) • 05/31/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/29/2024 08:05:07 PM
- Soligenix Encourages Stockholders to Vote their Shares at the Annual Meeting • PR Newswire (US) • 05/29/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/28/2024 08:08:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/24/2024 08:05:27 PM
- Soligenix, Inc. Announces Adjournment of Annual Meeting, Information for Reconvened Annual Meeting • PR Newswire (US) • 05/24/2024 11:30:00 AM
- Soligenix Encourages Stockholders to Vote "FOR" Reverse Stock Split • PR Newswire (US) • 05/23/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/22/2024 08:05:06 PM
- PRISM MarketView Highlights Soligenix, Inc. as it Builds on Compelling Phase 3 Data with Key Catalysts on the Horizon • GlobeNewswire Inc. • 05/21/2024 04:35:16 PM
- SuVax™ and MarVax™ Thermostable Vaccine Platform to be Presented at the Vaccine Technology IX Conference • PR Newswire (US) • 05/21/2024 11:30:00 AM
- Soligenix Encourages Stockholders to Vote Prior to Annual Meeting • PR Newswire (US) • 05/20/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/17/2024 08:25:40 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/17/2024 08:09:20 PM
- Positive Clinical Results from HyBryte™ Compatibility Study in the Treatment of Cutaneous T-Cell Lymphoma Published in JEADV Clinical Practice • PR Newswire (US) • 05/16/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/15/2024 08:05:38 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/10/2024 08:16:03 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 08:05:50 PM
- Soligenix Announces Recent Accomplishments And First Quarter 2024 Financial Results • PR Newswire (US) • 05/10/2024 11:30:00 AM
- Soligenix to Present at Upcoming Conferences • PR Newswire (US) • 05/06/2024 11:30:00 AM
- Soligenix Extends Patent Protection for its Filovirus Vaccine Platform to the United Kingdom and South Africa • PR Newswire (US) • 04/25/2024 11:30:00 AM
- Soligenix Announces Pricing of $4.75 Million Public Offering • PR Newswire (US) • 04/18/2024 12:30:00 PM
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