Aug. 13, 2014, 11:43 AM
Aug. 12, 2014, 4:05 PM
Jul. 16, 2014, 10:59 AM
- StemCells (STEM -1.4%) enters into a securities purchase agreement with two institutional biotech investors. It will sell up to 11,299,435 shares of its common stock and warrants to purchase up to 9,604,520 shares of common. Shares and warrants will be sold as a unit consisting of one share of common stock and one warrant to purchase 0.85 shares of common stock at an exercise price of $2.17 per share. Each unit will sell for $1.77. The warrants can be exercised six months from the date of issuance and will expire 13 months from the date of issuance.
- Net proceeds to the company will be ~19M.
Jul. 15, 2014, 12:45 PM
Jul. 15, 2014, 9:16 AM
Jul. 2, 2014, 12:56 PM
Jul. 2, 2014, 9:15 AM
Jun. 25, 2014, 12:47 PM
Jun. 19, 2014, 12:45 PM
Jun. 19, 2014, 9:58 AM
- Shares of StemCells (STEM +22.9%) jump on heavy volume in response to its announcement of positive interim results from the Phase 1/2 clinical trial of its HuCNS-SC human neural stem cell platform in dry age-related macular degeneration (AMD), albeit on a small group of seven patients.
- The platform showed a 65% reduction in the rate of geographic atrophy (GA) in the study eye compared to the expected natural history of the disease and a 70% reduction in the rate of GA compared to the control eye. GA is the progressive loss of two retinal tissue layers (photoreceptors and retinal pigmented epithelium) that cause vision loss in dry AMD.
- The company expects to initiate a Phase 2 proof-of-concept study later this year.
Jun. 19, 2014, 9:11 AM
May 29, 2014, 4:48 PM
- In a letter to shareholders, StemCells (STEM +4.3%) President and CEO Martin McGlynn says the interim data from the Phase 1/2 spinal cord injury trial is encouraging. Four of the eight severely-injured patients dosed to date have experienced a return of sensation, some as far as six segments below the injury level. The results surprised the experts and suggest a fundamental spinal cord regenerative process at work.
- Thirteen of sixteen patients have been enrolled in the Phase 1/2 dose-escalating trial in geographic atrophy of age-related macular degeneration. The study will evaluate the safety, tolerability and preliminary efficacy of a one-time transplant of the company's HuCNS-SC cells into the sub-retinal space in patients with the dry form of the disease. Interim results will be reported at the ISSCR meeting in Vancouver in June.
- An R&D day for investors is planned for the fall.
May 19, 2014, 9:13 AM
May 19, 2014, 8:50 AM
- StemCells (STEM) says that two additional patients have experienced "significant" gains in sensory function after receiving cell transplants using the company's HuCNS-SC (purified human neural stem cells) platform technology for spinal-cord injury. A third subject remained stable.
- Previously, two patients who had no mobility or sensory perception below the point of injury, experienced improvement in their symptoms. The patients in the latest results are less-severely injured.
- The subjects are being treated as part of a Phase I/II trial.
- StemCells said data on five new patients was provided at a conference, but the company doesn't seem to have supplied details about two of them in a press release.
- StemCells' shares are +10.1%. (PR)
- Previous coverage
May 14, 2014, 4:32 PM
Mar. 14, 2014, 1:40 PM
- Senators Barbara Boxer (D-CA) and Mark Kirk (R-IL) introduce legislation that will establish a national strategy to support regenerative medicine (RM) research.
- Among the requirements of the Regenerative Medicine Promotion Act are: a report by the GAO identifying all ongoing federal programs and activities pertaining to RM, the establishment of a Regenerative Medicine Coordinating Council and the maintenance of a national strategy for the promotion of RM R&D.
- Companies involved in the space include ONVO, HART, CUR, CYTX, STEM, ATHX.
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