Geron’s (GERN) collaboration with Corning launches Synthemax™ surface, a novel synthetic surface supporting the growth and differentiation of stem cells and growing hESCs.
PSTI (3/2/10) received approval from an independent Data Safety Monitoring Board (DSMB) to advance its placenta-derived cell therapy product, PLX-PAD.
The FDA has granted Orphan Drug designation for Advanced Cell Technology‘s (ACTC.OB) MA09-hRPE cells for use in the treatment of Stargardt’s Macular Dystrophy (SMD). As a result, ACTC.OB is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of as long as 7 years.
Merck KGaA agreed to buy Millipore (MIL), a supplier of drug-development equipment for biotechnology companies for about $6 B in cash, beating a rival offer from Thermo Fisher Scientific. BTIM’s ACTCellerate™ progenitor cell lines and ESpan™ cell growth media sell through MIL. Merck KGaA will pay $107 a share and is a Germany based company. The offer is 13 % more than Millipore’s closing price on 2/26/10 and 50 % higher. Millipore, based in Billerica, Massachusetts, put itself up for sale after getting an unsolicited takeover bid worth less than $95 a share from Thermo Fisher (Bloomberg).
GERN reported a Q4/09 net loss of $18.4 M, or $0.20 a share based on higher operating expenses. FY09’s loss was $70.4 M, or $0.80 a share.
Programs to create a new center for the study of stem cells and to increase capacity to deal with global health issues were among 7 scientific initiatives announced 2/25/10 by NIH Director Francis S. Collins, MD, PhD. The 7 research programs are supported through the NIH Common Fund, which encourages collaborative research programs across the NIH institutes and centers (IC) to accomplish work that no single IC could do alone. Read more…
The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), 2/24/10 unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. The initiative involves 2 interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.
Osiris Therapeutics is a stem cell therapeutic company focused on developing products in the inflammatory, orthopedic and cardiovascular areas. OSIR’s Q4/09 results reported achievement and data showing Prochymal achieved a 63% response rate when used as a rescue agent in children with end-stage GvHD with significant improvement in response rates over standard of care for both liver and gastrointestinal steroid-refractory GvHD – the two most deadly and difficult-to-treat forms of the disease. Graft-versus-host disease (GvHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as “foreign” and mount an immunologic attack.
Aastrom reported results from interim analysis of the multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. According to the interim analysis the safety profile was similar between the treatment and placebo arms. Based on a composite efficacy endpoint assessing time to treatment failure (including major amputations, wound size and gangrene), ASTMD’s autologous vascular repair cells (VRCs) were more effective than placebo (P<0.05). Other clinically meaningful endpoints (e.g., major amputation rate, complete wound closure) approached but did not reach statistical significance at interim analysis.
BCLI.OB announced that it has entered into agreements with 3 investors with each investing $500 K for a total of investment of $1.5 M with issuance to each of 3 investors, 2 M shares of stock based on the 30 day average share price as of 2/11/10 of $0.25 per share and 1 M warrants with an exercise price of $0.50 per share for a total issuance of 6 M shares and 3 M warrants. Read more…
Founder and Director of Research, Henry McCusker enters his eighth (8) year at Scimitar Equity with past experience in sell-side analysis, buy-side management, corporate management and due diligence.