Farmas USA

CLSN

EPS por encima de expectativas -0,19 vs -0,26

OCAT

Resumen del artículo del Life-Sciences Report de Reni Benjamin , analista de Raymond James.

The early data seem to suggest that stem cells have the ability to manufacture not just one drug but multiple drugs, since the cells can pump out multiple proteins and growth factors at any given time. We continue to like the space because of its potential, but the harnessing of that potential has taken much longer than expected.

investment needs to pour into the field, which means fundraising and dilution for smaller companies.

But it also means partnering with larger companies willing to put in capital for a share of the smaller company. Investors need to realize that this is part and parcel of moving these novel therapeutic platforms forward. We think, eventually, regenerative medicine will be used to treat a wide variety of illnesses and do it differently than what's currently out in the market place. From a stock perspective, your readers should know that these regenerative medicine companies represent trading opportunities for the time being.

on Oct. 5 we launched on two cellular therapy companies. One is Ocata Therapeutics Inc. (OCAT:NASDAQ)

Here's a company that has really turned things around, gotten investors to put money in, and is initiating a new study in dry age-related macular degeneration (AMD) for its embryonic cellular therapy product, MA09-hRPE.
The preliminary data with Ocata's MA09-hRPE, used in about 30 patients, have shown that people with dry AMD who are on the way to blindness actually show improvement in visual acuity when they have had the subretinal injection/transplantation of these cells in their eyes.

The marketplace is huge. It's multiple billions of dollars bigger than wet AMD, where Regeneron Pharmaceuticals Inc.'s (REGN:NASDAQ) Eylea (aflibercept) is currently selling billions of dollars on an annual basis. We think the Ocata data look promising, and the company has some very interesting prospects going forward.

http://www.thelifesciencesreport.com/pub/na/raymond-james-analyst-reni-benjamin-regenerating-portfolios-with-cell-therapies-antibodies-and-small-molecules

TGTX

Resumen del artículo del Life-Sciences Report de Reni Benjamin, analista de Raymond James.

RB: TG Therapeutics Inc. (TGTX:NASDAQ) is an interesting name because it has both a PI3K delta inhibitor, TGR-1202, a small molecule that is orally bioavailable, as well as an anti-CD20 monoclonal antibody TG-1101 (ublituximab), both of which are for hematopoietic malignancies. These two targets already have approved drugs on the market and selling: An anti-CD20 called rituximab (Rituxan) developed by Genentech (a unit of Roche Holding AG [RHHBY:OTCQX]), and a PI3K inhibitor called idelalisib (Zydelig), developed by Gilead Sciences Inc. (GILD:NASDAQ).

"We continue to like the regenerative space because of its potential, but the harnessing of that potential has taken much longer than expected."

The PI3K space has gotten quite heated. In September 2014, Infinity Pharmaceuticals Inc. (INFI:NASDAQ) made a deal with AbbVie Inc. (ABBV:NYSE) for the rights to IPI-145 (duvelisib), a PI3K delta and gamma inhibitor, for an upfront payment of $275M and as much as another $530M in milestones. The regulatory bar has been cleared with idelalisib on the market, so the question is trying to find other PI3K delta and gamma inhibitors that are differentiated by efficacy or safety.

TLSR: How is TG Therapeutics differentiating itself?

RB: TG Therapeutics' two products differentiate themselves from the viewpoint of safety. There does not seem to be as much liver toxicity with TGR-1202 as with Gilead's idelalisib. It's in a Phase 3 trial now, and we think the study will bear this out. We expect the first data in Q4/16, and if we are right, TG Therapeutics won't be a standalone company for too much longer. If you are a Novartis AG (NVS:NYSE), for example, it makes sense to acquire a product that's already gone through the development and regulatory challenges instead of developing one on your own, like AbbVie is doing.

We think TG Therapeutics is an interesting and compelling opportunity. The company has a significant amount of cash to get through the next value-driving events, the most important being the final data from the ongoing Phase 3 study by the end of next year.

CLSN

Resumen de la situación según el informe trimestral

Phase II DIGNITY: Based on available data, every patient experienced a clinical benefit of their highly refractory disease with a local response rate of 69% observed in the 13 evaluable patients, including 5 complete responses, 4 partial responses and 4 patients with stable disease. Local tumor control in this population provides clinical benefit sufficient to warrant its designation as a primary endpoint for pivotal studies.

Phase III HEAT: the combination of ThermoDox® and optimized RFA provided a 58% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.63 (95% CI 0.43 - 0.93) with a p-value of 0.0198. Median overall survival for the ThermoDox® group has been reached which translates into a 25.4 month (2.1 year) survival benefit over the optimized RFA only group (79 months for the ThermoDox® plus optimized RFA group versus 53.6 months for the optimized RFA only group). An overall survival benefit greater than 60 months is widely recognized as curative.

Experts noted that ThermoDox may represent a treatment with curative potential if the subgroup findings from the HEAT Study are confirmed.

Protocol for the Phase III OPTIMA Study is expected to enroll up to 550 patients globally in up to 75 clinical sites in the United States, Europe, China and Asia Pacific.

In August, the Company and myTomorrows expanded the ThermoDox European Early Access Program to include patients with primary liver cancer and liver cancer metastases in all countries in the European Union territory, Switzerland, Turkey and Israel. The EAP provides physicians with access to products in later stage development demonstrating evidence of clinical benefit, with an acceptable safety profile and a quality manufacturing process in place. Celsion will be allowed to price ThermoDox at commercial rates.

Enrolled the First Patient in the OVATION Study in October 2015

Announced Confirmatory Preclinical Data for its GEN-1 IL-12 Immunotherapy in Combination with Avastin® and Doxil® for Ovarian Cancer in October 2015, for the treatment of platinum resistant ovarian cancer. The preclinical studies provide evidence of a robust and synergistic anti-cancer advantage compared to untreated animals and suggest a statistically significant improvement over the combination of Avastin® and Doxil®. These studies support an IND filing for a Phase I/II trial evaluating the combination in ovarian cancer later this year.

Ended the third quarter of 2015 with $24.4 million of total cash, investments and accrued interest on these investments

http://investor.celsion.com/secfiling.cfm?filingid=1437749-15-19688&CIK=749647

Update de  H. C. Wainwright

Promotion of ANCHOR May Give Early Peek at Market for REDUCE-IT

Estoy viendo a BLUE con un -14% y de las grandes CELG -3% en premarket y GILD -0,5% ,. Eso si, al igual que ayer, futuros USA +0,25%

ASH

Pues ya han sido liberados los abstracts. Ahí podéis buscar los que os interesen

https://ash.confex.com/ash/2015/webprogram/start.html

Amgen Raised to “Overweight” at Piper Jaffray (AMGN)

http://zolmax.com/investing/amgen-raised-to-overweight-at-piper-jaffray-amgn/278832/