Eli Lilly (LLY) and Incyte (INCY) announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib for moderate-to-severe rheumatoid arthritis (RA). The FDA letter indicated that additional clinical data are required to determine the most appropriate doses. The FDA also stated that additional data are necessary for further characterization of safety concerns across treatment arms. The timing …

Prohost Letter #406 A Special Prohost Issue SYNOPSIS REASONS FOR THE FOLLOWING PROHOST PICKS RALLIES VERTEX Vertex (VRTX): Great news about 2016 revenues & earnings Growth and pipeline. FROM YESTERDAY: Tremendous Revenues Growth. Cystic fibrosis (CF) revenues grew up around 75%. FOR TOMORROW:  Boosting  the  pipeline  value  by Advancing CF novel correctors into Phase 2 trials while Producing and advancing new CF correctors. PROJECTIONS: Continued …

At the Annual European Congress of Rheumatology (EULAR 2016) in London, Eli Lilly and Company (LLY) and Incyte (INCY) presented data from RA-BEYOND study, demonstrating that their drug baricitinib was superior to placebo at inhibiting progressive radiographic joint damage in patients with rheumatoid arthritis (RA). A key goal of rheumatoid arthritis treatment is to impede the structural damage that this disease usually causes to the …

The FDA advisory committee members’ inability to rule for or against the approval of Valeant (VRX) anti plaque psoriasis drug brodalumab was not unexpected. However, more outside observers were expecting the committee to flatly reject the skin disease drug that would subject people to commit suicide or to cardiovascular side effects, including death. Indeed, the discussions were mostly about the drug’s side effects specifically the …

Pfizer (PF) terminated its acquisition agreement with Allergan Plc (AGN) The new set of rules released by the U.S. Treasury Department to make it difficult for U.S. companies to conduct tax inversions contributed Pfizer’s decision. Analysts noted that the new regulations seem almost directly aimed at Pfizer-Allergan. In one of two major parts of the new rules, the U.S. government would not consider the assets acquired …

Prohost Letter #394 Part 1 Gilead - Some people sold Gilead’s (GILD) stock on Wednesday, March 23 after news announced on Tuesday that a jury decided that Gilead has infringed on two HCV molecules patents that Ionis (IONS), formerly Isis, and Merck had secured from their research. Ionis CEO said in a press release that his firm and Merck used their expertise during their collaboration in …

Incyte (INCY) and Eli Lilly (LLY): The New England Journal of Medicine published detailed results of RA-BEACON — a pivotal phase 3 global study of baricitinib, a once-daily oral treatment for moderate-to-severe rheumatoid arthritis (RA). The study met its primary endpoint of ACR 20 response for baricitinib compared with placebo at week 12. ACR 20 response rates were (P≤0.001 for each baricitinib dose versus placebo): 55 percent for baricitinib 4 mg; 49 percent …

The market looks like angry, probably very angry, as stocks are in a severe selloff mood. There will be many explanations like usual, but it is difficult for us to speculate this time over the correctness of the offered explanations, including the Iran Saudi Arabia crisis, which led to an increase in the oil price whose decrease has caused the previous market’s bad mood. Like …