Saturday, January 27, 2018

SAGE Therapeutics Market Capitalization in Charts - $183.47

Sage Therapeutics - (SAGE) has a CNS drug with a unique fast acting mechanism of action, that has led the company to a current $7.41 billion dollar market capitalization. Previous writing's  about the company can be found here SAGE. Below is a market capitalization chart of SAGE, at certain stock prices.
The current market capitalization of the company is around $7.41 billion. We see SAGE reaching a $10 billion market cap ($240.00) in the near future based solely on their current pipeline, potentially reaching a $15 billion market cap ($361.00) on further success for SAGE-217 in other indications, and potential buyout of the company. The patent for SAGE-217 and SAGE-547 run to 2034. Thank you for reading.

Contact: 586-431-8000

Saturday, January 20, 2018

MIN-101 Phase 3 Primary Endpoint - $6.80

Minerva Neurosciences (NERV) has officially begun dosing patients for their pivotal phase 3 clinical trial for the negative symptoms or Schizophrenia. Let's examine the primary endpoint in the phase 3 (Marder NSFS) and compare it with their successfully completed phase 2 primary endpoint PANSS Negative Scale (Pentagonal Structure 5-Factor) to see how the items vary. Below is the phase 2.

Phase 2   PANSS Negative Scale (Pentagonal Structure)            p = 32mg  64mg
N1            Blunted Affect                                                                               .25         .17
N2            Emotional Withdrawal                                                               .01         .02           
N3            Poor Rapport                                                                               .00         .00
N4            Passive/apathetic social withdraw                                          .29         .01
N6            Lack of spontaneity and flow of conversation                      .07          .01
G7            Motor retardation                                                                       .68         .04
G8            Uncooperativeness                                                                     .41          .86
G13          Disturbance of volition                                                              .25          .88
G14          Poor impulse control                                                                  .89         .56

Phase 2   5-Factor Negative Score
32mg p=0.021   effect size 0.45     64mg p=0.003  effect size 0.58

Below is the phase 3 Marder NSFS (negative symptom factor score) items that will be tested versus placebo.

Phase 2   Marder Negative Symptoms Factor Score (NSFS)       p = 32mg  64mg
N1             Blunted Affect                                                                             .25         .17
N2            Emotional Withdrawal                                                              .01         .02
N3            Poor Rapport                                                                               .00         00
N4            Passive/apathetic social withdraw                                          .29         .01
N6            Lack of spontaneity                                                                    .07         .01
G7            Motor retardation                                                                       .68         .04
G16          Active social avoidance                                                              .01         .00


Notice that the phase 2 design included G8, G13, and G14, which scored the lowest on effect for the phase 2 primary endpoint, but will not be included in the phase 3 Marder (NSFS) primary endpoint. The currently running phase 3 primary endpoint includes the same items as the phase 2, (minus G8, G13, G14) with the inclusion of G16 (active social avoidance) which scored a .01 and .00 respectively in the phase 2 clinical trial. The Marder items that were included in the phase 2, would have scored better in itself, than the phase 2 primary endpoint PANSS Negative Scale (Pentagonal Structure) 5-Factor Negative Score of p=0.021 and p=0.003, which was achieved with the 32mg and 64mg dose. Thank you for reading.
 
 
 

Saturday, January 13, 2018

Patent Board Does Not Institute PGR Proceeding

The press release is here Concert Pharmaceuticals Announces Patent Trial and Appeal Board Did Not Institute PGR Proceeding.  What this means to Concert Pharma is that, Incyte Corporation may be able at some point in time, challenge the patent of CTP-543. The second setback was that Concert has announced that they will not at this time initiate further clinical trials for other auto-immune indications that CTP-543 may have been useful for. The company continues to proceed with CTP-543 in their phase 2 clinical trial for patients with Alopecia Areata.  In addition the phase 3 clinical trial for AVP-786, which was scheduled to read out in July of 2018, has been pushed back to April of 2019, eliminating a potential catalyst for the company in 2018. The second half of 2019, which should reveal AVP-786's trial success, and phase 2 CTP-543 12mg arm effectiveness for Alopecia Areata patients, should be an important time for the company. Thank you for reading.