Friday, July 29, 2016

GLPG2222 and GLPG2451 for Cystic Fibrosis

Galapagos updated their cystic fibrosis program.  The significant news today, was that the company was expected to test potentiator GLPG2451 with corrector GLPG2222, from a press release on June 15th.  Today, they have not made up their mind in full whether they are going to do a combination with 2451 and 2222, as potential for part of a triple combination.  GLPG2451 phase 1, will have a slight delay with results in early 2017, from expected end of 2016.   Thank you for reading.                                             

Thursday, July 21, 2016

Ruxolitinib Five Year Safety and Efficacy

Below is a press release from Incyte Corporation with data that was presented at ASCO early June. 
- COMFORT-I data demonstrate that treatment with Jakafi resulted in a 31 percent reduction in the risk of death and sustained durable spleen volume reduction in patients with MF
- These five-year data support previously published findings for Jakafi

Tuesday, July 12, 2016

SAGE-547 for Postpartum Depression

Sage Therapeutics (SAGE) stock soared higher by 37% on the companies phase 2 data release, for the indication of severe Postpartum Depression or PPD.  SAGE-547 has a differentiated mechanism of action (moa), and clean safety profile.  From their press release today.  

"SAGE-547 achieved primary objective with a significant reduction in HAM-D total score compared to placebo at 60 hours (p=0.008).  Baseline mean HAM-D scores were severe (28.1 for SAGE-547; 28.8 for Placebo), SAGE-547 showed reduction in HAM-D of greater than 20 points at 60 hours.  Improvement was 12 points greater vs. placebo.  Improvement maintained through 30-day follow-up (p=0.01)."

Quick Facts:
Shares Out 32M
Market Cap:  $1.2b
Cash:  150m
Patent:  2034

These results in PPD, signal the potential for other CNS uses.  SAGE-547 works very rapidly, and maintained the results through the 30 day follow-up period.  Thank you for reading.
 

Thursday, July 7, 2016

AXS-05 A Novel Mechanism of Action

Axsome Therapeutics (AXSM) is a company working to bring drugs into the clinic, and through FDA approval for the indications of pain, and CNS disorders.  We are focusing on their unique mechanism of action CNS drug, AXS-05 at this time.  AXS-05 combines dextromethorphan (DM), and bupropion (BP), and is targeting the indications below. 
  • Treatment Resistant Depression Disorder:  phase 3 initiated NCT02741791.
  • Agitation in Alzheimer's disease phase 2/3 planned end of 2016.
Quick Facts:
Share Out:  19M
Market Cap:  135M
Cash:  44M
Patent:  2034

Like other drug development companies, Axsome has identified Dextromethorphan as a potential treatment for CNS disorders, and is using bupropion as an inhibitor, with potential increased efficacy affect.  I  expect the company to raise cash soon through a secondary offering, to fund future clinical trials.  Thank you for reading.