JUNO
Juno Therapeutics (JUNO), the CAR T developing firm that aims at revolutionizing cancer treatment has gotten the news we anticipated, but significantly faster than we expected.
Indeed, the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Phase 2 of the ROCKET clinical trial of its CAR T product JCAR015. The trial was conducted in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).
Under the revised protocol, the ROCKET trial with JCAR015 will continue enrollment. The only change will be that the pre-conditioning used will be only cyclophosphamidewithout any other additional chemotherapy.
During the trading hours the stock had gained $0.47 dollar. When the news about the FDA removing the hold was announced the stock added $7.11 in after hour trading.
Of course there will be some profit-taking before the stock stages its bigger rally.
Prohost Observations
Following the news about the hold we wrote: JUNO CAR T drug JCAR015, is not the culprit in the deaths that occurred are attributed to the addition of the chemotherapy drugfludarabine to the pre-conditioning regimen. Before the addition, the preconditioning consisted only of one chemotherapy – cyclophosphamide.
Indeed, there is nothing wrong with Juno’s CAR T product. The FDA was aware that the problem was caused by fludarabine. That’s why the agency did not take long to remove the hold, but did what Juno has asked for faster than anticipated.
The human robots who caused a selloff in the stock put undeserved money in negative investors’ pockets, while selling their own shares at a huge loss.
We congratulate those who did not give up to fear from the misleading way the headlines of the news about the ban were presented to them.
This is Great News.
– – – – – – – – – – – – – –
In Other NEWS
Why Sage Therapeutics Stock Rallied
Sage Therapeutics’ (SAGE) stock rallied after the announcement of positive top-line results from its Phase 2 clinical trial of its product SAGE-547 for the treatment of severe postpartum depression (PPD).
Sage therapeutics is a clinical-stage biopharmaceutical company developing treatments for life-altering central nervous system (CNS) disorders. The firm’s pipeline of investigational products targeting critical CNS receptor systems, GABA and NMDA. Sage’s lead program, SAGE-547, which has the good results in PPD, is also in Phase 3 clinical development for super-refractory status epilepticus, which is a rare and severe seizure disorder.
Sage’s pipeline has a promising potential comprising several products, including, in addition to SAGE-547 SAGE-217, SAGE-689 and SAGE-718, which deal with acute and chronic central nervous system (CNS) conditions.
Why investors Enthusiasm?
SAGE-547, the drug with the good news achieved the primary endpoint of a significant reduction in the depression scores, greater than 12 points difference from placebo,which is a statistically significant difference in treatment effect that began at 24 hours to be maintained at similar magnitude through to the 30-day follow-up.
The PPD-202 Phase 2, multi-center, placebo-controlled, double-blind, 1:1 randomizationdemonstrate that 7 of 10 of the SAGE-547 group and 2 of 11 in the placebo group were in remission at day 30.
On the safety profile, SAGE-547 was found to be generally well-tolerated with no serious adverse events reported during the treatment and the follow-up periods. Good news about safety is the fact that a greater number of adverse events were reported in the placebo arm than in the treatment arm of the trial.
Important to know also that there are no specific treatments approved for PPD. Therapeutic options in severe PPD are limited.
Samantha Meltzer-Brody, M.D., M.P.H., Associate Professor and Director of the UNC Perinatal Psychiatry Program of the UNC Center for Women’s Mood Disorders and primary investigator for the PPD-202 Trial said, “This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date. The rapid onset of action of this drug observed in the trial is unlike anything else available in the field to date. The data demonstrated the potential of the drug to provide relief from the debilitating symptoms of PPD, and to markedly decrease suffering in women who are severely affected.”
The results of this study replicate and extend the findings of the firm’s original, open-label probe study of PPD reported in the past. Given the consistent activity signals seen in both the open-label and placebo-controlled trials,
Sage intends to examine the development pathways for several of its other proprietary pipeline compounds into the treatment of a variety of psychiatric disorders, such as major depression, bipolar disorder and panic disorder.”
Secondary endpoints, including the Montgomery-Åsberg Depression Rating Scale (MADRS) also showed a similar pattern of significant difference at 24 hours and maintained to 30 days.
Presentation of more comprehensive data from the trial is expected at future medical meetings and in publications.
Sage initiated an expansion of this Phase 2 clinical program to determine optimal dosing of SAGE-547 in PPD. In addition, the company intends to move forward with a PPD program with its oral molecule SAGE-217. It will seek regulatory input to determine the appropriate pathways for developing both medications for this indication.
And much more…
The Treated Condition
Postpartum Depression is an affective disorder impacting women after childbirth. PPD may have devastating consequences for a women and their families, which may include depressed mood and/or loss of interest in the women’s newborns. Associated symptoms of depression exist, including loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem.
Women with severe PPD may be hospitalized to provide a safe and stable environment for recovery if they are severely ill or unable to function and care for themselves, and their newborn babies.
It is estimated that PPD affects 10%-15% of mothers. A subset of these are severe enough to require hospitalization.
Again we remind that there are no approved therapies for severe PPD and there is a high unmet medical need for improved pharmacological therapy in PPD.
Prohost Comments
SAGE-547 has an increased chance to be the first approved drug for post partum depression (PPD). The drug is also being developed as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE) and has reached Phase 3 in the global STATUS Trial.
We will deal with the other pipeline drugs in a future article. Today the focus is on the successful outcome of the trial using SAGE-547 for PPM
SAGE surged yesterday, closing at $46.21 Up over $12. today morning SAGE is up another $0.50.
Market Cap: $1.48 billion
52-week range: $26.28 – $77.48
The news is, indeed, positive
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
JUNO Surged After the FDA Removed the Clinical Hold of the ROCKET Trial. See Also: Why SAGE Surged
JUNO
Juno Therapeutics (JUNO), the CAR T developing firm that aims at revolutionizing cancer treatment has gotten the news we anticipated, but significantly faster than we expected.
Indeed, the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Phase 2 of the ROCKET clinical trial of its CAR T product JCAR015. The trial was conducted in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).
Under the revised protocol, the ROCKET trial with JCAR015 will continue enrollment. The only change will be that the pre-conditioning used will be only cyclophosphamidewithout any other additional chemotherapy.
During the trading hours the stock had gained $0.47 dollar. When the news about the FDA removing the hold was announced the stock added $7.11 in after hour trading.
Of course there will be some profit-taking before the stock stages its bigger rally.
Prohost Observations
Following the news about the hold we wrote: JUNO CAR T drug JCAR015, is not the culprit in the deaths that occurred are attributed to the addition of the chemotherapy drugfludarabine to the pre-conditioning regimen. Before the addition, the preconditioning consisted only of one chemotherapy – cyclophosphamide.
Indeed, there is nothing wrong with Juno’s CAR T product. The FDA was aware that the problem was caused by fludarabine. That’s why the agency did not take long to remove the hold, but did what Juno has asked for faster than anticipated.
The human robots who caused a selloff in the stock put undeserved money in negative investors’ pockets, while selling their own shares at a huge loss.
We congratulate those who did not give up to fear from the misleading way the headlines of the news about the ban were presented to them.
This is Great News.
– – – – – – – – – – – – – –
In Other NEWS
Why Sage Therapeutics Stock Rallied
Sage Therapeutics’ (SAGE) stock rallied after the announcement of positive top-line results from its Phase 2 clinical trial of its product SAGE-547 for the treatment of severe postpartum depression (PPD).
Sage therapeutics is a clinical-stage biopharmaceutical company developing treatments for life-altering central nervous system (CNS) disorders. The firm’s pipeline of investigational products targeting critical CNS receptor systems, GABA and NMDA. Sage’s lead program, SAGE-547, which has the good results in PPD, is also in Phase 3 clinical development for super-refractory status epilepticus, which is a rare and severe seizure disorder.
Sage’s pipeline has a promising potential comprising several products, including, in addition to SAGE-547 SAGE-217, SAGE-689 and SAGE-718, which deal with acute and chronic central nervous system (CNS) conditions.
Why investors Enthusiasm?
SAGE-547, the drug with the good news achieved the primary endpoint of a significant reduction in the depression scores, greater than 12 points difference from placebo,which is a statistically significant difference in treatment effect that began at 24 hours to be maintained at similar magnitude through to the 30-day follow-up.
The PPD-202 Phase 2, multi-center, placebo-controlled, double-blind, 1:1 randomizationdemonstrate that 7 of 10 of the SAGE-547 group and 2 of 11 in the placebo group were in remission at day 30.
On the safety profile, SAGE-547 was found to be generally well-tolerated with no serious adverse events reported during the treatment and the follow-up periods. Good news about safety is the fact that a greater number of adverse events were reported in the placebo arm than in the treatment arm of the trial.
Important to know also that there are no specific treatments approved for PPD. Therapeutic options in severe PPD are limited.
Samantha Meltzer-Brody, M.D., M.P.H., Associate Professor and Director of the UNC Perinatal Psychiatry Program of the UNC Center for Women’s Mood Disorders and primary investigator for the PPD-202 Trial said, “This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date. The rapid onset of action of this drug observed in the trial is unlike anything else available in the field to date. The data demonstrated the potential of the drug to provide relief from the debilitating symptoms of PPD, and to markedly decrease suffering in women who are severely affected.”
The results of this study replicate and extend the findings of the firm’s original, open-label probe study of PPD reported in the past. Given the consistent activity signals seen in both the open-label and placebo-controlled trials,
Sage intends to examine the development pathways for several of its other proprietary pipeline compounds into the treatment of a variety of psychiatric disorders, such as major depression, bipolar disorder and panic disorder.”
Secondary endpoints, including the Montgomery-Åsberg Depression Rating Scale (MADRS) also showed a similar pattern of significant difference at 24 hours and maintained to 30 days.
Presentation of more comprehensive data from the trial is expected at future medical meetings and in publications.
Sage initiated an expansion of this Phase 2 clinical program to determine optimal dosing of SAGE-547 in PPD. In addition, the company intends to move forward with a PPD program with its oral molecule SAGE-217. It will seek regulatory input to determine the appropriate pathways for developing both medications for this indication.
And much more…
The Treated Condition
Postpartum Depression is an affective disorder impacting women after childbirth. PPD may have devastating consequences for a women and their families, which may include depressed mood and/or loss of interest in the women’s newborns. Associated symptoms of depression exist, including loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem.
Women with severe PPD may be hospitalized to provide a safe and stable environment for recovery if they are severely ill or unable to function and care for themselves, and their newborn babies.
It is estimated that PPD affects 10%-15% of mothers. A subset of these are severe enough to require hospitalization.
Again we remind that there are no approved therapies for severe PPD and there is a high unmet medical need for improved pharmacological therapy in PPD.
Prohost Comments
SAGE-547 has an increased chance to be the first approved drug for post partum depression (PPD). The drug is also being developed as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE) and has reached Phase 3 in the global STATUS Trial.
We will deal with the other pipeline drugs in a future article. Today the focus is on the successful outcome of the trial using SAGE-547 for PPM
SAGE surged yesterday, closing at $46.21 Up over $12. today morning SAGE is up another $0.50.
Market Cap: $1.48 billion
52-week range: $26.28 – $77.48
The news is, indeed, positive
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
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