Merck & Co., Inc. (MRK)
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1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
- Median Overall Survival not reached at a median follow-up of 43.1 weeks -
2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
https://www.mskcc.org/cancer-care/clinical-trials/17-654
3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.
4. $MRK Partnership / potential Upfront Money
5. $BMY Partnerhip / potential upfront Money
6. 3D Med Trial Initiation (s)
7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
Gps MRD+ Post ACST Trial Planned
8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.
GPS Phase 3 is a Registrational trial - meaning the parameters are pre approved by the fda - if their is a positive read at The Midpoint interim - and its powered to do so - the fda approval could happen in as little as 3 months from now along with a $100 share price.
Ceo stated Fda review Q1Q2 Multibillion dollar Phase 3 Fda Review and Triple digits Just about 3 months out NOW - Shares are cheap. The primary endpoint of the REGAL study is overall survival, and the study's powered at 90%, with assumptions of a median overall survival of only 10 months inthe GPS arm, versus 5.4 months in the best available treatment arm.
To declare statistical significance, i.e., a positive study for efficacy, one would need either a hazard ratio of less than 0.6 at interim analysis, or a hazard ratio of less than 0.675 at final analysis. ( <-- Approval at Interim)
Interim analysis will consist of one single readout for efficacy by the independent data monitoring committee after the first 80 deaths. Both the independent data monitoring committee and the study steering committee have been established and consist of internationally renowned leukemia and biostatistical experts, including Dr. Tom Fleming, the global principle investigator; Dr. Hagop #$%$arjian, Chief of the Leukemia Department at the MD Anderson Cancer Center, and the world renowned clinical trialist in AML responsible for the successful delivery of several agents currently FDA approved for this malignancy.
1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
- Median Overall Survival not reached at a median follow-up of 43.1 weeks -
2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
https://www.mskcc.org/cancer-care/clinical-trials/17-654
3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.
4. $MRK Partnership / potential Upfront Money
5. $BMY Partnerhip / potential upfront Money
6. 3D Med Trial Initiation (s)
7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
Gps MRD+ Post ACST Trial Planned
8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.
GPS Phase 3 is a Registrational trial - meaning the parameters are pre approved by the fda - if their is a positive read at The Midpoint interim - and its powered to do so - the fda approval could happen in as little as 3 months from now along with a $100 share price.
Ceo stated Fda review Q1Q2 Multibillion dollar Phase 3 Fda Review and Triple digits Just about 3 months out NOW - Shares are cheap. The primary endpoint of the REGAL study is overall survival, and the study's powered at 90%, with assumptions of a median overall survival of only 10 months inthe GPS arm, versus 5.4 months in the best available treatment arm.
To declare statistical significance, i.e., a positive study for efficacy, one would need either a hazard ratio of less than 0.6 at interim analysis, or a hazard ratio of less than 0.675 at final analysis. ( <-- Approval at Interim)
Interim analysis will consist of one single readout for efficacy by the independent data monitoring committee after the first 80 deaths. Both the independent data monitoring committee and the study steering committee have been established and consist of internationally renowned leukemia and biostatistical experts, including Dr. Tom Fleming, the global principle investigator; Dr. Hagop #$%$arjian, Chief of the Leukemia Department at the MD Anderson Cancer Center, and the world renowned clinical trialist in AML responsible for the successful delivery of several agents currently FDA approved for this malignancy.
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in JUST a PHASE 1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
- Median Overall Survival not reached at a median follow-up of 43.1 weeks - for Plat Refractory Ovarian cancer patients,
1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.
Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,
GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
This Phase 2 data will be world wide as a potential new therapy offering hope for these dying patients.
Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.
The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
Anyone interested can find the List of Press Releases Here
- Median Overall Survival not reached at a median follow-up of 43.1 weeks -
2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
https://www.mskcc.org/cancer-care/clinical-trials/17-654
3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.
4. $MRK Partnership / potential Upfront Money
5. $BMY Partnerhip / potential upfront Money
6. 3D Med Trial Initiation (s)
7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
Gps MRD+ Post ACST Trial Planned
8. GFH009 Preliminary Trial Result / ( before the
1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
- Median Overall Survival not reached at a median follow-up of 43.1 weeks -
2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
https://www.mskcc.org/cancer-care/clinical-trials/17-654
3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.
4. $MRK Partnership / potential Upfront Money
5. $BMY Partnerhip / potential upfront Money
6. 3D Med Trial Initiation (s)
7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
Gps MRD+ Post ACST Trial Planned
8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.
Jazz paid $1.5B for CPXX right when it Released P3 data - Note the EXACT SAME REV PROJECTIONS as GPS
-->WSJ Article " Celator previously projected sales between $200 million and $270 million in the U.S. and European markets; although sales could top out between $690 million and $780 million if Vyxeos is approved to treat AML patient populations outside of the subset used in the Phase-3 study."
This is the Cantor Fitz Rev Projection from last year - Virtually Identical to the CPxx Est.
Even in the initial niche target population of AML patients after second complete remission, “we project the peak sales to be about $200-million
Note: CPXX's drug vyxeos Treats the Same Secondary AML patients, there have been no new therapies Since. Jazz Bought Cpxx RIGHT when it Released its P3 data/ SLS is undervalued by a ton.
Fully Funded ready to run - Gps symposium re Commercialization - Expectations
- Compounded Evidence of EFFICACY - For funds who have determined approval is likely, a Definitive scope of market with drug pricing will cause additional serious investment. $200M - 800M in annual rev is worth billions. - The 10Q update, that the Phase 3 timeline is on track, set the clock ticking for New and Accumulating Institutional investors.
- More $$ Paying attention and getting more interested, fullest definition of the term 'interested' applies.
- CCo
- EAP - Gps investigators, the Chair of MD Anderson, sees 34 month old open label trial and has requested expanded access to Gps for ASCT patients.
Expanding the label potential to 50% of all AML patients MRD, Cr1- 5X Cr2
- Analysts appreciate clarity for investment return analysis
- Gps combination w Opdivo:
- $MRK Joint analysis Gps combination w Keytruda for Pr/rOC ovarian cancer patients.
- Currently Cantor Fitz Estimates GPs rev $200M for Cr2 + and growing to include CR1, a market 5 x the size. identical to the Cpxx revenue est prior to its buyout.
- Funds already invested are paying attention will be listening closely for the company plans to cash in on the potential.
- a fact SLS shares will instantly triple or quadruple:
If SLS does a license deal with $bmy $mrk for ovarian cancer or mesothelioma ( two trial readouts imminent ; )
This is the Phase 2 Moffitt Center Data
- Final analysis shows statistically significant median overall survival of 21 months in patients who received GPS compared to previously reported 5.4 months in the control arm (p-value < 0.02) -
- Data provides additional support for ongoing pivotal Phase 3 REGAL study of GPS in patients with AML -
NEW YORK, Feb. 26, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced final follow-up data for its Phase 1/2 study of GPS in patients with acute myeloid leukemia (AML) in second complete remission (CR2). The final data show a median overall survival (OS) of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS therapy compared to 5.4 months in the AML CR2 patients treated with best standard care, a statistically significant difference (p-value < 0.02). Final analysis also showed that GPS therapy continued to be well-tolerated throughout the study.
“We’re extremely pleased with this follow-up data, which show that GPS may have potential as a longer-term therapy for AML patients in CR2, an aggressive disease where the majority of patients typically relapse and have a survival rate of approximately 5 months with best standard therapy,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The 21-month survival data observed further increases our confidence in the potential of GPS as a maintenance treatment for AML patients in CR2, the same patient population as our pivotal Phase 3 study, known as REGAL.”
“These follow-up data build upon the initially published clinical results from the Phase 1/2 study of GPS in AML patients in CR2 and provide further evidence that this novel immunotherapeutic vaccine approach may improve outcomes for patients in this setting, who often harbor measurable residual disease and have a poor prognosis if they are unable to undergo allotransplant,” said Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center, and principal investigator of the Phase 1/2 study.
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.
Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,
GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
This Phase 2 data will be heralded world wide as a potential new therapy offering hope for these dying patients.
Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.
Do not get scammed by the short spammers obfuscating valuable facts.
Joint Merck Analysis Data incoming Q4 - last year SLS traded up to 15 ahead of a PreLim readout.
Now we are on the verge of larger, mature results - Gps is worth billions and Big Pharma will be Paying up Bigly. $MRK or $BMY May decide its time to Guppy this baby BIO
Merck has zero agents for PROC, Keytruda is ineffective as a single agent - they need Gps.
1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
- Median Overall Survival not reached at a median follow-up of 43.1 weeks -
2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
https://www.mskcc.org/cancer-care/clinical-trials/17-654
3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.
4. $MRK Partnership / potential Upfront Money
5. $BMY Partnerhip / potential upfront Money
6. 3D Med Trial Initiation (s)
7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
Gps MRD+ Post ACST Trial Planned
8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.
GPS Phase 3 is a Registrational trial - meaning the parameters are pre approved by the fda - if their is a positive read at The Midpoint interim - and its powered to do so - the fda approval could happen in as little as 3 months from now along with a $100 share price.
Ceo stated Fda review Q1Q2 Multibillion dollar Phase 3 Fda Review and Triple digits Just about 3 months out NOW - Shares are cheap. The primary endpoint of the REGAL study is overall survival, and the study's powered at 90%, with assumptions of a median overall survival of only 10 months inthe GPS arm, versus 5.4 months in the best available treatment arm.
To declare statistical significance, i.e., a positive study for efficacy, one would need either a hazard ratio of less than 0.6 at interim analysis, or a hazard ratio of less than 0.675 at final analysis. ( <-- Approval at Interim)
Interim analysis will consist of one single readout for efficacy by the independent data monitoring committee after the first 80 deaths. Both the independent data monitoring committee and the study steering committee have been established and consist of internationally renowned leukemia and biostatistical experts, including Dr. Tom Fleming, the global principle investigator; Dr. Hagop #$%$arjian, Chief of the Leukemia Department at the MD Anderson Cancer Center, and the world renowned clinical trialist in AML responsible for the successful delivery of several agents currently FDA approved for this malignancy.
Share price will double quadruple or more in Q4 IMO Prior to the FDA APPROVAL GREEN LIGHT
1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.
Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,
GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
This Phase 2 data will be world wide as a potential new therapy offering hope for these dying patients.
Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.
The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
Anyone interested can find the List of Press Releases Here
- Median Overall Survival not reached at a median follow-up of 43.1 weeks -
2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
https://www.mskcc.org/cancer-care/clinical-trials/17-654
3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.
4. $MRK Partnership / potential Upfront Money
5. $BMY Partnerhip / potential upfront Money
6. 3D Med Trial Initiation (s)
7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
Gps MRD+ Post ACST Trial Planned
8. GFH009 Preliminary Trial Result / ( before the FINAL Safety ) + New Trial Initiation(s)
REGAL Enrollment Completion / Jan - This catalyst is worth $500M in MC value.
1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.
Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,
GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
This Phase 2 data will be world wide as a potential new therapy offering hope for these dying patients.
Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.
The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
- Median Overall Survival not reached at a median follow-up of 43.1 weeks -
2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
https://www.mskcc.org/cancer-care/clinical-trials/17-654
3. CDK9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.
4. $MRK Partnership / potential Upfront Money
5. $BMY Partnerhip / potential upfront Money
6. 3D Med Trial Initiation (s)
7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
Gps MRD+ Post ACST Trial Planned
8. GFH009 Preliminary Trial Result / ( before the FINAL Safety ) + New Trial Initiation(s)
REGAL Enrollment Completion / Jan - This catalyst is worth $500M in MC value.
Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.
$7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.
Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,
GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".
This Phase 2 data will be world wide as a potential new therapy offering hope for these dying patients.
Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.
The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
Anyone interested can find the List of Press Releases Here
- Median Overall Survival not reached at a median follow-up of 43.1 weeks -
2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
https://www.mskcc.org/cancer-care/clinical-trials/17-654
3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.
4. $MRK Partnership / potential Upfront Money
5. $BMY Partnerhip / potential upfront Money
6. 3D Med Trial Initiation (s)
7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
Gps MRD+ Post ACST Trial Planned
8. GFH009 Preliminary Trial Result / ( before the final Safety reading)
Expectations:
- The 10Q update, that the Phase 3 timeline is on track, set the clock ticking for New and Accumulating Institutional investors.
- More $$ Paying attention and getting more interested, fullest definition of the term 'interested' applies.
- no material data, per sec regs
- CCo
- Analysts appreciate clarity for investment return analysis
- Gps combination w Opdivo:
- $MRK Joint analysis Gps combination w Keytruda for Pr/rOC ovarian cancer patients.
- EAP - Gps investigators, the Chair of MD Anderson, sees 34 month old open label trial and has requested expanded access to Gps for ASCT patients.
Expanding the label potential to 50% of all AML patients MRD, Cr1
- 5X Cr2