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Initiation
CTI BioPharma resumed with an Outperform at JMP Securities » 15:13
06/24/20
06/24
15:13
06/24/20
15:13
CTIC

CTI BioPharma

$1.20 /

-0.03 (-2.44%)

JMP Securities analyst…

JMP Securities analyst Reni Benjamin resumed coverage of CTI BioPharma with an Outperform rating and $3 price target. In a research note before market open, the analyst noted that the company is a clinical stage biopharmaceutical focused on developing and commercializing its only clinical asset pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1, and CSF1R, in MF patients with severe thrombocytopenia. "Significant evidence exists" that pacritinib can reduce spleen volumes and improve symptoms in severely thrombocytopenic MF patients in a dose-dependent manner, he contended, adding that based on analysis of the current study and past data, pacritinib could achieve $169M in risk-adjusted revenues by 2027. Further, Benjamin believes the path to approval has created a unique opportunity for investors looking to get on board in the near-term.

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CTIC CTI BioPharma
$1.20 /

-0.03 (-2.44%)

CTIC CTI BioPharma
$1.20 /

-0.03 (-2.44%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
CTIC CTI BioPharma
$1.20 /

-0.03 (-2.44%)

Over a month ago
Hot Stocks
CTI BioPharma: First patient enrolled in Phase 3 PRE-VENT trial » 07:10
06/01/20
06/01
07:10
06/01/20
07:10
CTIC

CTI BioPharma

$1.01 /

-0.02 (-1.94%)

CTI BioPharma announced…

CTI BioPharma announced that it has enrolled the first patient in the Phase 3 PRE-VENT trial of pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care versus placebo and standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28.

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CTIC CTI BioPharma
$1.01 /

-0.02 (-1.94%)

CTIC CTI BioPharma
$1.01 /

-0.02 (-1.94%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
CTIC CTI BioPharma
$1.01 /

-0.02 (-1.94%)

Hot Stocks
CTI BioPharma initiates Phase 3 PRE-VENT study » 07:04
04/27/20
04/27
07:04
04/27/20
07:04
CTIC

CTI BioPharma

$0.89 /

+0.0001 (+0.01%)

CTI BioPharma announced…

CTI BioPharma announced the initiation of PRE-VENT, a Phase 3 study evaluating pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care versus placebo plus standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28. CTI expects to commence enrollment of PRE-VENT in May at sites in the United States and in Europe with data expected by the end of 2020.

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CTIC CTI BioPharma
$0.89 /

+0.0001 (+0.01%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
Over a quarter ago
Earnings
CTI BioPharma reports Q4 EPS (14c), consensus (22c)  16:13
03/12/20
03/12
16:13
03/12/20
16:13
CTIC

CTI BioPharma

$0.83 /

-0.0568 (-6.38%)

 
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CTIC CTI BioPharma
$0.83 /

-0.0568 (-6.38%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
Conference/Events
CTI BioPharma management to meet with JMP Securities » 04:55
02/12/20
02/12
04:55
02/12/20
04:55
CTIC

CTI BioPharma

$1.43 /

+0.05 (+3.62%)

Meeting to be held in…

Meeting to be held in Boston, MA on February 12 hosted by JMP Securities.

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CTIC CTI BioPharma
$1.43 /

+0.05 (+3.62%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
03/05/19 Lake Street
CTI BioPharma initiated with a Buy at Lake Street
Conference/Events
CTI BioPharma management to meet with JMP Securities » 06:44
02/10/20
02/10
06:44
02/10/20
06:44
CTIC

CTI BioPharma

$1.33 /

+0.04 (+3.10%)

Meeting to be held in…

Meeting to be held in Boston, MA on February 12 hosted by JMP Securities.

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CTIC CTI BioPharma
$1.33 /

+0.04 (+3.10%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
03/05/19 Lake Street
CTI BioPharma initiated with a Buy at Lake Street
Syndicate
CTI BioPharma to raise $60M in rights offering » 07:13
02/03/20
02/03
07:13
02/03/20
07:13
CTIC

CTI BioPharma

$1.19 /

-0.03 (-2.46%)

CTI BioPharma announced…

CTI BioPharma announced its intent to raise $60M through a fully backstopped rights offering. Under the terms of the rights offering, investors as of February 13 in CTI BioPharma's common stock and preferred stock will receive a subscription right entitling them to purchase their pro rata share of the $60M offering amount. The rights offering will be fully backstopped by BVF Partners L.P., Stonepine Capital, L.P., OrbiMed Private Investments VI, LP and New Enterprise Associates, each of which have agreed to purchase, at a minimum, its respective as-converted pro rata share of the offering amount, plus an additional amount of securities that are not subscribed for by other purchasers in the rights offering, for a total of up to $60M.

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CTIC CTI BioPharma
$1.19 /

-0.03 (-2.46%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
03/05/19 Lake Street
CTI BioPharma initiated with a Buy at Lake Street
Hot Stocks
CTI BioPharma establishes accelerated approval pathway for pacritinib » 07:05
02/03/20
02/03
07:05
02/03/20
07:05
CTIC

CTI BioPharma

$1.19 /

-0.03 (-2.46%)

CTI BioPharma announced…

CTI BioPharma announced that following a meeting with the U.S. FDA, CTI has reached agreement on an accelerated approval pathway for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia. CTI will be amending the PACIFICA pivotal Phase 3 trial protocol to allow for the primary analysis of SVR rates on the first 168 patients, with an end-of-study analysis of TSS and OS following the full enrollment of 348 patients. If the primary endpoint of SVR is met following the planned review of data from the first 168 patients, CTI intends to submit a New Drug Application under the FDA's subpart H regulations, subject to review of all available efficacy and safety data. Conversion to a regular approval of pacritinib would be anticipated following the successful end-of-study assessment of the secondary efficacy endpoints, and the completion of post-marketing requirements. Based on the new trial design, CTI expects to report primary SVR data by the end of 2021, with a potential NDA filing in early 2022 if the SVR data is positive. Final study efficacy data is expected in 2023.

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CTIC CTI BioPharma
$1.19 /

-0.03 (-2.46%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
03/05/19 Lake Street
CTI BioPharma initiated with a Buy at Lake Street
Hot Stocks
CTI BioPharma: PAC203 results show pactritinib 200mg 'well tolerated' » 10:33
12/09/19
12/09
10:33
12/09/19
10:33
CTIC

CTI BioPharma

$0.95 /

+ (+0.00%)

CTI BioPharma announced…

CTI BioPharma announced the presentation of data from the company's pacritinib development program, including results from the PAC203 Phase 2 clinical trial, at the 61st American Society of Hematology Annual Meeting being held December 7-10 in Orlando, Florida. "The data presented at ASH underscore the clinical and scientific rationale for our ongoing PAC203 Phase 3 PACIFICA trial evaluating pacritinib at 200 mg BID in severely thrombocytopenic myelofibrosis patients," said Adam R. Craig, M.D., Ph.D. "Pacritinib has now been demonstrated to provide clinical benefit in treating severely thrombocytopenic myelofibrosis in three clinical trials, including two prior randomized Phase 3 studies. Further, the PAC203 Phase 2 results from the 200 mg BID cohort demonstrate a favorable risk-benefit profile for pacritinib when treating patients with advanced disease that have high mutational risk and long durations of prior ruxolitinib exposure." Pacritinib was shown to be generally well tolerated across dosing cohorts, with the most common treatment-emergent non-hematologic adverse events being gastrointestinal, including diarrhea and nausea, distributed similarly across arms. The most common hematologic AEs were thrombocytopenia and anemia, both occurring at higher frequencies at the 200 mg dose BID. The data from PAC203 support the Phase 3 PACIFICA trial, currently underway to compare the safety and efficacy of 200 mg BID of pacritinib to Physician's Choice in 180 adult myelofibrosis patients with severe thrombocytopenia.

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CTIC CTI BioPharma
$0.95 /

+ (+0.00%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
03/05/19 Lake Street
CTI BioPharma initiated with a Buy at Lake Street
Earnings
CTI BioPharma reports Q3 EPS (17c), consensus (23c) » 16:09
11/04/19
11/04
16:09
11/04/19
16:09
CTIC

CTI BioPharma

$0.81 /

+0.0067 (+0.83%)

Reports Q3 revenue…

Reports Q3 revenue $2.29M. Reports Q3 operating loss $9.7M. The company commented, "We advanced our pacritinib development program in the third quarter, and recently took an important step forward for the company by initiating and enrolling the first patient in the PACIFICA trial, our pivotal Phase 3 trial of pacritinib in myelofibrosis patients with severe thrombocytopenia. An estimated one-third of patients with myelofibrosis are severely thrombocytopenic - a population with limited therapeutic options and poor survival, thereby making this disease setting a very important area of unmet medical need. In the near-term, we look forward to presenting results from the PAC203 Phase 2 trial at a scientific conference before the end of the year."

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CTIC CTI BioPharma
$0.81 /

+0.0067 (+0.83%)

08/19/19 Lake Street
Celgene's fedratinib approval 'positive signal' for CTI Bio, says Lake Street
03/05/19 Lake Street
CTI BioPharma initiated with a Buy at Lake Street

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