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APTO

Aptose Biosciences

$2.31

-0.11 (-4.55%)

07:15
03/25/19
03/25
07:15
03/25/19
07:15

Aptose Biosciences announces FDA allowance of CG-806 IND

Aptose Biosciences announced that the FDA completed their review of the company's investigational new drug, or IND, submission for CG-806. Aptose has been granted IND allowance to initiate its Phase 1 clinical trial, which is a Phase 1, multicenter, open label, dose-escalation study with expansions to assess the safety, tolerability, PK and preliminary efficacy of CG-806 in patients with chronic lymphocytic leukemia, or CLL/SLL, or non-Hodgkin lymphomas, or NHL. Aptose will conduct a Phase 1 trial with orally administered CG-806 in patients with relapsed or refractory B cell malignancies, including CLL/SLL and NHL who have failed or are intolerant to standard therapies. The Phase 1 trial is expected to initiate in Q2. Pending collection and review of the initial safety data and predictive pharmacokinetic data in humans from this trial, Aptose plans to seek allowance from the FDA to move into patient populations that include relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes in a separate Phase 1 trial.

  • 25

    Mar

APTO Aptose Biosciences
$2.31

-0.11 (-4.55%)

01/25/19
OPCO
01/25/19
INITIATION
Target $6
OPCO
Outperform
Aptose Biosciences initiated with an Outperform at Oppenheimer
As previously reported, Oppenheimer analyst Matthew Biegler initiated Aptose Biosciences with an Outperform rating and $6 price target, citing the commercial potential of CG-806 in two major hematology/oncology indications. In a research note to investors, Biegler says he believes CG-806 can selectively disable key signaling pathways that cancer cells need without the "safety baggage" usually associated with multi-kinase inhibitors. Biegler says he would be a buyer of Aptose ahead of CG-806's expected 1H19 entry into the clinic.
01/25/19
01/25/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. SS&C (SSNC) initiated with a Buy at Buckingham. 2. Capital Southwest (CSWC) initiated with a Neutral at B. Riley FBR. 3. Natural Gas Services (NGS) initiated with a Buy at Maxim. 4. Aptose Biosciences (APTO) initiated with an Outperform at Oppenheimer. 5. AzurRx BioPharma (AZRX) initiated with a Buy at Roth Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
03/01/19
RBCM
03/01/19
INITIATION
Target $6
RBCM
Outperform
Aptose Biosciences initiated with an Outperform at RBC Capital
RBC Capital analyst Gregory Renza initiated Aptose Biosciences with an Outperform and $6 price target citing the promising profile and solid per-clinical data for key asset CG-806. Renza sees an opportunity as clinical data generated to de-risk and increase appreciation for its prospects in the complex heme/onc treatment paradigm and a driver of share upside.
03/01/19
RBCM
03/01/19
INITIATION
Target $6
RBCM
Outperform
Aptose Biosciences initiated with an Outperform at RBC Capital
RBC Capital analyst Gregory Renza started Aptose Biosciences with an Outperform rating and $6 price target, stating that he believes key asset CG-806 has a "promising profile and solid pre-clinical data" in targeted oncology.

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FTSV

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