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CKPT

Checkpoint Therapeutics

$1.67

0.105 (6.71%)

08:30
01/13/20
01/13
08:30
01/13/20
08:30

Checkpoint announces confirmation of registration path for cosibelimab

Checkpoint Therapeutics announced that feedback from the U.S. Food and Drug Administration has confirmed the company's plan to submit cosibelimab for full approval as a treatment for patients with metastatic cutaneous squamous cell carcinoma based on efficacy and safety data from the ongoing open-label, multicenter, Phase 1 clinical trial, Study CK-301-101. This registration-enabling clinical trial is currently enrolling a cohort of patients with metastatic CSCC, with a target enrollment of approximately 75 to 100 patients and a primary efficacy endpoint of confirmed objective response rate assessed by independent central review. Positive interim results for cosibelimab were presented at the European Society for Medical Oncology Congresa 2019 in Barcelona, Spain. The poster presentation provided interim efficacy and safety results from the ongoing clinical trial, including a 50% ORR by investigator assessment in the first 14 evaluable patients in the metastatic CSCC cohort. One patient achieved a complete response and six patients achieved partial responses. All seven responses were confirmed and ongoing at the time of analysis. Additionally, cosibelimab appeared to be safe and well-tolerated in 81 treated patients with diverse tumor types. A copy of the ESMO Congress poster presentation is available on the Publications page of the Pipeline section of Checkpoint's website, www.checkpointtx.com.

CKPT Checkpoint Therapeutics
$1.67

0.105 (6.71%)

05/29/19
LSCM
05/29/19
INITIATION
Target $12
LSCM
Buy
Checkpoint Therapeutics initiated with a Buy at Lake Street
Lake Street initiated Checkpoint Therapeutics with a Buy and $12 price target.
05/29/19
LSCM
05/29/19
INITIATION
Target $12
LSCM
Buy
Lake Street starts Checkpoint Therapeutics with Buy rating, $12 target
Lake Street analyst Thomas Flaten initiated coverage of Checkpoint Therapeutics with a Buy rating and $12 price target. The company should initiate a pivotal study in its non-small cell lung cancer treatment, CK-101, by year-end 2019, Flaten tells investors in a research note. He sees potential for clinical differentiation and "disruptive" commercial strategies to drive "significant value" for Checkpoint.
10/17/19
LSCM
10/17/19
NO CHANGE
Target $12
LSCM
Buy
Checkpoint Therapeutics shares reflect 'valuation disconnect,' says Lake Street
Lake Street analyst Thomas Flaten sees a "valuation disconnect" in shares of Checkpoint Therapeutics. After hosting investor meetings with management, the analyst continues to believe the value generation opportunity of both CK-101 and cosibelimab "remains large." He believes the current share price undervalues his opportunity and reiterates a Buy rating on Checkpoint with a $12 price target. The company remains on track to release updated safety and efficacy data in the next three-to-five months, says Flaten.
12/27/19
LSCM
12/27/19
NO CHANGE
Target $8
LSCM
Buy
Checkpoint Therapeutics price target lowered to $8 from $12 at Lake Street
Lake Street analyst Thomas Flaten lowered his price target for Checkpoint Therapeutics to $8 from $12 to reflect a new cash balance and number of shares following the company's recently completed equity financing. Checkpoint now has capital into 2021 and is "positively positioned" to advance its pipeline toward the initiation of a Phase 3 trial for CK-101 and the potential BLA submission for cosibelimab in 2021, Flaten tells investors in a research note. He reiterates a Buy rating on the shares.

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