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CALA

Calithera Biosciences

$3.27

-0.01 (-0.30%)

, INCY

Incyte

$72.84

-0.87 (-1.18%)

16:47
09/29/19
09/29
16:47
09/29/19
16:47

Calithera presents data from first-in-class oral arginase inhibitor INCB001158

Calithera Biosciences (CALA) announced the presentation of new data from the investigational first-in-class oral arginase inhibitor INCB001158 as a monotherapy and in combination with the checkpoint inhibitor pembrolizumab in microsatellite stable colorectal carcinoma patients. Calithera has a global collaboration and license agreement with Incyte (INCY) for the joint research, development and commercialization of INCB001158 in hematology and oncology. Calithera and Incyte are collaborating to conduct this Phase 1 study evaluating INCB001158 as monotherapy and in combination with the PD-1 inhibitor pembrolizumab in checkpoint inhibitor refractory and naive advanced/metastatic solid tumors. Data were presented as of the data cut-off of July 22, 2019. The study was designed as a dose escalation of INCB001158 alone and in combination with pembrolizumab followed by expansion cohorts which followed a Simon 2 Stage design. There were three monotherapy expansion cohorts and eight combination expansion cohorts, including PD-(L)1-naive and PD-(L)1 refractory patients. The PD-(L)1-naive MSS colorectal carcinoma patient cohort has advanced to stage 2 of a Simon 2-stage design. Among 43 response-evaluable patients who had received a median of 3 prior therapies, 3 patients achieved a confirmed partial response; the historical overall response rate is 0-1% in second- and third-line MSS CRC patients treated with checkpoint inhibitor therapies. Two of the three responders are ongoing at the time of data cutoff with a duration of response of 2.4+ and 7+ months respectively. The third responder had a duration of response of 6.7 months. The six month PFS rate for the cohort was 20%. Pharmacodynamic increases in total intratumoral CD8+ cells were seen post-treatment with INCB001158 + pembrolizumab in MSS CRC patients. The colorectal carcinoma monotherapy cohort has advanced to stage 2 of a Simon 2-stage design. Among 33 response-evaluable MSS CRC patients, one patient achieved a confirmed partial response and one patient achieved stable disease lasting seven months. Both patients had disease progression within six months on their immediately preceding line of therapy. The disease control rate for the monotherapy MSS CRC cohort was 27%. INCB001158 inhibited plasma arginase activity at all doses and induced dose-related increases in plasma arginine, including a mean three-fold increase at the recommended phase 2 dose of 100 mg bid. A total of 85 patients with advanced solid tumors were treated with INCB001158 as a monotherapy in doses of 50 to 150mg bid and were evaluable for safety. A maximum tolerated dose was not reached. Immune-related adverse events included one dose-limiting toxicity each of Grade 2 malaise and Grade 3 colitis. Clinically significant urea cycle inhibition was not seen. A total of 114 PD-(L)1-naive and PD-(L)1 refractory patients were treated in INCB001158 in combination with pembrolizumab and evaluable for safety across multiple disease specific cohorts. The overall frequency and severity of immune related adverse events was consistent with the pembrolizumab safety profile.

CALA

Calithera Biosciences

$3.27

-0.01 (-0.30%)

INCY

Incyte

$72.84

-0.87 (-1.18%)

  • 02

    Oct

CALA Calithera Biosciences
$3.27

-0.01 (-0.30%)

05/30/19
SBSH
05/30/19
INITIATION
Target $10
SBSH
Buy
Calithera Biosciences assumed with a Buy at Citi
Citi analyst Mohit Bansal assumed coverage Calithera Biosciences with a Buy rating and $10 price target. Under a prior analyst, Citi had a Buy rating on the shares with a $7 price target. Positive data mid-year from the small metastatic renal cell carcinoma trial could have read-through to the Cabo trial, Bansal tells investors in a research note.
INCY Incyte
$72.84

-0.87 (-1.18%)

09/05/19
09/05/19
UPGRADE
Target $100

Outperform
Incyte upgraded to Outperform on valuation at Oppenheimer
As previously reported, Oppenheimer analyst Jay Olson upgraded Incyte to Outperform from Perform and raised his price target on the shares to $100 from $85. The analyst cited "attractive" valuation for a company with increasing revenues, accelerating cash flows and a maturing pipeline of intriguing assets. The analyst believes Incyte has a track record of realizing high potential opportunities with innovative products in areas of unmet medical need.
09/05/19
09/05/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Comcast (CMCSA) upgraded to Outperform from Perform at Oppenheimer with analyst Timothy Horan saying the company's fundamentals are "healthy" in the near-term, and 2020 is setting up to be a "strong year." 2. Activision Blizzard (ATVI) upgraded to Overweight from Equal Weight at Stephens with analyst Jeff Cohen citing his view that estimates for 2019 are now "de-risked" due to the successful launch of World of Warcraft Classic and the announcement of a Nintendo Switch port of Overwatch. 3. Match Group (MTCH) upgraded to Buy from Hold at SunTrust with analyst Youssef Squali saying that the "positive" intra-quarter app traffic and revenue trends imply a positive quarter-to-date momentum for the company. 4. Incyte (INCY) upgraded to Outperform from Market Perform at JMP Securities and to Outperform from Perform at Oppenheimer. 5. National Oilwell (NOV) upgraded to Buy from Hold at Jefferies with analyst Bradley Handler saying even with the uncertain macro environment, National Oilwell's outlook includes backlog-based growth potential and less margin risk. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/11/19
BMOC
09/11/19
INITIATION
Target $85
BMOC
Market Perform
Incyte initiated with a Market Perform at BMO Capital
BMO Capital analyst George Farmer intiated Incyte with a Market Perform rating and $85 price target. Farmer believes the current valuation accurately reflects the value of Incyte's ruxolitinib management strategy, as well as the potential of its upcoming pipeline candidates.
09/27/19
PIPR
09/27/19
NO CHANGE
PIPR
Overweight
Incyte data continue to support CCA approval for pemigatinib, says Piper Jaffray
Piper Jaffray analyst Tyler Van Buren said updated FIGHT-202 data reported by Incyte continue to support approval of pemigatinib to treat cholangiocarcinoma, or CCA, next year. He noted that the response rate and median progression free survival time both came down from last year's update, but he still sees a "significant improvement over standard of care" for a set of patients who have very poor prognoses. Van Buren, who estimates that FGFR2-cholangio represents about a $250M opportunity for Incyte, keeps an Overweight rating on the shares.

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HSBC

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STT

State Street

$63.40

3.69 (6.18%)

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SUN

Sunoco

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0.32 (1.00%)

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TLF

Tandy Leather

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Tandy Leather

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AAPL

Apple

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JPM

JPMorgan

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, FB

Facebook

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MA

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BKNG

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GLD

SPDR Gold Shares

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TECK

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OSK

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OVLY

Oak Valley Bancorp

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FTNW

FTE Networks

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TNXP

Tonix Pharmaceuticals

$0.45

0.0048 (1.07%)

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RLMD

Relmada Therapeutics

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NWSA

News Corp.

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NYT

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WAIR

Wesco Aircraft

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FOMX

Foamix

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POAI

Predictive Oncology

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BK

BNY Mellon

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0.975 (2.20%)

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Foamix

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BAC

Bank of America

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LGC

Legacy Acquisition Corp

$10.24

0.02 (0.20%)

16:34
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Conference/Events
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MFGP

Micro Focus

$15.13

0.56 (3.84%)

, OTEX

OpenText

$39.30

-1.545 (-3.78%)

16:33
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OTEX

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