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GNFT

Genfit

$15.84

0.53 (3.46%)

, CBAY

CymaBay

$1.47

0.13 (9.70%)

14:01
11/26/19
11/26
14:01
11/26/19
14:01

Favorable safety a positive for Genfit's elafibranor, says H.C. Wainwright

After Genfit (GNFT) this morning announced that the Data Safety Monitoring Board issued a positive recommendation for the continuation, without any modifications, of the Resole-It Phase 3 trial evaluating elafibranor in nonalcoholic steatohepatitis, H.C. Wainwright analyst Ed Arce noted this is the seventh such report affirming the favorable safety profile of elafibranor. After CymaBay (CBAY) announced yesterday that it has halted all clinical development of its lead drug seladelpar, Arce also noted that there have been no cases of interface hepatitis seen in all trials to date with elafibranor. "One less competitor only benefits the other players in the space, and the two remaining PPARs, especially elafibranor," added Arce. Commenting further on Intercept's (ICPT) announcement yesterday that the FDA has accepted its NDA for obeticholic acid for accelerated approval for the treatment of fibrosis due to NASH, Arce said he sees "two very differentiated profiles with the first two drugs likely to be approved for NASH," namely Intercept's OCA and Genfit's elafibranor. The analyst, who concludes with the assertion that the "overall efficacy, safety and tolerability profile of elafibranor is hands down superior to that of OCA," keeps a Buy rating and $58 price target on Genfit shares.

GNFT

Genfit

$15.84

0.53 (3.46%)

CBAY

CymaBay

$1.47

0.13 (9.70%)

ICPT

Intercept

$100.86

4.62 (4.80%)

GNFT Genfit
$15.84

0.53 (3.46%)

06/25/19
STFL
06/25/19
INITIATION
STFL
Hold
Genfit initiated with a Hold at Stifel
Stifel analyst Derek Archila started Genfit with a Hold rating and EUR21 price target, telling investors that he finds it hard to have conviction about a positive read out for the Phase 3 RESOLVE-IT study of elafibranor in on-alcoholic steatohepatitis based on the drug's current data. He questions the drug's commercial viability if it only demonstrates a marginal benefit on NASH resolution, Archila added in his initiation note.
10/31/19
HCWC
10/31/19
NO CHANGE
Target $58
HCWC
Buy
Genfit price target lowered to $58 from $72 at H.C. Wainwright
H.C. Wainwright analyst Ed Arce lowered his price target for Genfit to $58 from $72 and keeps a Buy rating on the shares ahead of elafibranor's pivotal data readout from the Phase 3 RESOLVE-IT NASH trial expected in Q1 of 2020. The analyst expects the redound to settle doubts about elafibranor in nonalcoholic steatohepatitis.
10/01/19
HCWC
10/01/19
NO CHANGE
Target $72
HCWC
Buy
Genfit selloff brings 'compelling' entry point, says H.C. Wainwright
H.C. Wainwright analyst Ed Arce sees a "compelling" entry point for Genfit (GNFT) with the shares down 34% since June 10. An "uninformed and unfair derivative response" to the failure of CymaBay's (CBAY) seladelpar to reduce steatosis in nonalcoholic steatohepatitis patients by week 12 has drove the weakness in Genfit shares, Arce tells investors in a research note. He points out that while seladelpar is a highly selective PPAR delta agonist, Genfit's elafibranor is a dual agonist of PPAR alpha and PPAR delta. As such, there are clear mechanistic differences between the two PPAR-targeted compounds, says the analyst. He affirms a Buy rating on Genfit with a $72 price target.
09/11/19
RILY
09/11/19
NO CHANGE
Target $52
RILY
Buy
Genfit risk/reward 'extremely compelling' after selloff, says B. Riley FBR
B. Riley FBR analyst Mayank Mamtani finds Genfit's risk/reward profile "extremely compelling" at current levels following the recent selloff in the shares. The analyst expects a "sentiment turnaround" ahead of the company's Phase III Resolve-It trial results in Q1 of 2020. Genfit's lead program elafibranor offers one of the "very few" development programs currently in Phase III for large patient population non-alcoholic steatohepatitis, which is "also scientifically and clinically de-risked in a meaningful way," Mamtani tells investors in a research note. He reiterates a Buy rating on Genfit shares with a $52 price target.
CBAY CymaBay
$1.47

0.13 (9.70%)

11/26/19
HCWC
11/26/19
DOWNGRADE
Target $2
HCWC
Neutral
CymaBay downgraded to Neutral from Buy at H.C. Wainwright
H.C. Wainwright analyst Ed Arce downgraded CymaBay Therapeutics to Neutral from Buy with a price target of $2, down from $16, after the company halted all clinical development of lead drug seladelpar. The analyst believes the drug is "probably done." However, he believes further share downside like "likely limited" with the company's current cash at approximately $200M or about $2.91 per share.
11/26/19
RAJA
11/26/19
DOWNGRADE
RAJA
Market Perform
CymaBay double downgraded at Raymond James after seladelpar setback
As previously reported, Raymond James analyst Steven Seedhouse double downgraded CymaBay to Market Perform from Strong Buy following the "unexpected setback" for seladelpar that has resulted in the company terminating or halting all programs for the drug. He cut his view on the probability of success in primary biliary cholangitis, the remaining indication being studied, to 25% from 90% and sees uncertainty for any path forward for the lead program, Seedhouse tells investors.
11/26/19
ROTH
11/26/19
DOWNGRADE
Target $2
ROTH
Neutral
CymaBay downgraded to Neutral from Buy at Roth Capital
Roth Capital analyst Yasmeen Rahimi downgraded CymaBay to Neutral from Buy with a price target of $2, down from $22, following the company's announcement of a clinical halt for seladelpar and subsequent call providing more details of histology findings. She walked away from CymaBay update call with more understanding of the atypical histological findings, but still remains uncertain regarding the cause and how the clinical halt will be resolved, Rahimi tells investors. She prefers to step to the sidelines while awaiting more clarity regarding timelines and casualty, the analyst added.
11/26/19
11/26/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Tesla (TSLA) downgraded to Hold from Buy at China Renaissance with analyst Carson Ng citing valuation. 2. CenterPoint Energy (CNP) downgraded to Market Perform from Outperform at Wells Fargo with analyst Sarah Akers saying she now now assumes the company will need $2.5B in equity funding in reaction to negative developments including, most recently, the Public Utilities Commission of Texas' cost of capital decision. 3. CymaBay (CBAY) was downgraded to Market Perform from Strong Buy at Raymond James, to Neutral from Overweight at Cantor Fitzgerald, as well as to Neutral from Buy at H.C. Wainwright and Roth Capital. 4. Molson Coors (TAP) downgraded to Market Perform from Outperform at BMO Capital with analyst Amit Sharma saying Molson's "persistently low" valuation and high free cash flow yield has failed to entice investors as its "structurally compromised" sales growth has been "too high a hurdle," even for deep-value investors. 5. Comerica (CMA) downgraded to Equal Weight from Overweight at Morgan Stanley with analyst Ken Zerbe saying he sees "far more" net interest margin compression at Comerica by the end of 2020 than the median he expects at its peers. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
ICPT Intercept
$100.86

4.62 (4.80%)

11/25/19
STFL
11/25/19
NO CHANGE
Target $102
STFL
Hold
Intercept price target raised to $102 from $86 at Stifel
Stifel analyst Derek Archila raised his price target for Intercept Pharmaceuticals (ICPT) to $102 from $86 after the FDA accepted OCA's new drug application for nonalcoholic steatohepatitis and granted it a priority review. The stock in midday trading is up 10.5% to $98.24. The FDA plans to hold a panel meeting, which is in-line with expectations, Archila tells investors in a research note. In addition, CymaBay (CBAY) terminating its Phase 2b study in NASH due to atypical histology findings and halting its studies for seladelpar in primary biliary cirrhosis means Intercept will likely have one less competitor in NASH but more importantly, one less in PBC, says the analyst. He thinks CymaBay's issues are a positive development for Intercept's PBC franchise but keeps a Hold rating on the shares.
11/26/19
WEDB
11/26/19
NO CHANGE
Target $257
WEDB
Outperform
Intercept price target raised to $257 from $243 at Wedbush
Wedbush analyst Liana Moussatos raised her price target for Intercept Pharmaceuticals to $257 from $243 after the FDA accepted the company's new drug application of obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis and granted priority review. The analyst anticipates a positive FDA panel vote and approval for OCA. She projects potential achievement of blockbuster, or over $1B, revenue in 2024 after a potential U.S. launch in October 2020. Moussatos keeps an Overweight rating on shares of Intercept.
11/06/19
STFL
11/06/19
NO CHANGE
Target $86
STFL
Hold
Stifel says most Intercept investors still focused on upcoming OCA updates
Stifel analyst Derek Archila reiterates his Hold rating on Intercept shares after the company reported Q3 Ocaliva sales that were in-line with estimates and management raised full year sales guidance by 2%. He thinks the majority of investors are focused on whether or not obeticholic acid has an advisory committee meeting, whether it receives a priority review in NASH and the drug's potential PDUFA date in NASH, which he expects updates on within the next few weeks. He remains cautious on obeticholic acid's commercial viability in nonalcoholic steatohepatitis given unknowns that include the pricing strategy, payer requirements and real-world compliance, Archila noted.
11/06/19
RBCM
11/06/19
NO CHANGE
Target $134
RBCM
Outperform
RBC Capital sees Intercept as out-year multi-billion dollar opportunity
RBC Capital analyst Brian Abrahams is nudging his price target on Intercept down to $134 from $135 on adjustment of his model to a blend of DCF and probability-adjusted multiple but also keeping his Outperform rating on the stock after its Q3 results and raised FY19 Ocavia sales guidance. The analyst is positive on the company's "substantial progress establishing the commercial infrastructure and payer network ahead of the OCA launch in NASH" and believes that the stock is a multi-billion dollar out-year opportunity that is currently underappreciated by investors.

TODAY'S FREE FLY STORIES

CME

CME Group

$204.61

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GLG

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WPX

WPX Energy

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-0.24 (-2.15%)

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Periodicals
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  • 23

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HZNP

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$54.49

-1.98 (-3.51%)

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  • 13

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VKTX

Viking Therapeutics

$7.94

0.045 (0.57%)

16:26
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Conference/Events
Viking Therapeutics management to meet with SVB Leerink »

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  • 19

    Dec

VCYT

Veracyte

$28.50

-0.16 (-0.56%)

16:24
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12/13
16:24
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Conference/Events
Veracyte management to meet with SVB Leerink »

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  • 16

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MCK

McKesson

$140.56

-3.44 (-2.39%)

16:21
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16:21
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Conference/Events
McKessonto hold a sell-side analyst meeting »

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  • 18

    Dec

MDR

McDermott

$0.82

0.0412 (5.31%)

16:20
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ICPT

Intercept

$114.26

-1.52 (-1.31%)

16:20
12/13/19
12/13
16:20
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Conference/Events
Intercept to hold a meeting for investors »

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  • 16

    Dec

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VIX

Volatility Index S&P 500 Options

$0.00

(0.00%)

16:20
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Options
Closing CBOE SPX and VIX Index summary for December 13th »

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IPWR

Ideal Power

$2.45

0.04 (1.66%)

16:19
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Breaking Syndicate news story on Ideal Power »

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ERIE

Erie Indemnity

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  • 28

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ESRT

Empire State Realty

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0.055 (0.40%)

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HST

Host Hotels

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$NSD

NASDAQ Market Internals

$0.00

(0.00%)

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NASDAQ market internals summary »

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$NYE

NYSE Market Internals

$0.00

(0.00%)

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PACW

PacWest Bancorp

$38.11

-0.54 (-1.40%)

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ICPT

Intercept

$114.03

-1.75 (-1.51%)

16:13
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12/13
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Conference/Events
Intercept to hold a meeting for investors »

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  • 26

    Mar

OC

Owens Corning

$64.62

-1.03 (-1.57%)

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CRR

Carbo Ceramics

$0.42

0.0132 (3.21%)

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CHK

Chesapeake

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-0.0009 (-0.11%)

16:07
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SCVL

Shoe Carnival

$36.15

-1.43 (-3.81%)

16:06
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XXII

22nd Century

$0.91

0.0192 (2.15%)

16:05
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22nd Century CEO Cliff Fleet to step down »

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