Breaking News Instant updates and real-time market news.

REPL

Replimune Group

$12.05

-0.35 (-2.82%)

, REGN

Regeneron

$305.64

4.62 (1.53%)

07:03
10/15/19
10/15
07:03
10/15/19
07:03

Replimune Group announces patient enrollment in Phase 2 trial of RP1

Replimune Group (REPL) announced that the first patient has been enrolled in its registration-directed, randomized, controlled Phase 2 clinical trial of RP1 in combination with Regeneron (REGN) and Sanofi's (SNY) Libtayocompared to Libtayo alone in patients with cutaneous squamous cell carcinoma. The Company also announced plans to initiate a new clinical trial of RP1 as monotherapy in organ transplant recipients with CSCC in early 2020. The registration-directed Phase 2 clinical trial in CSCC is a multi-center, randomized, controlled clinical trial intended to enroll approximately 240 patients. The study's primary objective is to compare the response rate following treatment with RP1 in combination with Libtayo to the response rate achieved with Libtayo alone. Libtayo is an anti-PD-1 therapy developed by Regeneron and Sanofi, which was approved by the U.S. Food and Drug Administration last year for the treatment of patients with metastatic CSCC or locally-advanced CSCC who are not candidates for curative surgery or curative radiation. This clinical trial is being conducted under the Company's collaboration agreement with Regeneron. The first patient in the trial has now been enrolled, and multiple clinical trial sites in the U.S. and Australia are open for enrollment. Additional clinical trial sites in these and other countries will be added, with recruitment expected to take approximately 18 to 24 months. Replimune intends to initiate a new Phase 1b clinical trial of single agent RP1 in organ transplant recipients with CSCC, for which the clinical trial protocol has been accepted by the FDA under the Company's Investigational New Drug application. This clinical trial is intended to enroll approximately 30 patients and assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC, and is expected to initiate in the first quarter of 2020. The Phase 1 part of Replimune's Phase 1/2 clinical trial of RP1 enrolled 36 patients with advanced heavily pre-treated cancers who have failed available therapy, evaluating treatment with RP1 alone given up to five times, and RP1 given up to eight times in combination with Opdivo from the second RP1 dose. Following completion of the Phase 1 part of the clinical trial, the Company opened enrollment for Phase 2 cohorts of 30 patients each in patients with melanoma, non-melanoma skin cancers, bladder cancer, and MSI-H tumors. Five patients with CSCC have been enrolled and treated with RP1 combined with Opdivo in this clinical trial, including one from the Phase 1 expansion in combination with Opdivo, and four from the Phase 2 non-melanoma skin cancer cohort. Initial results in these CSCC patients showed:The first patient achieved a biopsy-confirmed complete response of extensive disease of the scalp. Clear tumor flattening was observed after the first dose of RP1 and prior to the first dose of Opdivo, prior to the patient ultimately achieving a CR. PD-L1 and CD8 T cell levels were also substantially increased post-treatment as compared to baseline. The second patient achieved a partial response of bulky bi-lateral disease in the neck, with substantial reduction observed after the first dose of RP1 and prior to the first dose of Opdivo, including of the uninjected tumor contralateral to the injection site. The third patient had extensive and rapidly progressing metastatic disease and died from disease progression within 6 weeks of starting therapy. The fourth patient, also with bulky disease in the neck, had a substantial reduction after the first RP1 dose, which continued to reduce following the introduction of Opdivo. The fifth patient, with recurrent bone invasive CSCC of the cheek, had substantial flattening after the first RP1 dose and has recently initiated the combination therapy phase with RP1 and Opdivo. All patients other than the third patient continue on treatment.

REPL

Replimune Group

$12.05

-0.35 (-2.82%)

REGN

Regeneron

$305.64

4.62 (1.53%)

SNY

Sanofi

$44.88

-0.05 (-0.11%)

  • 31

    Oct

  • 05

    Nov

  • 06

    Nov

  • 12

    Nov

REPL Replimune Group
$12.05

-0.35 (-2.82%)

09/04/19
ROTH
09/04/19
INITIATION
Target $20
ROTH
Buy
Replimune Group initiated with a Buy at Roth Capital
Roth Capital analyst Tony Butler started Replimune Group with a Buy rating and $20 price target. The analyst is hopeful that oncolytic viruses, such as the company's RP1, in combination with immune checkpoint inhibitors could widen the population of patients who may benefit from ICIs. His price target is driven by Replimune's commercial opportunities of RP1 in the treatment of cutaneous squamous cell carcinoma and urothelial carcinoma in the U.S. and Europe.
08/06/19
WEDB
08/06/19
NO CHANGE
WEDB
Replimune Group, Sallie Mae removed from Best Ideas List at Wedbush
Wedbush removed Replimune Group (REPL) and Sallie Mae (SLM) from its Best Ideas List due to its investment price discipline. The firm has an Outperform rating on both stocks.
07/23/19
CHDN
07/23/19
INITIATION
Target $28
CHDN
Buy
Replimune Group initiated with a Buy at Chardan
Chardan started Replimune Group with a Buy rating and $28 price target.
07/12/19
JPMS
07/12/19
UPGRADE
Target $26
JPMS
Overweight
JPMorgan upgrades Replimune to Overweight with 41% dtop from highs
JPMorgan analyst Anupam Rama upgraded Replimune Group to Overweight from Neutral while lowering his price target for the shares to $26 from $27. The analyst says that despite the stock being down 41% from the September 2018 highs, he still believes Replimune will be a key player in the emerging oncolytic immunotherapy field driven by lead asset RP1.
REGN Regeneron
$305.64

4.62 (1.53%)

10/02/19
RILY
10/02/19
NO CHANGE
Target $95
RILY
Buy
The Medicines Co. price target raised to $95 from $74 at B. Riley FBR
B. Riley FBR analyst Mayank Mamtani raised his price target for The Medicines Co. (MDCO) to $95 from $74 and added the shares to FBR's Alpha Generator List. The analyst has "heightened conviction" in inclisiran taking a dominant market share in the anti-PCSK9 marketplace, particularly at the expense of Regeneron's (REGN) Praluent. Mamtani's penetration-share scenario analysis suggests worldwide peak sales of $4.1B to $8.0B. The analyst keeps a Buy rating on The Medicines Co. The stock is yet to still reflect last week's "strong" Phase III Orion program execution and evidence generation on safety, efficacy, and durability of effect to reaffirm inclisiran's differentiated clinical profile, Mamtani tells nivestors in a research note.
10/04/19
GUGG
10/04/19
NO CHANGE
GUGG
Guggenheim positively biased on Biotech heading into earnings
Guggenheim analysts Whitney Ijem, Etzer Darout, Yatin Suneja and Michael Schmidt offered a preview for their joint Biotech coverage ahead of the group's earnings reporting season. Biotech stocks continued their downward trend in the quarter amid negative market sentiment and the analysts think the bar for companies to raise 2019 guidance again may be a bit higher following increases in FY19 consensus estimates on the heels of strong Q2 earnings results. However, they are postively biased on the group and have confidence in FY19 guidance and estimates, the analysts said. They see Alexion (ALXN), Biogen (BIIB), Genmab (GMAB), GW Pharmaceuticals (GWPH), Incyte (INCY), Neurocrine (NBIX), Regeneron (REGN) and Seattle Genetics (SGEN) as well positioned relative to expectations, Ijem, Darout, Suneja and Schmidt tell investors.
10/08/19
PIPR
10/08/19
NO CHANGE
Target $435
PIPR
Overweight
Piper positive on Regeneron after 'significant let-down' Novartis label
Piper Jaffray analyst Christopher Raymond is "incrementally positive" on Regeneron Pharmaceuticals (REGN) after the FDA approved Novartis' (NVS) Beovu for the treatment of wet age-related macular degeneration. While the approval was anticipated and physician anticipation of the drug has been high, doctors are likely to view the drug's label "as a significant let-down," Raymond tells investors in a research note. The analyst says that with inflammation and immunogenicity rates meaningfully higher than Regeneron's Eylea, and the lack of flexibility to dose more frequently, he sees little reason for doctors to switch. And while some investors may point to price as another meaningful lever, off-label Avastin makes for an "insurmountable bar for the price-sensitive segment," says Raymond. He keeps an Overweight rating on Regeneron shares with a $435 price target. The label "renders Beovu as little more than an also-ran," contends the analyst. As such, Raymond thinks Eylea's dominance in remains intact.
10/14/19
ROTH
10/14/19
NO CHANGE
ROTH
Ophthalmic therapies 'could go from 0 to 100 real quick,' says Roth Capital
Commenting on the Ophthalmology space, Roth Capital analyst Zegbeh Jallah highlights her conviction for stronger valuations, driven by the increasing number of companies with innovative pipelines, and pending changes at both the FDA and CMS. The analyst suspects that these changes could lead to more wins in the space, which could drive valuations. Further, she cautions investors to keep "their eyes peeled on developments in the space." Jallah sees this as possible relevant for KalVista (KALV), Regenxbio (RGNX), Kala Pharmaceuticals (KALA), Kodiak Sciences (KOD), Regeneron (REGN), Aerie Pharmaceuticals (AERI), Applied Genetic (AGTC), Aldeyra (ALDX), Adverum Biotechnologies (ADVM), Clearside Biomedical (CLSD), Ocugen (OCGN), and many others.
SNY Sanofi
$44.88

-0.05 (-0.11%)

10/15/19
BOFA
10/15/19
NO CHANGE
BOFA
Europe 1 List changes at BofA/Merrill
BofA/Merrill added Roche (RHHBY) and Sanofi (SNY) to the Europe 1 List and removed AstraZeneca.
10/02/19
STFL
10/02/19
NO CHANGE
Target $45
STFL
Buy
Stifel remains buyer of Principia Biopharma into Q4 data readouts
Stifel analyst Derek Archila remains bullish and a buyer of Principia Biopharma (PRNB) shares ahead of the company's two Phase 2 readouts for PRN1008 in immune thrombocytopenia and pemphigus vulgaris. The shares could reach the mid-$50 range if results are positive, Archila tells investors in a research note. He believes the bogey for each study is not that high and keeps a Buy rating on Principia with a $45 price target. The two clinical catalysts, coupled with Phase 2 data expected in the first half of 2020 from the company's partnered program with Sanofi (SNY) in multiple sclerosis, offers "multiple shots for valuation creation" over the next nine months.
09/23/19
GUGG
09/23/19
UPGRADE
Target $403
GUGG
Buy
Guggenheim upgrades Regeneron to Buy, says sentiment too negative
As previously reported, Guggenheim upgraded Regeneron (REGN) to Buy from Neutral as analyst Yatin Suneja noted that Eylea has maintained its dominance in the branded anti-VEGF retinal disease market despite "stiff branded competition" from Roche's (RHHBY) Lucentis and off-label use of Roche's Avastin. Eylea's expansion into new indications has resulted in a diversified business and defensible market position, argued Suneja, who also believes the Street is substantially under-appreciating the market opportunity for Dupixent, which is expected to drive significant leverage in the Sanofi (SNY) antibody collaboration that recently became profitable. Suneja raised the price target on Regeneron shares to $403 from $355.
09/23/19
GUGG
09/23/19
UPGRADE
GUGG
Buy
Sanofi upgraded to Buy on Dupixent's accelerating uptake at Guggenheim
Guggenheim analyst Seamus Fernandez upgraded Sanofi (SNY) to Buy from Neutral based on his view that Dupixent's accelerating uptake across Asthma and Atopic Dermatitis, and several other indications, should drive earlier than expected profitability of the Regeneron (REGN) antibody collaboration. He also believes that emerging markets growth should help stabilize the large established products and overall diabetes franchises and thinks that vaccines business growth looks sustainable. Fernandez, who also thinks pipeline expectations seem low, set a EUR96 price target on Sanofi shares.

TODAY'S FREE FLY STORIES

BCLI

BrainStorm

$3.88

0.05 (1.31%)

06:12
11/14/19
11/14
06:12
11/14/19
06:12
Earnings
BrainStorm reports Q3 EPS (25c), consensus (22c) »

"On October 11, 2019…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 14

    Nov

  • 11

    Dec

RMBL

RumbleON

$1.50

-0.83 (-35.62%)

06:11
11/14/19
11/14
06:11
11/14/19
06:11
Recommendations
RumbleON analyst commentary  »

RumbleON price target…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 21

    Nov

AXNX

Axonics

$25.49

0.53 (2.12%)

06:09
11/14/19
11/14
06:09
11/14/19
06:09
Hot Stocks
Axonics announces FDA approval of Axonics r-SNM System »

Axonics announced the…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 14

    Nov

  • 21

    Nov

EPAM

Epam Systems

$200.74

0.85 (0.43%)

06:09
11/14/19
11/14
06:09
11/14/19
06:09
Initiation
Epam Systems initiated  »

Epam Systems initiated…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 21

    Nov

FENG

Phoenix New Media

$3.04

0.04 (1.33%)

06:07
11/14/19
11/14
06:07
11/14/19
06:07
Hot Stocks
Phoenix New Media declares 17.14c per share special cash dividend »

The company also…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

ATHX

Athersys

$1.37

0.04 (3.01%)

06:07
11/14/19
11/14
06:07
11/14/19
06:07
Hot Stocks
Athersys: Healios receives orphan designation for ARDS clinical program »

Athersys announced that…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

CSCO

Cisco

$48.44

0.06 (0.12%)

06:06
11/14/19
11/14
06:06
11/14/19
06:06
Recommendations
Cisco analyst commentary  »

Piper stays on sidelines…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 09

    Dec

  • 10

    Dec

GRUB

GrubHub

$36.63

-0.7 (-1.88%)

06:05
11/14/19
11/14
06:05
11/14/19
06:05
Periodicals
GrubHub to create 'task force' after NYC Council threatens action, NYP says »

GrubHub will create a…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

WTT

Wireless Telecom Group Inc

$1.50

0.04 (2.74%)

06:05
11/14/19
11/14
06:05
11/14/19
06:05
Hot Stocks
Wireless Telecom Group Inc to Acquire Holzworth Instrumentation »

Wireless Telecom Group…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 14

    Nov

FVRR

Fiverr

$22.55

0.99 (4.59%)

06:04
11/14/19
11/14
06:04
11/14/19
06:04
Upgrade
Fiverr rating change  »

Fiverr upgraded to Buy…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 09

    Dec

  • 12

    Dec

ROLL

RBC Bearings

$165.06

-1.19 (-0.72%)

06:04
11/14/19
11/14
06:04
11/14/19
06:04
Downgrade
RBC Bearings rating change  »

RBC Bearings downgraded…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

SWK

Stanley Black & Decker

$155.38

-2.295 (-1.46%)

06:04
11/14/19
11/14
06:04
11/14/19
06:04
Upgrade
Stanley Black & Decker rating change  »

Stanley Black &…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 18

    Nov

NRZ

New Residential

$16.06

-0.07 (-0.43%)

06:03
11/14/19
11/14
06:03
11/14/19
06:03
Downgrade
New Residential rating change  »

New Residential…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

NBEV

New Age Beverages

$2.50

0.04 (1.63%)

06:02
11/14/19
11/14
06:02
11/14/19
06:02
Earnings
New Age Beverages reports Q3 EPS (14c), consensus (4c) »

Reports Q3 revenue…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 14

    Nov

SFTBF

SoftBank

$0.00

(0.00%)

, SFTBY

SoftBank

$0.00

(0.00%)

06:02
11/14/19
11/14
06:02
11/14/19
06:02
Periodicals
SoftBank's Yahoo Japan in talks to merge with Naver's Line, Nikkei reports »

SoftBank's Yahoo…

SFTBF

SoftBank

$0.00

(0.00%)

SFTBY

SoftBank

$0.00

(0.00%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

CSCO

Cisco

$48.44

0.06 (0.12%)

06:01
11/14/19
11/14
06:01
11/14/19
06:01
Recommendations
Cisco analyst commentary  »

Citi keeps Buy on Cisco…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 09

    Dec

  • 10

    Dec

XRX

Xerox

$37.60

0.14 (0.37%)

, HPQ

HP Inc.

$19.54

-0.005 (-0.03%)

06:00
11/14/19
11/14
06:00
11/14/19
06:00
Periodicals
Carl Icahn pushes for Xerox, HP Inc union, WSJ reports »

Carl Icahn, who owns a…

XRX

Xerox

$37.60

0.14 (0.37%)

HPQ

HP Inc.

$19.54

-0.005 (-0.03%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 26

    Nov

  • 09

    Dec

MYO

Myomo

$0.54

-0.1126 (-17.26%)

05:58
11/14/19
11/14
05:58
11/14/19
05:58
Downgrade
Myomo rating change  »

Roth Capital downgrades…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

FLGT

Fulgent Genetics

$13.62

0.11 (0.81%)

05:57
11/14/19
11/14
05:57
11/14/19
05:57
Syndicate
Fulgent Genetics 2.325M share Spot Secondary priced at $11.25 »

The deal size was…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 14

    Nov

ECOR

electroCore

$1.88

0.06 (3.30%)

05:56
11/14/19
11/14
05:56
11/14/19
05:56
Downgrade
electroCore rating change  »

electroCore downgraded to…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

ECOR

electroCore

05:56
11/14/19
11/14
05:56
11/14/19
05:56
Downgrade
electroCore rating change  »

electroCore downgraded to…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

05:55
11/14/19
11/14
05:55
11/14/19
05:55
Conference/Events
SunTrust hosted company meetings at conference »

SunTrust hosted Meetings…

NICE

Nice

$159.16

0.87 (0.55%)

05:54
11/14/19
11/14
05:54
11/14/19
05:54
Earnings
Nice raises FY19 EPS view to $5.15-$5.35 from $5.13-$5.33, consensus $5.26 »

Sees FY19 revenue…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 14

    Nov

  • 19

    Nov

  • 26

    Nov

EMR

Emerson

$73.10

-0.47 (-0.64%)

05:52
11/14/19
11/14
05:52
11/14/19
05:52
Downgrade
Emerson rating change  »

HSBC downgrades Emerson…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 19

    Nov

  • 21

    Nov

NICE

Nice

$159.16

0.87 (0.55%)

05:51
11/14/19
11/14
05:51
11/14/19
05:51
Earnings
Nice reports Q3 EPS $1.30, consensus $1.28 »

Reports Q3 revenue $386M,…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 14

    Nov

  • 19

    Nov

  • 26

    Nov

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.