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AIMT

Aimmune

$26.40

1.23 (4.89%)

, REGN

Regeneron

$384.20

12.47 (3.35%)

08:12
10/15/18
10/15
08:12
10/15/18
08:12

Aimmune Therapeutics announces initiation of Phase 2 study of AR101

Aimmune Therapeutics (AIMT) announced the initiation of a phase 2 study, with Regeneron (REGN) and Sanofi (SNY), of AR101 with adjunctive dupilumab in peanut-allergic patients. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy, and dupilumab is Regeneron and Sanofi's fully human monoclonal antibody that inhibits signaling of IL-4 and IL-13 cytokines, which are believed to be major drivers of type 2 inflammation. Aimmune is providing clinical supply of AR101, as well as food challenge materials, for the Regeneron-sponsored study. The phase 2 clinical trial is designed to evaluate the efficacy and safety of dupilumab as adjunct to AR101 and is expected to enroll approximately 160 peanut-allergic patients ages 6-17 at 25 sites across the United States. All participants will receive AR101 and will be initially randomized 2:1 to receive dupilumab or placebo. Dosing with dupilumab or placebo will take place in combination with AR101 treatment through the AR101 up-dosing period. The primary objective of the trial is to assess whether dupilumab as adjunct to AR101 in a Characterized Oral Desensitization ImmunoTherapy regimen, compared to placebo with AR101 in a CODIT regimen, improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a double-blind, placebo-controlled food challenge with a single-highest tolerated dose of 1,000 mg of peanut protein. There will be additional DBPCFCs after a 24-week maintenance period and at the end of a 12-week, treatment-free follow-up period.

AIMT

Aimmune

$26.40

1.23 (4.89%)

REGN

Regeneron

$384.20

12.47 (3.35%)

SNY

Sanofi

$42.89

-0.83 (-1.90%)

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AIMT Aimmune
$26.40

1.23 (4.89%)

05/29/18
JMPS
05/29/18
NO CHANGE
JMPS
JMP says AnaptysBio weakness ahead of asthma read-out a buying opportunity
After Aimmune Therapeutics (AIMT) presented new results from its Phase 3 trial of AR101 in peanut allergy at a medical congress, JMP Securities analyst Konstantinos Aprilakis noted that shares of competitor AnaptysBio (ANAB) are off about 42% over the last three months. He remains a buyer of AnaptysBio on any weakness going into the top-line proof of concept data from the Phase 2a trial of ANB020 in eosinophilic asthma, which is expected in Q3. The analyst, who reminds investors that he assigns about $61/share for the eosinophilic asthma indication in his valuation of AnaptysBio, maintains an Outperform rating and $180 price target on AnaptysBio shares, which closed Friday at $77.90.
06/12/18
JMPS
06/12/18
NO CHANGE
Target $40
JMPS
Outperform
JMP Securities continues to recommend Aimmune after Dallas named CEO
JMP Securities analyst Liisa Bayko continues to recommend Aimmune (AIMT) shares following the company's "not-so-unexpected announcement" of a new CEO. Stephen Dilly announced plans to retire last fall and the incoming CEO, Jayson Dallas, who was most recently EVP and Chief Commercial Officer of Ultragenyx Pharmaceutical (RARE), has a skillset and expertise that should prove useful ahead of a potential launch of AR101, Bayko tells investors. She thinks a 5x multiple on her estimated peak sales of about $1B for AR101 is "justifiable," noting that this is before considering Aimmune's pipeline for egg and walnut allergy. Bayko keeps an Outperform rating and $40 price target on Aimmune shares.
08/13/18
FBCO
08/13/18
NO CHANGE
Target $40
FBCO
Outperform
Aimmune price target lowered to $40 form $47 at Credit Suisse
Credit Suisse analyst Vamil Divan lowered his price target for Aimmune to $40 from $47, while reiterating an Outperform rating on the shares. In conjunction with earnings, the analyst has adjusted his expected sales ramp for AR101, while also increasing his assumptions around expenses that will be required to successfully commercialize the product.
09/13/18
STFL
09/13/18
INITIATION
Target $33
STFL
Hold
Aimmune initiated with a Hold at Stifel
Stifel analyst Derek Archila initiated Aimmune with a Hold rating and a price target of $33. The analyst contends that its "AR101 is approvable", with a meaningful uptake in the newly created peanut allergy immunotherapy category, which he estimates to become a "$3B market opportunity". Archila further notes that AR101 could achieve 20%-40% market share at its peak, adding that he would recommend the stock at a price below $25 per share.
REGN Regeneron
$384.20

12.47 (3.35%)

10/01/18
PIPR
10/01/18
NO CHANGE
PIPR
Overweight
Piper keeps Overweight on Regeneron after Libtayo approval
Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Regeneron Pharmaceuticals (REGN) after Friday's FDA approval of Libtayo in cutaneous squamous cell carcinoma. Timing is about a month ahead of the late-October FDA action date for Regeneron/Sanofi's (SNY) PD-1 inhibitor, but a positive decision was expected given the drug's "compelling data" in advanced CSCC, Raymond tells investors in a research note. While Libtayo will enter the market as the sixth approved PD-(L)1 inhibitor and third approved PD-1 agent, Raymond thinks readouts from the ongoing development program in other indications such as first-line non-small-cell lung carcinoma may make the case for moderate Libtayo uptake. However, he continues to like the set-up for Regeneron shares going forward.
10/01/18
CANT
10/01/18
INITIATION
Target $415
CANT
Neutral
Regeneron initiated with a Neutral at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young started Regeneron Pharmaceuticals with a Neutral rating and $415 price target.
10/01/18
LEER
10/01/18
NO CHANGE
Target $512
LEER
Outperform
Regeneron price target raised to $512 from $506 at Leerink
Leerink analyst Geoffrey Porges raised his price target for Regeneron to $512 from $506 after the FDA approved the jointly developed and commercialized REGN/SNY PD-1 antibody cemiplimab, now known as Libtayo. The analyst reiterates an Outperform rating on the shares.
10/11/18
PIPR
10/11/18
NO CHANGE
Target $450
PIPR
Overweight
Piper remains buyer of Regeneron ahead of October 20 FDA action date
Piper Jaffray analyst Christopher Raymond says he remains a buyer of Regeneron Pharmaceuticals (REGN) ahead of the Dupixent asthma October 20 FDA action date. With consensus expecting this indication to contribute well over $1B in revenue in coming years, approval is a "critical near-term catalyst" for the shares, Raymond tells investors in a research note. The analyst adds that while some investors have expressed angst over the breadth of the label, namely restricting use to eosinophilic asthma, he believes recent Sanofi (SNY) commentary provides reason for optimism. The totality of clinical data and the biology behind Dupixent supports a broad label, Raymond contends. He maintains an Overweight rating on Regeneron with a $450 price target.
SNY Sanofi
$42.89

-0.83 (-1.90%)

10/08/18
GUGG
10/08/18
INITIATION
GUGG
Neutral
Sanofi initiated with a Neutral at Guggenheim
Guggenheim analyst Seamus Fernandez started Sanofi with a Neutral rating and EUR83 price target. He sees its low earnings risk, strong dividend, and reasonable valuation being offset by competitive intensity building for Dupixent and its hemophilia franchises.
10/09/18
BARD
10/09/18
INITIATION
Target $50
BARD
Outperform
Principia Biopharma initiated with an Outperform at Baird
Baird analyst Brian Skorney started Principia Biopharma (PRNB) with an Outperform rating and $50 price target, stating that its BTK inhibitor partnered with Sanofi (SNY) for multiple sclerosis has blockbuster potential. He also believes PRN1008, which is entering Phase 3, has a worldwide opportunity over $500M in pemphigus that would also open the door for a host of other indications.

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RNG

RingCentral

$167.20

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CASY

Casey's General Stores

$161.02

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$254.72

-19.88 (-7.24%)

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Adobe

$270.00

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IP

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