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NERV

Minerva

$4.60

-0.16 (-3.36%)

, CTLT

Catalent

$49.58

0.93 (1.91%)

07:57
11/04/19
11/04
07:57
11/04/19
07:57

Minerva to complete enrollment for Phase 3 trial of roluperidone at year-end

The company said, "The Company is currently enrolling patients in the U.S. and Europe into a Phase 3 trial of roluperidone for the treatment of negative symptoms in schizophrenia. The Company expects to complete patient enrollment at approximately year-end 2019, and top line results from the 12-week, double-blind part of the trial are expected to be available in the first half of 2020. Following the most recent meeting of the Data Safety Monitoring Board in July, the DSMB recommended continuation of the study with no changes to the protocol. This trial is a multicenter, randomized, double-blind, parallel group, placebo-controlled, 12-week trial to evaluate the efficacy and safety of 32 mg and 64 mg doses of roluperidone as measured by the Positive and Negative Syndrome Scale Marder negative symptoms factor score. The core 12-week study is followed by a 40-week, open-label extension period during which patients on the drug continue receiving their original dose and patients on placebo receive one of the two doses of roluperidone. In September, 2019, the Company entered into a long-term commercial supply agreement with Catalent under which Catalent (CTLT) will manufacture and package the finished dose form of the drug. The Company is working with Catalent to enable the tech transfer from pilot to commercial-scale production."

NERV

Minerva

$4.60

-0.16 (-3.36%)

CTLT

Catalent

$49.58

0.93 (1.91%)

  • 05

    Nov

  • 12

    Nov

  • 20

    Nov

NERV Minerva
$4.60

-0.16 (-3.36%)

09/17/19
SBSH
09/17/19
NO CHANGE
SBSH
Citi puts Amarin and Sarepta on top five SMid cap biotech pick list
Citi analyst Joel Beatty removed The Medicines Co. (MDCO) and Minerva (NERV) from his top five Buy-rated stocks in SMid cap Biotech. These stocks are up 34% and 28%, respectively, since the analyst established them as among his top five Buy-rated stocks in July. Beatty replaced The Medicines Co. and Minerva with Amarin (AMRN) and Sarepta Therapeutics (SRPT). His top five buys are now Amarin, Eloxx Pharmaceuticals (ELOX), NGM Biopharmaceuticals (NGM), PTC Therapeutics (PTCT) and Sarepta. He wants to own Amarin into the November FDA panelmeeting, believing it will be "innocuous" and lead to a risk reduction label for Vascepa. On Sarepta, Beatty thinks the recent share pullback is overblown, and he reiterates his thesis that "although there will likely be some minor bumps on the road," the company will ultimately win the Image result for Duchenne muscular dystrophy gene therapy race
09/18/19
WBLR
09/18/19
INITIATION
WBLR
Outperform
Minerva initiated with an Outperform at William Blair
William Blair analyst Myles Minter started Minerva Neurosciences, a clinical-stage biopharmaceutical company developing therapies for mood disorders and central nervous system diseases, with an Outperform rating and $26 fair value estimate. The company has four pipeline assets, three of which are in late-stage clinical development, Minter tells investors in a research note. The analyst is confident in the patient screening process and risk/benefit profile of roluperidone as potentially the first FDA-approved therapy to treat negative symptoms of schizophrenia.
09/25/19
CHDN
09/25/19
INITIATION
Target $17
CHDN
Buy
Minerva initiated with a Buy at Chardan
Chardan started Minerva Neurosciences with a Buy rating and $17 price target.
10/02/19
HCWC
10/02/19
NO CHANGE
Target $22
HCWC
Buy
Minerva investors 'missing the forest for the trees,' says H.C. Wainwright
H.C. Wainwright analyst Douglas Tsao is not that surprised that shares of Minerva Neurosciences came under pressure yesterday after the company disclosed a cyber-attack on a vendor delayed completion of enrollment for roluperidone and that the Phase 3 trial is now expected to readout in the first half of 2020. However, another "strong data set for seltorexant should have been enough to carry the day," Tsao tells investors in a research note partially titled "Missing the Forest for the Trees as Seltorexant Shines Again." While the data released by the company was not powered for statistical significance, it added "another impressive piece to the body of evidence supporting its utility," contends the analyst. Further, Tsao says that while pushing back roluperidone's readout is a disappointment, the news "doesn't fundamentally change things" since Minerva is capitalized into mid-2021 and the drug's new drug application submission has not been meaningfully impacted. The analyst reiterates a Buy rating on Minerva with a $22 price target.
CTLT Catalent
$49.58

0.93 (1.91%)

08/28/19
08/28/19
DOWNGRADE

Sector Weight
Catalent downgraded to Sector Weight on valuation at KeyBanc
As previously reported, KeyBanc analyst Donald Hooker downgraded Catalent to Sector Weight from Overweight on valuation, with shares now at near all-time highs. The analyst believes free cash flow will be limited at 20%-30% of EBITDA due to heavy capital spending, and the company will be carrying a high debt ratio, both of which may limit flexibility.
08/28/19
BARD
08/28/19
NO CHANGE
Target $60
BARD
Outperform
Catalent price target raised to $60 from $50 at Baird
Baird analyst Evan Stover raised his price target on Catalent to $60 from $50 citing recent smaller challenges fading, Paragon and broader Biologics update was solid, and the company is accelerating toward its EBITDA growth goal. Stover reiterated his Outperform rating on Catalent shares.
08/28/19
08/28/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Autodesk (ADSK) downgraded to Underperform from Neutral at BofA/Merrill with analyst Kash Rangan saying while the company posted solid July quarter results, uncertainty has increased as its fiscal 2020 guidance was lowered across the board. 2. Antero Midstream (AM) downgraded to Market Perform from Outperform at Raymond James. 3. Catalent (CTLT) downgraded to Sector Weight from Overweight at KeyBanc with analyst Donald Hooker saying he believes free cash flow will be limited at 20%-30% of EBITDA due to heavy capital spending, and the company will be carrying a high debt ratio, both of which may limit flexibility. 4. Kelly Services (KELYA) downgraded to Neutral from Buy at Northcoast with analyst John Healy saying shares are approaching his liquidation value of around $26. 5. Nabors Industries (NBR), Nine Energy Services (NINE), and Quintana Energy Services (QES) downgraded to Neutral from Buy at BofA/Merrill. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/17/19
SPHN
10/17/19
INITIATION
Target $56
SPHN
Overweight
Catalent resumed with an Overweight at Stephens
Stephens analyst Jacob Johnson resumed coverage of Catalent with an Overweight rating and $56 price target. While the stock's valuation is relatively elevated on a historical basis, he thinks the premium is warranted given the growth prospects for the company's biologics and cell/gene therapy assets.

TODAY'S FREE FLY STORIES

DY

Dycom

$50.93

0.495 (0.98%)

12:48
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12:48
Syndicate
Dycom withdraws senior notes offering due to market conditions »

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  • 11

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IMV

IMV Inc.

$2.92

0.07 (2.46%)

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IMV announces updated results from Phase 2 study of DPX-Survivac »

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KURA

Kura Oncology

$15.67

0.48 (3.16%)

12:27
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Kura Oncology announces updates for lead drug candidate tipifarnib »

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  • 08

    Dec

PTLA

Portola Pharmaceuticals

$29.22

0.86 (3.03%)

12:24
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12:24
Hot Stocks
Portola presents interim results from Phase 2a study of cerdulatinib »

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  • 08

    Dec

11:25
12/08/19
12/08
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11:25
Conference/Events
Piper Jaffray biotech analysts to hold a KOL luncheon »

Biotech Analysts hold a…

FATE

Fate Therapeutics

$13.64

0.07 (0.52%)

10:49
12/08/19
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Hot Stocks
Fate Therapeutics announces vivo preclinical data for FT596 »

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STOK

Stoke Therapeutics

$28.91

3.99 (16.01%)

10:04
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Hot Stocks
Stoke Therapeutics presents STK-001 preclinical data in Dravet syndrome »

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AUTL

Autolus Therapeutics

$14.60

-0.18 (-1.22%)

09:25
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Hot Stocks
Autolus announces new data highlighting progress on AUTO3 »

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  • 09

    Dec

AGIO

Agios Pharmaceuticals

$40.93

0.81 (2.02%)

09:22
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Agios says proof-of-concept has been established for mitapivat »

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  • 09

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ZIOP

Ziopharm

$5.16

0.06 (1.18%)

09:20
12/08/19
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09:20
Hot Stocks
Ziopharm reports pre-clinical data of Rapid Personalized Manufacture »

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  • 08

    Dec

TGTX

TG Therapeutics

$7.11

-0.57 (-7.42%)

09:18
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Hot Stocks
TG Therapeutics reports triple therapy data from Phase I/II study of ublitux »

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  • 09

    Dec

KPTI

Karyopharm

$16.30

-1.15 (-6.59%)

09:16
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12/08
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09:16
Hot Stocks
Karyopharm says four posters will be presented at ASH »

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IPHA

Innate Pharma

$6.30

(0.00%)

09:13
12/08/19
12/08
09:13
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09:13
Hot Stocks
Innate Pharma reports long-term data from Phase III trial of Lumoxiti »

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REGN

Regeneron

$372.26

4.02 (1.09%)

09:11
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12/08
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09:11
Hot Stocks
Regeneron reports initial data for REGN5458 in myeloma patients »

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  • 08

    Dec

BPMC

Blueprint Medicines

$78.50

3.92 (5.26%)

09:09
12/08/19
12/08
09:09
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09:09
Hot Stocks
Blueprint reports 77% overall response rate in 48 patients from Explorer trial »

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  • 08

    Dec

BPMC

Blueprint Medicines

$78.50

3.92 (5.26%)

09:06
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12/08
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Hot Stocks
Blueprint announces initial data from Phase 2 Pioneer trial in mastocytosis »

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  • 08

    Dec

PCG

PG&E

$9.65

-0.13 (-1.33%)

08:12
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Periodicals
PG&E settlement threatens bondholders plan, WSJ reports »

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  • 07

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SYRS

Syros Pharmaceuticals

$4.60

-0.02 (-0.43%)

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Syros announces fetal hemoglobin repressor using gene control platform »

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  • 08

    Dec

ABBV

AbbVie

$86.97

0.3 (0.35%)

08:06
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RHHBY

Roche

$0.00

(0.00%)

08:03
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Genentech reports data from two Phase III Venclexta studies in leukemia »

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  • 09

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ORTX

Orchard Therapeutics

$11.85

0.37 (3.22%)

07:59
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Hot Stocks
Orchard to present data from multiple programs at ASH meeting »

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SRRA

Sierra Oncology

$0.49

0.1035 (27.13%)

06:55
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Conference/Events
Sierra Oncology to hold an analyst and investor event »

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  • 08

    Dec

RUHN

Ruhnn

$6.19

-0.2 (-3.13%)

04:55
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Conference/Events
Ruhnn management to meet with Mizuho »

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  • 08

    Dec

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SRRA

Sierra Oncology

$0.49

0.1035 (27.13%)

04:55
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Conference/Events
Sierra Oncology to hold an analyst and investor event »

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  • 08

    Dec

04:55
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Piper Jaffray biotech analysts to hold a KOL luncheon »

Biotech Analysts hold a…

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