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MRNA

Moderna

$16.34

-0.78 (-4.56%)

06:35
09/12/19
09/12
06:35
09/12/19
06:35

Moderna reports 'positive' Phase 1 results from study of mRNA-1944

Moderna announced positive data in the first analysis of safety and activity in its Phase 1 study evaluating escalating doses of mRNA-1944 administered via intravenous infusion in healthy adults. mRNA-1944 encodes for an antibody with activity against chikungunya virus. At all three dose levels, the administration of mRNA-1944 led to detectable levels of CHKV-24 antibody in all participants, ranging from 1 microg/mL to 14 microg/mL. These results mark the first systemic mRNA therapeutic to show production of a secreted protein in humans. mRNA-1944 is being developed with financial support from the Defense Advanced Research Projects Agency, an agency of the U.S. Department of Defense. mRNA-1944 is the first development candidate from the company's systemic therapeutics modality to start clinical testing and utilizes the same lipid nanoparticle formulation as the company's rare disease program for methylmalonic acidemia. A total of 22 healthy adults have been enrolled in the study to date. The initial analysis evaluated the safety and pharmacology of intravenous administration of mRNA-1944 at three dose levels of 0.1 mg/kg, 0.3 mg/kg, and 0.6 mg/kg; six participants received placebo. Administration of mRNA-1944 resulted in dose-related increases in CHKV-24 antibody levels, with average Cmax antibody levels of 2.0, 7.9 and 10.2 ug/mL at the low, middle and high doses, respectively. At all doses, all participants exceeded the levels of antibody expected to be protective against chikungunya infection following a single dose, with the middle and high doses projected to maintain antibody levels above protective levels for at least 16 weeks. All participants also showed circulating neutralizing antibody activity against chikungunya virus replication in an NT50 assay, demonstrating that mRNA-1944 resulted in the production of fully functional protein in vivo. All participants in the study received antihistamine premedication. No participants received corticosteroids either as premedication or treatment. None of the participants treated with mRNA-1944 at the low or middle doses experienced significant adverse events. Three of the four participants at the high dose had infusion-related AEs, with the highest grade by subject being Grade 1, Grade 2 and Grade 3. The Grade 3 AEs were tachycardia and an elevated white blood cell count. The same participant experienced Grade 2 AEs of nausea, emesis, fever and inverted T waves on a routine EKG (without associated cardiac symptoms and which later resolved). The fourth participant at the high dose had no related adverse events. There were no meaningful changes in liver or kidney laboratory results. There have been no serious AEs in the study. All AEs were transient and resolved spontaneously without treatment.

  • 12

    Sep

MRNA Moderna
$16.34

-0.78 (-4.56%)

05/29/19
OPCO
05/29/19
NO CHANGE
Target $31
OPCO
Outperform
Moderna price target raised to $31 from $27 at Oppenheimer
Oppenheimer analyst Hartaj Singh raised his price target for Moderna to $31 from $27 after spending time with management. The analyst was "consistently impressed" with the updates on safety, manufacturing, and increasing dosing experience of various Moderna therapeutics in different modalities. He reiterates an Outperform rating on the shares.
06/20/19
PIPR
06/20/19
NO CHANGE
Target $30
PIPR
Overweight
Moderna recent weakness a buying opportunity, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff recommends using the recent weakness in shares of Moderna as a buying opportunity. The stock is down 19% on increased volume since the initial public offering lock-up expiry on June 5, Tenthoff tells investors in a research note. The analyst is most focused on the Phase I chikungunya antibody data in the second half of 2019, which he believes will have read-through to Moderna's growing orphan disease pipeline. He reiterates an Overweight rating on the shares with a $30 price target.
07/24/19
MSCO
07/24/19
NO CHANGE
MSCO
Warming could create need for up to $125B more vaccinations, says Morgan Stanley
Morgan Stanley analysts led by Matthew Harrison offered a report sizing the impact on biopharma from climate change. They conclude that warmer temperatures are likely to create more hospitable environments for disease transmission and they cite recent research that suggests 385M-725M more people than today may be exposed to infectious diseases such as dengue, Zika, chickungunya, and yellow fever by 2050. They estimate $50B-$125B of incremental vaccinations may be needed, but see the potential for that figure to be as high as $200B with branded pricing of more complicated vaccines. The companies best positioned to benefit from a rising need for infectious disease vaccines include Sanofi (SNY), GlaxoSmithKline (GSK), Moderna (MRNA), Merck (MRK), Johnson & Johnson's (JNJ) Janssen, Pfizer (PFE) and Takeda (TAK), according to Harrison and the team.
08/16/19
PIPR
08/16/19
NO CHANGE
Target $30
PIPR
Overweight
Moderna should be bought ahead of catalysts, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff recommends buying shares of Moderna on weakness ahead of the company's R&D day on September 12. Moderna has completed enrollment of the Phase I study of cytomegalovirus vaccine mRNA-1647 with data soon, and the company could also report preliminary Phase I data on intratumoral mRNA-2754 by the end of 2019, Tenthoff tells investors in a research note. Further, the analyst is focused on the Phase I chikungunya antibody mRNA-1944 data in Q4 for read-through to Moderna's orphan disease pipeline. He sees multiple clinical data readouts through the end of the year and reiterates an Overweight rating on the shares with a $30 price target.

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STT

State Street

$63.40

3.69 (6.18%)

20:09
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Upgrade
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SUN

Sunoco

$32.43

0.32 (1.00%)

19:53
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Upgrade
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TLF

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AAPL

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, FB

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GLD

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TECK

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OVLY

Oak Valley Bancorp

$16.40

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FTNW

FTE Networks

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TNXP

Tonix Pharmaceuticals

$0.45

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RLMD

Relmada Therapeutics

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16:55
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NWSA

News Corp.

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-0.19 (-1.39%)

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FOMX

Foamix

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POAI

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BK

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FOMX

Foamix

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BAC

Bank of America

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