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TORC

ResTORbio

$9.00

0.02 (0.22%)

07:12
07/25/18
07/25
07:12
07/25/18
07:12

ResTORbio announces 'positive' topline results in Phase 2b trial of RTB101

resTORbio announced positive topline results from its dose-ranging Phase 2b clinical trial that enrolled 652 elderly patients at increased risk of morbidity and mortality associated with respiratory tract infections. In this trial, RTB101, an oral, selective, and potent inhibitor of target of rapamycin complex 1, demonstrated a statistically significant and clinically meaningful reduction in the percentage of patients with one or more laboratory-confirmed RTIs during the 16-week treatment period compared to placebo, the primary endpoint of the study, with the 10 mg once daily dose. Greater TORC1 inhibition with RTB101 10 mg in combination with everolimus 0.1 mg did not meet the primary endpoint, suggesting that that less TORC1 inhibition with RTB101 10 mg once daily may have greater benefit in high-risk elderly patients. The Phase 2b trial was a two-part, randomized, double-blind, placebo-controlled clinical trial conducted during the winter cold and flu season in the southern hemisphere and northern hemisphere. Patients enrolled were those at increased risk of morbidity and mortality from RTIs including patients who were: 85 years of age or older, or 65 years of age or older with asthma, type 2 diabetes mellitus, chronic obstructive pulmonary disease, or current smokers. The doses investigated in Part 1 were RTB101 5 mg and RTB101 10 mg once daily. The doses investigated in Part 2 were RTB101 10 mg once daily, RTB101 10 mg twice daily and RTB101 10 mg in combination with everolimus 0.1 mg once daily. The following was observed in an analysis of the primary endpoint: A 30.6% decrease relative to placebo in the percentage of all patients treated with RTB101 10 mg once daily who developed one or more laboratory-confirmed RTs. A 20.6% decrease relative to placebo in the percentage of all patients treated with RTB101 5 mg once daily who developed one or more laboratory-confirmed RTIs. No decrease relative to placebo in the percentage of patients treated with either RTB101 10 mg twice daily or the combination of RTB101 10 mg + everolimus 0.1 mg once daily who developed one or more laboratory-confirmed RTIs, suggesting that less TORC1 inhibition with RTB101 10 mg once daily may have greater benefit in high-risk elderly patients. To better understand the activity observed in the RTB101 10 mg once daily cohort, a pre-specified analysis of each patient subgroup enrolled in the study was conducted. The following decreases in the percentage of patients with laboratory-confirmed RTIs were observed in the RTB101 10 mg once daily cohort as compared to the placebo cohort: A 68.4% decrease in all asthma patients. A 66.7% decrease in all patients 85 years of age and older. A 26.9% decrease in all T2DM patients. No decrease was observed in either COPD patients or current smokers; a 42.0% decrease in all patients was observed when excluding patients with COPD and a 43.9% decrease in all patients was observed when excluding current smokers. All doses were observed to be well-tolerated. Data from the RTB101 10 mg once daily cohort are as follows: Adverse events were balanced between the RTB101 10 mg once daily and placebo treatment groups. 4.5% of subjects in the RTB101 10 mg once daily cohort and 7.2% of subjects in the placebo cohort had a serious adverse event, none of which were considered related to study drug. 4.5% of subjects in the RTB101 10 mg once daily cohort and 6.1% of subjects in the placebo cohort discontinued study drug due to an AE. All AEs were mild or moderate except for 11 severe AEs in the RTB101 10 mg once daily cohort and 22 severe AEs in the placebo cohort.

TORC ResTORbio
$9.00

0.02 (0.22%)

02/20/18
EVER
02/20/18
INITIATION
Target $28
EVER
Outperform
ResTORbio initiated with an Outperform at Evercore ISI
Evercore initiated ResTORbio with an Outperform and $28 price target.
02/20/18
BOFA
02/20/18
INITIATION
Target $23
BOFA
Buy
ResTORbio initiated with a Buy at BofA/Merrill
BofA/Merrill analyst Tazeen Ahmad initiated ResTORbio with a Buy and $23 price target telling investors its pipeline addresses unmet needs to to enhance the weakened immune system among the elderly, PH2a RTB101 data showed favorable efficacy and safety in preventing RTIs, has the potential to expand into broader indications, and is the most advanced immunosenescence-targeted clinical program.
02/20/18
WEDB
02/20/18
INITIATION
Target $30
WEDB
Outperform
ResTORbio initiated with an Outperform at Wedbush
Wedbush analyst Robert Driscoll started ResTORbio with an Outperform rating and $30 price target saying it is developing a potential best-in-class TORC1 inhibition program for the treatment of aging-related diseases, with an initial focus on the reduction of respiratory-tract infections in the elderly.
02/20/18
LEER
02/20/18
INITIATION
Target $36
LEER
Outperform
ResTORbio initiated with an Outperform at Leerink
Leerink analyst Geoffrey Porges started ResTORbio with an Outperform rating and $36 price target based on his sales forecast for lead asset RTB101 +/- RAD001 in respiratory tract infection prevention in the elderly.

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Tellurian

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Roku

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Conference/Events
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EHTH

eHealth

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Jefferies Financial Group

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Solaris Oilfield

$13.12

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CNB Financial

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Earnings
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Sunesis

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HRI

Herc Holdings

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Gabelli reports 18.15% stake in Herc Holdings »

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GMAB

Genmab

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Genmab discloses BlackRock stake in company reached 5% »

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DISH

Dish

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Dish call volume above normal and directionally bullish »

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Gap

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Action Economics Survey results: »

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JCP

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Sale of T-Mobile, Sprint assets to Dish 'imminent,' NY Post says »

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