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ASND

Ascendis Pharma

$119.21

-3.85 (-3.13%)

15:35
03/24/19
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15:35
03/24/19
15:35

Ascendis Pharma announces top-line results from Phase 3 heiGHt trial

Ascendis Pharma announced top-line results from its pivotal Phase 3 heiGHt Trial were presented at the Endocrine Society's annual meeting, ENDO 2019, in New Orleans. Trial results demonstrated that TransCon Growth Hormone administered once-weekly to children with pediatric growth hormone deficiency had comparable safety and tolerability to daily Genotropin, with a significantly greater increase in annualized height velocity over the one-year study period. TransCon hGH has been designed to provide sustained release of unmodified hGH, the same growth hormone used in daily therapies, at a predictable rate over one week. The heiGHt Trial evaluated 161 treatment-naive children with GHD randomized in a 2:1 ratio to receive either once-weekly TransCon hGH or daily Genotropin for 52 weeks. Top-line results showed that once-weekly TransCon hGH was superior to once-daily hGH on the primary endpoint of annualized height velocity at 52 weeks. In the primary analysis of the intent-to-treat population using ANCOVA, TransCon hGH demonstrated an AHV of 11.2 cm/year compared to 10.3 cm/year for the daily hGH. The treatment difference was 0.86 cm/year with a 95% confidence interval of 0.22 to 1.50 cm/year. The AHV for TransCon hGH was significantly greater than the daily hGH. In addition, the incidence of poor responders was 4% and 11% in the TransCon hGH and daily hGH arms, respectively. In the trial, no serious adverse events related to study drug were observed in either arm. No treatment-emergent adverse events leading to discontinuation of study drug were observed in either arm. Adverse events leading to dose reduction occurred twice in the TransCon hGH arm and once in the daily hGH arm. Two subjects in each treatment arm experienced mild injection site reactions that were considered adverse events. Two subjects, one from each arm, withdrew from the trial prior to the final visit.

ASND Ascendis Pharma
$119.21

-3.85 (-3.13%)

03/04/19
CANT
03/04/19
NO CHANGE
CANT
Ascendis Pharma price target raised to $185 from $102 at Cantor Fitzgerald
03/04/19
CANT
03/04/19
NO CHANGE
Target $185
CANT
Overweight
Ascendis Pharma price target raised to $185 from $102 at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young raised her price target for Ascendis Pharma to $185 from $102 as she was "positively surprised" that the TransCon hGH study for growth hormone achieved a superior result on annualized growth velocity of .86cm. The analyst thinks that the expectation had been non-inferiority with a slightly favorable numerical trend. Young also thinks safety was clean as well, which has been a challenge with other long acting growth hormones. She would expect shares to trade up 50%-100% based on her model, and sees continued upside from shares as additional programs, such as TransCon PTH, achieve proof of concept and more candidates from the proprietary TransCon platform enter the clinic. The analyst reiterates an Overweight rating on the shares.
03/07/19
JPMS
03/07/19
NO CHANGE
Target $145
JPMS
Overweight
Ascendis Pharma price target raised to $145 from $85 at JPMorgan
JPMorgan analyst Jessica Fye raised her price target for Ascendis Pharma to $145 from $85 and reiterates an Overweight rating on the shares. While the analyst does not see an "obvious catalyst" over the next two years to drive a similar magnitude single-day move as Monday's Phase III data, she sees a "compelling case for continued steady value creation." Ascendis' platform is now de-risked and its story "is still in the early innings with multiple untapped levers in the model," Fye tells investors in a research note.
03/07/19
WEDB
03/07/19
NO CHANGE
Target $217
WEDB
Outperform
Ascendis Pharma price target raised to $217 from $81 at Wedbush
Wedbush analyst Liana Moussatos raised her price target for Ascendis Pharma to $217 from $81 to her acquisition price following "impressive" topline results from the pivotal Phase 3 heiGHt trial testing TransCon hGH for treatment of pediatric growth hormone deficiency. The analyst believes the results not only validates Ascendis proprietary TransCon technology and its ability to create best-in-class clinical profiles but may also lead to Ascendis' acquisition if fliGHt results in Q2 achieve at least non-inferiority. Moussatos reiterates an Outperform rating on the shares.

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