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RARE

Ultragenyx

$60.55

-0.75 (-1.22%)

16:04
01/15/20
01/15
16:04
01/15/20
16:04

GeneTx, Ultragenyx announce IND application active for GTX-102

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical (RARE) announced that GeneTx's Investigational New Drug, or IND, application for GTX-102, an experimental antisense oligonucleotide being evaluated for the treatment of Angelman syndrome, filed with the FDA is now active. Enrollment in the Phase 1/2 study is expected to begin in the first half of 2020. "The FDA's clearance of the IND to evaluate GTX-102 in patients with Angelman syndrome represents a significant milestone for the Angelman community," said Paula Evans, CEO at GeneTx. "Assessing an investigational therapy that aims to address the underlying cause of this devastating disorder has the potential to meaningfully alter the clinical course of patients' lives." "Based on preclinical data, we believe that GTX-102 offers tremendous promise and may one day provide patients with a potentially transformative therapeutic option," said Camille Bedrosian, Chief Medical Officer of Ultragenyx. "We look forward to continuing our partnership with GeneTx to address this devastating disorder for which there are currently no approved treatments."

  • 31

    Jul

RARE Ultragenyx
$60.55

-0.75 (-1.22%)

11/27/19
COWN
11/27/19
NO CHANGE
Target $62
COWN
Outperform
Ultragenyx weakness a buying opportunity, says Cowen
Cowen analyst Yaron Werber noted Ultragenyx shares have been weak due to concerns about the likelihood for success for DTX401 in GSD1a and its Q3 miss on global Crysvita sales. also leading to investor concerns was the announcement of its COO resignation. The analyst believes the change in protocol with DTX401 should boost its chance for success and recent weakness in Crysvita sales in Germany due to pricing should normalize. Werber reiterated his Outperform rating and $62 price target on Ultragenyx shares.
12/18/19
PIPR
12/18/19
NO CHANGE
Target $70
PIPR
Overweight
Piper remains buyer of Ultragenyx after Royalty Pharma deal
Piper Jaffray analyst Christopher Raymond reiterated an Overweight rating on Ultragenyx Pharmaceutical but cut his price target to $70 from $75, saying he remains a buyer of the stock after the company announced it will offload EU burosumab royalty rights to Royalty Pharma for $320M. In that his sum of parts had this royalty stream, the analyst said he believes Ultragenyx has monetized it for a "good price," as this brings the pro-forma cash balance up close to $850M to fund pipeline activities and potentially bring in additional rare disease assets. Raymond added that, with key catalysts well into next year, including updates from gene therapy assets DTX301 and DTX401, as well as a July 2020 PDUFA date for UX007, he continues to "like the setup."
01/10/20
PIPR
01/10/20
NO CHANGE
Target $70
PIPR
Overweight
Ultragenyx gene therapy update 'surprisingly positive,' says Piper Sandler
Piper Sandler analyst Christopher Raymond says Ultragenyx Pharmaceutical issued a "surprisingly positive" update for its DTX301 gene therapy program. While it seemed expectations for the data were lowered after an additional prophylactic steroid treatment cohort was added to the study earlier this year, yesterday's update for Cohort 3 in the ongoing Phase 1/2 study "knocked it out of the park," Raymond tells investors in a research note. Two of three patients in the highest dose cohort responded to treatment, and the third patient has been deemed a potential responder, plus an additional patient from Cohort 2 responded, adds the analyst. The update removes "any sort of" overhang to the DTX301 program and the gene therapy franchise, he contends. Raymond remains a buyer of Ultragenyx and continues to like the stock's setup. He has an Overweight rating on the name with a $70 price target.
01/10/20
RHCO
01/10/20
NO CHANGE
Target $80
RHCO
Buy
Ultragenyx price target raised to $80 from $75 at SunTrust
Before the market open, SunTrust analyst Joon Lee raised his price target for Ultragenyx to $80 from $75 and reiterated a Buy rating after the company reported topline Cohort 3 data from the DTX301 Ph1/2 study which led to 3 out of 3 patients showing a response. Lee tells investors in a research note that the company plans to start Cohort 4 using the same 1x10^13 GC/kg dose used in cohort 3 but adding a prophylactic oral steroid regimen to possibly further boost efficacy, adding that a simple updosing can drive improved efficacy without increases in safety risk should come as a relief to many investors.

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APLS

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$NSD

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