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Ultragenyx

$53.91

10.275 (23.55%)

08:20
01/13/20
01/13
08:20
01/13/20
08:20

Ultragenyx, Kyowa Kirin submit sBLA to FDA for Crysvita

Ultragenyx Pharmaceutica and Kyowa Kirin announced that they submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration on December 18, 2019, for Crysvita for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized. The companies expect to hear back from FDA on submission acceptance and review designation in February 2020. The sBLA package includes data from two single-arm Phase 2 studies, a 144-week study in 14 adult patients conducted by Ultragenyx in the U.S. and an 88-week study in 13 adult patients conducted by Kyowa Kirin in Japan and South Korea. In both studies, Crysvita was associated with increases in serum phosphorus and serum 1,25-dihydroxyvitamin D levels. Increased phosphate levels led to improvements in osteomalacia, mobility and vitality. Bone scans also demonstrated an increase in healed fractures and a decrease in new fractures during Crysvita treatment. During the studies, adverse events generally reflected the patients' underlying disease, and there were no serious treatment-related adverse events. Crysvita is approved by the FDA for the treatment of X-linked hypophosphatemia in adult and pediatric patients six months of age and older, and by Health Canada and Brazil's National Health Surveillance Agency for the treatment of XLH in adult and pediatric patients one year of age and older. It is approved by Japan's Ministry of Health, Labor and Welfare for the treatment of FGF23-related hypophosphatemic rickets and osteomalacia. The medicine has received European conditional marketing authorization for the treatment of XLH with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons, and an application for the expanded use in adults with XLH is currently under review by the European Medicines Agency. See below for Important Safety Information for Crysvita in X-linked hypophosphatemia.

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RARE Ultragenyx
$53.91

10.275 (23.55%)

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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