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RARE

Ultragenyx

$53.91

10.275 (23.55%)

09:27
01/13/20
01/13
09:27
01/13/20
09:27

Ultragenyx announces 2020 milestones

Recent Updates and Upcoming Milestones: Crysvita for X-linked Hypophosphatemia: Non-dilutive $320 million royalty sale of future European royalties. In December, Ultragenyx sold to Royalty Pharma for $320 million its royalty interest in Crysvita in the European territory, where it is being commercialized by Kyowa Kirin Co., Ltd. Crysvita for Tumor-Induced Osteomalacia: Supplemental Biologics License Application submitted. Ultragenyx submitted the sBLA to the U.S. FDA on December 18, 2019 and expects to hear back from FDA on submission acceptance and review designation in February 2020. UX007 for Long-Chain Fatty Acid Oxidation Disorders: NDA under review by U.S. FDA. The U.S. FDA accepted for review the New Drug Application and has set a Prescription Drug User Fee Act date of July 31, 2020. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss the application. DTX301 for Ornithine Transcarbamylase Deficiency: Positive data from higher cohort of Phase 1/2 study; data from prophylactic steroid cohort in second half 2020. Recent positive data from Cohort 3 indicated two confirmed responders and a potential third responder out of three total patients, as well as a new responder in Cohort 2. There are currently up to six responders of the nine dosed to date with a more consistent response at higher doses. Ultragenyx is initiating a fourth cohort using prophylactic steroids at the same dose as Cohort 3. The first patient is expected to be enrolled in the first half of 2020, and data from the prophylactic steroid cohort are expected in the second half of 2020. DTX401 for Glycogen Storage Disease Type Ia: Positive data from Phase 1/2 study; enrollment complete in confirmatory cohort and data expected in first half 2020. Enrollment is complete in the confirmatory cohort of three patients at the second dose cohort, with data expected in the first half of 2020. Following the results of the confirmatory cohort, a Phase 3 study could begin in the second half of 2020. GTX-102 for Angelman Syndrome: Partnered program with GeneTx; IND expected in first half 2020. An investigational new drug application is expected in the first half of 2020. In August 2019, Ultragenyx and GeneTx announced a partnership to develop GTX-102 with Ultragenyx receiving an exclusive option to acquire GeneTx. UX701 for Wilson Disease: IND expected in second half 2020: An IND application is expected in the second half of 2020 for a new gene therapy for Wilson disease, a larger rare metabolic disease. UX701 will be the company's second clinical program to utilize its HeLa manufacturing system. The Hemophilia A program partnered with Bayer uses the HeLa system and has released its first clinical data.

  • 13

    Jan

  • 31

    Jul

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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