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RARE

Ultragenyx

$42.54

0.02 (0.05%)

08:37
09/30/19
09/30
08:37
09/30/19
08:37

Ultragenyx, Kyowa Kirin announce FDA approval for label update for Crysvita

Ultragenyx Pharmaceutical and Kyowa Kirin announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Crysvita. The label has been updated to include new clinical data demonstrating superiority of treatment with Crysvita versus oral phosphate and active vitamin D in pediatric patients with XLH, and improvement in stiffness, and maintenance of efficacy of Crysvita in adult patients with longer-term treatment. The indication has also been expanded to include infants as young as six months of age. Crysvita is an antibody that binds to and inhibits the biological activity of fibroblast growth factor 23, restoring renal phosphate reabsorption and increasing the serum concentration of 1,25 dihydroxy vitamin D. It was first approved in the U.S. in April 2018 for the treatment of XLH in adult and pediatric patients one year of age and older. For the pediatric XLH population, the U.S. label update is based on 64-week efficacy and safety data from the randomized active-controlled Phase 3 study of Crysvita compared with oral phosphate and active vitamin D in 61 children with XLH. The results showed that Crysvita was superior to conventional therapy for all key efficacy endpoints, showing a meaningful improvement in rickets severity, lower limb deformity and growth. The 64-week safety profile was similar to that observed at 40 weeks and in other Crysvita pediatric XLH studies. For the adult XLH population, the label update incorporates results from the open-label treatment period of the Phase 3 study in 134 adult patients with XLH through week 48, demonstrating that serum phosphorus levels were maintained with no evidence of loss of effect. The updated label also includes results demonstrating the continued healing of fractures and pseudofractures at week 48 and improvement in the patient-reported outcome of stiffness at week 24. The safety profile is consistent with what has been previously observed in this study, with no new adverse reactions identified during the extended treatment period.

RARE Ultragenyx
$42.54

0.02 (0.05%)

08/02/19
08/02/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Alphabet (GOOG, GOOGL), Facebook (FB), and Amazon.com (AMZN) initiated with a Buy at MKM Partners. 2. iHeartMedia (IHRT) initiated with an Overweight at JPMorgan. 3. NuStar Energy (NS) initiated with a Neutral at Mizuho. 4. Ultragenyx (RARE) assumed with an Outperform at Wedbush. 5. Avantor (AVTR) initiated with a Neutral at Cleveland Research. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
08/15/19
08/15/19
NO CHANGE

JMP Securities says Ultragenyx partnership with GeneTx a positive
JMP Securities analyst Liisa Bayko maintained an Outperform rating and $82 price target on Ultragenyx (RARE), after the company announced a partnership with GeneTx to develop preclinical asset GTX-102, which is for the treatment of Angelman Syndrome. The analyst liked the partnership, noting that it "extends the company's rare disease focus from small molecules and therapeutic proteins to oligonucleotide therapies," which the analyst believes is a significant growth area.
09/04/19
PIPR
09/04/19
NO CHANGE
Target $75
PIPR
Overweight
Ultragenyx announced positive DTX401 update, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on shares of Ultragenyx Pharmaceutical with a $75 price target following today's DTX401 update. All three patients in cohort 2 saw increases in time to hypoglycemia, with additional reductions in cornstarch consumption and daily cornstarch intake continuing to be tapered, Raymond tells investors in a research note. The analyst says that while DTX401 represents just $6 per share in his sum-of-the-parts analysis, he thinks this success should draw more attention to Ultragenyx's broader gene therapy effort, which he believes is underappreciated.
09/04/19
LEER
09/04/19
NO CHANGE
Target $85
LEER
Outperform
Ultragenyx price target raised to $85 from $80 at SVB Leerink
SVB Leerink analyst Joseph Schwartz raised his price target for Ultragenyx to $85 from $80 as he remains positive on DTX401 on the heels of encouraging Phase 1/2 cohort 2 data. The analyst notes that cohort 2 update is encouraging although the benefits reported may be more modest since the data could be confounded by the influence of cornstarch. Although the stock is down likely due to the company pushing out its Phase 1/2 cohort 3 update for DTX301 to Q4, potentially enrolling a more diverse patients group for its Phase 1/2 dose confirmation study for DTX401 and uncertainty on Phase 3 endpoints for DTX401, Schwartz remains positive on DTX401 as he believes that Ultragenyx could continue to deliver clinical benefit for patients. He reiterates an Outperform rating on the shares.

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