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RARE

Ultragenyx

$53.35

1.85 (3.59%)

08:40
01/22/19
01/22
08:40
01/22/19
08:40

Ultragenyx reports reductions in major clinical events sustained in UX007 trial

Ultragenyx Pharmaceutical announced topline data from an ongoing long-term extension study of UX007 in patients with long-chain fatty acid oxidation disorder, demonstrating sustained reductions in the duration and frequency of major clinical events and a long-term safety profile similar to what has previously been seen with UX007. A total of 75 patients are enrolled in the long-term safety and efficacy study including 24 patients who were previously enrolled in the company-sponsored Phase 2 study, 20 naive patients who had not previously been treated with UX007 and 31 patients from expanded access or investigator-sponsored studies. For the Phase 2 study and naive patients, retrospective medical chart data were collected allowing comparison of the annualized major clinical event and duration rates between pre-UX007 and UX007 treatment periods. Patients who previously completed the Phase 2 company-sponsored study and rolled over to the extension study have now received treatment for an additional 78 weeks. The median annualized major clinical event and duration rates during the extension treatment period were zero. Over the entire treatment period, patients had a 67 percent reduction in median annualized event rate and a 66 percent reduction in the median annualized duration rate. The safety profile observed in the long-term extension study was consistent with what has been previously observed with UX007. The most common treatment-related adverse events were diarrhea, vomiting, and abdominal pain. One patient discontinued due to a treatment-related adverse event. There were two deaths during the extension study, both deemed to be related to disease progression and not due to treatment with UX007. Ultragenyx is on track to submit the New Drug Application in mid-2019. The submission will include these data from this long-term efficacy and safety extension study in 75 patients, the Phase 2 study of UX007 in 29 patients, a retrospective medical record review of 20 original compassionate use patients, data from 70 patients treated through expanded access, and a randomized controlled investigator-sponsored study of 32 patients showing an effect of UX007 on cardiac function.

RARE Ultragenyx
$53.35

1.85 (3.59%)

11/08/18
11/08/18
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Archer Daniels (ADM) upgraded to Buy from Hold at Argus with analyst Deborah Ciervo citing the company's recent strong performance and improvement in its Oilseeds, Origination, and Nutrition divisions. 2. Ultragenyx (RARE) upgraded to Neutral from Sell at Citi with analyst Yigal Nochomovitz saying his long-standing concerns on Ultragenyx's valuation "have substantially played out with recent pipeline disclosures having rapidly reset the valuation." 3. Medifast (MED) upgraded to Buy from Neutral at Sidoti. 4. Knight-Swift (KNX) upgraded to Buy from Neutral at Goldman Sachs with analyst Matthew Reustle saying he is bullish on Knight citing incremental evidence that the merger with Swift Transportation will deliver margin improvement through the end of the decade, reduced investor expectations following recent estimate revisions, and a view that Knight is more defensive through a down-cycle with a de-risked valuation. 5. Axon (AAXN) Enterprise upgraded to Overweight from Neutral at JPMorgan with analyst Mark Strouse saying the stock pulled back 16% yesterday following the company's Q3 results and guidance that implies a dip in revenue growth during Q4. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
01/02/19
RAJA
01/02/19
DOWNGRADE
RAJA
Market Perform
Ultragenyx downgraded to Market Perform from Outperform at Raymond James
01/02/19
RAJA
01/02/19
DOWNGRADE
RAJA
Market Perform
Ultragenyx downgraded to Market Perform on lack of catalysts at Raymond James
As previously reported, Raymond James downgraded Ultragenyx to Market Perform from Outperform. Analyst Laura Chico said Ultragenyx lacks near-term catalysts which makes it more vulnerable in a "risk off" environment. Chico remains encouraged by the Crysvita launch, but said the company is only proportion of the economics.
01/04/19
PIPR
01/04/19
NO CHANGE
Target $70
PIPR
Overweight
Ultragenyx preliminary results for DTX401 'impressive,' says Piper Jaffray
Piper Jaffray analyst Christopher Raymond noted that Ultragenyx management had been guiding that the DTX401 dose in the first patient cohort was likely suboptimal, making expectations low, but he called the preliminary results reported for the first three patients treated "impressive." Two of three patients experienced significant increases in time to hypoglycemia at Week 12, while a biologic response was observed in patient three, Raymond points out. He expects today's update to provide further confidence and value for the company's gene therapy pipeline, which has been "seemingly underappreciated," added Raymond, who keeps an Overweight rating on Ultragenyx shares.

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