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uniQure selloff on clinical hold brings good entry point, says Chardan » 10:2912/2212/22/20
The 16% selloff yesterday…
The 16% selloff yesterday in uniQure shares after the FDA placed a clinical hold on its Phase III trial of AAV5-based gene therapy EtranaDez in hemophilia B creates a good entry point, Chardan analyst Gbola Amusa tells investors in a research note. The clinical hold relates to a "possibly related" serious adverse event associated with a preliminary diagnosis of hepatocellular carcinoma in one patient treated with EtranaDez in October 2019, the analyst points out. Amusa adds that uniQure's deal with CSL Behring has no opt-out based on the clinical hold, the patient was "extremely high risk," and that the company's guidance for a Biologics License Application filing is unchanged for the second half of 2021. Amusa keeps a Buy rating on uniQure with an $85 price target.
uniQure's EtranaDez unlikely to raise HCC risk in hemB patients, says Jefferies » 07:4212/2212/22/20
After uniQure announced…
After uniQure announced its Phase 3 HOPE-B trial for EtranaDez was placed on clinical hold by the FDA after a safety report of a preliminary diagnosis of hepatocellular carcinoma, or HCC, in one patient, Jefferies analyst Suji Jeong noted that no other cases of liver cancer have been reported in uniQure's clinical and animal studies, or in other AAV gene therapy trials. Given those facts, and the fact that the patient already carried multiple risk factors for liver cancer, Jeong views it as unlikely that EtranaDez increases HCC risk in hemophilia B population, the analyst tells investors. Joeng maintains a Buy rating on uniQure with a $62 price target.
uniQure price target lowered to $53 from $61 at RBC Capital » 06:2812/2212/22/20
RBC Capital analyst Luca…
RBC Capital analyst Luca Issi lowered the firm's price target on uniQure to $53 from $61 and keeps an Outperform rating on the shares after EtranaDez was put on clinical hold due to a single case of suspected hepatocellular carcinoma. Issi believes this tilts the risk/benefit profile less favorably and increases regulatory risk, though thinks the CSL deal is unlikely at risk. The analyst is bullish on the Huntington's program going into 2021.
uniQure price target lowered to $80 from $85 at H.C. Wainwright » 06:1312/2212/22/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Patrick Trucchio lowered the firm's price target on uniQure to $80 from $85 and reiterates a Buy rating on the shares after the company announced that its hemophilia B program has been placed on clinical hold by the FDA. The analyst notes that patient dosing in each of uniQure's three hemophilia B gene therapy trials is complete so the existing timelines for HOPE-B top-line data in the second half of 2021 and a potential Biologics License Application submission remain intact.
Fly Intel: Wall Street's top stories for Monday » 16:3912/2112/21/20
MRNA, PFE, BNTX, LMT, AJRD, RP, NKE, WBAI, NK, QURE, FGEN
The major averages…
Fly Intel: Wall Street's top stories at midday » 13:3512/2112/21/20
LMT, AJRD, RP, NKE, TSLA, WBAI, NK, QURE, FGEN
The major averages were…
AMT-061 clinical hold 'obviously negative,' implications less clear, says Stifel » 10:2612/2112/21/20
Stifel analyst Paul…
Stifel analyst Paul Matteis acknowledges that uniQure's announcement of AMT-061 clinical hold is "obviously negative," but notes that at this stage "it's simply less clear what the actual implications will be." The analyst believes "a lot is at stake," including the regulatory prospects of AMT-061, AMT-061 commercial potential, and cash flows via the CSL deal. While the stock deserves to be down some, post-deal close, uniQure should have almost $700M in cash to fund Huntington's and the rest of its pipeline, he contends. Matteis has a Buy rating on the shares.
uniQure says hemophilia B gene therapy program placed on clinical hold » 07:0712/2112/21/20
uniQure announced that…
uniQure announced that its hemophilia B gene therapy program, including the pivotal, Phase III HOPE-B study, has been placed on clinical hold by the U.S. Food and Drug Administration. Patient dosing is complete in each of uniQure's three hemophilia B gene therapy studies, and there is no plan to enroll or treat additional patients. The clinical hold was initiated following the submission of a safety report in mid-December relating to a possibly related serious adverse event associated with a preliminary diagnosis of hepatocellular carcinoma, a form of liver cancer, in one patient in the HOPE-B trial that was treated with etranacogene dezaparvovec in October 2019. The patient has multiple risk factors associated with HCC, including a twenty-five-year history of hepatitis C, hepatitis B virus, evidence of non-alcoholic fatty liver disease and advanced age. Chronic infections with hepatitis B and C have been associated with approximately 80% of HCC cases.1 The liver lesion was detected during a routine abdominal ultrasound conducted as part of the required study assessments in patients at one-year post dosing. A full surgical resection of the lesion is scheduled this week that will allow for confirmation of the diagnosis. No other cases of HCC have been reported in uniQure clinical trials conducted in more than 100 patients in hemophilia B and other indications, with some patients dosed more than 10 years ago. "Patient safety will always be our top priority, and we are working closely with the FDA and our advisors to conduct a thorough investigation into the cause of this event which we expect to be completed in early 2021," said Ricardo Dolmetsch, Ph.D., president of research and development at uniQure. "We will investigate whether there is a relationship to treatment. At this time, we do not have adequate data to determine a possible causal relationship, especially in the context of the other known risk factors."
uniQure price target raised to $85 from $80 at H.C. Wainwright » 06:1312/2112/21/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Patrick Trucchio raised the firm's price target on uniQure to $85 from $80 and reiterates a Buy rating on the shares. EtranaDez appears well positioned to lead in hemophilia B, Trucchio tells investors in a research note.
uniQure price target raised to $62 from $55 at Jefferies » 08:1412/0912/09/20
Jefferies analyst Suji…
Jefferies analyst Suji Jeong raised the firm's price target on uniQure to $62 from $55 and keeps a Buy rating on the shares after the company shared "positive" data at the ASH meeting for EtranaDez in hemophilia B, which the analyst said support durable efficacy and safety. The Phase 3 topline data supports estimated U.S. EU launches of EtranaDez in 2022/2023, said Jeong.