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GEMP

Gemphire Therapeutics

$3.26

-0.09 (-2.69%)

06:03
08/10/18
08/10
06:03
08/10/18
06:03

Gemphire Therapeutics announces termination of Phase 2a trial of gemcabene

Gemphire Therapeutics announces that the Data and Safety Monitoring Board at Emory University School of Medicine overseeing the investigator-led open label Phase 2a proof-of-concept trial evaluating gemcabene in pediatric patients with non-alcoholic fatty liver disease has recommended that the trial be terminated due to unanticipated problems. This pediatric NAFLD trial was initiated in early 2018. Patients were treated with gemcabene at a dose of 300 mg once daily. The primary endpoint is a measure of the change in serum alanine transaminase, an enzyme that serves as a biomarker of liver function, from baseline to 12 weeks, and secondary endpoints include, among others, change in hepatic steatosis (liver fat) as measured by non-invasive magnetic resonance imaging - proton density fat fraction. Data on the first three patients who underwent 12 weeks of treatment showed that all three experienced an increase in liver fat content, as measured by MRI-PDFF, and demonstrated increases in ALT. The increase in liver fat was deemed an unexpected problem by the trial investigator because it was an unexpected consistent pattern of worsening of the disease, rather than improvement, creating risk to the patients, which the investigator believed was likely due to the drug. Other patients currently enrolled in the trial have now been taken off gemcabene and early termination visits are being scheduled. The DSMB has recommended additional follow-up of the study subjects to gather additional safety data. The DSMB will provide Gemphire with a written report of their findings in the future once all the patient results have been collated and analyzed.

GEMP Gemphire Therapeutics
$3.26

-0.09 (-2.69%)

01/26/18
HCWC
01/26/18
NO CHANGE
Target $28
HCWC
Buy
Gemphire Therapeutics price target raised to $28 from $22 at H.C. Wainwright
H.C. Wainwright analyst Ed Arce raised his price target for Gemphire Therapeutics to $28 saying he sees a "catalyst-rich" 2018 for the company. The analyst says his confidence grows in the emerging multiple mechanisms of the compound as the gemcabene pipeline expands. He keeps a Buy rating on Gemphire Therapeutics.
05/16/18
RAJA
05/16/18
INITIATION
Target $22
RAJA
Outperform
Gemphire Therapeutics initiated with an Outperform at Raymond James
Raymond James analyst Laura Chico initiated Gemphire Therapeutics with an Outperform and $22 price target saying its gemcabene offs a potentially differentiated profile in the dyslipidemia space, which should narrow the gap versus peers with successful data.
07/27/18
ROTH
07/27/18
NO CHANGE
Target $40
ROTH
Buy
Gemphire Therapeutics price target raised to $40 from $30 at Roth Capital
Roth Capital analyst Yasmeen Rahimi raised her price target for Gemphire Therapeutics to $40 from $30 based on a positive forecast for the company's lead molecule in the pediatric NASH trial. In a research note to investors, Rahimi projects $415M peak sales for gemcabene for pediatric NASH in the U.S. in 2028 based on assumptions that include ~7.5M children with NAFLD among which 25% progress to NASH of which 12% have advanced NASH, as well as a U.S. launch in 2022 in 4% with peak market penetration of 55%. Rahimi, who has a Buy rating on Gemphire, sees top-line six-month histology results for the 24-week Phase 2a study in eight NASH patients with familial partial lipodystrophy in the fall, which will give clearer and early indications of gemcabene's effects on biopsy.
08/07/18
RAJA
08/07/18
DOWNGRADE
RAJA
Market Perform
Gemphire Therapeutics downgraded to Market Perform from Outperform at Raymond James

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