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MGTX

MeiraGTx

$17.86

-0.51 (-2.78%)

07:38
05/14/19
05/14
07:38
05/14/19
07:38

MeiraGTx announces AAV-RPE65 trial meets primary endpoint

MeiraGTx announced data from a Phase 1/2 dose escalation trial of AAV-RPE65, the company's investigational gene therapy for the treatment of RPE65-deficiency, a condition that causes blindness. AAV-RPE65 is a second-generation gene therapy candidate developed specifically to treat RPE65-deficiency, and optimized for transduction efficiency, potency and stability. The trial achieved the primary endpoint of safety and tolerability of AAV-RPE65. Additionally, AAV-RPE65 demonstrated statistically significant improvement across several secondary endpoints designed to assess clinical activity. The Phase 1/2 open-label, multi-center, dose-finding trial evaluated AAV-RPE65 in patients with retinal dystrophy associated with disease-causing variants in the RPE65 gene. The trial was conducted at two centers in the U.S. and UK, and three surgeons undertook the surgery across these sites. The trial enrolled 15 patients, including nine young adults across three dose escalation cohorts, and six children in a pediatric expansion cohort. Each patient was treated with subretinal delivery of AAV-RPE65 in the eye that was more affected at baseline. The patient's other eye served as an untreated control. Significant improvement in vision was demonstrated at six months after AAV-RPE65 treatment, as measured by assessments of vision-guided mobility, retinal sensitivity, visual acuity and contrast sensitivity. Larger improvements from baseline in functional vision were observed between treated and control eyes at lower light levels. These outcomes address the core functional manifestation of RPE65-deficiency, which typically causes vision impairment beginning in early childhood that is most pronounced in low-light conditions and is consistent with the proposed mechanism of action of AAV-RPE65. MeiraGTx intends to meet with regulatory authorities in the second half of 2019 to define the development pathway for regulatory approval of AAV-RPE65.

MGTX MeiraGTx
$17.86

-0.51 (-2.78%)

07/03/18
07/03/18
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Veru Inc. (VERU) initiated with a Buy at Maxim. 2. ViewRay (VRAY) initiated with a Buy at Jefferies. 3. MeiraGTx (MGTX) initiated with an Overweight at Barclays. 4. Zafgen (ZFGN) initiated with an Overweight at Piper Jaffray. 5. Eloxx Pharmaceuticals (ELOX) initiated with a Buy at Citi. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
07/09/18
EVER
07/09/18
INITIATION
Target $21
EVER
Outperform
MeiraGTx initiated with an Outperform at Evercore ISI
Evercore ISI analyst Steven Breazzano initiated MeiraGTx with an Outperform and $21 price target.
08/23/18
CHDN
08/23/18
INITIATION
Target $30
CHDN
Buy
MeiraGTx initiated with a Buy at Chardan
Chardan analyst Gbola Amusa initaited MeiraGTx with a Buy and $30 price target saying the company is "primed" for significant long-term returns as its ocular, salivary, and neurodegenerative diseases franchises contribute to the broader arrival of AAV-based gene therapy. Amusa is forecasting $1.1B in risk adjusted 2028 estimated sales, making MeiraGTx a hing-conviction pick in AAV-based gene therapy coverage.
02/27/19
CHDN
02/27/19
NO CHANGE
Target $40
CHDN
Buy
MeiraGTx price target raised to $40 from $30 at Chardan
Chardan analyst Gbola Amusa raised his price target for MeiraGTx Holdings (MGTX) to $40 from $30 following Johnson & Johnson's equity stake in the company. MeiraGTx , a top pick for 2019 at Chardan, announced a strategic collaboration on inherited retinal diseases with J&J's Janssen Pharmaceuticals and an $80M private placement, with the investment arm of J&J taking a $40M stake, Amusa tells investors in a research note. The news represents the third announced collaboration or investment by a J&J vehicle in MeiraGTx, the analyst points out. This may signal potential takeover interest by J&J longer term and suggests the pharma giant sees significant value in the inherited retinal diseases market opportunities, contends Amusa. He keeps a Buy rating on MeiraGTx.

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