|Over a week ago|
MeiraGTx shares offer 'great entry point,' says Piper Sandler » 05:0607/2407/24/20
Piper Sandler analyst…
Piper Sandler analyst Tyler Van Buren believes current MeiraGTx share levels offer a "great entry point" for investors. Through year-end, investors should expect to receive more XLRP data, which "should continue to be positive," Van Buren tells investors in a research note. By year-end, the analyst also expects initial Phase I/II data from the first few radiation-induced xerostomia patients who were treated before the pandemic. MeiraGTx's six clinical-stage gene therapy programs are receiving "little-to-no value" when considering the existing cash and manufacturing plant, says Van Buren.
H.C. Wainwright says Applied Genetic still in 'pole position' in XLRP » 12:1607/1707/17/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Joseph Pantginis reiterates his Buy rating on shares of Applied Genetic Technologies (AGTC) after competitor MeiraGTX (MGTX) announced interim safety and efficacy data from the ongoing Phase 1/2 clinical trial of AAV-RPGR for the treatment of X-linked retinitis pigmentosa, or XLRP. Although he calls the six-month data reported by MeiraGTX "overall positive," Pantginis believes they fall behind those announced by Applied "on multiple levels," he tells investors. The analyst, who continues to view AGTC-501's profile as "highly competitive," keeps an $18 price target on the shares.
MeiraGTx should be bought after XLRP data, says Piper Sandler » 11:2707/1707/17/20
Piper Sandler analyst…
Piper Sandler analyst Tyler Van Buren reiterates an Overweight rating on MeiraGTx (MGTX) with a $40 price target after the company presented six-month data from the ongoing Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy in development for the treatment of patients with X-linked retinitis pigmentosa. This is the most comprehensive XLRP data presentation to date, Van Buren tells investors in a research note. The retinal sensitivity improvements appear at least as good as competitors AGTC and Biogen/Nightstar (BIIB), contends the analyst. He expects MeiraGTx's program to advance into Phase III soon and believes XLRP could be a $1.5B global opportunity. Van Buren says buy shares of MeiraGTx at current levels.
MeiraGTx announces clinical data from Phase 1/2 trial of AAV-RPGR » 07:3407/1707/17/20
MeiraGTx Holdings (MGTX)…
MeiraGTx Holdings (MGTX) announced six-month data from the ongoing Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy in development for the treatment of patients with X-linked retinitis pigmentosa with genetically confirmed variants in the RPGR gene. Significant improvement in vision was demonstrated in the dose escalation phase of the trial and AAV-RPGR was found to be generally well tolerated. These initial results from the trial are being presented as a late-breaker oral presentation at the American Society of Retina Specialists 2020 Virtual Annual Meeting. MeiraGTx and Janssen Pharmaceuticals (JNJ) are jointly developing AAV-RPGR as part of a broader collaboration to develop and commercialize gene therapies for the treatment of inherited retinal diseases. The ongoing Phase 1/2 MGT009 clinical trial consists of three phases: dose-escalation, dose-confirmation, and dose-expansion. In the dose-escalation phase, adults were administered low, intermediate, or high dose AAV-RPGR. Each patient was treated with subretinal delivery of AAV-RPGR in the eye that was more affected at baseline. The patient's other eye served as an untreated control. The primary endpoint of the trial is safety, with secondary endpoints assessing changes in visual function at pre-specified timepoints post-treatment. Baseline values were determined in triplicate. At six months, significant improvement in retinal sensitivity was demonstrated in patients treated with low and intermediate dose AAV-RPGR. Improvement was evident at first post-treatment perimetry assessments at three months, with improvements generally sustained or increased at six months. Significant differences were observed in retinal sensitivity between treated and untreated eyes over time. Based on the robust safety and efficacy signals observed in the dose escalation portion of the study, the low and intermediate doses were selected for use in the ongoing randomized, controlled dose-expansion phase of the trial. Based on the safety and efficacy data demonstrated in the MGT009 trial to date, MeiraGTx and Janssen expect to advance AAV-RPGR into the Phase 3 Lumeos clinical trial for the treatment of patients with XLRP caused by mutations in RPGR gene. Data obtained to date suggest AAV-RPGR is generally well-tolerated. Most adverse events were related to the surgical delivery procedure, were transient and resolved without intervention. There were no dose-limiting events. Inflammatory responses to therapy were observed in two out of three patients in the high dose cohort, which may have been associated with decreased activity of AAV-RPGR in these patients. Inflammation was effectively managed with an extended steroid protocol. Six-month data from the dose escalation portion of the study demonstrated meaningful improvement from baseline in retinal sensitivity in the low and intermediate dose cohorts. Importantly, these improvements were evident when assessed with two perimetry approaches and three analysis metrics. Significant differences in mean retinal sensitivity were observed between treated eyes and untreated eyes in the intermediate dose cohort: 1.02 dB. Significant differences were observed in central visual field progression ratebetween treated eyes and untreated eyes in both the low, 1.10 dB-sr/year and intermediate, 1.26 dB-sr/year, dose cohorts. Efficacy signals were observed at first post-treatment assessments at three months, with improvements generally sustained or increased at six months. Perimetry is a sensitive standard-of-care measure of retinal function that reproducibly determines retinal sensitivity both cross-sectionally and longitudinally, thereby accurately defining disease progression over time.
|Over a month ago|
MeiraGTx reports Q1 EPS (43c), consensus (48c) » 17:1805/0705/07/20
Cash, cash equivalents…
Cash, cash equivalents and restricted cash were $210.8 million as of March 31, 2020, compared to $227.4 million as of March 31, 2019.License revenue was $4.2 million for the quarter ended March 31, 2020, compared to $0.8 million for the quarter ended March 31, 2019. The increase represents increased amortization of the $100.0 million upfront payment that the Company received in March 2019 from its collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
|Over a quarter ago|
MeiraGTx Holdings trading resumes 09:5103/2003/20/20
MeiraGTx Holdings trading halted, volatility trading pause 09:4103/2003/20/20
MeiraGTx announces PRIME, ATMP designations for AAV-RPGR gene therapy » 09:0303/0203/02/20
MeiraGTx Holdings announced that the European Medicines Agency has granted Priority Medicines and Advanced Therapy Medicinal Product designations to AAV-RPGR, MeiraGTx's investigational gene therapy for the treatment of x-linked retinitis pigmentosa caused by mutations in the RPGR gene. PRIME designation was granted based on clinical data from MeiraGTx and Janssen's ongoing Phase 1/2 trial of AAV-RPGR in patients with XLRP. AAV-RPGR is the only gene therapy in development for the treatment of XLRP to receive PRIME designation.
MeiraGTx has most exciting Parkinson's disease program, says Piper Jaffray » 05:2412/1612/16/19
Piper Jaffray analyst…
Piper Jaffray analyst Tyler Van Buren says MeiraGTx has the most exciting Parkinson's disease development program that he's seen. The company's AAV-GAD is the only gene therapy to have generated statistically significant results via the gold standard UPDRS, Van Buren tells investors in a research note. He believes AAV-GAD has multi-billion dollar potential given the ~300,000 addressable patients in the U.S. alone. Van Buren reiterates an Overweight rating on MeiraGTx with a $40 price target.
MeiraGTx management to meet with Piper Jaffray » 04:5511/2611/26/19
Meetings to be held in…
Meetings to be held in London, England on November 25 and in Stockholm, Sweden on November 26 hosted by Piper Jaffray.