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19:37 EDT LeMaitre acquires biologic patch business from Admedus - LeMaitre Vascular announced that it has acquired the biologic patch business of Admedus for $15.5M, of which $14.2M was paid at closing and $1.3M is due in two post-closing installments, as well as potential earnout payments of $7.8M payable based upon performance of the acquired business as well as other milestones. The parties also signed a license agreement for the tissue processing technology limited to the CardioCel and VascuCel product lines and a transition services agreement under which Admedus will continue to manufacture the products for up to three years while LeMaitre Vascular transitions manufacturing to its U.S. headquarters. LeMaitre Vascular will not take ownership of the Admedus factory in Perth, Australia. The acquired patches, marketed under the brands CardioCel and VascuCel, are processed in a manner that is intended to reduce the risk of calcification. Annualized 2019 sales of these product lines were $7.1M, mostly in the U.S. and Europe.

18:23 EDT Adverum Biotechnologies reports additional data from Phase 1 trial of ADVM-022 - Adverum Biotechnologies announced additional clinical data for the first cohort of patients in the ongoing OPTIC phase 1 clinical trial of ADVM-022, the company's intravitreal injection gene therapy, in treatment-experienced patients with wet age-related macular degeneration. Adverum also announced enrollment plans for the third and fourth cohorts in the ongoing OPTIC trial. The third cohort has been initiated and patients will be treated with ADVM-022 at a dose of 2 x 10^11 vg/eye, the same dose used in the second cohort. Subsequently, patients in the fourth cohort will be treated with ADVM-022 at a dose of 6x10^11 vg/eye, the same dose used in the first cohort. Since inflammation has generally been mild and responsive to steroid eye drops, patients in the third and fourth cohorts will receive prophylactic steroid eye drops instead of prophylactic oral steroids. Previously, on September 12, 2019, Adverum presented data from the first cohort in the ongoing OPTIC trial at a pre-specified 24-week time point. The additional data for this cohort includes key outcomes with a median follow-up of 34 weeks. In treatment-experienced patients previously requiring frequent anti-VEGF injections to maintain vision, the data continue to demonstrate that the single ADVM-022 injection in this cohort was sufficient to maintain vision, with zero rescue injections required for any of the six patients. Aaron Osborne, MBBS, chief medical officer of Adverum, added, "The clinical profile of ADVM-022 demonstrates this gene therapy's potential to be a significant advance for patients with wet AMD. It is very encouraging that there continues to be zero rescue injections in this cohort of treatment-experienced patients with more than 6 months follow-up on all patients. We are expanding the development of ADVM-022 and are excited to share that enrollment is now open for the third cohort in OPTIC. We look forward to being able to deliver this novel intravitreal gene therapy candidate as soon as possible to patients with wet AMD and diabetic retinopathy, our second indication for ADVM-022. We are grateful for all of the investigators, patients, and caregivers who continue to participate in the OPTIC trial." Adverum plans to begin dosing patients in the third cohort of the OPTIC trial in the fourth quarter of 2019 and plans to begin enrollment in the fourth cohort in the first quarter of 2020. Adverum plans to present 52-week data from the first cohort of patients in the OPTIC trial as well as 24-week data from the second cohort of patients in the first half of 2020. Adverum plans to submit an investigational new drug application for the treatment of ADVM-022 in diabetic retinopathy in the first half of 2020. Adverum expects to be able to occupy its new corporate headquarters in Redwood City, CA, by the end of this year, allowing for the expansion of in-house process development capabilities to the 1000-liter production scale.

16:23 EDT Allergan, Molecular Partners present data from Phase 3 Abicipar pegol studies - Allergan and Molecular Partners announced two-year data from the CEDAR and SEQUOIA clinical studies of investigational Abicipar in patients with neovascular age-related macular degeneration, or nAMD. In the second year of these studies, four injections of Abicipar resulted in the maintenance of visual gains comparable to monthly ranibizumab. These data were presented as a late-breaking oral presentation during Retina Subspecialty Day at the Annual Meeting of the American Academy of Ophthalmology, or AAO. Through week 104, patients received Abicipar 2 mg every 8-weeks or every 12-weeks or ranibizumab 0.5 mg every 4 weeks. At week 104 in the pooled Phase 3 data, the proportion of patients with stable vision was 93%, 90% and 94% in 8-week Abicipar; 12-week Abicipar and 4-week ranibizumab treatment regimens, respectively. This continuation of stable vision in year 2 further reinforces the ability of Abicipar to deliver consistent quarterly dosing for the majority of patients. "Current anti-VEGF treatments for neovascular age-related macular degeneration require frequent intravitreal injections," said Rahul N. Khurana, M.D., Northern California Retina Vitreous Associates Medical Group. "Based on the results of CEDAR and SEQUOIA, which reinforce the efficacy of Abicipar while decreasing the number of injections, Abicipar could transform anti-VEGF treatment regimens."

15:29 EDT Concert Pharmaceuticals presents Phase 2 data in Alopecia Areata - Concert Pharmaceuticals presented results from its recently completed Phase 2 dose-ranging trial of the investigational medicine CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss. Patients in the study treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p less than0.001) relative to placebo in the percentage of patients achieving a greater than or equal to 50% relative change from baseline at 24 weeks using the Severity of Alopecia Tool. In the Phase 2 trial, the primary efficacy endpoint in the 12 mg twice-daily cohort was met with 58% of patients achieving a greater than or equal to 50% relative reduction in their overall SALT score from baseline compared to 9% for placebo, with statistically significant separation from placebo occurring at Week 12. In the 8 mg twice-daily cohort, 47% of patients achieved the primary endpoint compared to placebo. For the 4 mg cohort, 21% of patients achieved a greater than or equal to 50% relative reduction in their overall SALT score from baseline, however there was not a statistically significant difference from placebo. Data from the Patient Global Impression of Improvement scale showed 78% of the patients receiving 12 mg twice-daily and 58% of the patients receiving 8 mg twice-daily rated their alopecia areata as "much improved" or "very much improved" at Week 24. For both doses there was a statistically significant difference from placebo. In the Phase 2 trial, the most common side effects in the 12 mg CTP-543 dose group were headache, nasopharyngitis, upper respiratory tract infection and acne. One serious adverse event of facial cellulitis was reported as possibly related to treatment. After a brief dosing interruption, treatment was continued and this patient completed the trial. No thromboembolic events were reported during the trial.

14:15 EDT Eli Lilly says Taltz met co-primary endpoints in Phase 3 plaque psoriasis study - Eli Lilly announced that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89% of patients treated with Taltz achieved a significant 75% improvement from baseline to Week 12 on their Psoriasis Area and Severity Index score and 81% of patients treated with Taltz achieved a static Physician's Global Assessment of clear or almost clear skin. Results of the study are being presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress, or EADV, in Madrid, Spain. Based on these results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis, the company said. Lotus Mallbris, vice president of immunology development at Lilly, added, "We're pleased to see positive results for Taltz in pediatric patients. These results build on more than five years of safety and efficacy data in adults and support the potential for Taltz in this new population, pending regulatory approvals."