Alnylam initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Alethia Young started Alnylam Pharmaceuticals with an Overweight rating and $135 price target.
Monday, October 1, 2018
Vertex initiated at Cantor Fitzgerald
Vertex initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Alethia Young started Vertex Pharmaceuticals with an Overweight rating and $217 price target.
Insys Therapeutics in definitive license agreement with Lunatus for Subsys
Insys Therapeutics announced that it has signed a definitive license agreement with Lunatus for commercialization of Subsys in eight countries in the Middle East. In May, the two companies announced their intent to form an exclusive partnership. This announcement confirms that the definitive agreement has been executed, making Dubai-based Lunatus the exclusive licensee and authorized agent for Subsys in the territory, which comprises Bahrain, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia and the United Arab Emirates.
Viking Therapeutics says Phase 2 study of VK5211 achieves primary endpoint
Viking Therapeutics announced positive new findings from the company’s 12-week, Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture. As previously reported, the trial achieved its primary endpoint, demonstrating statistically significant, dose-dependent increases in lean body mass, less head, following treatment with VK5211 as compared to placebo. Additionally, newly presented data demonstrated dose-dependent decreases in mean fat mass, coupled with dose-dependent increases in mean body weight following VK5211 treatment. Findings also demonstrated dose-dependent increases in 6-minute walk distance following VK5211 treatment, reaching a greater than 20-meter improvement over placebo at the study’s highest dose. VK5211, Viking’s lead program for musculoskeletal disorders, is an orally available, non-steroidal selective androgen receptor modulator designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, parallel group, international study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. A total of 108 patients were randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks. Key results presented at ASBMR included: All doses of VK5211 demonstrated statistically significant increases in total lean body mass, less head, following 12 weeks of treatment, the study’s primary endpoint. Placebo-adjusted increases in lean body mass were 4.8% at 0.5 mg, 7.2% at 1.0 mg, and 9.1% at 2.0 mg. Patients receiving VK5211 experienced dose-dependent decreases in mean fat mass following 12 weeks of treatment, which reached statistical significance at the study’s highest dose of 2.0 mg. Placebo-adjusted reductions in mean fat mass were approximately 2.2% at 0.5 mg, 5.4% at 1.0 mg, and 6.2% at 2.0 mg. The observed reductions in mean fat mass were coupled with dose-dependent increases in mean body weight following 12 weeks of treatment, demonstrating beneficial changes in overall body composition among VK5211-treated subjects. The increases in mean body weight were 2.54 kg at 0.5 mg, 2.95 kg at 1.0 mg, and 3.09 kg at 2.0 mg. Patients receiving VK5211 demonstrated dose-dependent improvements in the 6-minute walk distance as compared to placebo, though this exploratory endpoint was not powered for significance. For patients in the 2.0 mg VK5211 treatment arm, the mean distance increased by approximately 22 meters compared to placebo. VK5211 treatment resulted in statistically significant improvements compared to placebo in serum procollagen type 1 propeptide, a marker of anabolic bone turnover, at 12 weeks. Patients were also assessed 12 weeks after completion of the study to evaluate safety and efficacy at 24 weeks. At this 24-week timepoint, the increases in total lean body mass, less head, for all VK5211 treatment arms remained above placebo, though the increases were no longer statistically significant. The durable increases in muscle mass that were maintained three months following the last dose of VK5211 highlight the potent treatment effect VK5211 demonstrated in these patients. No drug-related SAEs were observed in patients receiving VK5211. There were no significant differences in the rates of adverse events reported among patients receiving VK5211 compared with placebo. There were no dose-related differences in reported adverse events among various VK5211 treatment groups.
Avrobio announces updates from AVR-RD-01 trial
Avrobio announced clinical data and patient updates from the investigator-sponsored Phase 1 study and the Avrobio-sponsored Phase 2 clinical trial of AVR-RD-01. AVR-RD-01 is an ex vivo lentiviral gene therapy being investigated in Fabry disease. Designed to be a one-time therapy, it works by inserting the GLA gene that encodes functional a-galactosidase A to enable continuous AGA production and distribution to tissues and organs. The investigator-sponsored Phase 1 study is designed to assess the safety of AVR-RD-01 in up to six patients with Fabry disease who have been treated with standard of care enzyme replacement therapy, or ERT, for at least six months prior to receiving AVR-RD-01. The Phase 1 study is conducted by the FACTs team in Canada. As a Phase 1 study, the primary endpoint of this study is safety. Continued patient enrollment is planned and the protocol has been amended to allow the FACTs team, at their discretion, to discontinue ERT six months after treatment with AVR-RD-01. Preliminary safety data from these three subjects indicate AVR-RD-01 was generally well tolerated and no serious adverse events related to AVR-RD-01 have been reported. Preliminary safety data from patient FAB-201-1 indicate that AVR-RD-01 was generally well tolerated. Enrollment in the FAB-201 Study is ongoing.
Viking Therapeutics price target raised to $31 from $28 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis raised his price target for Viking Therapeutics to $31 after the company and investigators presented updated VK5211 data in an oral plenary presentation at the American Society of Bone and Mineral Research. The key takeaways from the VK5211 Phase 2 data in hip fracture patients include: VK5211 produces significant muscle growth in hip fracture patients, VK5211-treated patients experienced overall weight gain, the six-minute walk test demonstrated a trend favoring the treatment arms and the tolerability profile in elderly patients was encouraging with no treatment-emergent adverse events, Pantginis tells investors in a research note. The analyst keeps a Buy rating on Viking Therapeutics.
Veeva downgraded to Hold from Buy at Canaccord
Canaccord analyst David Hynes Jr. downgraded Veeva Systems to Hold from Buy, telling investors in a research note that he is stepping to the sidelines “for a bit.” The analyst says his downgrade is about valuation, and notes that he has “zero qualms” about Veeva’s opportunity, execution or management team. Most likely, the analyst says Veeva will probably “grind along sideways” for a period of time while the underlying business and metrics catch up with the stock’s valuation and raised his price target to $105 from $98.
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