|Over a week ago|
Alnylam price target raised to $197 from $154 at Cowen » 08:4701/1301/13/21
Cowen analyst Ritu Baral…
Cowen analyst Ritu Baral raised the firm's price target on Alnylam to $197 from $154 and keeps an Outperform rating on the shares. The analyst noted preliminary revenues were inline with estimates and showed continued geographically even growth. The company also has healthy reserves which should fuel progress across the expanded preclinical and clinical pipeline.
Dicerna price target raised to $37 from $30 at B. Riley Securities » 08:4401/1101/11/21
B. Riley Securities…
B. Riley Securities analyst Mayank Mamtani raised the firm's price target on Dicerna Pharmaceuticals (DRNA) to $37 from $30 and reiterates a Buy rating on the shares. The analyst believes nedosiran will be a "fast follower" to Alnylam's marketed RNAi drug, Oxlumo. Dicerna is one of his top picks for 2021.
Alnylam trading resumes 07:3001/0701/07/21
Alnylam announces HELIOS-A study met primary, both secondary endpoints » 07:2701/0701/07/21
Alnylam announced that…
Alnylam announced that the HELIOS-A Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated, or ATTR, amyloidosis, met its primary and both secondary endpoints at nine months in patients with hATTR amyloidosis with polyneuropathy. The primary endpoint was the change from baseline in the modified Neuropathy Impairment Score, or mNIS+7, at nine months as compared to historical placebo data from the APOLLO Phase 3 study of patisiran. The two secondary endpoints were changes in quality of life assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy, or Norfolk QoL-DN, and gait speed assessed by the timed 10-meter walk test, or 10-MWT, compared to historical placebo. Vutrisiran met the primary endpoint and achieved statistically significant results for each of the Norfolk QoL-DN and 10-MWT secondary endpoints. In addition, vutrisiran treatment showed improvement compared to placebo on the exploratory cardiac biomarker endpoint, NT-proBNP. Vutrisiran also demonstrated an encouraging safety and tolerability profile. Based on these positive results, the company plans to submit a new drug application, or NDA, for vutrisiran with the FDA in early 2021, and to follow with regulatory filings in additional countries, such as Brazil and Japan. The company plans to submit a marketing authorization application, or MAA, in the EU upon obtaining the results of the 18-month analysis - expected in late 2021 - as previously aligned with the European Medicines Agency, or EMA. HELIOS-A is a Phase 3 global, randomized, open-label study to evaluate the efficacy and safety of vutrisiran. The study enrolled 164 patients with hATTR amyloidosis with polyneuropathy at 57 sites in 22 countries. Patients were randomized 3:1 to receive either 25mg of vutrisiran via subcutaneous injection once every three months or 0.3 mg/kg of patisiran via intravenous infusion once every three weeks for 18 months. The primary endpoint is the change from baseline in mNIS+7 score at nine months, relative to historical placebo. Secondary endpoints at nine months are the change from baseline in the Norfolk QoL-DN score and the timed 10-MWT, relative to historical placebo. Changes from baseline in NT-proBNP were evaluated as an exploratory endpoint at nine months. The efficacy results of vutrisiran in HELIOS-A are compared to historical placebo control data from the landmark APOLLO Phase 3 study, which evaluated the efficacy and safety of patisiran in a patient population similar to that studied in HELIOS-A. Additional secondary endpoints at 18 months will be evaluated in the HELIOS-A study, including change from baseline in mNIS+7, Norfolk QoL-DN, 10-MWT, modified body mass index, Rasch-built Overall Disability Scale, and serum transthyretin levels. Additional exploratory cardiac endpoint data at the 18-month time point will be evaluated, including NT-proBNP, echocardiographic measures and cardiac amyloid assessments with technetium scintigraphy imaging. Following the 18-month study period, all patients are eligible to receive vutrisiran for an additional 18 months as part of an open-label extension study. Full 9-month results will be presented at a medical conference in early 2021 and topline 18-month results, including further exploratory cardiac endpoint data, are expected to be announced in late 2021. Vutrisiran demonstrated an encouraging safety profile. There were two study discontinuations due to adverse events in the vutrisiran arm by Month 9, both due to deaths, neither of which was considered related to study drug. There were two serious adverse events deemed related to vutrisiran by the study investigator, consisting of dyslipidemia and urinary tract infection. Treatment emergent adverse events occurring in 10% or more patients included diarrhea, pain in extremity, fall and urinary tract infections, with each of these events occurring at a similar or lower rate as compared with historical placebo. Injection site reactions were reported in five patients and were all mild and transient. There were no clinically significant changes in liver function tests.
Alnylam trading halted, news pending 06:5501/0701/07/21
Henry Schein buys majority interest in Prism Medical Products, terms not stated » 16:0801/0501/05/21
Henry Schein announced…
Henry Schein announced the acquisition of a majority ownership position in Prism Medical Products, LLC, a nationwide provider of specialty home medical supplies with a "core competency in advanced wound care products." PRISM is a privately held company founded in 2006 with headquarters in Elkin, North Carolina, as well as an operations office in Las Vegas, Nevada, and 10 fulfillment centers located across the U.S. The company has more than 200 team members and had net revenue for the 12 months ended September 30, 2020, of approximately $52M. PRISM is expected to be neutral to Henry Schein's 2021 earnings per diluted share and accretive thereafter. Financial terms were not disclosed.
Henry Schein upgraded to Outperform at Baird on recovery potential » 08:4801/0401/04/21
As previously reported,…
As previously reported, Baird analyst Jeff Johnson upgraded Henry Schein to Outperform from Neutral with a price target of $79, up from $70. The analyst, who expects dental patient volumes to improve sequentially throughout 2021, sees "a sentiment-driven potential recovery" for Henry Schein against that backdrop, he tells investors.
Henry Schein upgraded to Outperform from Neutral at Baird » 05:3801/0401/04/21
Baird analyst Jeff…
Baird analyst Jeff Johnson upgraded Henry Schein to Outperform from Neutral with a price target of $79, up from $70.
Patterson contract loss unexpected but manageable, says Piper Sandler » 10:0912/3012/30/20
Piper Sandler analyst…
Piper Sandler analyst Jason Bednar keeps a Neutral rating on Patterson Companies (PDCO) after the company announced that DSO Heartland Dental selected one of Patterson's competitors as its primary distribution partner effective April 1, 2021. Henry Schein (HSIC) seems the most likely competitor to win the contract, Bednar tells investors in a research note. While the analyst did not expect this outcome as he saw Patterson's incumbent status and the switching costs for Heartland to move to an alternate provider as giving Patterson the inside track to remain Heartland's primary distribution partner, he sees the associated profit headwind for Patterson in fiscal 2022, or $75M in revenue and 3c in earnings per share, as manageable. Shares of Patterson Companies are down 2% to $31.02 in morning trading while Henry Schein is up 33c to $66.05.
|Over a month ago|
Alnylam appoints Tolga Tanguler to Chief Commercial Officer role » 08:1212/2112/21/20
Alnylam Pharmaceuticals announced the appointment of Tolga Tanguler to the role of Chief Commercial Officer where he will lead global marketing, sales, market access, commercial operations, training, new product commercialization and commercial strategy for the Company. Tolga will also join the Company's Management Board. "After an in-depth and comprehensive search, we have selected Tolga Tanguler, a dynamic and highly skilled commercial leader to join Alnylam. With over 20 years of global pharmaceutical and biotech experience, most recently at Pfizer and Alexion, Tolga's considerable success commercializing multiple rare, specialty and common disease products positions him as an excellent choice for this key role," said John Maraganore, Ph.D., Chief Executive Officer at Alnylam. "With Tolga, Kasha, Salil and Aggie joining Alnylam, we have now rounded out our world-class leadership team across our commercial, medical and compliance expertise areas. Together, these outstanding leaders stand poised to support the ongoing global launches of our three marketed products and promising pipeline of innovative medicines addressing a range of patient needs, while we continue on our path towards profitability."