Piper Jaffray analyst Joseph lowered his price target for Stemline Therapeutics to $23 to reflect reduced 2019 Elzonris estimates. Given the shortened Q1 selling period and expectations that early use will be heavily weighted towards blastic plasmacytoid dendritic cell neoplasm, who receive fewer cycles of therapy, the analyst reduced his 2019 Elzonris estimates. However, he believes the drug’s long-term opportunity is intact. Catanzaro continues to view Stemline shares as undervalued and thinks the now approved U.S. BPDCN label is a $250M opportunity. He keeps an Overweight rating on Stemline Therapeutics.
Wednesday, February 6, 2019
MacroGenics: ‘positive’ results from Phase 3 SOPHIA study of margetuximab
MacroGenics announced positive results from SOPHIA, the company’s Phase 3 clinical study of margetuximab in HER2-positive metastatic breast cancer patients. Margetuximab is an investigational immune-enhancing monoclonal antibody derived from the company’s proprietary Fc Optimization technology platform. The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. Patients in the margetuximab arm experienced a 24% risk reduction in PFS compared to patients in the trastuzumab arm. Notably, approximately 85% of patients in the study were carriers of the CD16A 158F allele, which has been previously associated with diminished clinical response to HERCEPTIN and other antibodies. In this pre-specified subpopulation, patients in the margetuximab arm experienced a 32% risk reduction in PFS compared to patients in the trastuzumab arm. Results of the SOPHIA study are being prepared for submission for publication and presentation later this year at a major scientific conference. Follow-up for determination of the impact of therapy on the sequential primary endpoint of overall survival is ongoing, as pre-specified in the study protocol and recommended by the trial’s independent Data Safety Monitoring Committee. MacroGenics anticipates submitting a Biologics License Application to the U.S. FDA in the second half of 2019. The SOPHIA study enrolled 536 patients at approximately 200 trial sites across North America, Europe and Asia. Patients were treated with either margetuximab or trastuzumab in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine). All study patients had previously received trastuzumab and pertuzumab, and approximately 90% had previously received ado-trastuzumab emtansine. The combination of margetuximab and chemotherapy demonstrated acceptable safety and tolerability, comparable overall to that of trastuzumab and chemotherapy.
Neurocrine lack of guidance not cause for concern, says Piper Jaffray
Piper Jaffray analyst David Amsellem says he would not interpret the absence of an Ingrezza guidance range as suggestive of a more challenging outlook for Neurocrine Biosciences. “Quite the contrary,” the analyst continues to believe the size of the underlying tardive dyskinesia population and “relatively favorable” payer landscape point to “ample room for continued aggressive Ingrezza sales growth.” Amsellem reiterates an Overweight rating Neurocrine Biosciences and lowered his price target for the shares to $105 from $113 owing primarily to higher operating expense estimates.
Boston Scientific sees FY19 adjusted EPS $1.53-$1.58, consensus $1.58
The company estimates revenue growth for the full year 2019, versus the prior year period, to be in a range of approximately 7 to 9 percent on a reported basis and a growth range of approximately 7 to 8.5 percent on an organic basis, excluding the impact of changes in foreign currency exchange rates and contribution of approximately 110 basis points from the acquisitions of NxThera, Claret and Augmenix, each with no prior year comparable sales. Consensus is $10.66B. The company estimates income on a GAAP basis in a range of $1.13 to $1.18 per share and estimates adjusted earnings, excluding amortization expense, acquisition-related, restructuring- and restructuring-related and litigation-related net charges in a range of $1.53 to $1.58 per share.
Eli Lilly cuts FY19 EPS view to $5.55-$5.65 from $5.90-$6.00, consensus $5.77
Cuts FY19 revenue view to $25.1B-$25.6B from $25.3B-$25.8B, consensus $25.27B.
Capricor Therapeutics resumes dosing of enrolled patients in HOPE-2 trial
Capricor Therapeutics (NASDAQ: CAPR), a clinical-stage biotechnology company, today announced that it has resumed per protocol dosing of patients already enrolled in its HOPE-2 clinical trial of CAP-1002, the company’s novel cell therapy candidate to treat Duchenne muscular dystrophy. Approximately 20 young men and boys in advanced stages of Duchenne muscular dystrophy have already been enrolled in the randomized, double-blind, placebo-controlled trial to date. Capricor had put a voluntary hold on dosing in December after a patient in the HOPE-2 trial had a serious adverse event in the form of anaphylaxis. The investigation suggested the patient may have been allergic to something contained in the investigational product, including an excipient, or inactive ingredient, in the formulation. To reduce the risk of future events, Capricor initiated a pre-medication strategy commonly used by physicians to prevent and treat allergic reactions. The U.S. Food and Drug Administration and the Data and Safety Monitoring Board have granted permission to resume enrollment in the HOPE-2 study. The HOPE-2 trial is studying the safety and effectiveness of CAP-1002 in older Duchenne patients who are not currently eligible for gene therapy clinical trials. Enrollment of new patients will depend on various factors but will not commence until additional funding is secured. To reduce expenses and better align resources and personnel on the company’s core lead programs, Capricor has reduced its staff by 21 full-time employees. The reduction in operating expenses is expected to extend the company’s cash, cash equivalents and marketable securities into late 2019. Additionally, Capricor is exploring strategic alternatives, with respect to one or more of its product candidates.
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