BioCryst announced the dosing of the first subject in a randomized, placebo-controlled phase 1 clinical trial to evaluate intravenous galidesivir in healthy volunteers. The main goals of this trial are to evaluate the safety, tolerability and pharmacokinetics of escalating doses of galidesivir in healthy subjects. Up to four single-dose cohorts will be evaluated with a total of up to 32 volunteers participating. The galidesivir development program is substantially funded with federal funds from the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, and by the Biomedical Advanced Research and Development Authority.
Wednesday, January 2, 2019
OrthoPediatrics price target raised to $37 at BTIG
BTIG analyst Ryan Zimmerman raised his price target on OrthoPediatrics to $37 and kept his Buy rating, calling the stock his “2019 Top Pick in Musculoskeletal” sector. The analyst points to a “combination of durable demographic and epidemiological trends, stable procedural volumes within hospitals, and a robust economy spurring elective procedure demand” supporting the sector’s continued growth. Zimmerman is also positive on the company’s “strengthened balance sheet from a recent equity raise, a large total addressable market, limited competition, and a growing portfolio of niche products.”
Insmed initiated at Canaccord
Insmed initiated with a Buy at Canaccord. Canaccord analyst Dewey Steadman initiated Insmed with a Buy rating as he views the launch of Arikayce positively given the severe unmet need in nontuberculous mycobacterial lung disease and the potential for the drug to become core to the NTM treatment paradigm over time. He believes Insmend is well positioned as a specialty play and thinks the company has been unfairly caught up in broader infectious disease market meltdown as several antibiotic companies have disappointed investors. Steadman has a $20 price target on Insmed shares.
Henry Schein downgraded to Neutral at Baird
Baird analyst Jeff Johnson downgraded Henry Schein to Neutral from Outperform. The analyst is more cautious on the combination of the dental sector’s secular overhangs, softer Q4 patient volume checks, and accelerating equipment pricing pressures. He trimmed his estimates across the sector and believes lower EBITDA will drive a lower sum-of-the-parts valuation. Johnson lowered his price target to $85 from $95 on Henry Schein shares.
Deciphera: ‘positive’ preliminary data from Phase 1 study with DCC-3014
Deciphera Pharmaceuticals announced positive, preliminary, top-line data from the ongoing dose escalation part of the Phase 1 clinical study with DCC-3014, the Company’s investigational small molecule switch control inhibitor of CSF1R, in patients with advanced malignancies. In addition, the Company announced a plan to expand the Phase 1 study to evaluate DCC-3014 in patients diagnosed with Tenosynovial Giant Cell Tumors. A review of further data from this Phase 1 study will be presented at a medical meeting in 2019. The Phase 1 study was designed to evaluate the safety, pharmacokinetics and pharmacodynamics of multiple doses of DCC-3014 in up to 55 patients. As of the data cut-off date of November 9, 2018, increasing doses of DCC-3014 were assessed in five dose cohorts across 24 patients with advanced solid tumor malignancies. This included one dose cohort that received 10 mg once daily and four dose cohorts that followed a schedule of once or twice-weekly maintenance dosing preceded by a five-day loading dose regimen at doses of up to 30 mg per dose. In addition, four patients are currently enrolled in a dose cohort that will receive 40 mg twice weekly preceded by a five-day loading regimen. Preliminary pharmacokinetic analysis showed dose-proportional exposure for DCC-3014 that we believe supports twice-weekly maintenance dosing preceded by a five-day loading dose regimen. Biomarker data demonstrated strong target engagement of CSF1R, including material reductions in CSF1R positive macrophages in the blood that we believe constitutes mechanistic proof-of-concept for DCC-3014. DCC-3014 was generally well tolerated in patients enrolled in the dose cohorts that received twice-weekly maintenance doses of DCC-3014 preceded by a five-day loading regimen at doses of up to 30 mg, which is summarized below: Treatment emergent adverse events were mostly Grade 1 or 2; No Grade 3 or 4 DCC-3014 related TEAEs in greater than or equal to10% of patients; No dose-limiting toxicities; and A maximum tolerated dose has yet to be established. In the dose-cohort that received 10 mg QD, clinically asymptomatic laboratory values were recorded as dose-limiting toxicities in two of seven patients.
Moderna initiated with an Overweight at Morgan Stanley
Morgan Stanley analyst Matthew Harrison started Moderna with an Overweight rating and $29 price target, stating that he currently models peak, risk-adjusted sales of $8B, with prophylactic vaccines, rare diseases and cancer vaccines driving the bulk of that. However, Harrison added that the company’s broad pipeline includes 21 programs and if the entire pipeline were to be successful he believes peak sales could be as high as about $35B.
Vertex downgraded to Market Perform on lack of catalysts at Raymond James
Raymond James downgraded Vertex to Market Perform from Outperform. Analyst Laura Chico said Vertex lacks near-term catalysts which makes it more vulnerable in a “risk off” environment and said success is largely priced in at this point.
https://thefly.com/landingPageNews.php?id=2842467
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