Crispr Therapeutics and MaxCyte announced the expansion of their existing relationship by entering into a non-exclusive commercial license agreement that will allow Crispr Therapeutics to deploy MaxCyte’s flow electroporation technology to develop Crispr/Cas9-based therapies in immuno-oncology. The expanded relationship builds on an existing agreement announced in March 2017 which allowed for the development of commercial therapeutics for hemoglobin-related diseases. Under the terms of the new license agreement, Crispr Therapeutics will obtain non-exclusive development and commercial-use rights to MaxCyte’s cell engineering platform to develop immuno-oncology cell therapies. MaxCyte will supply its technology to Crispr Therapeutics as part of the enabling technology license agreement and will receive milestone and sales-based payments in addition to other licensing fees.
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Friday, November 9, 2018
Immunomedics selloff yesterday a buying opportunity, says Wells Fargo
Shares of Immunomedics were under pressure yesterday due to management comments on outstanding review issues for the Biologics License Application for sacituzumab govitecan in triple negative breast cancer, Wells Fargo analyst Jim Birchenough tells investors in a research note. The analyst spoke with management and understands that outstanding questions “are in line with that expected in the normal course of a BLA review.” Further, experience suggests that absence of interaction before a PDUFA is a bad sign and that increased interaction, as appears to be the case here, is positive, says Birchenough. The analyst remains confident in the prospects for a timely approval and would be buyers of Immunomedics shares on the weakness.
Kala price target lowered to $15 from $32 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju lowered his price target for Kala Pharmaceuticals to $15 following the company’s Q3 results but reiterates a Buy rating on the shares. The analyst adjusted his 2019 revenue projections lower due to the time needed for commercial payors to start covering Inveltys. Further, due to recent late-stage trial initiations of competitor candidates in dry eye, the analyst more than halved his projected peak annual sales of KPI-121 0.25% from over $2B to $1B, while maintaining the probability of success at 65%.
Surmodics sees FY19 adjusted EPS (7c)-23c, consensus 23c
Surmodics expects fiscal year 2019 revenue to range from $92M to $97M, consensus $90.37M. The company expects diluted EPS in the range of (32c) to (2c) per share, which reflects the company’s continued investment in research and development to further its whole-product solutions strategy. Non-GAAP diluted EPS is expected to be in the range of (7c) to 23c per share.
Perrigo share valuation should rebound, says Canaccord
Canaccord analyst Dewey Steadman said Perrigo posted a decent quarter for its core consumer businesses but saw softness in its prescription generics unit. The company has been trying to sell the unit, but he expects guidance to be soft as the business weighs on near-term results. The analyst said he expects the share price to rebound as the company emerges from its strategic challenges. Steadman maintained his Buy rating and $90 price target on Perrigo shares.
Gilead presents Phase 2 data on investigational FXR agonist GS-9674
Gilead Sciences announced new data from the company’s clinical development program for advanced fibrosis due to nonalcoholic steatohepatitis. Data presented support the ongoing development of the company’s investigational compounds, evaluate the utility of noninvasive tests for the identification of patients with advanced fibrosis, and demonstrate the significant burden of disease in affected patients. Data from a Phase 2 randomized, placebo-controlled trial of the investigational, selective, non-steroidal farnesoid X receptor agonist GS-9674 will be presented. In this study, 140 NASH patients were treated with GS-9674 100 mg, GS-9674 30 mg or placebo orally once daily for 24 weeks. A decline of at least 30 percent in hepatic fat measured by magnetic resonance imaging-proton density fat fraction was observed in 38.9 percent of patients treated with GS-9674 100 mg, 14 percent treated with GS-9674 30 mg, and 12.5 percent with placebo. Improvements in liver biochemistry tests and markers of reduced bile acid synthesis were observed in the 30 mg and 100 mg arms of GS-9674-treated patients. GS-9674 was generally well tolerated; moderate to severe pruritus, or itching, occurred in 14 percent of patients in the GS-9674 100 mg arm compared to four percent in the GS-9674 30 mg and placebo arms. Changes in lipid profile and glycemic parameters did not differ between GS-9674 and placebo-treated patients. The most common adverse events in patients treated with GS-9674 were pruritus, upper respiratory tract infection, headache and fatigue. Treatment was discontinued due to adverse events in one patient treated with GS-9674 100 mg, five patients treated with GS-9674 30 mg, and two patients with placebo. A separate Phase 2 study is investigating treatment with GS-9674, the investigational apoptosis signal-regulating kinase 1 inhibitor selonsertib, and the investigational acetyl-CoA carboxylase inhibitor GS-0976 alone or in combination, in patients with advanced fibrosis due to NASH. This randomized, double-blind 52-week study will assess improvement in fibrosis without worsening of NASH, adverse events and laboratory abnormalities in approximately 350 patients. In a late-breaker session, Gilead will present an analysis of baseline data from its Phase 3 STELLAR trials of selonsertib suggesting that the use of currently available noninvasive tests can accurately identify patients with advanced fibrosis due to NASH and potentially reduce the need for liver biopsy. The use of the Fibrosis-4 index, Enhanced Liver Fibrosis test and liver stiffness measurement by FibroScan each demonstrated good sensitivity and specificity for the discrimination of advanced fibrosis due to NASH when compared to liver biopsy. When used sequentially, FIB-4 followed by FS or the ELF test accurately identified advanced fibrosis in 76-81 percent of patients while reducing the frequency of indeterminate results to as low as 13 percent. Baseline data from patients enrolled in the STELLAR Phase 3 program presented in a poster session at The Liver Meeting 2018 demonstrate the significant burden of disease among people with advanced fibrosis due to NASH. In 1,660 patients enrolled in the STELLAR trials, patient-reported outcome measures were assessed prior to treatment initiation and compared with population norms. The data demonstrate that physical health-related PRO scores of NASH patients were significantly lower than population norms. In addition, patients with cirrhosis had lower PRO scores than those with bridging fibrosis in areas including bodily pain, social functioning, and all but one domain of the disease-specific Chronic Liver Disease Questionnaire for nonalcoholic fatty liver disease and NASH.
Globus Medical price target raised to $65 from $61 at Leerink
Leerink analyst Richard Newitter raised his price target on Globus Medical shares to $65 from $61 citing the company’s accelerating core U.S. spine results and higher 2018 outlook. He said the Q3 results and raised outlook increase his confidence that Globus is on a sustained double-digit revenue growth trajectory in 2018 and beyond. Newitter reiterated an Outperform rating on Globus Medical shares.
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