Tuesday, January 22, 2019
Citi downgrades Crispr Therapeutics to Sell with $21 price target
Citi downgrades Crispr Therapeutics to Sell with $21 price target. Citi analyst Yigal downgraded Crispr Therapeutics to Sell from Neutral and cut his price target for the shares to $21 from $28. Crispr’s near-term valuation driver and lead program in related blood disorders “substantially lags” more advanced competitors, Nochomovitz tells investors in a research note. The analyst believes the company’s CTX-001 is “at best equivalent” to more advanced competitors and “could have some important liabilities.”
iRadimed suspends sales of 3880 patient vital signs monitoring system
iRadimed announced that it temporarily suspended sales of its 3880 MRI compatible patient vital signs monitoring systems in European Commission, or EC, markets due to the expiration of its CE Mark on January 17. Products are regulated in Europe by the U.K. Notified Body, UL International, who provides certification allowing use of the CE Mark and permitting shipments of products into EC markets. Maintaining certification and use of the CE Mark requires manufacturers to routinely undergo periodic re-certification, which typically involves the re-review of a product technical file. The company’s 3880 MRI compatible patient vital signs monitoring system, originally cleared by UL and added to the EC Certificate in June 2017, was recently subjected to such re-review. On January 16, the company was notified by UL that their recent technical file review of our 3880 MRI compatible patient vital signs monitoring system could not be completed as aspects of clinical evaluation reporting, as required by newly issued guidance from the European Union, was not acceptable, resulting in a technical non-conformity. Accordingly, UL is issuing a temporary EC Certificate that excludes the company’s 3880 patient vital signs monitoring system. This temporary EC Certificate will extend for six months, during which time the company expects to cure the non-conformity and be permitted to again use the CE Mark on its 3880 patient vital signs monitoring system. In full compliance with this notification, iRadimed immediately suspended shipments of its 3880 patient vital signs monitor to all markets requiring a CE Mark. This action is not the result of safety, effectiveness or performance issues with the 3880 patient vital signs monitoring system. This action does not impact sales of 3880 patient vital signs monitoring system in the U.S. or in other markets that do not require a CE Mark for importation purposes. This action does not impact shipments of MRI compatible IV infusion pump and related accessories, disposables or services. “Despite the retrospective application of new guidance to our previously cleared 3380 MRI compatible patient vital signs monitoring system, we are fully cooperating and in direct discussions with UL to agree upon the necessary and proper application of the new guidance. We believe that data collection, documentation and UL’s review of the required information will take between three to four months, after which time we believe UL will renew the EC Certificate, once again permitting use of the CE Mark on our MRI compatible patient vital signs monitoring system. We expect to fully resolve this matter prior to the end of our second quarter,” said Roger Susi, president and CEO. “We expect this action may reduce full-year 2019 revenue by approximately two percent. After considering this impact, we still expect mid 20 percent revenue growth in 2019. We will provide our full-year 2019 revenue, GAAP and non-GAAP earnings guidance in our fourth quarter earnings release,” said Susi.
Immunomedics cut to Equal Weight after CRL receipt at Morgan Stanley
Morgan Stanley analyst Matthew Harrison downgraded Immunomedics to Equal Weight from Overweight, stating that he recommends taking a more conservative approach following last week’s Complete Response Letter from the FDA for sacituzumab govitecan in triple negative breast cancer. While he believes consensus has a more positive than negative view of the company’s ability to solve the CMC issues quickly, he is concerned that management’s view of the issues and the FDA’s view of the issues differ significantly, Harrison tells investors. He lowered his peak sales estimate to $1.6B from $2B after lowering his odds of success for the mTNBC program from 100% to 75% and cut his price target on Immunomedics shares to $17 from $38.
Translate Bio announces clinical hold on MRT5201 IND application from FDA
Translate Bio announced that the company has received verbal notification from the FDA that the agency has completed its review of the company’s investigational new drug application, or IND, submission for MRT5201 for the treatment of ornithine transcarbamylase, or OTC, deficiency and has additional clinical and nonclinical questions. The company submitted the IND in December 2018 to support the initiation of a Phase 1/2 clinical trial in patients with OTC deficiency. The FDA is placing the IND on clinical hold until these questions are resolved. The company expects to receive formal written communication with additional information from the FDA in the near future and plans to work with the FDA in an effort to resolve its questions as promptly as possible.
Insys Therapeutics initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Brandon Folkes started Insys Therapeutics with an Overweight rating and $9 price target. The analyst sees 2019 as a “pivotal and transformational year” for Insys with two potential filings with its spray platform along with two data readouts from its cannabinoids platform. 2019 could be the year in which investors are able to return to Insys and “appreciate the value which could be unlocked from within the company’s spray and cannabinoids pipeline,” Folkes tells investors in a research note.
Cytokinetics announces FDA feedback for potential reldesemtiv program
Cytokinetics announced that it has received feedback from the FDA that the six minute walk test, or 6MWT, is an acceptable primary efficacy endpoint for a potential registration program for reldesemtiv in patients with spinal muscular atroph, or SMA, who have maintained ambulatory function. The FDA also recommended adding a global function scale as a secondary endpoint, such as the Hammersmith Functional Motor Scale, or HFMSE. In collaboration with Astellas, Cytokinetics is developing reldesemtiv as a potential treatment for people with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue. The companies are discussing potential next steps regarding the ongoing development program for reldesemtiv in this patient population. Results from a Phase 2 clinical study of reldesemtiv in patients with SMA showed a statistically significant exposure-response relationship in changes from baseline in six minute walk distance, or 6MWD, a sub-maximal exercise test of aerobic capacity and endurance. The study also showed statistically significant increases for maximal expiratory pressure, or MEP, a measure of strength of respiratory muscles. Other assessments, including the HFMSE, did not demonstrate differences between reldesemtiv versus placebo. Adverse events in the Phase 2 study in patients with SMA were similar between treatment groups receiving reldesemtiv and placebo. Cytokinetics is preparing to conduct an additional Phase 1 study of reldesemtiv in healthy volunteers designed to assess whether higher doses than were evaluated in the Phase 2 study of patients with SMA may result in higher plasma concentrations. This study is expected to begin in Q1.
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