Tocagen announced that it has completed the planned enrollment of 380 patients in the global Toca 5 pivotal Phase 3 trial approximately three months ahead of schedule. Toca 5 is a randomized, multi-center study evaluating the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent high grade glioma. The principal investigator is Timothy Cloughesy, M.D., director of the University of California, Los Angeles Neuro-Oncology Program.
Wednesday, September 19, 2018
Cardiovascular Systems shares poised to move ‘meaningfully higher,’ says Leerink
Leerink analyst Danielle Antalffy reiterates an Outperform rating and $45 price target on Cardiovascular Systems after hosting meetings with management. The meetings reinforced the analyst’s view that the company represents a sustainable double-digit growth story for the next few years. She continues to believe Cardiovascular Systems has a “significant” competitive advantage in both calcified and below-the-knee lesions within Peripheral that should drive above-market growth. The shares are poised to move “meaningfully higher” as management drives back toward a sustainable mid-teens sales growth range, Antalffy tells investors in a research note.
Leerink sees risk of Athenahealth returning to $125 share level
Leerink analyst David Larsen is more cautious on Athenahealth following news reports that Elliott Management may be backing away from its original $160 per share offer and other potential acquirers have “gone quiet.” The analyst believes Elliott’s initial offer was meant mainly to initiate a sales process, consistent with its prior activist campaigns. Without other serious bidders emerging, Larsen says he has reduced conviction that Athenahealth will sell for above $160 per share. He sees greater risk that the shares return to the $125 level and keeps a Market Perform rating on the name.
Launch of GW Epidiolex ‘likely imminent’: Morgan Stanley
Morgan Stanley analyst David Lebowitz noted that the FDA approved GW Pharmaceuticals’ cannabis-based Epidiolex for the treatment of two ultra rare forms of epilepsy on June 25 and the Drug Enforcement Agency rescheduling of the therapy to allow medicinal use was expected to take place within 90 days, or by about September 23. He sees the U.S. launch being “imminent,” pending the rescheduling, and said it will be a catalyst for GW Pharmaceuticals given that Epidiolex is the first FDA approved cannabinoid-based therapy. The analyst, who sees the drug being a blockbuster with off label use driving $1.3B in sales by 2025, reiterates his Overweight rating and $197 price target on GW Pharmaceuticals shares.
Fitbit in focus amid expanded strategic partnership with Humana
Shares of smartband and smartwatch maker Fitbit (FIT) are higher after the company announced it is expanding its strategic partnership with Humana (HUM) to drive healthy habits and manage chronic disease. STRATEGIC PARTNERSHIP EXPANSION: On Wednesday, Fitbit and Humana announced that they are expanding their partnership to help members adopt and implement healthy behaviors to help prevent and manage chronic conditions. Humana has selected Fitbit Care as a preferred health coaching solution for Humana’s employer group segment and through this partnership, over five million Humana members will have the potential to access Fitbit wellness solutions or health coaching. Fitbit Care is a connected health platform, launched today, that combines health coaching and virtual care, Fitbit’s wearable devices and self-tracking and personalized digital interventions. The Fitbit Care health coaching solution has coaches working with participants to create personalized care plans and connecting with members through multiple channels that include in-app communications, phone and in-person meetings. Users who already have health coaches can connect with them through the platform or they can opt for “a fully wrapped solution” where the company provides the technology and wellness advice. Fitbit and Humana also announced the availability of the Humana Go365 clock face on Fitbit Versa and Fitbit Ionic devices, making members’ Go365 activity data accessible right from the wrist. EXECUTIVE COMMENTARY: “Working with Fitbit, we have been able to provide our members with wearable devices, data and insights they can use to achieve their best health and wellness. By adding Fitbit Care’s new health coaching capabilities, we can offer even more personalized, meaningful support to our members who are focused on specific health goals, such as smoking cessation or weight loss, or the management or prevention of chronic conditions,” said Jeff Reid, Humana’s senior vice president of Wellness Solutions. “Fitbit’s intuitive technology and human coaches are powerful tools to engage and motivate members, creating more frequent, convenient touch-points that support our members beyond the walls of a doctor’s office.” Adam Pelligrini, general manager of Fitbit Health Solutions, said, “We’re already seeing proof points that the solutions we’re building are taking hold and are resonating with our health plan and employer customers.” Pelligrini added Fitbit already works with over 100 health plans and its health solutions business unit currently represents less than 10% of the company’s overall revenue. WHAT’S NOTABLE: Shares of Fitbit fell on September 12 after Apple (AAPL) unveiled its new Watch Series 4 at its product event. The device features a larger display, new user interface, digital crown with haptics, faster performance, louder speaker and electrical heart sensor with electrocardiogram app and an optical heart sensor. In addition, the company said it received Food and Drug Administration approval for the built-in ECG scanner and it is the first over-the-counter ECG product. Following the fall, Morgan Stanley analyst Yuuji Anderson told investors that he believes the drop “rightly reflects” concerns over the pace of software and sensor improvements at Fitbit. However, the analyst added that he is more concerned that the functionalities of Fitbit’s Versa and Charge 3 are not sufficiently differentiated to avoid cannibalization and their aggregate demand will not sufficiently offset legacy product declines. ‘SIGNIFICANT EVOLUTION:’ Craig-Hallum analyst Alex Fuhrman called Fitbit’s Fitbit Care launch a “significant evolution” in the company’s strategy to add value as a healthcare partner and to increase its recurring revenues. He also views the concurrent Humana (HUM) partnership announcement as evidence of the strong market demand for companies and healthcare providers to partner with Fitbit and integrate its data into users’ other care plans. PRICE ACTION: Fitbit is up 2.1% to $5.92 in morning trading.
Novartis, Tencent to partner, focus on cardiovascular disease
Bloomberg cites an email from Novartis (NVS) regarding its cooperation agreement with Tencent (TCEHY) in China.
Elanco initiated with a Buy at Gabelli
Gabelli analyst Kevin Kedra initiated Elanco (ELAN) with a Buy rating and 2020 private market value estimate of $32 per share, stating that he views the animal health market as attractive given that it is predominately cash-pay with lower development costs and longer product life cycles than human health. The operating margins at Elanco, which is a carve-out of parent Eli Lilly (LLY) expected to go public on September 20, lag the industry leader and Kedra sees a significant opportunity for margin expansion, he tells investors.
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