Shares of Intrexon are rising in pre-market trading after the company announced advances in the development of its microbial platform to produce cannabinoids for medical uses. “Through Intrexon’s proprietary technologies, the company has engineered a yeast strain to produce low-cost, robust and consistent cannabinoid outputs via fermentation. This process utilizing microbes has potential to provide greater supply-chain security, and avoids the resource-intensive isolation that often leads to quality and quantity variability in end products,” the company stated. Chris Savile, Executive Director of Commercial Operations at Intrexon, added, “As with some of our other similar projects, in thebaine, for example, microbial fermentation routes to produce cannabinoids provide advantages over traditional plant-based extraction. Through our capabilities and experience, we expect to optimize strains to produce specific cannabinoids that may be commercialized in the coming years.” Following the company’s press release, shares of Intrexon are up $1.89, or 13%, to $16.39 ahead of the opening bell.
Monday, September 24, 2018
Sarepta preclinical hold lifted as expected, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff says that as he expected, the FDA lifted the clinical hold on Sarepta Therapeutics’ Phase I/IIa micro-dystrophin GeneRx study related to drug material supplied by a third-party. Sarepta, which recently partnered with Brammer Bio to manufacture GMP plasmid, remains on track to begin a pivotal trial by the end of 2018, Tenthoff tells investors in a research note. He believes Sarepta “has assembled a rich preclinical pipeline” of GeneRx to treat a range of rare diseases and keeps an Overweight rating on the shares with a $168 price target. The stock in premarket trading is up $2.41 to $150.00.
Ovid Therapeutics, Takeda announce initiation of two Phase 2 trials
Ovid Therapeutics (OVID) announced initiations of the Phase 2 ELEKTRA and ARCADE trials for OV935/TAK-935 in pediatric patients with rare epilepsies. The company reports that the first patient has been randomized to receive either OV935 or placebo in the ELEKTRA trial and that patient screening is underway for the ARCADE trial. These trials are being conducted together with Ovid’s collaboration partner Takeda (TKPYY).
Gilead subsidiary to launch authorized generics of Epclusa, Harvoni
Gilead Sciences announced plans to launch authorized generic versions of Epclusa and Harvoni, Gilead’s leading treatments for chronic hepatitis C virus, in the United States, through a newly created subsidiary, Asegua Therapeutics. The authorized generics will launch at a list price of $24,000 for the most common course of therapy and will be available in January 2019. Since the launch of Gilead’s first HCV medication in 2013, the average price paid for each bottle of medicine in the U.S. has decreased by more than 60 percent off of the public list prices, across health insurers and government payers. Due to the complexity and structure of the U.S. healthcare system, however, these discounts provided by Gilead may not always translate into lower costs for patients. Further, existing contracts, together with laws associated with government pricing policies, make it challenging to quickly lower a product’s list price once it is on the market.The authorized generics are priced to more closely reflect the discounts that health insurers and government payers receive today. Insurers will have the choice of offering either the authorized generics or the branded medications for both Epclusa and Harvoni. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to our medications to beneficiaries who were previously denied coverage. Beyond the company’s efforts to reduce patient costs, Gilead is continuing to pursue innovative collaborations and long-term financing models, such as a potential subscription model, that could not only expand access, but aim to eliminate HCV in the U.S. and around the world.
Abbott Mitraclip data a ‘grand slam,’ says Cowen
Abbott Mitraclip data a ‘grand slam,’ says Cowen. Cowen analyst Joshua Jennings said the Abbott trial results meaningfully outperformed skeptical consensus expectations with Mitraclip generating statistically significant decreases in the rates of both heart failure hospitalizations and all-cause mortality. The analyst said the results are so strong that COAPT now represents a landmark study for functional mitral regurgitation and reemphasizes Abbott’s leadership in TMV repair. Jennings reiterated his Outperform rating and $72 price target on Abbott shares.
Quest Diagnostics price target raised to $128 from $121 at Credit Suisse
Credit Suisse analyst A.J. Rice raised his price target for Quest Diagnostics to $128 from $121 after meeting with CEO Steve Rusckowski and VP of Investor Relations Shawn Bevec. The analyst notes that management sees the clinical lab industry going through a period of disruptive change that should play to the strengths of national laboratory companies, such as Quest, at the expense of small regional labs and hospital outreach programs. Rice reiterates an Outperform rating on the shares.
Nightstar Therapeutics price target raised to $41 from $30 at BMO Capital
BMO Capital analyst Matthew Luchini raised his price target on Nightstart to $41 and kept his Outperform rating, saying he is adding to his model the impact of NSR-RPGR disclosed last week in the presentation of early dose escalation Phase I/II data. The analyst notes says the improvements in microperimetry cohorts 3-5 “provide preliminary proof-of-concept and support initiation of the expansion study planned for Q4”, adding that XLRP could achieve peak sales of about $675M.
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