Wednesday, January 2, 2019
Ultragenyx cut to Market Perform on lack of catalysts at Raymond James
Raymond James downgraded Ultragenyx to Market Perform from Outperform. Analyst Laura Chico said Ultragenyx lacks near-term catalysts which makes it more vulnerable in a “risk off” environment. Chico remains encouraged by the Crysvita launch, but said the company is only proportion of the economics.
https://thefly.com/landingPageNews.php?id=2842469
Leerink says expectations high for Medidata, initiates with Market Perform
Leerink analyst David Larsen started Medidata with a Market Perform Rating and a $70 price target. The analyst likes how the company is considered to be the premium solution with respect to clinical trial electronic data capture. But while the fundamentals of the industry and company are favorable, Larsen thinks there is significant risk to the stock. The overall market has been volatile which will pressure higher multiple stocks, and investor expectations for revenue growth are very high and any disappointment could result in a significant sell-off, he contents. Further, the analyst believes 95%-plus of biopharma already have electronic clinical solutions in place, and the market is becoming more competitive.
https://thefly.com/landingPageNews.php?id=2842475
Allena Pharmaceuticals aligns with FDA on design of URIROX-2
Allena Pharmaceuticals announced that it has reached alignment with the FDA on both the design of URIROX-2, its second pivotal Phase 3 trial of reloxaliase in patients with enteric hyperoxaluria and its strategy to pursue a biologics license application, or BLA, submission for reloxaliase using the accelerated approval regulatory pathway. Allena’s URIROX program consists of two pivotal Phase 3 clinical trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria. URIROX-1 is currently enrolling patients, and Allena initiated URIROX-2 in Q4. The primary efficacy endpoint for URIROX-2 is the percent change from baseline in 24-hour urinary oxalate, or UOx, excretion measured during weeks 1-4, the same primary efficacy endpoint as URIROX-1. The FDA agreed that, if positive, biomarker data on 24-hour UOx excretion in URIROX-1 and URIROX-2 would be used for a BLA filing for accelerated approval of reloxaliase in enteric hyperoxaluria and that patients would continue in URIROX-2 to confirm clinical benefit during the long-term follow-up phase of the trial.
https://thefly.com/landingPageNews.php?id=2842489
Merus in strategic collaboration with Betta Pharmaceuticals for MCLA-129
Merus announced that it has agreed to grant Betta Pharmaceuticals an exclusive license to develop and commercialize Merus Biclonics MCLA-129 in China. Merus will retain all rights outside of China. Under the terms of the agreement, Betta Pharmaceuticals has agreed to be responsible for clinical development and commercialization of MCLA-129 in China. As a key strategic component of the collaboration, Betta will retain a contract manufacturing organization with experience in filing initial new drug, or IND, applications with U.S. and European regulatory authorities in order to produce clinical trial materials for the Chinese market and rest of world. Betta will facilitate regulatory filings and early stage clinical trial materials supply for potential use by Merus for development of MCLA-129 outside of China. In preclinical studies, MCLA-129 showed a significant reduction in tumor volume for EGFR inhibitor resistant lung cancer models lacking immune cells. Additionally, in cell lines that co-express both EGFR and c-MET, MCLA-129 effectively induced tumor cell lysis at low antibody concentrations. In addition to receiving an upfront payment, Merus will be eligible to receive payments contingent upon Betta Pharmaceuticals achieving certain specified development and commercial goals in China. Merus will also be eligible to receive tiered royalty payments on sales in China from Betta Pharmaceuticals. Betta Pharmaceuticals will be eligible to receive payments contingent upon Merus achieving certain specified development and commercial goals, and will be eligible to receive tiered royalty payments on sales outside of China from Merus.
https://thefly.com/landingPageNews.php?id=2842517
Blair sees blockbuster opportunity for Portola following approval
William Blair analyst Matt Phipps believes Monday’s FDA approval of Portola Pharmaceuticals’ second-generation manufacturing process of Andexxa opens up a blockbuster opportunity for the company. Given the new supply source, Portola is now on track to significantly broaden the launch of Andexxa in 2019, Phipps told investors in a research note on Monday night. He believes “solid execution” on the commercial front will drive Andexxa sales and shareholder value. He sees additional upside from approval of Andexxa in patients requiring emergency surgery and acute major bleeding on additional anticoagulants, such as edoxaban and enoxaparin, creating a blockbuster opportunity. The analyst keeps an Outperform rating on Portola Pharmaceuticals.
https://thefly.com/landingPageNews.php?id=2842575
https://thefly.com/landingPageNews.php?id=2842575
Sarepta secures source of plasmid DNA for gene therapy programs
Sarepta Therapeutics (NASDAQ:SRPT) inks a long-term agreement with Aldevron for the supply of plasmid DNA to support its gene therapy programs.
Aldevron will supply GMP-grade plasmid for Sarepta’s DMD and Limb-girdle muscular dystrophy (LGMD) programs as well as plasmid source material for future programs, including Charcot-Marie-Tooth, MPS IIIA, Pompe and other CNS disorders.
Financial terms are not disclosed.
Piper upgrades Bausch Health
Moderna (NASDAQ:MRNA) initiated with Buy rating and $25 (64% upside) price target at Goldman Sachs. Initiated with Overweight rating and $22 price target at JPMorgan. Initiated with Overweight rating and $24 price target at Piper Jaffray. Initiated with Overweight rating and $29 price target at Morgan Stanley. Initiated with Outperform rating and $27 price target at Oppenheimer.
Bausch Health Companies (NYSE:BHC) upgraded to Overweight with a $27 (46% upside) price target at Piper Jaffray.
Stryker (NYSE:SYK) upgraded to Outperform at Evercore ISI.
Hologic (NASDAQ:HOLX) downgraded to Underweight at Morgan Stanley. Shares down 3% premarket.
Ultragenyx Pharmaceutical (NASDAQ:RARE) downgraded to Market Perform at Raymond James. Shares down 3% premarket.
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