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Fly News Breaks for February 10, 2020
RHHBY, LLY, BIIB
Feb 10, 2020 | 12:18 EDT
William Blair analyst Matt Phipps noted that Eli Lilly (LLY) and Roche (RHHBY) announced that the Dominantly Inherited Alzheimer's Network Trials Unit, or "DIAN-TU," study of solanezumab and gantenerumab in patients with or at-risk for autosomal dominant Alzheimer's disease did not meet its primary endpoint, which he sees as "discouraging for the amyloid hypothesis of Alzheimer's disease." However, Phipps believe the effect on sentiment toward Biogen's (BIIB) aducanumab will be minimal given that the FDA review will come down to the regulator's interpretation of the subgroup analysis from the ENGAGE and EMERGE trials as well as "any political pressures that come into play." Phipps, who does not believe aducanumab will be approved on this review, but admits that "political pressures for devastating diseases with no alternative therapies have led to FDA approvals based on less-than-perfect clinical data packages," keeps a Market Perform rating on Biogen shares.
News For RHHBY;LLY;BIIB From the Last 2 Days
BIIB
Apr 8, 2020 | 12:45 EDT
Shares of healthcare-related stocks are outperforming a strong move in the broader market on Wednesday after Senator Bernie Sanders ended his presidential campaign, paving the path to for Joe Biden's Democratic nomination. "In a race reshaped, and eclipsed, by the escalating coronavirus crisis, Mr. Sanders faced no realistic path to the nomination after a series of lopsided losses to Mr. Biden, beginning in South Carolina in late February and culminating with a string of losses last month in crucial states like Michigan and Florida," said The New York Times earlier. WHAT'S NOTABLE: Senator Sanders had backed the notion of "Medicare for All," which worried some healthcare investors because of the natural pricing pressures. Biden is leaning towards an expansion of government-subsidized health insurance coverage but would keep the private system. Biden proposes to build on the Affordable Care Act signed into law 10 years ago by President Barack Obama and would look to add a public option to private plans sold on the ACA's public exchange. PRICE ACTION: Shares of health service organizations UnitedHealth Group (UNH), Cigna Corporation (CI) and Anthem (ANTM) are trading higher as is CVS Health (CVS), the owner of Aetna, as well as biotech stocks like Biogen (BIIB).
RHHBY
Apr 7, 2020 | 16:07 EDT
PTC Therapeutics (PTCT) announced that the FDA has extended the Prescription Drug User Fee Act, or PDUFA, date for its review of the New Drug Application, or NDA, of risdiplam to August 24. Roche (RHHBY) recently submitted additional data including comprehensive data from SUNFISH part 2 to help provide access to risdiplam for a broad range of people living with spinal muscular atrophy, SMA, triggering this extension. The FDA has informed Roche that the review team is working expeditiously to complete their review of the application as quickly as possible. The FDA has also indicated to Roche that no substantive review issues have been identified to date. In order to further support broad, global access to risdiplam for people living with SMA, Roche has submitted applications for approval in Indonesia, Taiwan, Chile, Brazil, South Korea and Russia and the submission of the filing in China is imminent. The submission of a Marketing Authorization Application to the EMA and filings in other international markets remain on track for mid-2020.
RHHBY
Apr 7, 2020 | 16:06 EDT
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act date for its review of the New Drug Application of risdiplam with a decision expected by August 24, 2020. The extension is a result of the recent submission of additional data by Genentech, including data from the pivotal SUNFISH Part 2 study, in close collaboration with the FDA. These data were recently presented at the 2nd International Scientific and Clinical Congress on Spinal Muscular Atrophy. In November 2019, the FDA granted Priority Review for risdiplam with a decision for approval expected by May 24, 2020. In February 2020, based on discussions with the FDA, Genentech submitted additional data which could help ensure access to risdiplam for a broad range of people living with the condition, if approved. This included 12-month efficacy and safety data from the pivotal SUNFISH Part 2 study (n=180), the only placebo-controlled study ever undertaken in people aged 2-25 years with Type 2 or 3 SMA. Given the volume of additional data submitted, the FDA requires more time for review. "We strongly believe in the potential of risdiplam as a new therapeutic option and recognize that unmet need remains in the treatment of SMA," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We are working closely with the FDA to support the review of risdiplam. Our goal is to bring this therapy to infants, children and adults living with SMA as quickly as possible."