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Monday, April 15, 2019

Measles Gone Viral: Personal Choice vs Public Health

Topic: The U.S. is currently in the second largest measles outbreak to occur since the virus was declared eradicated in 2000. In this exclusive MedPage Today Facebook Live interview, pediatricians Stanley Jacob, MD, and Elizabeth Pulikkottil Jacob, MD, of Helping Kids Pediatrics in New City, New York, will discuss the recent outbreaks across the country, where they originated, and what can be done to prevent the virus from spreading.
When: Thursday, April 18, at noon ET.
Questions? If you have questions before Thursday’s Facebook Live interview, submit them by commenting below and we will address them during the event!
How to Join: Follow us on Facebook @MedPageToday and join the interview live on our feed. Feel free to comment, ask questions, and react during the interview!

Oppenheimer Joins Chorus Of CVS Analysts Cautious On Near Term

Less than a week after BMO Capital Markets downgraded CVS Health Corp CVS 2.57%, Oppenheimer is stepping to the sidelines.

The Analyst

Analyst Michael Wiederhorn downgraded CVS from Outperform to Perform and removed the $85 price target.

The Thesis

CVS is more of a long-term opportunity, given the timeline needed to execute on its strategy and near-term legacy business challenges, Wiederhorn said in the Monday downgrade note.
The company had made several large acquisitions over the last decade, including Coram and Target Corporation TGT 1.61% pharmacies. Going by CVS’ history and the magnitude of the Aetna buy, the analyst said he is taking a prudent stance on the near-term outlook for integration.
The long-term opportunity to reduce costs and improve access to care will take years to play out, Wiederhorn said, adding that this could also detract from earnings due to the time and capital required.
The managed care segment will account for only 31 percent of CVS’ projected earnings in 2019, with the fortunes of the company still hinging on the less lucrative pharmacy business, the analyst said.
Oppenheimer is “not overly bullish” on the near-term outlook for CVS’ retail/long-term care and pharmacy benefit manager businesses, which it said face company-specific pressures from contract movement.
Wiederhorn also sees headwinds from industry pressures and an uncertain reimbursement environment.
“Although the valuation appears attractive by historical levels, we expect these factors to dominate the story for the foreseeable future.”

Achaogen’s Bankruptcy Filing, Proposed Sale: What You Need to Know

Nanocap biotech Achaogen Inc AKAO 68.48% has been pushed to the brink, with the companyannouncing Monday that it has voluntarily filed for Chapter 11 bankruptcy protection.
The company said it has filed a motion seeking authorization for an auction and sale process.
What caused the once high-flying biotech to go bankrupt?

Split Verdict Chokes Stock

The writing on the wall was clear after Achaogen’s lead product candidate Zemdri, or plazomicin — an antibacterial agent evaluated for complication urinary tract and bloodstream infections — secured a go-ahead from the DFA only for the former indication.
The split verdict was announced June 26, 2018 and sent shares of Achaogen down by about 20 percent in a single session. Subsequently, the shares were in a freefall, dropping from a little over $12 on June 25 to 50 cents at the close Friday.

Damage Control Fails

Achaogen announced a restructuring initiative in late July, trimming 28 percent of its workforce, or 80 positions, as it embarked on Zemdri commercialization in the U.S. and filed for marketing authorization approval in the EU while also developing its C-Scape program.
In late February, the company announced a $15-million underwritten public offering.
The fourth-quarter results reported in March showed that Zemdri fetched merely $800,000 in sales in 2018.

The Path Forward

Achaogen said it has enlisted court support to continue normal operations during the sale process. It also said it has support of its secured lender Silicon Valley Bank, which has committed to $25 million in funding to facilitate the auction and sale process.

Key Dates

  • May 29: Submission of bids
  • June 3: latest date for commencement of structured auction
  • June 13: expected date of completion of sale
With the stock now near-worthless, long-term believers in Achaogen are likely to be left with nothing. Even with the sale process being contemplated, the shareholders are unlikely to get much from the liquidation, as common shareholders are last in line in claiming ownership to the company’s assets.
Achaogen’s lead product as well as its pipeline could be swooped up by another company.

Adverum clinical hold likely short-lived, says Piper Jaffray

Piper Jaffray analyst Tyler Van Buren believes the clinical hold placed on Adverum Biotechnologies’ investigational new drug application will be short-lived.The clinical hold is unrelated to safety and Adverum responded to the FDA within days, Van Buren tells investors in a research note. This gives him confidence that patients could be dosed in the second cohort later this quarter. Further, the disclosure that initial efficacy data from the first six patients will be reported later this year is earlier than anticipated and suggests that the company may be seeing encouraging signs of activity at the first dose level, says the analyst. He keeps an Overweight rating on Adverum Biotechnologies with an $8 price target.
https://thefly.com/landingPageNews.php?id=2892715

Notable companies reporting before tomorrow’s open

Notable companies reporting before tomorrow’s open, with earnings consensus, include Johnson & Johnson (JNJ), consensus $2.04… UnitedHealth (UNH), consensus $3.59.
https://thefly.com/landingPageNews.php?id=2892704

Lumasiran could give Alnylam 3 RNAi drugs approved by 2021: Piper Jaffray

After Alnylam presented new Phase 2 open-label extension data for lumasiran in primary hyperoxaluria type 1 patients, Piper Jaffray analyst Edward Tenthoff said he believes that lumasiran could become Alnylam’s third approved RNAi drug after the expected approval in 2020 of givosiran to combine with currently marketed Onpattro. The analyst, who projects lumasiran to launch in 2021 and for sales to exceed $1B by 2024, keeps an Overweight rating and $142 price target on Alnylam shares.

Allergan Snags Key Endorsement For Brent Saunders To Remain CEO, Chair

On Monday, a pair of key shareholder advisory firms backed Allergan‘s (AGN) decision to allow Chief Executive Brent Saunders to also retain his chairman position.
Proxy advisory firms Institutional Shareholder Services and Glass Lewis recommended shareholders vote to against a proposal that would force Allergan to separate the two roles, Allergan said in a news release.
Activist investor Appaloosa Management is pushing for Allergan to find a “seasoned, independent chairman with extensive pharmaceutical experience.” It renewed that call in a letter to shareholders in February. Investors vote on the initiative May 1.

Will Brent Saunders Keep His Dual Roles?

Allergan plans to separate CEO and chairman roles in the future when Saunders steps down, ISS noted in its recommendation. The proxy advisory firm also applauded Allergan’s addition of an independent director role. Further, ISS noted Allergan has added six new directors since 2016.
“There are no significant concerns regarding the board’s current leadership structure sufficient to suggest that an immediate split of the CEO and chairman roles is warranted at this time rather than at the next CEO transition,” ISS wrote in its recommendation.
Glass Lewis, too, said the proposal from Appaloosa “is not necessary at this time.”
“We believe that the company’s phasing in of this policy upon the next CEO transition essentially implements the request of this proposal,” the firm said. “We do not believe that the adoption of this proposal would affect any meaningful change in the company’s leadership structure following the next CEO transition.”