Cigna ups 2021 guidance

 Cigna Corp. on Friday raised its full-year earnings projection, although the company noted it expects to record a net unfavorable impact from the Covid-19 pandemic in the year.

The Bloomfield, Conn.-based healthcare company now expects full-year adjusted earnings of at least $20.20 a share, an increase of 20 cents from previous guidance. Analysts surveyed by FactSet had been forecasting full-year adjusted earnings of $20.27 a share.

The Covid-19 pandemic will lead to a forecast net unfavorable outlook of about $1.25 a share, the company predicted.

Cigna also raised its guidance for medical-customer growth. It now expects medical customers to increase by at least 350,000, compared with a previous estimate of at least 325,000.

https://www.marketscreener.com/quote/stock/CIGNA-CORPORATION-49690049/news/Cigna-Raises-Full-Year-Guidance-33192827/

Pfizer-BioNTech start full U.S. approval application for COVID-19 vaccine

 Pfizer Inc and German partner BioNTech SA said on Friday they have started an application process with the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine, currently only authorized for emergency use.

If approved, the vaccine will be the first fully approved COVID-19 shot and could help ease vaccine hesitancy due to longer-term data required for an FDA approval.

The companies said they would submit data to support the so-called biologic license application, which requires longer-term follow-up data, on a rolling basis over the next few weeks.

In April, Pfizer-BioNTech said their vaccine was around 91% effective at preventing COVID-19, supported by data on more than 12,000 people fully inoculated for at least six months, positioning the duo to submit for full U.S. regulatory approval.

The companies said on Friday they have submitted nonclinical and clinical data needed to support licensure of the shot for use in individuals aged 16 and above, including updated data announced in April.

The FDA will set a goal date for a regulatory decision once the application is complete and formally accepted for review by the agency.

Under an emergency use authorization, the FDA makes a product available to the public based on the best available evidence during an emergency, without waiting for all the evidence needed for FDA approval or clearance, according to the regulator. (https://bit.ly/3h9ncLy)

More than 170 million doses of Pfizer-BioNTech's vaccine have been delivered across the U.S. since it was authorized for emergency use in December.

Last month, the companies asked U.S. to allow the emergency use of their vaccine in adolescents aged 12 to 15, with the FDA set to give the nod by next week.

There are three vaccines available in the United States: Pfizer-BioNTech, Moderna and Johnson & Johnson. All have been authorized for emergency use.

https://finance.yahoo.com/news/pfizer-biontech-start-full-u-104501792.html

ANI beats views for Q1

-- First quarter 2021 net revenues of $54.5 million; net income of $0.1 million and diluted earnings per share of $0.01 --

-- First quarter adjusted non-GAAP EBITDA of $18.9 million and adjusted non-GAAP diluted earnings per share of $1.04 --

-- Cortrophin® Gel sNDA re-filing on track for Q2 2021 submission --

-- Strengthened R&D engine and enhanced generics and CDMO business through pending acquisition of Novitium Pharma--

-- Expanded branded products portfolio through April 1 acquisition of Sandoz Inc. NDAs --

ANI Pharmaceuticals management will host its first quarter 2021 conference call as follows:

Date			Friday, May 7, 2021
Time			8:30 a.m. ET
Toll free (U.S.)			(866) 518-6930
Webcast (live and replay)			www.anipharmaceuticals.com, under the "Investors" section

A replay of the conference call will be available within two hours of the call’s completion and will remain accessible for one week by dialing 800-934-5153 and entering access code 5412658.

https://finance.yahoo.com/news/ani-pharmaceuticals-reports-first-quarter-105000609.html

New results on Work From Home

 By Jose Maria Barrero, Nicholas Bloom, and Steven J. Davis, there are several points of note, with emphasis added by this author:

COVID-19 drove a mass social experiment in working from home (WFH). We survey more than 30,000 Americans over multiple waves to investigate whether WFH will stick, and why. Our data say that 20 percent of full workdays will be supplied from home after the pandemic ends, compared with just 5 percent before. We develop evidence on five reasons for this large shift: better-than-expected WFH experiences, new investments in physical and human capital that enable WFH, greatly diminished stigma associated with WFH, lingering concerns about crowds and contagion risks, and a pandemic-driven surge in technological innovations that support WFH. We also use our survey data to project three consequences: First, employees will enjoy large benefits from greater remote work, especially those with higher earnings. Second, the shift to WFH will directly reduce spending in major city centers by at least 5-10 percent relative to the pre-pandemic situation. Third, our data on employer plans and the relative productivity of WFH imply a 5 percent productivity boost in the post-pandemic economy due to re-optimized working arrangements. Only one-fifth of this productivity gain will show up in conventional productivity measures, because they do not capture the time savings from less commuting.

Here is the link to the NBER working paper.

https://marginalrevolution.com/marginalrevolution/2021/05/new-results-on-work-from-home.html

Peloton cut to Neutral from Buy by B of A

 Target to $100 from $150

https://finviz.com/quote.ashx?t=PTON&ty=c&ta=1&p=d

Talaris Therapeutics prices IPO

 Talaris Therapeutics, Inc., a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced the pricing of its initial public offering of 8,825,000 shares of common stock at a price to the public of $17.00 per share. All shares are being offered by Talaris. The gross proceeds to Talaris from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $150.0 million. The shares are expected to begin trading on The Nasdaq Global Select Market under the ticker symbol “TALS” on May 7, 2021. The offering is expected to close on May 11, 2021, subject to the satisfaction of customary closing conditions. In addition, the underwriters have a 30-day option to purchase up to an additional 1,323,750 shares of common stock at the initial public offering price less underwriting discounts and commissions.

Morgan Stanley, SVB Leerink, Evercore ISI and Guggenheim Securities are acting as joint book-running managers for the offering.

https://www.globenewswire.com/news-release/2021/05/07/2225195/0/en/Talaris-Therapeutics-Announces-Pricing-of-Initial-Public-Offering.html

Orphazyme misses endpoints in pivotal ALS trial

 

• Pivotal trial did not meet primary and secondary endpoints evaluating impact on function and survival
  
  

  • Orphazyme remains focused on commercial readiness and potential U.S. approval of arimoclomol for Niemann-Pick disease type C (NPC) in June
    
    

Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, today announced that the ORARIALS-01 pivotal trial of arimoclomol in amyotrophic lateral sclerosis (ALS) did not meet its primary and secondary endpoints to show benefit in people living with ALS. No important safety signals were reported in the trial. Topline data will be presented at the upcoming virtual European Network to Cure ALS (ENCALS) meeting, May 12-14, and complete data from the study will be published later this year.

“We are disheartened by these results, as we had hoped arimoclomol might represent a viable new approach against the formidable challenge of this devastating disease. We express our sincere thanks to the investigators, patients and families for their participation and collaboration in our program,” said Thomas Blaettler, MD, Chief Medical Officer, Orphazyme. “With over 18 months of evaluation, this trial represents one of the longest running clinical studies in this category. While unsuccessful, the data generated will contribute meaningfully to the scientific dialogue on this challenging disease. We will apply the invaluable insights from this and other studies to further our pipeline as we continue to pursue the full potential of the heat shock protein response.”

The randomized, placebo-controlled Phase 3 trial was conducted among 245 patients at 29 sites in 12 countries in North America and Europe. Participants were randomized (2:1 ratio) to receive either arimoclomol (248 mg three times daily)i or placebo for up to 76 weeks. The primary endpoint was to determine the efficacy of chronic treatment with arimoclomol compared to placebo in participants with ALS as assessed by the combined assessment of function and survival (CAFS). This endpoint was selected to illustrate the overall treatment effect based on survival and the change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. Secondary endpoints included survival, change in ALSFRS-R, and slow vital capacity (SVC).

https://finance.yahoo.com/news/orphazyme-announces-topline-data-pivotal-050000035.html