Regeneron, Sanofi : Libtayo Phase 3 Study Meets Primary Endpoint

 Regeneron Pharmaceuticals Inc. and Sanofi SA on Thursday said a Phase 3 study of their anti-PD-1 cancer drug Libtayo met its overall-survival primary endpoint in patients with advanced non-small cell lung cancer, prompting the companies to end the trial early.

The companies said adding Libtayo to platinum-doublet chemotherapy significantly improved overall survival compared to chemotherapy alone in the study, which enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels.

Libtayo combined with chemotherapy increased median overall survival to 22 months from 13 months, leading to a 29% reduction in the risk of death, the companies said.

Regeneron and Sanofi said the decision to stop the trial early is based on a recommendation by the study's independent data monitoring committee during a protocol-specified interim analysis, adding that the study data will form the basis of regulatory submissions in the U.S. and European Union.

Regeneron, of Tarrytown, N.Y., and France's Sanofi are jointly developing and commercializing Libtayo under a global collaboration agreement.

https://www.marketscreener.com/quote/stock/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Sanofi-Libtayo-Phase-3-Study-Meets-Primary-Endpoint-36080770/

Becton Dickinson 3Q Profit, Revenue Rise

 Becton Dickinson & Co. said its profit and revenue rose for the fiscal third quarter as healthcare utilization levels continued to recover from the initial effects of the Covid-19 pandemic.

The Franklin Lakes, N.J.-based medical-technology company on Thursday posted net income of $525 million, compared with $286 million a year earlier. Earnings were $1.72 a share, compared with 97 cents a share.

Adjusted earnings were $2.74 a share. Analysis polled by FactSet were expecting $2.45 a share.

Revenue rose 26.9% to $4.89 billion, the company said. Analysts were looking for $4.51 billion.

Covid-19 testing revenue was $300 million, including BD Veritor Plus System revenue of $212 million, the company said.

https://www.marketscreener.com/quote/stock/BECTON-DICKINSON-AND-COM-11801/news/Becton-Dickinson-3Q-Profit-Revenue-Rise-36077537/

Eiger BioPharmaceuticals Gets Breakthrough Therapy Designation for Avexitide

 Eiger BioPharmaceuticals Inc. said the U.S. Food and Drug Administration granted breakthrough therapy designation for avexitide for the treatment of congenital hyperinsulism.

The designation is a process designed to speed up the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

Eiger said its application was supported by data from three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism. Avexitide is a targeted GLP-1 antagonist in development for the treatment of metabolic disorders, including congential hyperinsulinism, an ultra-rare, life-threatening, pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to 50% of children.

https://www.marketscreener.com/quote/stock/EIGER-BIOPHARMACEUTICALS-26727607/news/Eiger-BioPharmaceuticals-Gets-Breakthrough-Therapy-Designation-for-Avexitide-36081773/

Gilead's Kite, Appia Bio to Collaborate on Allogeneic Cell Therapies for Cancer

 Gilead Sciences Inc. on Thursday said its Kite unit signed a collaboration and license agreement with biotechnology startup Appia Bio Inc. to research and develop allogeneic cell therapies for cancer.

The Foster City, Calif., biopharmaceutical company said Appia would receive an upfront payment, an equity investment, and additional milestone payments for a total value of up to $875 million, along with royalties on product sales.

Gilead said Appia, founded last year, is developing engineered allogeneic cell therapies from hematopoietic stem cells for cancer patients.

The company said Kite, a cancer immunotherapies company it bought in late 2017 for nearly $12 billion, and Appia would develop chimeric antigen receptor-engineered invariant natural killer T cells using Appia's ACUA technology platform for allogeneic cell therapy.

Gilead said Appia would be responsible for preclinical and early clinical research of two product candidates engineered with chimeric antigen receptors provided by Kite, which in turn would be responsible for the development, manufacturing and commercialization of the product candidates.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-s-Kite-Appia-Bio-to-Collaborate-on-Allogeneic-Cell-Therapies-for-Cancer-36082014/

Cigna sees larger impact from pandemic to 2021 earnings

 

Health insurer Cigna Corp doubled its estimate of the hit to full-year earnings from the pandemic as it reported a better-than-expected quarterly profit and maintained its annual adjusted earnings forecast.

The company's shares were down 3.9% at $222.50 in premarket trading on Thursday.

Cigna said it now expects full-year earnings to take a hit of about $2.50 per share due to COVID-19, compared with its previous forecast of about $1.25 per share. The company stuck to its annual adjusted income from operations target of at least $20.20 per share.

The insurer, which also has a pharmacy benefits management business, said medical costs in the second quarter grew as demand for non-COVID healthcare services normalized.

Health insurers have largely benefited from a decline in patient use of discretionary healthcare services due to the pandemic, but demand for these services is recovering as more Americans get vaccinated.

Cigna's medical care ratio (MCR), the amount spent on medical claims versus income from premiums, worsened to 85.4% in the quarter, from 70.5% a year earlier, compared with an estimate of 81.04%, according to analysts polled by Refinitiv.

The company now expects 2021 MCR to be between 83.0% and 84.0%, compared with its prior forecast of 81.0% to 82.0%.

A lower medical expense ratio is better for health insurers as it signals a tight rein on medical costs.

Rivals Anthem Inc and Centene Corp recently warned about a potential increase in coronavirus-related costs in the second half of 2021 due to the impact of the Delta variant.

The increase in Cigna's MCR outlook and higher quarterly medical costs may reflect greater Delta variant impact than other health insurers, which reported quarterly results earlier, Bernstein analyst Lance Wilkes said.

Excluding items, Cigna earned $5.24 per share in the quarter ended June 30, beating estimates of $4.96.

https://www.marketscreener.com/news/latest/Cigna-sees-larger-impact-from-pandemic-to-2021-earnings--36076969/

Moderna: Vaccine 93% effective up to 6 months but booster likely needed before winter

 Moderna’s COVID-19 vaccine remained 93% effective against symptomatic illness six months after the second dose, but amid the ongoing spread of the highly contagious delta variant, the company said it believes a booster dose will be necessary prior to the winter season. 

The company announced the findings Thursday ahead of an earnings call, which also said its vaccine booster candidates produced a "robust" immune response against the delta variant.

Moderna said it believes the ongoing spread of the delta strain combined with more people gathering indoors as it gets colder will "lead to an increase of breakthrough infections in vaccinated individuals." 

"While we see durable Phase 3 efficacy through 6 months, we expect neutralizing titers will continue to wane and eventually impact vaccine efficacy," the company said. "Given this intersection, we believe dose 3 booster will likely be necessary prior to the winter season."

The vaccine’s latest 93% effectiveness figure is just short of the shot’s initial reported efficacy of 94%. Moderna said data shared Thursday was collected from an analysis of its large clinical trial that began in July of 2020 and was completed before the delta variant became the dominant strain in the U.S. 

"We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months, but recognize that the delta variant is a significant new threat so we must remain vigilant," Moderna CEO Stephane Bancel said in a statement.

Moderna’s booster shot candidates also showed "robust antibody responses" to the delta variant, as well as other COVID-19 variants of concern, in a Phase 2 study, according to the company. The data have been submitted to a peer-reviewed journal for publication.

Moderna has stated the rolling submission process for full approval of its two-dose vaccine by the U.S. Food and Drug Administration and said it expects to complete its submission this month.

"We have begun preparing late-stage studies for our flu vaccine and RSV vaccine, which received fast track designation from the FDA a few days ago and are looking forward towards our vision of a single dose annual booster that provides protection against COVID-19, flu and RSV for adults," Bancel added.

To date, nearly 140 million doses of Moderna’s COVID-19 vaccine have been administered in the U.S.

https://www.fox29.com/news/moderna-covid-19-vaccine-remains-93-effective-for-up-to-6-months-company-says

Pfizer will require U.S. employees to get Covid vaccine or tests weekly

 Pfizer said Wednesday it will require all its U.S. employees and contractors to get vaccinated against Covid-19 or participate in regular weekly testing.

The new initiative will “best protect the health and safety of our colleagues and the communities we serve,” Pfizer spokesperson Pamela Eisele said in a statement to CNBC.

“Outside the U.S., the company is strongly encouraging all colleagues who are able to do so in their countries get vaccinated,” Eisele added. “Colleagues who have medical conditions or religious objections will be able to seek accommodations. Colleagues are still required to adhere to all COVID-19 state, local and Pfizer safety procedures while engaged in Pfizer work.”

Pfizer, whose Covid vaccine with German drugmaker BioNTech was the first to be authorized in the United States, is just the latest company to require its employees to get the shots. The mandates come as coronavirus cases in the U.S. spike once again, fueled by the highly contagious delta variant.

On Tuesday, New York City became the first major city in the U.S. to require proof of vaccination at restaurants, gyms and other businesses.

A new CNBC All-America Economic Survey published Wednesday found Americans are sharply divided over vaccine mandates.

The poll of 802 Americans taken from July 24-28 found 49% favoring vaccine mandates and 46% opposing — a difference that’s within the survey’s 3.5 percentage point margin of error. Five percent said they were unsure.

https://www.cnbc.com/2021/08/04/vaccine-mandate-pfizer-will-require-covid-shot-or-testing-for-us-employees-.html