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Tuesday, December 22, 2020

Hepion Pharma to begin CRV431 testing in COVID-19 patients

 

Teladoc, 'Large Player In Fast-Growing Market': Evercore ISI

 Teladoc Health Inc 

TDOC 2.35% benefits from a first-mover advantage in telehealth and has been a beneficiary of the shift to virtual care during COVID-19, according to Evercore ISI.

The Teladoc Health Analyst: Elizabeth Anderson initiated coverage of Teladoc Health with an In-Line rating and $215 price target.

The Teladoc Health Thesis: The company has a wide range of offerings for remote care, including general medicine, mental health and expert opinions, with a total addressable market of around $70 billion, Anderson said in the Tuesday initiation note.

“The recently closed Livongo transaction adds additional digital scalpels to TDOC’s surgical kit, particularly in chronic diseases such as diabetes and hypertension,” the analyst said.

These segments add $50 billion to the company’s total addressable market, she said. 

“Given the continued high interest in these areas as ways to limit healthcare costs as well as the limited customer overlap between legacy TDCO and LVGO, we see $500+ MM of revenue synergy targets as attainable by 2025.” 

Evercore expects Teladoc Health to generate more than 30% organic growth over the next few years, “with improving profitability as the company scales and achieves ~$60 MM in cost synergies.”

https://www.benzinga.com/analyst-ratings/analyst-color/20/12/18894112/teladoc-health-a-large-player-in-a-fast-growing-market-evercore-isi

Covid-19 Variant Could Make Herd Immunity More Difficult, Says BioNTech

 The new coronavirus variant that is spreading across the U.K. could make it more difficult to reach so-called herd immunity, according to the chief executive of BioNTech SE, the German company that developed the Covid-19 vaccine with Pfizer Inc.

British authorities have said the new variant of the coronavirus is more contagious than the existing one -- prompting a raft of countries to cut off travel to and from the U.K.

A more contagious version of the virus means a greater number of people than originally expected would need to be vaccinated to halt its spread, said Ugur Sahin, CEO of BioNTech. The Pfizer-BioNTech vaccine is now being deployed in the U.S. and U.K. and is expected to roll out in the European Union from next week.

Herd immunity occurs when a sufficient proportion of a population has been immunized by vaccination or after having been infected, effectively ending the disease's spread. The threshold at which herd immunity is achieved varies between diseases.

That threshold is related to the speed of the viral spread, known as R. Most experts agree the herd immunity threshold for coronavirus is between 60% and 70% of a population.

Should the new variant -- which is believed to have originated in the U.K. but has now spread in small numbers to a handful of other countries -- boost the R number of the virus, the threshold for collective immunity will go up and governments will need more vaccines to stop contagion, Dr. Sahin said Tuesday.

"If the virus becomes more efficient in infecting people, we might need even a higher vaccination rate to ensure that normal life can continue without interruption," he said.

If the new strain becomes prevalent and boosts the R number, countries may face further outbreaks even after 70% of their population has been immunized, Dr. Sahin said. But, in that case, the severity of the spread would be greatly reduced, allowing for a gradual return to normal life, he said.

The Pfizer-BioNTech vaccine, which has now been administered to over one million people world-wide, is highly likely to be effective against the new coronavirus variant, Dr. Sahin said. It will take about two weeks to confirm that through testing, he said, adding that the company will publish the resulting data.

"We have scientific confidence that the vaccine might protect, but we will know it only when the experiment is done," he said.

Pfizer and BioNTech's vaccine works by injecting genetic material known as messenger RNA, or mRNA, into the body, which then alerts the immune system to a protein used by the virus to cause infection. The variant that was discovered in the U.K. has nine mutations, Dr. Sahin said, but only 1% of the protein targeted by the vaccine has changed -- making it unlikely likely the vaccine could become less efficient.

The vaccine has already proven effective against 20 other known mutations that appeared in recent months, he added.

Should a new mutation render the vaccine ineffective, BioNTech can develop another tailored to the new coronavirus variant in six weeks, according to Dr. Sahin. It is, however, unclear whether regulators such as the U.S. Food and Drug Administration would require a new vaccine to undergo fresh trials and a new authorization process.

In Europe, the BioNTech-Pfizer vaccine will as of this week be marketed under the brand name Comirnaty. Dr. Sahin said the name was derived from the words Covid, mRNA, community and immunity.

https://www.marketscreener.com/quote/stock/BIONTECH-SE-66771992/news/BioNTech-Covid-19-Variant-Could-Make-Herd-Immunity-More-Difficult-Says-BioNTech-32069356/

French call Abivax Covid-19 Phase 2b/3 miR-AGE trial Research National Priority

 

 
*Abivax's Covid-19 Phase 2b/3 miR-AGE trial with ABX464 declared Research National 
Priority by the French government's Clinical Trial Council* 
 
  · _Research National Priority has priority for patient enrollment in clinical 
  trials for an accelerated review and approval process with the French regulatory 
  authorities_ 
 
  · _Effective Covid-19 treatments very much needed because optimal vaccination 
  coverage of millions of individuals and public acceptance will take time_ 
 
  · _ABX464 mechanism of action not expected to be impacted by viral mutations_ 
 
  · _Pivotal phase 2b/3 Covid-19 trial results expected in Q2 2021 and ABX464 
  manufacturing scale-up is ongoing to meet potential demand from commercialization 
  in 2021_ 
https://www.marketscreener.com/quote/stock/ABIVAX-22387984/news/PRESS-RELEASE-Abivax-s-Covid-19-Phase-2b-3-miR-AGE-trial-with-ABX464-declared-Research-National-Pr-32070964/

FDA resumes eIND approval for use of CytoDyn leronlimab in COVID-19

 

Rhythm Pharma's setmelanotide shows efficacy in obesity study

 

  • Rhythm Pharmaceutical (NASDAQ:RYTM) gains 9% in premarket, on announcement of positive topline results from Phase 3 trial evaluating setmelanotide, for the treatment of insatiable hunger and severe obesity in individuals with Bardet-Biedl syndrome (BBS) or Alström syndrome
  • The study met primary and secondary endpoints by showing statistically significant and clinically meaningful reductions in weight and hunger scores.
  • 11 of 31 or 34.5% of participants achieved the primary endpoint of at least 10% reduction in body weight from baseline at ~52 weeks of therapy.
  • All primary endpoint responders were Bardet-Biedl patients.
  • The company intends to complete regulatory submissions to the FDA and the EMA in 2H of 2021.
  • Setmelanotide activates a protein called melanocortin 4 receptor that plays a key role in controlling appetite.
  • Last month, the FDA approved Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients 6 years of age and older with pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity.
  • Earlier in June, the company announced interim Phase 2 data from obese volunteers, that demonstrated weekly setmelanotide administration showed weight loss efficacy, compared to daily treatment.
  • https://seekingalpha.com/news/3646550-rhythm-pharmas-setmelanotide-shows-efficacy-in-obesity-study

Veracyte and Bayer collaborate in precision oncology

 

  • Veracyte (NASDAQ:VCYT) is up +16.8% after announcing a collaboration with Bayer (OTCPK:BAYZF) to advance its Afirma Xpression Atlas for targeted therapies in patients with advanced or metastatic thyroid cancer.
  • Regardless of the results and the treatment decision, Bayer will provide Afirma XA testing at no cost to all eligible patients, when ordered by the physician, according to the agreement.
  • The program focuses on patients with advanced or metastatic thyroid cancer, that is RAIR (refractory to radioactive iodine), who may potentially benefit from biomarker-driven therapies.
  • On fine needle aspirates taken from thyroid nodules or lymph nodes, the Afirma XA can identify 905 DNA variants and 235 RNA fusions in 593 genes, including novel NTRK gene fusions, more common in patients with RAIR thyroid cancer (2.4%-12% of patients).
  • The companies expect to launch the program in Q1 2021. 
  • Veracyte recently partnered with Johnson & Johnson (NYSE:JNJ) to accelerate the development of its non-invasive nasal swab test for early lung cancer detection.
  • https://seekingalpha.com/news/3646727-veracyte-and-bayer-collaborate-in-precision-oncology-shares-jumpplus-17