DaVita Inc. (DVA) shares rose in the extended session Thursday after the dialysis center company topped Wall Street estimates, and hiked its forecast for the year. DaVita shares rose as much as 5% after hours, following a 0.4% decline in the regular session to close at $101.56. The company reported second-quarter net income of $178.7 million, or $1.91 a share, compared with $224.8 million, or $2.30 a share, in the year-ago period. Adjusted earnings, which exclude stock-based compensation expenses and other items, were $2.08 a share, compared with $2.30 a share in the year-ago period. Revenue rose to $3 billion from $2.93 billion in the year-ago quarter. Analysts surveyed by FactSet had forecast $1.71 a share on revenue of $2.95 billion. Also, DaVita hiked its earnings forecast for the year to a range of $7 to $7.80 a share, from a previous range of $6.20 to $7.30 a share. Analysts estimate $6.79 a share.
Thursday, August 3, 2023
Amgen says FTC has ignored commitments it made to address Horizon deal concerns
Amgen (AMGN) CEO Robert Bradway said the Federal Trade Commission has ignored the commitments that the company has made to address concerns over its deal to acquire Horizon.
Infant RSV shot wins backing of CDC advisors, paving way for fall availability
The first shot that protects all infants against respiratory syncytial virus, or RSV, won the unanimous backing of an advisory panel to the Centers for Disease Control and Prevention on Thursday.
RSV is the leading cause of hospitalization among infants in the U.S. The shot, branded under the name Beyfortus, would provide families with a simple option to protect their babies during the respiratory virus season.
CDC Director Dr. Mandy Cohen is not obligated to endorse the vote of the advisors, though the head of the agency usually follows the panel’s advice.
AstraZeneca and Sanofi are prepared to roll the shot out before RSV season this fall and do not foresee any challenges meeting demand, a Sanofi spokesperson said.
If Beyfortus receives CDC backing, most insurance plans will be required to cover the shot at no cost to consumers due to requirements under the Affordable Care Act. The shot has a list price of $495.
It could potentially take months for some insurance plans to update their policies to comply with the requirement.
The CDC advisors also voted to include the shot in the federal Vaccines for Children Program, which provides shots to kids whose families are struggling financially.
Beyfortus works like a vaccine, but the shot is considered a drug, not a vaccine, because it is an antibody injection. Vaccines prepare the body’s immune system to release antibodies that fight viruses, while Beyfortus injects these antibodies directly into the bloodstream.
Infants younger than 8 months entering their first RSV season would receive one dose. Kids 8 to 19 months who face an increased risk from the virus would receive another dose in their second RSV season.
Another option, called palivizumab, is already on the market but it is primarily used for pre-term babies and those with congenital heart and lung conditions. It is also more difficult to administer because infants have to receive a shot monthly during RSV season.
Beyfortus, on the other hand, would be broadly available for all infants regardless of whether they have a health condition. It is also administered as a single dose to protect babies during the entire RSV season.
Beyfortus was up to 75% effective at preventing lower respiratory tract infections that required medical attention among infants and 78% effective at preventing hospitalization, according to an FDA review.
The FDA did not identify any safety issues when it reviewed Beyfortus. Some monoclonal antibodies have been associated with allergic reactions and skin rashes.
RSV kills nearly 100 infants every year, according to a study published in the medical journal JAMA Network Open in 2022. It is also the leading cause of hospitalization among children less than a year old, according to a study published in the Journal of Infectious Diseases.
Children’s hospitals were overwhelmed last year by a surge of RSV infections at the same time that flu and Covid were also circulating.
The wave of illness strained hospitals so much that they called on the Biden administration to declare a public health emergency in response. The White House ultimately did not declare one.
Addex to Receive Additional CHF2.7 M from Indivior in Extended Substance Use Disorder Research
Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today announced that its collaboration agreement with Indivior PLC (LON: INDV) for the discovery of novel oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) drug candidates for the treatment of substance use disorder has been extended until June 30, 2024. As part of the extended agreement, Indivior has committed CHF 2.7 million to support research and discovery activities during this period. Addex retains exclusive rights to advance its own independent GABAB PAM program and is developing compounds for the treatment of chronic cough.
https://finance.yahoo.com/news/addex-gabab-positive-allosteric-modulator-050000009.html