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Business Wire
20-05-2025
- Business
- Business Wire
ZEVTERA ® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections
WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability of ZEVTERA ® (ceftobiprole medocaril sodium for injection), the newest addition to the Company's growing antibiotic portfolio. ZEVTERA is the only U.S. Food and Drug Administration (FDA) approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates. i ZEVTERA is the latest approved MRSA SAB therapy since 2006. 'The availability of ZEVTERA in the U.S. marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,' said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. 'This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform.' MRSA, a strain of Staphylococcus aureus, has developed resistance to methicillin and many other commonly used antibiotics. Infections with MRSA have a high morbidity and mortality rate. Each year, over one hundred thousand individuals in the U.S. experience bacteremia caused by Staphylococcus aureus, with nearly 20,000 of these cases resulting in death. In April 2024, the U.S. FDA approved ZEVTERA for three indications. It is the only FDA-approved MRSA cephalosporin antibiotic for treating adult patients with SAB and right-side endocarditis. In addition to Staphylococcus aureus bacteremia, ZEVTERA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). ii Unlike earlier-generation cephalosporins, ZEVTERA retains effectiveness against Gram-negative bacteria and provides activity against MRSA and methicillin-susceptible Staphylococcus aureus (MSSA). In the Phase 3 ERADICATE study, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. The overall success rate was 69.8% with ceftobiprole, compared to 68.7% with daptomycin, in the Modified Intention-to-Treat (mITT) population at 70 days post-randomization. Both treatments were well tolerated. The overall rate of adverse events was similar between the ceftobiprole and daptomycin groups. iii 'ZEVTERA is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases,' said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics, Inc. 'With the approval of ZEVTERA for three different indications, physicians and other health care providers will have a new option for serious bacterial infections, including Staphylococcal aureus bacteremia caused by methicillin-susceptible and methicillin-resistant isolates. Through our collaboration with specialty pharmacies and pharmacy distributors nationwide, ZEVTERA is available for immediate access.' Despite the availability of standard-of-care therapies, the mortality rate for SAB remains high, with approximately 30% of patients succumbing to the infection at 90 days. iv Patients with MRSA are three times more likely to experience prolonged bacteremia compared to those with methicillin-sensitive Staphylococcus aureus. Furthermore, MRSA bacteremia increased hospital length of stay and systemic infection vs. methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. v ZEVTERA is supplied in a single-dose vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for intravenous infusion after reconstitution. Please visit for more information. ZEVTERA was developed by Basilea Pharmaceutica Ltd, Allschwil ('Basilea') and received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. In December 2024, Innoviva Specialty Therapeutics, Inc., acquired exclusive U.S. marketing rights through a licensing agreement with Basilea. 'We congratulate our partner Innoviva Specialty Therapeutics on making ZEVTERA available in the U.S., which marks a significant milestone for the brand,' said David Veitch, Chief Executive Officer of Basilea. 'The U.S. is the most critical commercial market for newer antibacterials, and there is a substantial medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. We are excited to support Innoviva Specialty Therapeutics in bringing ZEVTERA to patients in the U.S. who are suffering from these severe infections.' About MRSA According to the Centers for Disease Control and Prevention (CDC), methicillin-resistant Staphylococcus aureus (MRSA) is considered a serious public health threat. MRSA is a type of staph infection that has become resistant to commonly used antibiotics, including methicillin, oxacillin, penicillin, and amoxicillin. This resistance has contributed to MRSA's status as a significant public health concern. MRSA infections can lead to severe complications both in healthcare settings and in the community, including pneumonia, sepsis, surgical site infections, and endocarditis. Individuals at highest risk for contracting MRSA include those who have prolonged hospital stays, have been admitted to intensive care, underwent recent invasive procedures, or reside in nursing homes. Healthcare workers who come into direct contact with patients infected with MRSA are also at increased risk. About ZEVTERA ® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the U.S., the brand is currently approved and marketed in several European countries and beyond as ZEVTERA ® and Mabelio ® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. INDICATIONS & USAGE Indications ZEVTERA ® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae. Adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin- susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications: ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and Precautions: Increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed. Adverse Reactions: SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics, Inc.™ 1‑800‑651‑3861 medinfo@ U.S. Food and Drug Administration 1‑800‑FDA‑1088 For smaller pieces, AE language can be: To report suspected adverse reactions, contact Innoviva Specialty Therapeutics, Inc. at 1‑800‑651‑3861 (medinfo@ or the FDA at 1-800-FDA-1088 or For full prescribing information, go to: About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB. vi About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in healthcare settings. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved. vii About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US. viii About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea is committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. Basilea has successfully launched two hospital brands, Cresemba (isavuconazonium sulfate), for the treatment of invasive fungal infections and ZEVTERA for the treatment of bacterial infections. In addition, the Company has preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ('IST'), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ('GSK'). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ®. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA ® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. ANORO ®, RELVAR ® and BREO ® are trademarks of the GSK group of companies. ZEVTERA ® is a trademark of Basilea Pharmaceutica Ltd, Allschwil.
Yahoo
20-05-2025
- Business
- Yahoo
ZEVTERA® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections
ZEVTERA is the first and only U.S. Food and Drug Administration-approved cephalosporin indicated to treat Staphylococcus aureus bacteremia (SAB), including right-sided endocarditis, caused by the methicillin-resistant Staphylococcus aureus (MRSA). WALTHAM, Mass., May 20, 2025--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability of ZEVTERA® (ceftobiprole medocaril sodium for injection), the newest addition to the Company's growing antibiotic portfolio. ZEVTERA is the only U.S. Food and Drug Administration (FDA) approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.i ZEVTERA is the latest approved MRSA SAB therapy since 2006. "The availability of ZEVTERA in the U.S. marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings," said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. "This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform." MRSA, a strain of Staphylococcus aureus, has developed resistance to methicillin and many other commonly used antibiotics. Infections with MRSA have a high morbidity and mortality rate. Each year, over one hundred thousand individuals in the U.S. experience bacteremia caused by Staphylococcus aureus, with nearly 20,000 of these cases resulting in death. In April 2024, the U.S. FDA approved ZEVTERA for three indications. It is the only FDA-approved MRSA cephalosporin antibiotic for treating adult patients with SAB and right-side endocarditis. In addition to Staphylococcus aureus bacteremia, ZEVTERA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).ii Unlike earlier-generation cephalosporins, ZEVTERA retains effectiveness against Gram-negative bacteria and provides activity against MRSA and methicillin-susceptible Staphylococcus aureus (MSSA). In the Phase 3 ERADICATE study, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. The overall success rate was 69.8% with ceftobiprole, compared to 68.7% with daptomycin, in the Modified Intention-to-Treat (mITT) population at 70 days post-randomization. Both treatments were well tolerated. The overall rate of adverse events was similar between the ceftobiprole and daptomycin "ZEVTERA is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases," said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics, Inc. "With the approval of ZEVTERA for three different indications, physicians and other health care providers will have a new option for serious bacterial infections, including Staphylococcal aureus bacteremia caused by methicillin-susceptible and methicillin-resistant isolates. Through our collaboration with specialty pharmacies and pharmacy distributors nationwide, ZEVTERA is available for immediate access." Despite the availability of standard-of-care therapies, the mortality rate for SAB remains high, with approximately 30% of patients succumbing to the infection at 90 Patients with MRSA are three times more likely to experience prolonged bacteremia compared to those with methicillin-sensitive Staphylococcus aureus. Furthermore, MRSA bacteremia increased hospital length of stay and systemic infection vs. methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia.v ZEVTERA is supplied in a single-dose vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for intravenous infusion after reconstitution. Please visit for more information. ZEVTERA was developed by Basilea Pharmaceutica Ltd, Allschwil ("Basilea") and received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. In December 2024, Innoviva Specialty Therapeutics, Inc., acquired exclusive U.S. marketing rights through a licensing agreement with Basilea. "We congratulate our partner Innoviva Specialty Therapeutics on making ZEVTERA available in the U.S., which marks a significant milestone for the brand," said David Veitch, Chief Executive Officer of Basilea. "The U.S. is the most critical commercial market for newer antibacterials, and there is a substantial medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. We are excited to support Innoviva Specialty Therapeutics in bringing ZEVTERA to patients in the U.S. who are suffering from these severe infections." About MRSA According to the Centers for Disease Control and Prevention (CDC), methicillin-resistant Staphylococcus aureus (MRSA) is considered a serious public health threat. MRSA is a type of staph infection that has become resistant to commonly used antibiotics, including methicillin, oxacillin, penicillin, and amoxicillin. This resistance has contributed to MRSA's status as a significant public health concern. MRSA infections can lead to severe complications both in healthcare settings and in the community, including pneumonia, sepsis, surgical site infections, and endocarditis. Individuals at highest risk for contracting MRSA include those who have prolonged hospital stays, have been admitted to intensive care, underwent recent invasive procedures, or reside in nursing homes. Healthcare workers who come into direct contact with patients infected with MRSA are also at increased risk. About ZEVTERA® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the U.S., the brand is currently approved and marketed in several European countries and beyond as ZEVTERA® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. INDICATIONS & USAGE Indications ZEVTERA® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae. Adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin- susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications: ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and Precautions: Increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed. Adverse Reactions: SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics, Inc.™ 1‑800‑651‑3861 medinfo@ U.S. Food and Drug Administration 1‑800‑FDA‑1088 For smaller pieces, AE language can be: To report suspected adverse reactions, contact Innoviva Specialty Therapeutics, Inc. at 1‑800‑651‑3861 (medinfo@ or the FDA at 1-800-FDA-1088 or For full prescribing information, go to: About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in healthcare settings. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea is committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. Basilea has successfully launched two hospital brands, Cresemba (isavuconazonium sulfate), for the treatment of invasive fungal infections and ZEVTERA for the treatment of bacterial infections. In addition, the Company has preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ("IST"), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ("GSK"). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. ____________________ i Full US prescribing information: ii U.S. Food and Drug Administration. (2024, April 3). FDA approves new antibiotic for three different uses. [FDA News Release] iii Holland TL, Cosgrove SE, Doernberg SB, et al. Ceftobiprole for treatment of complicated Staphylococcus aureus bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. iv Van der Vaart, Thomas; All-Cause and Infection-Related Mortality in Staphylococcus aureus Bacteremia, a Multicenter Prospective Cohort Study; Open Forum Infectious Diseases; December 2022, Volume 9, Issue 12; v Minejima, E., Mai, N., Bui, N., Mert, M., Mack, W. J., She, R. C., Nieberg, P., Spellberg, B., & Wong-Beringer, A. (2020). Defining the Breakpoint Duration of Staphylococcus aureus Bacteremia Predictive of Poor Outcomes. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 70(4), 566–573. vi K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48 vii J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518 viii J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with pneumonia in the United States: Incidence, epidemiology, and mortality. Clinical Infectious Diseases 2017 (65), 1807-1812 View source version on Contacts Investors and Media: Innoviva, PattiCorporate Communications(908) Eleanor BarisserInvestor Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
08-05-2025
- Business
- Yahoo
Innoviva, Inc. (INVA): Among Stocks with Insanely High PE Ratios Insiders Are Selling
We recently published a list of . In this article, we are going to take a look at where Innoviva, Inc. (NASDAQ:INVA) stands against other stocks with insanely high PE ratios insiders are selling. The U.S. stock market has turned into a theater of extremes right now. Growth stocks are seeing an abnormal price hike, but in some cases, it is almost proportionately met with the insiders cashing out. The flood of insider sales in companies trading at unbelievable price-to-earnings (PE) ratios has become the prime example of what would happen when euphoria crashes with caution. But why are corporate executives – the insiders who know the company best- selling shares when investors are piling in on them? Let's connect the dots. READ ALSO: Growth stocks continue to be at the center of attraction in 2025. They have been outperforming their value counterpart over the past decade, fueled by declining interest rates and increasing bets on innovation. Even when the Fed hiked the rates in 2023, growth stocks strived under pressure, with some sectors continuing to command premium valuations. Many of these companies are now trading at PE ratios that even optimistic analysts could not justify. For that reason, insiders are selling, and they are doing it aggressively. Retail investors chase fast-paced moments while corporate executives and major stakeholders pull their investments from the company. Data from the SEC's Form 4 filings reveal that insider sales for high-PE firms have increased recently, reflecting a widening gap between Wall Street's optimism and Main Street's reality. It is yet to be decided whether these sales are a vote of no confidence in the insanely high valuations or simply prudent profit-taking. To answer this, we need to look at the broader economic environment. Recently, President Trump proposed a $163 billion budget cut, which involves slashing domestic programs while concentrating on defense and border security. The reduced funding for housing, education, and healthcare could hurt consumer spending, and hence, the cut has introduced fresh uncertainty into a market where investors are already scrambling due to interest rate and tariff rate uncertainties. On the other hand, the Treasury bond market is also flashing warning signs. According to a report by Reuters, two-year yields have declined to 3.57%, nearly a full percentage point below the Fed's benchmark rate. Treasury Secretary Scott Bessent calls the gap a clear signal for rate cuts. When we look back at history, we will see that these dislocations usually preceded economic slowdowns, and in such an environment, the high PE stocks that could not meet the inflated expectations with their earnings will fall. That said, high PE ratios are not always bad. They often reflect the market's confidence in the company's future growth. But when insiders start to dump the stocks amid geopolitical disturbances and rate cut debates, we cannot help but wonder whether this is calm before a storm. And it is here we must exercise caution. From our picks, you could see a red flag or a buying opportunity. However, one thing is clear. In today's market, ignoring the warning signs could be the riskiest move. We have followed a few criteria when putting together our list of 10 stocks with unbelievably high PE ratios, being sold by insiders. All the stocks in the list have a PE ratio of 35 or more, which defines the term insanely-high for our article. We have further reduced the number of stocks to 10 by considering only those with an insider selling of 5% change or more in the last 6 months. This is to ensure that the potential investors are aware of the change in institutional mindset for stocks with an upward-trending PE ratio. Based on this insider selling, our picks have been ranked from 10 to 1. All the data in the article was taken from financial databases and analyst reports, with all information updated as of May 05, 2025. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). A pharmacist handing a patient medication meant to treat chronic obstructive pulmonary disease. California-based company, Innoviva, Inc. (NASDAQ:INVA) is a healthcare asset management firm with royalty interests in respiratory therapies. The company also has a growing portfolio of healthcare investments. Initially deriving its revenue from GlaxoSmithKline-partnered drugs like Trelegy and Anoro, the company is now diversified into hospital and infectious disease assets through strategic acquisitions. With market peers like Royalty Pharma and similar monetization entities increasing the competition levels, the company's future performance is hanging on optimizing investment returns and capturing synergies across its expanding healthcare holdings. Innoviva, Inc. (NASDAQ:INVA)'s core royalty platform showed continued strength in 2024, realizing $255.6 million in revenue for the full year. Additionally, Innoviva Specialty Therapeutics's U.S. net product sales growth of 47% year-over-year translates positively among the investors in the market. The company has also secured U.S. rights to ZEVTERA® and plans to launch it in mid-2025. The integration is expected to strengthen the company's therapeutics platform and raise the possibility of significant future revenue. Meanwhile, the gross royalty revenue from GSK decreased in Q4 2024 to $66 million, signaling caution. Investment value has also dropped, mainly in Armata Pharma, causing a loss of $123.4 million to the net income in 2024 and suggesting potential hurdles to profit-making in the future. With a substantially high P/E ratio of 89.58, Innoviva, Inc. (NASDAQ:INVA) appears priced far beyond fundamental norms. Insider selling in the last six months has spiked by over 69.15%, reinforcing that insiders could not see any justification for such a high valuation. Overall, INVA ranks 1st on our list of stocks with insanely high PE ratios insiders are selling. While we acknowledge the potential of INVA as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than INVA but that trades at less than 5 times its earnings, check out our report about this . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
10-04-2025
- Business
- Yahoo
Are Innoviva, Inc.'s (NASDAQ:INVA) Mixed Financials Driving The Negative Sentiment?
With its stock down 4.2% over the past week, it is easy to disregard Innoviva (NASDAQ:INVA). It is possible that the markets have ignored the company's differing financials and decided to lean-in to the negative sentiment. Long-term fundamentals are usually what drive market outcomes, so it's worth paying close attention. Particularly, we will be paying attention to Innoviva's ROE today. ROE or return on equity is a useful tool to assess how effectively a company can generate returns on the investment it received from its shareholders. Put another way, it reveals the company's success at turning shareholder investments into profits. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. The formula for return on equity is: Return on Equity = Net Profit (from continuing operations) ÷ Shareholders' Equity So, based on the above formula, the ROE for Innoviva is: 3.4% = US$23m ÷ US$691m (Based on the trailing twelve months to December 2024). The 'return' is the profit over the last twelve months. Another way to think of that is that for every $1 worth of equity, the company was able to earn $0.03 in profit. Check out our latest analysis for Innoviva We have already established that ROE serves as an efficient profit-generating gauge for a company's future earnings. Based on how much of its profits the company chooses to reinvest or "retain", we are then able to evaluate a company's future ability to generate profits. Assuming everything else remains unchanged, the higher the ROE and profit retention, the higher the growth rate of a company compared to companies that don't necessarily bear these characteristics. As you can see, Innoviva's ROE looks pretty weak. Even compared to the average industry ROE of 21%, the company's ROE is quite dismal. Therefore, it might not be wrong to say that the five year net income decline of 14% seen by Innoviva was possibly a result of it having a lower ROE. We reckon that there could also be other factors at play here. For instance, the company has a very high payout ratio, or is faced with competitive pressures. However, when we compared Innoviva's growth with the industry we found that while the company's earnings have been shrinking, the industry has seen an earnings growth of 8.0% in the same period. This is quite worrisome. Earnings growth is a huge factor in stock valuation. The investor should try to establish if the expected growth or decline in earnings, whichever the case may be, is priced in. Doing so will help them establish if the stock's future looks promising or ominous. One good indicator of expected earnings growth is the P/E ratio which determines the price the market is willing to pay for a stock based on its earnings prospects. So, you may want to check if Innoviva is trading on a high P/E or a low P/E , relative to its industry. Innoviva doesn't pay any regular dividends, meaning that potentially all of its profits are being reinvested in the business, which doesn't explain why the company's earnings have shrunk if it is retaining all of its profits. So there might be other factors at play here which could potentially be hampering growth. For example, the business has faced some headwinds. In total, we're a bit ambivalent about Innoviva's performance. While the company does have a high rate of profit retention, its low rate of return is probably hampering its earnings growth. Wrapping up, we would proceed with caution with this company and one way of doing that would be to look at the risk profile of the business. Our risks dashboard would have the 3 risks we have identified for Innoviva. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Yahoo
12-03-2025
- Business
- Yahoo
Armata Pharmaceuticals Announces $10 Million Secured Credit Agreement with Innoviva
Proceeds to be used to continue to advance development of Armata's phage product candidates LOS ANGELES, March 12, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced that it has entered into a secured credit agreement with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Inc. (Nasdaq: INVA) (collectively, "Innoviva"), Armata's largest shareholder. The gross proceeds to be received by the Company at closing are $10 million before deducting transaction-related expenses. Proceeds from the new financing transaction will be used to advance the Company's lead therapeutic phage candidates, including AP‐PA02 and AP‐SA02, which target infections caused by Pseudomonas aeruginosa and Staphylococcus aureus, respectively. "Innoviva continues to be an instrumental partner to Armata in support of our mission, the clinical development of our two lead phage cocktails, AP-PA02 and AP-SA02, and our committed team," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "This financing will enable Armata to readout its Phase 1b/2a trial in acute Staphylococcus aureus bacteremia, which represents the first clinical trial for AP-SA02, and to prepare the Company for an end-of-Phase 2 meeting with the FDA in support of further clinical inquiry including a potential pivotal trial. I would like to thank the Innoviva team for their continued support. We are continuing to pursue additional sources of funding, including non-dilutive sources, to support our late-stage clinical trials." The secured credit agreement provides for a secured term loan facility in an aggregate amount of $10 million at an interest rate of 14.0% per annum with a maturity date of March 12, 2026. The Company and Innoviva also entered into amendments to the three credit and security agreements previously entered into, in order to, among other things, extend the maturity dates under such agreements to March 12, 2026. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage-specific cGMP manufacturing to support full commercialization. Forward Looking Statements This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant current Good Manufacturing Practices; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2024, and in its subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Media Contacts: At Armata:Pierre KymeArmata Pharmaceuticals, x234 Investor Relations:Joyce AllaireLifeSci Advisors, LLCjallaire@ View original content to download multimedia: SOURCE Armata Pharmaceuticals, Inc. Sign in to access your portfolio
