VAX-31

Vaccinex to Delist from Nasdaq Despite Promising Alzheimer's Drug Results

2 months ago

• Vaccinex will delist from Nasdaq on March 17 after failing to meet equity requirements, despite reporting positive Phase II results for its lead Alzheimer's candidate pepinemab in 2024. • The company's market capitalization has fallen to approximately $2.5 million, with cash reserves of just $2.9 million as of September 2024, reflecting financial challenges despite initial success raising $40 million in its 2018 IPO. • Vaccinex plans to continue developing pepinemab for both Alzheimer's disease and oncology indications through partnerships, including ongoing collaborations with MSD and Merck KGaA for cancer trials.

Dynavax Reports Strong Growth with HEPLISAV-B Revenue Up 26% in 2024, Advances Pipeline Programs

3 months ago

• HEPLISAV-B achieved record net product revenue of $268.4 million in 2024, representing a 26% year-over-year growth, with market share reaching 44% in the U.S. hepatitis B vaccine market. • Dynavax expects to report top-line results from its Phase 1/2 shingles vaccine trial in Q3 2025 and plans to initiate a Phase 2 plague vaccine trial in collaboration with the U.S. Department of Defense. • The company projects HEPLISAV-B net product revenue to reach $305-325 million in 2025 and anticipates completing its $200 million share repurchase program by year-end.

Vaxcyte Advances 31-Valent Pneumococcal Vaccine to Final Phase II Stage in Infant Trial

3 months ago

• Vaxcyte has initiated the final stage of Phase II trials for VAX-31, its 31-valent pneumococcal conjugate vaccine, following successful safety review of Stage 1 data in infants. • VAX-31 demonstrates potential to provide approximately 94% coverage against invasive pneumococcal disease and 93% coverage for acute otitis media in U.S. children under five years. • The company expects to report topline data from the primary three-dose immunization series by mid-2026, with booster dose results following approximately nine months later.

Merck's CAPVAXIVE Receives Positive EU CHMP Opinion for Pneumococcal Vaccine

4 months ago

• The European Medicines Agency's CHMP recommended CAPVAXIVE for active immunization against invasive pneumococcal disease and pneumonia in adults 18 and older. • CAPVAXIVE is designed to protect against Streptococcus pneumoniae serotypes responsible for the majority of invasive pneumococcal disease cases. • The recommendation is supported by Phase 3 STRIDE trial results, evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults. • If approved, this would be the fourth authorization of CAPVAXIVE, having already been approved in the U.S., Canada, and Australia.

Vaxcyte's 31-Strain Pneumococcal Vaccine Shows Superior Immune Response Over Prevnar 20 in Phase 1/2 Trial

4 months ago

Vaxcyte's VAX-31 pneumococcal vaccine demonstrated stronger immune responses against 18 out of 20 serotypes compared to Pfizer's Prevnar 20 in Phase 1/2 trials. The promising results have prompted the company to advance to Phase 3 trials in 2025, potentially challenging Pfizer's dominance in the $10+ billion pneumococcal vaccine market.

Vaccine Updates: FDA Approves Self-Administered FluMist, Updated Novavax COVID-19 Vaccine

8 months ago

• The FDA has approved FluMist, a nasal spray flu vaccine, for self- or caregiver-administration, making it the first flu vaccine with this capability, indicated for individuals aged 2 to 49 years. • Novavax's updated COVID-19 vaccine has received FDA emergency use authorization for individuals aged 12 years and older, set to be available in pharmacies and grocers across the United States. • GSK reported positive topline data from a phase 3 study for co-administration of its RSV vaccine (Arexvy) with its shingles vaccine (Shingrix) in adults 50 years and older. • The WHO has added the MVA-BN (Imvanex) vaccine to its prequalification list, marking the first mpox vaccine to receive this designation, indicated for adults and potentially for off-label use in younger populations.

Liraglutide Shows Promise in Pediatric Obesity, While Oncology Trials Face Setbacks

8 months ago

• Novo Nordisk's liraglutide demonstrated a significant reduction in BMI in a Phase III trial involving children aged 6-11, showing potential for pediatric obesity treatment. • Vaxcyte's VAX-31 pneumonia vaccine showed positive Phase I/II topline data, increasing its Phase Transition Success Rate (PTSR) in streptococcal pneumonia. • Pfizer terminated a Phase I trial of maplirpacept, leading to a decrease in its PTSR for peripheral T cell lymphoma and B cell Hodgkin lymphoma. • Les Laboratoires Servier's oncology drug trial was terminated due to business reasons, impacting the PTSR of S-64315 and S-65487 in multiple myeloma and leukemia.

Vaxcyte's VAX-31 Shows Promise in Broad-Spectrum Pneumococcal Disease Prevention

8 months ago

• Vaxcyte's VAX-31 vaccine demonstrated a favorable safety profile and strong immune response against all 31 serotypes in adults aged 50 and older. • The company's XpressCF platform enables the development of broad-spectrum vaccines that overcome the limitations of traditional cell-based approaches. • VAX-31 is rapidly advancing to Phase 3 clinical trials, with potential FDA approval expected by late 2026 or 2027, positioning Vaxcyte as a leader in the pneumococcal vaccine market. • Vaxcyte's robust financial position, with $2.8 billion in liquid reserves, supports its research and development efforts through FDA approval and commercialization.

FDA Approves Digital Therapeutic for GAD, Updated Novavax COVID-19 Vaccine, and New Insulin Patch Pump

9 months ago

• The FDA cleared DaylightRX, the first digital therapeutic for generalized anxiety disorder (GAD), to be used as an adjunct to usual care for patients aged 22 years and older. • Novavax received emergency use authorization (EUA) from the FDA for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older. • Embecta gained FDA 510(k) clearance for its disposable insulin delivery system, designed for adults with type 1 and type 2 diabetes, featuring a 300-unit reservoir.

Drug Development Updates