Focuses on ten product approvals through 2027
Expects to submit next-generation COVID vaccine for approval in 2024
Expects to submit flu/COVID combination vaccine for approval in 2024
Announces positive Phase 3 results for its RSV vaccine for high-risk adults aged 18 to 59; expects to submit sBLA for U.S. approval in 2024
Announces positive Phase 3 results for its standalone flu vaccine for adults aged 65 and older relative to high-dose licensed comparator
Announces norovirus vaccine advances into Phase 3 study, bringing the total of non-respiratory pivotal stage programs to five, across oncology, rare diseases and first-in-class vaccines
Implements portfolio prioritization and cost efficiencies to reduce R&D expense by $1.1 billion, from $4.8 billion in 2024E to $3.6-3.8 billion in 2027
Updates and extends financial framework through 2028
Read MoreFolate receptor alpha targeting drug conjugate & hexa silanol exatecan (FRA-H) payloads tested in animal models of ovarian cancer
Strong efficacy for FRA-H in KB and IGROV-1 mouse models of ovarian cancer
Strong safety profile for FRA-H with no loss of bodyweight as compared with control in animal models
Success of tADC proof-of-concept study paves way for creating multiple potential therapeutic candidates for preclinical and clinical evaluation
-Proof of Concept Study in Rapid Acting GLP-1 to commence in October 2024 with data expected in November 2024
-Pre-clinical study to explore use of MODD1 pump as a personalized delivery system for people who discontinue long-acting GLP-1 formulations
-CEO to discuss further details of the program in Tribe Public Webinar on Wednesday, September 11 at 8:30 a.m. Pacific time
Read MoreFDA-approved Gelclair® is company's third commercialized prescription product
Susan Krizancic appointed to role of National Sales Director at Jaguar family company Napo Pharmaceuticals
Read MoreMeet with Modular Medical CEO, Jeb Besser
There are more than 3 million individuals who use daily insulin to help with the care of Diabetes in the US.100% of patient population require daily insulin injection. Only 20% currently use an insulin pump.
Obesity is linked to 30% to 53% of new diabetes cases in the U.S. every year, per research in the Journal of the American Heart Association
About half of all patients prescribed a GLP-1 drug for weight loss discontinued after the first 12 weeks, with approximately 30% discontinuing in the first four weeks
Participation at Global Investment Conference follows the successful $4.0 million equity raise executed by H.C. Wainwright in July
The Company expects to generate between $2.0 million and $2.5 million in revenue in the third quarter of 2024
The Company expects to achieve run-rate adjusted EBITDA profitability in 2025
Company's Canalevia®-CA1 prescription drug is FDA conditionally approved for treatment of chemotherapy-induced diarrhea (CID) in dogs and is the first and only treatment for CID in dogs to receive any type of approval from FDA
Read MoreModerna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European Commission authorization decision
Read MoreDomitner GmbH placed initial order that is expected to ship in the third quarter of 2024
Combined with the German distribution announced in July, there is strong coverage in central Europe
Additional European distributors are expected to be secured in 2024
MODD1 is a patch pump for ALL adults with Type 1 and Type 2 diabetes
Designed to be simpler and more affordable to expand access to diabetes technology for previously underserved communities
Commercial availability expected in early 2025
Click here to view interview video
Paramount near-term activities include planned October 2024 commercial launch of FDA-approved oral mucositis prescription product Gelclair® and results from independent, investigator-initiated trials of crofelemer for rare diseases
Read MoreApproval follows recommendation from global public health bodies to develop JN.1 COVID-19 vaccines
At present, the JN.1 group of subvariants remain dominant in the UK
The updated vaccine will be available for eligible groups as part of the NHS autumn vaccination program, and will also be available to purchase privately in the UK for the first time
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