– Unaudited 2023 total revenue of $946 million, representing 35% year-over-year growth – – Regulatory filings in the EU and US for sepiapterin in PKU, a potential $1 billion global commercial opportunity, remain on track for 2024 – – Multiple study readouts planned for 2024, including 12-month interim data from the PIVOT-HD study of PTC518 in HD patients – PTC Therapeutics, Inc. (NASDAQ: PTCT) will present an update on its commercial progress and R&D pipeline at the 42nd Annual J.P. Morgan Healthcare Conference today, Monday, January 8, at 10:30am EST/7:30am PST. Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics, will provide an update on 2023 accomplishments and highlight potential 2024 value-creating milestones. Preliminary 2023 unaudited financial results and 2024 financial guidance will also be provided. The presentation is being webcast live on the Events and Presentations page of the Investors section of PTC Therapeutics website at www.ptcbio.com. https://www.biospace.com/article/releases/ptc-therapeutics-provides-an-update-on-commercial-progress-and-r-and-amp-d-pipeline-at-42nd-annual-j-p-morgan-healthcare-conference/ |
Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced preliminary, unaudited financial highlights for the fourth quarter and full year ended December 31, 2023.
"In 2023, we delivered a record year of revenue for HEPLISAV-B, driven by the expansion of the adult hepatitis B vaccine market in the U.S., and our team's progress toward establishing HEPLISAV-B as the market leading vaccine. We are extremely pleased with our market share growth in the fourth quarter, which enabled us to achieve our increased product revenue guidance for the year despite the impact of expected seasonality due to increased focus on respiratory disease vaccines during the fall and winter seasons. We believe the seasonal market decline for adult hepatitis B vaccines will be limited to the fourth quarter in line with the administration of the vast majority of influenza and COVID-19 vaccines," said Ryan Spencer, Chief Executive Officer of Dynavax. "Turning to this year, we believe HEPLISAV-B is well-positioned entering 2024, supported by significant market share gains in the total market and in key market segments. We remain extremely confident in the long-term growth of the hepatitis B market, with HEPLISAV-B expected to achieve a majority market share in the U.S. In addition to HEPLISAV-B, we continue to advance our pipeline of innovative vaccine candidates and continue to pursue strategic opportunities to accelerate our growth."
Preliminary Fourth Quarter and Full Year 2023 Financial and Commercial Highlights
The preliminary selected financial results contained herein are unaudited, subject to adjustment, and provided as an estimate in advance of the Company's announcement of complete financial results, for the three and twelve months ended December 31, 2023. Market share data are preliminary and are as of the latest market data available on December 22, 2023.
Expected Commercial and Pipeline Milestones
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and Great Britain that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.
Clinical Pipeline
Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018® adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.
Shingles vaccine program:
Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 and older.
Tdap vaccine program:
Tdap-1018 is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis (Tdap).
Plague vaccine program:
Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018® currently in a Phase 2 clinical trial in collaboration with, and fully funded by, the U.S. Department of Defense.
J.P. Morgan Healthcare Conference Presentation Webcast Details
Dynavax will present at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11 at 11:15 a.m. PT.
The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/events-presentations.
Preliminary, Unaudited Select Full Year 2023 Financial Results
Cipla to take sole responsibility for development of PUR1900, refocused on markets with greatest unmet need and faster path to approval, in exchange for 2% royalty on net sales payable to Pulmatrix Pulmatrix to significantly reduce cash burn and focus on strategic alternatives that leverage the company's promising pipeline, iSPERSE™ technology and approximately $19 million cash on hand as of 12/31/23 |
Agency Continues to Encourage Ethylene Oxide Sterilization Alternatives
The U.S. Food and Drug Administration (FDA) is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP's long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. This update will facilitate broader adoption of VHP as a sterilization method for the medical device industry, is part of the agency's multi-pronged approach to reducing the use of ethylene oxide (EtO) where possible and further supports the agency's efforts to advance medical device supply chain resiliency.
Effective sterilization processes are necessary for certain devices to be safe because sterilization inactivates or kills potentially harmful microorganisms. In addition to effectively inactivating or killing potentially harmful microorganisms, sterilization processes must not damage devices. For many devices marketed as sterile, a premarket submission must contain information sufficient to show the sterilization process is effective and consistent with internationally accepted consensus standard(s) that the FDA has recognized.
EtO is the most commonly used sterilization method for medical devices in the U.S., with more than 20 billion devices sold in the U.S. every year sterilized with EtO, accounting for approximately 50% of devices that require sterilization. Since 2019, the FDA has promoted the development of alternatives to EtO and has implemented a number of programs and initiatives to support innovation in medical device sterilization. This includes developing Sterilization Master File Pilot programs to support certain changes to sterilization processes, launching innovation challenges to encourage new strategies to reduce EtO emissions and the development of new sterilization methods or technologies and proactively engaging with industry to help advance innovative alternatives to EtO.
"The FDA's commitment is to protect public health, a critical mission in today's complex medical device ecosystem," said Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA's Center for Devices and Radiological Health. "Vaporized hydrogen peroxide's addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages. As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health."
Methods with a long history of safe and effective use on medical devices are considered Established Category A sterilization methods and include moist heat, dry heat, EtO and radiation. With the recent FDA recognition of the ISO standard 22441:2022, the FDA is adding VHP to Established Category A, which the agency expects will strengthen industry's capacity to adopt alternative sterilization processes that pose less potential risk to the environment and communities in which they operate.
The FDA remains committed to reducing adverse impacts to the environment and public health and to developing solutions that avert potential shortages of devices that the American public relies upon.
Cytek Biosciences Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today announced preliminary, unaudited revenue results for the full year ended December 31, 2023.
Cytek expects its full year revenue for 2023 to be near the high end of the company’s most recent revenue guidance range of $188 million to $192 million, provided on November 9, 2023.
The preliminary financial results in this press release are not a comprehensive statement of Cytek’s financial results for the year ended December 31, 2023 and have not been audited, reviewed or compiled by its independent registered public accounting firm. Cytek’s actual revenue may differ from the estimate due to the completion of the Company’s year-end closing and auditing procedures and are therefore subject to adjustment. Cytek plans to report financial results for the fourth quarter and full year ended December 31, 2023 and to provide 2024 financial guidance during its earnings call expected to be held at the end of February 2024.
J.P. Morgan Healthcare Conference
Cytek is providing these updates in advance of its participation in the 42nd Annual J.P. Morgan Healthcare Conference, which begins today in San Francisco, CA. CEO Wenbin Jiang is scheduled to present and participate in a Q&A session on Thursday, January 11, 2024, at 8:15 a.m. Pacific Time / 11:15 a.m. Eastern Time. Interested parties may access a live and archived webcast of the presentation on the “Investors” section of the company website at: investors.cytekbio.com.
