PPD, Inc. (PPD)
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DESCRIPTION
PPD, Inc. provides drug development services to the biopharmaceutical industry worldwide. The company operates through Clinical Development Services and Laboratory Services segments. It offers clinical development services, including product development and consulting, early development, Phases II-IV clinical trial management, accelerated enrollment, peri- and post-approval, and medical communications services. The company also provides laboratory services comprising bioanalytical, biomarker, vaccine science, good manufacturing practice, and central laboratory services. It serves pharmaceutical, biotechnology, medical device, and government organizations, as well as other industry participants. The company was founded in 1985 and is headquartered in Wilmington, North Carolina.
NEWS

Lipocine Announces Last Patient Last Visit in Pivotal Phase 3 Trial of LPCN 1154 for Postpartum Depression (PPD)
prnewswire.com
2026-02-18 08:00:00SALT LAKE CITY, Feb. 18, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the last patient has completed the final study visit (Last Patient Last Visit) in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). The randomized, double-blind, placebo-controlled study enrolled a total of 90 patients with severe PPD, having an average baseline Hamilton depression rating scale (HAM-D) of 28.3.

Lipocine Announces Completion of Enrollment and Dosing in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)
prnewswire.com
2026-01-20 08:00:00SALT LAKE CITY, Jan. 20, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that enrollment and participant dosing have been completed in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). A total of 90 patients were randomized in the study.

Lipocine Reports Encouraging Progress Post Second Interim Safety Review in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)
prnewswire.com
2026-01-12 08:00:00Company on track to report topline results early in the second quarter of 2026 Second planned Data and Safety Monitoring Board (DSMB) meeting evaluated all available safety data for the 82 randomized No drug discontinuations, excessive sedation, loss of consciousness, or drug-related SAEs reported Study is no longer screening new participants SALT LAKE CITY, Jan. 12, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the second of two DSMB reviews planned during the study.

Thermo Fisher Scientific Launches PPD CorEvitas Alzheimer's Disease Registry to Advance Real-World Evidence in Neurodegenerative Care
businesswire.com
2025-12-18 07:37:00WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific Launches PPD CorEvitas Alzheimer's Disease Registry to Advance Real-World Evidence in Neurodegenerative Care.

Lipocine Highlights Promising Interim Safety Profile in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)
prnewswire.com
2025-11-18 08:00:00Per the Drug Safety Monitoring Board (DSMB) meeting evaluating one-third of planned participants, study to continue as planned More than half of planned participants have completed dosing with no dose reductions, discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation reported Topline results are on track for the second quarter of 2026 SALT LAKE CITY , Nov. 18, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the first of two DSMB reviews planned during the study and conducted after approximately one-third of planned 80 participants completed at least the day seven follow-up visit (n=30).

Lipocine Provides Progress Update on LPCN 1154 Phase 3 Clinical Trial in Postpartum Depression (PPD)
prnewswire.com
2025-09-30 08:00:00One-Third of Patients Randomized; Topline Results Expected in 2Q 2026 DSMB Safety Review Update Planned for 4Q 2025 SALT LAKE CITY , Sept. 30, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD).

Reunion Neuroscience Announces Positive Topline Results from RECONNECT Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression (PPD)
globenewswire.com
2025-08-18 07:30:00-- Achieved Primary Endpoint with 30mg Dose of RE104 Demonstrating 23.0-Point Reduction from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Score on Day 7, a 5.8-Point Greater Reduction Than Patients Treated with 1.5mg Dose (p=0.0094) -- -- Clinically Meaningful Reductions in MADRS Observed for RE104 30mg on the First Day Following Administration and Maintained Through Day 28 Follow-Up --

Reunion Neuroscience Announces Last Patient Dosed in RECONNECT Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression (PPD)
globenewswire.com
2025-05-19 07:30:00-- Enrollment Completed on Schedule; Topline Results Expected Q3 2025 -- -- Company to Present Poster Reviewing RE104 Phase 1 Results at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 28, 2025 --

FINAL PPD DEADLINE: Bronstein, Gewirtz & Grossman LLC Reminds PDD Holdings Inc. f/k/a Pinduoduo Inc. Investors to Join the Class Action Lawsuit!
accesswire.com
2024-10-15 07:00:00NEW YORK, NY / ACCESSWIRE / October 15, 2024 / Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against PDD Holdings Inc. f/k/a Pinduoduo Inc. ("PDD" or "the Company") (NASDAQ:PDD) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired PDD securities between April 30, 2021, and August 23, 2024, inclusive (the "Class Period").

ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.
businesswire.com
2023-12-14 06:30:00CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States, with product already at specialty pharmacies and delivered to patients. ZURZUVAE is the first and only oral, 14-day treatment course for adults with PPD that can provide rapid improvements in depressive symp.

Brii Biosciences Provides Corporate Update and Reports Full-Year 2022 Financial Results
headlinesoftoday.com
2023-03-24 01:18:00Company maintains priority focus on clinical programs to develop a novel functional cure for hepatitis B viral (HBV) infection and a potential first-of-its-kind treatment for postpartum depression (PPD) and major depressive disorders (MDD) Multiple Phase 2a proof-of-concept (POC) clinical data readouts and Phase 2b clinical trial initiations expected in 2023 Operations well-funded through 2025 Company to host […]...

Thermo Fisher Scientific's PPD Clinical Research Business Earns TOPRA Award for Regulatory Affairs Excellence in Supporting Novavax's COVID-19 Vaccine Approval
businesswire.com
2022-03-30 08:30:00WILMINGTON, N.C.--(BUSINESS WIRE)--The clinical research business of Thermo Fisher Scientific has won a 2021 TOPRA Award for Regulatory Excellence.

Saama Appoints Scott Rogers as Company's Chief Financial Officer
businesswire.com
2022-02-02 08:00:00CAMPBELL, Calif.--(BUSINESS WIRE)-- #AI--Veteran finance executive Scott Rogers appointed Saama CFO following recent $430 million dollar growth investment announcement

Thermo Fisher Scientific Completes Acquisition of PPD, Inc.
prnewswire.com
2021-12-08 08:45:00WALTHAM, Mass., Dec. 8, 2021 /PRNewswire/ -- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has completed its acquisition of PPD, Inc. (Nasdaq: PPD), a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4 billion.

PPD Named to ‘Best Workplaces in Greater China’ for Second Consecutive Year
businesswire.com
2021-12-07 09:00:00WILMINGTON, N.C.--(BUSINESS WIRE)--PPD, Inc. (Nasdaq: PPD) was named one of the “Best Workplaces in Greater China™ 2021” by Great Place to Work® for successfully creating an inclusive workplace experience for employees. PPD has more than 20 years of experience in the Asia-Pacific region, including providing a broad range of clinical development and laboratory services in Greater China. This is the second year PPD has received this recognition from Great Place to Work®, a global authority on high-trust, high-performance workplace cultures. “We remain committed to providing a healthy and open work environment for our employees, and this award shows that we continue to be successful in our efforts for yet another year,” said Ding Ming, Ph.D., vice president and general manager of PPD’s China operations. “PPD’s reputation in Greater China is a direct reflection of our inclusive culture, robust employee relations and attractive benefits. We continue to raise the bar as a preferred employer in this competitive market, and we remain dedicated to cultivating a diverse work atmosphere to attract and recruit highly qualified candidates to deliver quality results for our customers.” Great Place to Work® surveyed more than 150 companies in Mainland China, Hong Kong and Taiwan to assess employees' perceptions of leadership, organizational culture and trust. PPD was one of 61 companies named to the 2021 list. PPD continues to expand in Asia-Pacific to serve local and global customers, with operations across the region. PPD provides a broad range of Phase I-IV services in Asia-Pacific, including clinical monitoring, project management, regulatory affairs, pharmacovigilance, data management and patient recruitment. Earlier this year, PPD opened its new multipurpose laboratory in Suzhou, China, to provide bioanalytical, biomarker and vaccine laboratory services to support Western and China-based pharmaceutical and biotech companies managing China research studies. About PPD PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With more than 30,000 professionals worldwide, PPD has conducted clinical trials in more than 100 countries to help customers deliver life-changing therapies to improve health. We apply innovative technologies, therapeutic expertise and a firm commitment to quality to bend the cost and time curve of drug development and optimize value. For more information, visit www.ppd.com. This news release contains forward-looking statements. These statements often include words such as “expect,” “believe,” “project,” “forecast,” “estimate,” “target” and other similar expressions. Although we believe these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our actual financial results, and therefore actual results might differ materially from those expressed in the forward-looking statements. Factors that might materially affect such forward-looking statements include, but are not limited to, the fragmented and highly competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to keep pace with rapid technological changes that could make our services less competitive or obsolete; political, economic and/or regulatory influences and changes; the risks related to the proposed merger of PPD by Thermo Fisher Scientific Inc.; and other factors disclosed under the “Risk Factors” section in our periodic reports filed with the Securities and Exchange Commission (SEC), including our latest Annual Report on Form 10-K and Quarterly Report on form 10-Q, which are available on our website at https://investors.ppd.com or the SEC’s website at www.sec.gov. We assume no obligation and disclaim any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.
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Lipocine Announces Last Patient Last Visit in Pivotal Phase 3 Trial of LPCN 1154 for Postpartum Depression (PPD)
prnewswire.com
2026-02-18 08:00:00SALT LAKE CITY, Feb. 18, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the last patient has completed the final study visit (Last Patient Last Visit) in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). The randomized, double-blind, placebo-controlled study enrolled a total of 90 patients with severe PPD, having an average baseline Hamilton depression rating scale (HAM-D) of 28.3.

Lipocine Announces Completion of Enrollment and Dosing in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)
prnewswire.com
2026-01-20 08:00:00SALT LAKE CITY, Jan. 20, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that enrollment and participant dosing have been completed in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). A total of 90 patients were randomized in the study.

Lipocine Reports Encouraging Progress Post Second Interim Safety Review in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)
prnewswire.com
2026-01-12 08:00:00Company on track to report topline results early in the second quarter of 2026 Second planned Data and Safety Monitoring Board (DSMB) meeting evaluated all available safety data for the 82 randomized No drug discontinuations, excessive sedation, loss of consciousness, or drug-related SAEs reported Study is no longer screening new participants SALT LAKE CITY, Jan. 12, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the second of two DSMB reviews planned during the study.

Thermo Fisher Scientific Launches PPD CorEvitas Alzheimer's Disease Registry to Advance Real-World Evidence in Neurodegenerative Care
businesswire.com
2025-12-18 07:37:00WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific Launches PPD CorEvitas Alzheimer's Disease Registry to Advance Real-World Evidence in Neurodegenerative Care.

Lipocine Highlights Promising Interim Safety Profile in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)
prnewswire.com
2025-11-18 08:00:00Per the Drug Safety Monitoring Board (DSMB) meeting evaluating one-third of planned participants, study to continue as planned More than half of planned participants have completed dosing with no dose reductions, discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation reported Topline results are on track for the second quarter of 2026 SALT LAKE CITY , Nov. 18, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the first of two DSMB reviews planned during the study and conducted after approximately one-third of planned 80 participants completed at least the day seven follow-up visit (n=30).

Lipocine Provides Progress Update on LPCN 1154 Phase 3 Clinical Trial in Postpartum Depression (PPD)
prnewswire.com
2025-09-30 08:00:00One-Third of Patients Randomized; Topline Results Expected in 2Q 2026 DSMB Safety Review Update Planned for 4Q 2025 SALT LAKE CITY , Sept. 30, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD).

Reunion Neuroscience Announces Positive Topline Results from RECONNECT Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression (PPD)
globenewswire.com
2025-08-18 07:30:00-- Achieved Primary Endpoint with 30mg Dose of RE104 Demonstrating 23.0-Point Reduction from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Score on Day 7, a 5.8-Point Greater Reduction Than Patients Treated with 1.5mg Dose (p=0.0094) -- -- Clinically Meaningful Reductions in MADRS Observed for RE104 30mg on the First Day Following Administration and Maintained Through Day 28 Follow-Up --

Reunion Neuroscience Announces Last Patient Dosed in RECONNECT Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression (PPD)
globenewswire.com
2025-05-19 07:30:00-- Enrollment Completed on Schedule; Topline Results Expected Q3 2025 -- -- Company to Present Poster Reviewing RE104 Phase 1 Results at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 28, 2025 --

FINAL PPD DEADLINE: Bronstein, Gewirtz & Grossman LLC Reminds PDD Holdings Inc. f/k/a Pinduoduo Inc. Investors to Join the Class Action Lawsuit!
accesswire.com
2024-10-15 07:00:00NEW YORK, NY / ACCESSWIRE / October 15, 2024 / Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against PDD Holdings Inc. f/k/a Pinduoduo Inc. ("PDD" or "the Company") (NASDAQ:PDD) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired PDD securities between April 30, 2021, and August 23, 2024, inclusive (the "Class Period").

ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.
businesswire.com
2023-12-14 06:30:00CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States, with product already at specialty pharmacies and delivered to patients. ZURZUVAE is the first and only oral, 14-day treatment course for adults with PPD that can provide rapid improvements in depressive symp.

Brii Biosciences Provides Corporate Update and Reports Full-Year 2022 Financial Results
headlinesoftoday.com
2023-03-24 01:18:00Company maintains priority focus on clinical programs to develop a novel functional cure for hepatitis B viral (HBV) infection and a potential first-of-its-kind treatment for postpartum depression (PPD) and major depressive disorders (MDD) Multiple Phase 2a proof-of-concept (POC) clinical data readouts and Phase 2b clinical trial initiations expected in 2023 Operations well-funded through 2025 Company to host […]...

Thermo Fisher Scientific's PPD Clinical Research Business Earns TOPRA Award for Regulatory Affairs Excellence in Supporting Novavax's COVID-19 Vaccine Approval
businesswire.com
2022-03-30 08:30:00WILMINGTON, N.C.--(BUSINESS WIRE)--The clinical research business of Thermo Fisher Scientific has won a 2021 TOPRA Award for Regulatory Excellence.

Saama Appoints Scott Rogers as Company's Chief Financial Officer
businesswire.com
2022-02-02 08:00:00CAMPBELL, Calif.--(BUSINESS WIRE)-- #AI--Veteran finance executive Scott Rogers appointed Saama CFO following recent $430 million dollar growth investment announcement

Thermo Fisher Scientific Completes Acquisition of PPD, Inc.
prnewswire.com
2021-12-08 08:45:00WALTHAM, Mass., Dec. 8, 2021 /PRNewswire/ -- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has completed its acquisition of PPD, Inc. (Nasdaq: PPD), a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4 billion.

PPD Named to ‘Best Workplaces in Greater China’ for Second Consecutive Year
businesswire.com
2021-12-07 09:00:00WILMINGTON, N.C.--(BUSINESS WIRE)--PPD, Inc. (Nasdaq: PPD) was named one of the “Best Workplaces in Greater China™ 2021” by Great Place to Work® for successfully creating an inclusive workplace experience for employees. PPD has more than 20 years of experience in the Asia-Pacific region, including providing a broad range of clinical development and laboratory services in Greater China. This is the second year PPD has received this recognition from Great Place to Work®, a global authority on high-trust, high-performance workplace cultures. “We remain committed to providing a healthy and open work environment for our employees, and this award shows that we continue to be successful in our efforts for yet another year,” said Ding Ming, Ph.D., vice president and general manager of PPD’s China operations. “PPD’s reputation in Greater China is a direct reflection of our inclusive culture, robust employee relations and attractive benefits. We continue to raise the bar as a preferred employer in this competitive market, and we remain dedicated to cultivating a diverse work atmosphere to attract and recruit highly qualified candidates to deliver quality results for our customers.” Great Place to Work® surveyed more than 150 companies in Mainland China, Hong Kong and Taiwan to assess employees' perceptions of leadership, organizational culture and trust. PPD was one of 61 companies named to the 2021 list. PPD continues to expand in Asia-Pacific to serve local and global customers, with operations across the region. PPD provides a broad range of Phase I-IV services in Asia-Pacific, including clinical monitoring, project management, regulatory affairs, pharmacovigilance, data management and patient recruitment. Earlier this year, PPD opened its new multipurpose laboratory in Suzhou, China, to provide bioanalytical, biomarker and vaccine laboratory services to support Western and China-based pharmaceutical and biotech companies managing China research studies. About PPD PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With more than 30,000 professionals worldwide, PPD has conducted clinical trials in more than 100 countries to help customers deliver life-changing therapies to improve health. We apply innovative technologies, therapeutic expertise and a firm commitment to quality to bend the cost and time curve of drug development and optimize value. For more information, visit www.ppd.com. This news release contains forward-looking statements. These statements often include words such as “expect,” “believe,” “project,” “forecast,” “estimate,” “target” and other similar expressions. Although we believe these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our actual financial results, and therefore actual results might differ materially from those expressed in the forward-looking statements. Factors that might materially affect such forward-looking statements include, but are not limited to, the fragmented and highly competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to keep pace with rapid technological changes that could make our services less competitive or obsolete; political, economic and/or regulatory influences and changes; the risks related to the proposed merger of PPD by Thermo Fisher Scientific Inc.; and other factors disclosed under the “Risk Factors” section in our periodic reports filed with the Securities and Exchange Commission (SEC), including our latest Annual Report on Form 10-K and Quarterly Report on form 10-Q, which are available on our website at https://investors.ppd.com or the SEC’s website at www.sec.gov. We assume no obligation and disclaim any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.










