Search Results for: apl 130277

Cynapsus Therapeutics’ APL 130277 for Parkinson’s Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

TORONTO, ONTARIO–(Marketwire – Oct 29, 2012) – Cynapsus Therapeutics Inc. (TSX VENTURE:CTH) today announced that its APL-130277 for Parkinson”s was recognized as one of the Top Ten Neurology Projectsto Watch in 2012 by a joint selection committee including Dr. Harry Tracy, a noted authority on pharmacological interventions for diseases of the brain and editor of the highly respected biotechnology publication NeuroPerspective, as well as with Elsevier Business Intelligence, the publishers of In Vivo, Startup and The Pink Sheet.Cynapsus has been invited to present the APL-130277 Project at Elsevier”s Therapeutic Area Partnerships Meeting taking place on November 28-30, 2012 at the Westin Copley in Boston.

Criteria for selection of the Top 10 Neurology Projects to Watch in 2012 were:

APL130277 is a unique and innovative, sublingual thin film strip formulation of apomorphine. Apomorphine is an approved drug prescribed in the US, Europe and several other countries. It is administered as a subcutaneous injection or infusion to Parkinson”s patients experiencing daily “OFF” or motor fluctuation episodes. APL130277 would provide patients with a convenient and more tolerable alternative to multiple daily injections. As a new means of delivering an approved drug, this clinical stage project is expected to follow a bioequivalence regulatory and clinical path which would culminate in a New Drug Approval application in 2015.

“We are humbled to be recognized from among several hundred worthy neuroscience projects, worldwide. This is a significant honor and further independent validation of the potential of APL-130277. This comes only a few months after receiving a significant grant from The Michael J. Fox Foundation for Parkinson”s Research (MJFF) to help support our next clinical study (CTH103). The MJFF Clinical Intervention Award was provided through the Edmond J. Safra Core Programs for Parkinson”s Research,” said Mr. Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus.”Since we started this project, we determined that there are a large number of Parkinson”s patients who would benefit from needle-free delivery of the drug.This includes patients who want a convenient alternative to a very painful injection regimen, patients who have resisted initiating therapy because of the needle issues, and the increase in PD population as a result of the growing aging baby boomer generation. These factors combined indicate that the number of Parkinson”s patients worldwide could potentially increase 2-to-3 fold over the next 8 to 10 years. This significant potential unmet medical need coupled with a short and lower risk clinical pathway would be of interest to many in global and specialty pharma, especially given that our pending patent estate, when approved and granted, would provide protection to 2031 at a minimum.”

About Parkinson”s Disease

Parkinson”s disease is a chronic, degenerative neurological disorder that results from the loss of dopamineproducing nerve cells in the brain. Currenttreatments for Parkinson”s disease are able to reduce the symptoms of the disease but are not able to treat the underlying neurodegenerative processes that lead to a decline in physical and cognitive functions that affects some patients with Parkinson”s disease. It is estimated that over one million people in the United States and 5 million people globally are living with Parkinson”s disease. According to the National Institute of Neurodegenerative Disease and Stroke, the average age of onset is 60, although some people are diagnosed at age 40 or younger.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing the only orally administered convenient (sublingual) delivery of the only approved drug (apomorphine) to treat the motor symptoms of Parkinson”s disease. Over one million people in the United States and an estimated 5 million people globally suffer from Parkinson”s disease. Parkinson”s disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on the IMPACT Registry Study and the results of Cynapsus” Global 500 Neurologists Survey, is estimated that between 25 percent and 50 percent of patients experience “OFF episodes” in which they have impaired movement or speaking capabilities. Current medications only control the disease”s symptoms, and most drugs become less effective over time as the disease progresses.

Cynapsus” lead drug candidate, APL130277, is an easytoadminister, fastacting reformulation of an approved drug, apomorphine, used to rescue patients from OFF episodes. Cynapsus is focused on rapidly maximizing the value of APL130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2015. Cynapsus anticipates outlicensing to an appropriate pharmaceutical partner before such an application is submitted.

More information about Cynapsus (TSX VENTURE:CTH) is available at http://www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at http://www.sedar.com.

Go here to see the original:
Cynapsus Therapeutics' APL 130277 for Parkinson's Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

Source:
http://www.longevitymedicine.tv/cynapsus-therapeutics-apl-130277-for-parkinsons-chosen-as-one-of-the-top-ten-neurology-projects-to-watch-for-2012/

Posted in Longevity Medicine | Comments Off on Cynapsus Therapeutics’ APL 130277 for Parkinson’s Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

Cynapsus Therapeutics' APL 130277 for Parkinson's Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

TORONTO, ONTARIO--(Marketwire - Oct 29, 2012) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH) today announced that its APL-130277 for Parkinson''s was recognized as one of the Top Ten Neurology Projectsto Watch in 2012 by a joint selection committee including Dr. Harry Tracy, a noted authority on pharmacological interventions for diseases of the brain and editor of the highly respected biotechnology publication NeuroPerspective, as well as with Elsevier Business Intelligence, the publishers of In Vivo, Startup and The Pink Sheet.Cynapsus has been invited to present the APL-130277 Project at Elsevier''s Therapeutic Area Partnerships Meeting taking place on November 28-30, 2012 at the Westin Copley in Boston.

Criteria for selection of the Top 10 Neurology Projects to Watch in 2012 were:

APL130277 is a unique and innovative, sublingual thin film strip formulation of apomorphine. Apomorphine is an approved drug prescribed in the US, Europe and several other countries. It is administered as a subcutaneous injection or infusion to Parkinson''s patients experiencing daily "OFF" or motor fluctuation episodes. APL130277 would provide patients with a convenient and more tolerable alternative to multiple daily injections. As a new means of delivering an approved drug, this clinical stage project is expected to follow a bioequivalence regulatory and clinical path which would culminate in a New Drug Approval application in 2015.

"We are humbled to be recognized from among several hundred worthy neuroscience projects, worldwide. This is a significant honor and further independent validation of the potential of APL-130277. This comes only a few months after receiving a significant grant from The Michael J. Fox Foundation for Parkinson''s Research (MJFF) to help support our next clinical study (CTH103). The MJFF Clinical Intervention Award was provided through the Edmond J. Safra Core Programs for Parkinson''s Research," said Mr. Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus."Since we started this project, we determined that there are a large number of Parkinson''s patients who would benefit from needle-free delivery of the drug.This includes patients who want a convenient alternative to a very painful injection regimen, patients who have resisted initiating therapy because of the needle issues, and the increase in PD population as a result of the growing aging baby boomer generation. These factors combined indicate that the number of Parkinson''s patients worldwide could potentially increase 2-to-3 fold over the next 8 to 10 years. This significant potential unmet medical need coupled with a short and lower risk clinical pathway would be of interest to many in global and specialty pharma, especially given that our pending patent estate, when approved and granted, would provide protection to 2031 at a minimum."

About Parkinson''s Disease

Parkinson''s disease is a chronic, degenerative neurological disorder that results from the loss of dopamineproducing nerve cells in the brain. Currenttreatments for Parkinson''s disease are able to reduce the symptoms of the disease but are not able to treat the underlying neurodegenerative processes that lead to a decline in physical and cognitive functions that affects some patients with Parkinson''s disease. It is estimated that over one million people in the United States and 5 million people globally are living with Parkinson''s disease. According to the National Institute of Neurodegenerative Disease and Stroke, the average age of onset is 60, although some people are diagnosed at age 40 or younger.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing the only orally administered convenient (sublingual) delivery of the only approved drug (apomorphine) to treat the motor symptoms of Parkinson''s disease. Over one million people in the United States and an estimated 5 million people globally suffer from Parkinson''s disease. Parkinson''s disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on the IMPACT Registry Study and the results of Cynapsus'' Global 500 Neurologists Survey, is estimated that between 25 percent and 50 percent of patients experience "OFF episodes" in which they have impaired movement or speaking capabilities. Current medications only control the disease''s symptoms, and most drugs become less effective over time as the disease progresses.

Cynapsus'' lead drug candidate, APL130277, is an easytoadminister, fastacting reformulation of an approved drug, apomorphine, used to rescue patients from OFF episodes. Cynapsus is focused on rapidly maximizing the value of APL130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2015. Cynapsus anticipates outlicensing to an appropriate pharmaceutical partner before such an application is submitted.

More information about Cynapsus (TSX VENTURE:CTH) is available at http://www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at http://www.sedar.com.

Go here to see the original:
Cynapsus Therapeutics' APL 130277 for Parkinson's Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

Posted in Parkinson's disease | Comments Off on Cynapsus Therapeutics' APL 130277 for Parkinson's Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

Cynapsus Therapeutics’ APL 130277 for Parkinson’s Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

TORONTO, ONTARIO--(Marketwire - Oct 29, 2012) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH) today announced that its APL-130277 for Parkinson''s was recognized as one of the Top Ten Neurology Projectsto Watch in 2012 by a joint selection committee including Dr. Harry Tracy, a noted authority on pharmacological interventions for diseases of the brain and editor of the highly respected biotechnology publication NeuroPerspective, as well as with Elsevier Business Intelligence, the publishers of In Vivo, Startup and The Pink Sheet.Cynapsus has been invited to present the APL-130277 Project at Elsevier''s Therapeutic Area Partnerships Meeting taking place on November 28-30, 2012 at the Westin Copley in Boston.

Criteria for selection of the Top 10 Neurology Projects to Watch in 2012 were:

APL130277 is a unique and innovative, sublingual thin film strip formulation of apomorphine. Apomorphine is an approved drug prescribed in the US, Europe and several other countries. It is administered as a subcutaneous injection or infusion to Parkinson''s patients experiencing daily "OFF" or motor fluctuation episodes. APL130277 would provide patients with a convenient and more tolerable alternative to multiple daily injections. As a new means of delivering an approved drug, this clinical stage project is expected to follow a bioequivalence regulatory and clinical path which would culminate in a New Drug Approval application in 2015.

"We are humbled to be recognized from among several hundred worthy neuroscience projects, worldwide. This is a significant honor and further independent validation of the potential of APL-130277. This comes only a few months after receiving a significant grant from The Michael J. Fox Foundation for Parkinson''s Research (MJFF) to help support our next clinical study (CTH103). The MJFF Clinical Intervention Award was provided through the Edmond J. Safra Core Programs for Parkinson''s Research," said Mr. Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus."Since we started this project, we determined that there are a large number of Parkinson''s patients who would benefit from needle-free delivery of the drug.This includes patients who want a convenient alternative to a very painful injection regimen, patients who have resisted initiating therapy because of the needle issues, and the increase in PD population as a result of the growing aging baby boomer generation. These factors combined indicate that the number of Parkinson''s patients worldwide could potentially increase 2-to-3 fold over the next 8 to 10 years. This significant potential unmet medical need coupled with a short and lower risk clinical pathway would be of interest to many in global and specialty pharma, especially given that our pending patent estate, when approved and granted, would provide protection to 2031 at a minimum."

About Parkinson''s Disease

Parkinson''s disease is a chronic, degenerative neurological disorder that results from the loss of dopamineproducing nerve cells in the brain. Currenttreatments for Parkinson''s disease are able to reduce the symptoms of the disease but are not able to treat the underlying neurodegenerative processes that lead to a decline in physical and cognitive functions that affects some patients with Parkinson''s disease. It is estimated that over one million people in the United States and 5 million people globally are living with Parkinson''s disease. According to the National Institute of Neurodegenerative Disease and Stroke, the average age of onset is 60, although some people are diagnosed at age 40 or younger.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing the only orally administered convenient (sublingual) delivery of the only approved drug (apomorphine) to treat the motor symptoms of Parkinson''s disease. Over one million people in the United States and an estimated 5 million people globally suffer from Parkinson''s disease. Parkinson''s disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on the IMPACT Registry Study and the results of Cynapsus'' Global 500 Neurologists Survey, is estimated that between 25 percent and 50 percent of patients experience "OFF episodes" in which they have impaired movement or speaking capabilities. Current medications only control the disease''s symptoms, and most drugs become less effective over time as the disease progresses.

Cynapsus'' lead drug candidate, APL130277, is an easytoadminister, fastacting reformulation of an approved drug, apomorphine, used to rescue patients from OFF episodes. Cynapsus is focused on rapidly maximizing the value of APL130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2015. Cynapsus anticipates outlicensing to an appropriate pharmaceutical partner before such an application is submitted.

More information about Cynapsus (TSX VENTURE:CTH) is available at http://www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at http://www.sedar.com.

Go here to see the original:
Cynapsus Therapeutics' APL 130277 for Parkinson's Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

Posted in Parkinson's disease | Comments Off on Cynapsus Therapeutics’ APL 130277 for Parkinson’s Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

Cynapsus Therapeutics Inc. : Cynapsus Therapeutics Has Article Published in Journal of Commercial Biotechnology

TORONTO--(Marketwire -06/13/12)-

Cynapsus Therapeutics Has Article Published in Journal of Commercial Biotechnology

Cynapsus Therapeutics (CTH.V) today announced that an article discussing its APL-130277 drug candidate will be published in the July 2012 Issue of the Journal of Commercial Biotechnology. The article titled "Creating systemic oral transmucosal drug delivery strategies: Case study of APL-130277" was co-authored by Anthony Giovinazzo, President and CEO of Cynapsus, Nathan Bryson, Chief Scientific Officer of Cynapsus, and Timothy Tankosic, Managing Director of Aqua Partners, LLC.

The July 2012 issue of the Journal of Commercial Biotechnology will be published on July 1, 2012 and distributed earlier at the BIO International Convention (http://convention.bio.org/) being held in Boston, MA, USA, from June 18 to 21, 2012.

The article broadly addresses the strategic application of systemic oral transmucosal (i.e., sublingual and buccal) drug delivery. The article also provides a specific discussion of the scientific, clinical and commercial considerations driving APL-130277, an easy-to-administer, fast-acting, oral reformulation of an approved drug, apomorphine, being developed to rescue Parkinson's patients from "off" episodes. The principal advantages the oral transmucosal route and APL-130277 include: circumvention of first-pass hepatic metabolism in the gut, rapid onset of action, easy access via the oral cavity, easy administration for patients with dysphagia, and a high level of patient acceptance.

The full text version of the article is available at http://commercialbiotechnology.com (Subscription Required), or by contacting Anthony Giovinazzo at ajg@cynapsus.ca.

The TSX Venture Exchange Inc. has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson's disease. Over one million people in the United States and an estimated 5 million people globally suffer from Parkinson's disease. Parkinson's disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. It is estimated that between 25 percent and 50 percent of patients experience off episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease's symptoms, and most drugs become less effective over time as the disease progresses.

Cynapsus' lead drug candidate, APL-130277, is an easy-to-administer, fast-acting, oral reformulation of an approved drug, apomorphine, used to rescue patients from off episodes. Cynapsus is focused on rapidly maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2014. Cynapsus anticipates out-licensing to an appropriate pharmaceutical partner before such an application is submitted.

See the rest here:
Cynapsus Therapeutics Inc. : Cynapsus Therapeutics Has Article Published in Journal of Commercial Biotechnology

Posted in Biotechnology | Comments Off on Cynapsus Therapeutics Inc. : Cynapsus Therapeutics Has Article Published in Journal of Commercial Biotechnology

Cynapsus Therapeutics has Article Published in Journal of Commercial Biotechnology

TORONTO, ONTARIO--(Marketwire - June 13, 2012) - Cynapsus Therapeutics (CTH.V) today announced that an article discussing its APL-130277 drug candidate will be published in the July 2012 Issue of the Journal of Commercial Biotechnology. The article titled "Creating systemic oral transmucosal drug delivery strategies: Case study of APL-130277" was co-authored by Anthony Giovinazzo, President and CEO of Cynapsus, Nathan Bryson, Chief Scientific Officer of Cynapsus, and Timothy Tankosic, Managing Director of Aqua Partners, LLC.

The July 2012 issue of the Journal of Commercial Biotechnology will be published on July 1, 2012 and distributed earlier at the BIO International Convention (http://convention.bio.org/) being held in Boston, MA, USA, from June 18 to 21, 2012.

The article broadly addresses the strategic application of systemic oral transmucosal (i.e., sublingual and buccal) drug delivery. The article also provides a specific discussion of the scientific, clinical and commercial considerations driving APL-130277, an easy-to-administer, fast-acting, oral reformulation of an approved drug, apomorphine, being developed to rescue Parkinson's patients from "off" episodes. The principal advantages the oral transmucosal route and APL-130277 include: circumvention of first-pass hepatic metabolism in the gut, rapid onset of action, easy access via the oral cavity, easy administration for patients with dysphagia, and a high level of patient acceptance.

The full text version of the article is available at http://commercialbiotechnology.com (Subscription Required), or by contacting Anthony Giovinazzo at ajg@cynapsus.ca.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson's disease. Over one million people in the United States and an estimated 5 million people globally suffer from Parkinson's disease. Parkinson's disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. It is estimated that between 25 percent and 50 percent of patients experience off episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease's symptoms, and most drugs become less effective over time as the disease progresses.

Cynapsus' lead drug candidate, APL-130277, is an easy-to-administer, fast-acting, oral reformulation of an approved drug, apomorphine, used to rescue patients from off episodes. Cynapsus is focused on rapidly maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2014. Cynapsus anticipates out-licensing to an appropriate pharmaceutical partner before such an application is submitted.

More information about Cynapsus (CTH.V) is available at http://www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at http://www.sedar.com.

About The Journal of Commercial Biotechnology

The Journal of Commercial Biotechnology is the definitive international quarterly publication for bioscience business professionals. The Journal is designed specifically for those professionals who need to enhance their knowledge of biotechnology business strategy and management, improve and advance their product development or want to keep up-to-date with current issues and industry trends. Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as Management, Policy, Finance, Law, Regulation and Bioethics.

See the article here:
Cynapsus Therapeutics has Article Published in Journal of Commercial Biotechnology

Posted in Biotechnology | Comments Off on Cynapsus Therapeutics has Article Published in Journal of Commercial Biotechnology

Cynapsus Therapeutics Reports First Quarter 2012 Financial Results and Recent Developments

TORONTO, ONTARIO–(Marketwire – May 30, 2012) – Cynapsus Therapeutics Inc. (CTH.V – News), a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson’s disease, today announced its results for the three months ended March 31, 2012. Unless specified otherwise, all amounts are in Canadian dollars.

“In the first quarter our team continued to make significant progress on our lead drug candidate, APL-130277,” said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. “In particular, the first quarter was highlighted by the announcement of the completion of the first human clinical trial for APL-130277. Building on this success, we remain focused on the completion of a second dose escalation study in the next 60-90 days, as well as preparations for an Investigational New Drug Application to the US FDA for a clinical BioEquivalence study later in the year. The BEQ study is the next critical de-risking milestone that we believe will drive significant shareholder value.”

Financial Highlights

Recent Developments

The following achievements were made during the quarter:

Cynapsus Completed the First Human Volunteer Pilot Proof-of-Concept Clinical Trial For APL-130277. On January 10, 2012, Cynapsus announced positive headline data from its recently completed human volunteer pilot proof-of-concept trial for APL-130277, a sublingual thin film strip formulation of apomorphine. The study showed a pharmacokinetic (PK) profile that compared favorably to injected apomorphine with a mean T-max of 25 minutes and good tolerability, and therefore confirms that APL-130277 has the potential to treat motor fluctuations or “off episodes” in Parkinson’s disease. This was a significant milestone and de-risking event for the project.

Cynapsus Obtained Independent Research Coverage. In February 2012, the Company announced that Loewen, Ondaatje, McCutcheon Limited (“LOM”) initiated analyst coverage of the Company. LOM’s biotech analyst initiation of research coverage provides further independent opinion and view of the strengths, risks and commercial potential of APL-130277.

Cynapsus Added an Additional Expert to the Clinical Advisory Board (“CAB”). During the quarter, Management initiated a search for new CAB candidates that have extensive experience in the clinical management of Parkinson’s patients. In April 2012, subsequent to the end of the quarter, the Company announced that it has appointed Dr. Abraham Lieberman to the CAB. Dr. Lieberman is the current Director of the Muhammad Ali Parkinson Center and Movement Disorder Clinic of the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, Arizona.

Cynapsus Initiated Discussions to Strengthen the Board of Directors. During the quarter, the Board initiated a search for new Board candidates. In May 2012, subsequent to the end of the quarter, the Company announced that Dr. Perry Molinoff, Dr. Thomas Picone, and Anthony Giovinazzo, were named as candidates to join its Board of Directors at the May 30, 2012 Annual and Special Meeting of Shareholders. Mr. Giovinazzo and Dr. Molinoff were nominated and elected to the Board at the meeting held earlier in the day, along with Mr. Ronald Hosking, Dr. Julia Levy, Dr. Alan Ryley, Ms. Rochelle Stenzler and Mr. Alan Torrie. Dr. Picone was not nominated today for personal reasons, however his candidacy is still in process and he may join the Board of Directors in the next three months, subject to Board and Exchange approval.

Cynapsus Commenced Work on the Second Human Volunteer Pilot Proof-of-Concept Clinical Trial For APL-130277. During the quarter, the Company began work on a second Phase 1 healthy human volunteer pilot study to provide additional insights related to a two dose comparison, as well as some minor changes to the prototype composition. This pilot study commenced in May 2012, subsequent to the end of the quarter, with results expected to be announced in July or August 2012.

Go here to read the rest:
Cynapsus Therapeutics Reports First Quarter 2012 Financial Results and Recent Developments

Source:
http://www.longevitymedicine.tv/feed/

Posted in Longevity Medicine | Comments Off on Cynapsus Therapeutics Reports First Quarter 2012 Financial Results and Recent Developments