PTC Therapeutics

Chasing Breakthrough Innovation in a Time of Uncertainty With Insights from McKinsey & Company

Retrieved on: 
Tuesday, September 19, 2023
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TRENTON, N.J., Sept. 19, 2023 /PRNewswire/ -- BioNJ has released the agenda and speaker roster for its Eleventh Annual C-Suite Summit, taking place Friday, October 6, 2023, at the Bridgewater Marriott. The C-Suite Summit brings together life sciences executives representing a wide breadth of companies from early to late stage, public and private and revenue and pre-revenue to discuss the topics impacting C-Suite decision-making in bringing new innovative treatments to market.

Key Points: 
  • Friday, October 6, 2023 • 7:30 a.m.-4:00 p.m. Bridgewater Marriott, 700 Commons Way, Bridgewater
    TRENTON, N.J., Sept. 19, 2023 /PRNewswire/ -- BioNJ has released the agenda and speaker roster for its Eleventh Annual C-Suite Summit, taking place Friday, October 6, 2023, at the Bridgewater Marriott.
  • The C-Suite Summit brings together life sciences executives representing a wide breadth of companies from early to late stage, public and private and revenue and pre-revenue to discuss the topics impacting C-Suite decision-making in bringing new innovative treatments to market.
  • "As the policy environment churns and investment in biopharma fluctuates, questions are being raised about the future of innovation for our industry," said BioNJ President and CEO, Debbie Hart.
  • "The C-Suite Summit allows stakeholders to come together for an open conversation on where the greatest opportunities lie and how to best prepare for and shape the next paradigm in life sciences and medical discovery."

Deep Genomics Announces the Appointment of Brian O’Callaghan as CEO

Retrieved on: 
Friday, September 15, 2023
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View the full release here: https://www.businesswire.com/news/home/20230915844643/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230915844643/en/
    “I am impressed with the work underway at Deep Genomics and see tremendous opportunity to build on the technology innovations spearheaded by Brendan and the team to achieve value for patients, partners and investors,” said Brian O’Callaghan, chief executive officer at Deep Genomics.
  • Brian’s appointment as CEO comes after a thorough succession discussion with the board and with Brendan’s full approval,” said Chip Baird, chairman of the board at Deep Genomics.
  • “Artificial intelligence has achieved significant momentum across multiple sectors and industries, and Deep Genomics is well-positioned to play a key role in applying this innovative technology to RNA-based drugs.
  • Having Brian as chief executive officer and Brendan as chief innovation officer positions the company for success in business and innovation, now and into the future.”

CHMP Delivers Opinion on Translarna™ for Conversion to Full Authorization

Retrieved on: 
Friday, September 15, 2023
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SOUTH PLAINFIELD, N.J., Sept. 15, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). The negative opinion also applies to the renewal of the existing conditional authorization. PTC plans to submit a request for re-examination per EMA guidelines. Translarna will remain on the market and available to patients with nmDMD until the re-examination process is completed. Based on CHMP procedural guidance, the opinion following the re-examination process would be expected to occur in January 2024, with EC ratification of the opinion within the following 67 days.

Key Points: 
  • The negative opinion also applies to the renewal of the existing conditional authorization.
  • Based on CHMP procedural guidance, the opinion following the re-examination process would be expected to occur in January 2024, with EC ratification of the opinion within the following 67 days.
  • We will be submitting a request for re-examination to the CHMP to reverse this opinion, as we have done previously in the regulatory history of Translarna in Europe."
  • Translarna received conditional marketing authorization in Europe in 2014 based on the results of Study 007, and the conditional authorization was renewed in 2017.

Sensorium Therapeutics Appoints Veteran Life Sciences Executive Mr. David Southwell to its Board of Directors

Retrieved on: 
Tuesday, September 12, 2023
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BOSTON, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Sensorium Therapeutics (Sensorium), a biotechnology company translating insights from nature and human experience to deliver transformational therapeutics, today announced the appointment of veteran life sciences executive David Southwell to its Board of Directors.

Key Points: 
  • BOSTON, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Sensorium Therapeutics (Sensorium), a biotechnology company translating insights from nature and human experience to deliver transformational therapeutics, today announced the appointment of veteran life sciences executive David Southwell to its Board of Directors.
  • “We are excited to welcome David to our Board,” said Dick Simon, Chief Executive Officer of Sensorium.
  • “He is a seasoned life sciences executive with a track record of success that spans multiple therapeutic areas and development stages.
  • in economics and managerial studies from Rice University and an M.B.A. from the Tuck School of Business at Dartmouth College.

PTC Therapeutics' 2023 STRIVE Awards Program Funds Initiatives Supporting the Duchenne Patient Community

Retrieved on: 
Thursday, September 7, 2023
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SOUTH PLAINFIELD, N.J., Sept. 7, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the two recipients of its 2023 STRIVE Awards for Duchenne Muscular Dystrophy. Through the STRIVE program, the company awards grants to non-profit patient advocacy organizations serving the Duchenne community. This year's grants will fund projects focused on developing a digital health app to support patients transitioning to adulthood in Australia and the expansion of a power soccer (also known as powerchair football) program in Brazil.

Key Points: 
  • SOUTH PLAINFIELD, N.J., Sept. 7, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the two recipients of its 2023 STRIVE Awards for Duchenne Muscular Dystrophy.
  • Through the STRIVE program, the company awards grants to non-profit patient advocacy organizations serving the Duchenne community.
  • "As we near a decade of the STRIVE Awards program, we are proud to continue to provide organizations with support to expand their services for the Duchenne community."
  • "It has been such a rewarding experience to be part of the judging panel for the STRIVE Awards Program.

PTC Therapeutics to Participate at Upcoming Investor Conferences

Retrieved on: 
Wednesday, August 30, 2023
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SOUTH PLAINFIELD, N.J., Aug. 30, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will present a company overview at the following conferences:

Key Points: 
  • SOUTH PLAINFIELD, N.J., Aug. 30, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will present a company overview at the following conferences:
    The presentations will be webcast live on the Events and Presentations page under the Investor section of PTC Therapeutics' website at https://ir.ptcbio.com/events-presentations and will be archived for 30 days following the presentation.
  • It is recommended that users connect to PTC's website several minutes prior to the start of the webcast to ensure a timely connection.

Fennec Pharmaceuticals Announces Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 3, 2023
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RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today reported its financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • ET ~
    RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today reported its financial results for the second quarter ended June 30, 2023 and provided a business update.
  • These results reflect strong growth in patient starts and new account orders,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals.
  • Selling and marketing expenses for the second quarter of 2023 were $2.3 million compared to $2.5 million in the first quarter of 2023.
  • ET, to discuss the Company’s financial results from the second quarter, ended June 30, 2023, and provide a business outlook for the remainder of 2023.

Plus Therapeutics Strengthens Clinical Program with the Appointment of Pius Maliakal as Vice President of Clinical Operations

Retrieved on: 
Thursday, July 27, 2023
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Pharm., Ph.D., as Vice President of Clinical Operations.

Key Points: 
  • Pharm., Ph.D., as Vice President of Clinical Operations.
  • Dr. Maliakal will be responsible for the strategy and planning of key clinical operational initiatives, focusing on advancing the Company’s lead clinical trials, ReSPECT-GBM and ReSPECT-LM, and further developing the broader pipeline.
  • Dr. Maliakal is an accomplished R&D professional who brings over 20 years of global and domestic experience to Plus Therapeutics.
  • Prior to joining the Company, he served as Director of Clinical Science at PTC Therapeutics, leading the clinical development, clinical trial operations, strategies, and data interpretations of all oncology assets across the enterprise.

CHMP Recommends Evrysdi® for Babies Under Two Months Old with Spinal Muscular Atrophy

Retrieved on: 
Friday, July 21, 2023
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SOUTH PLAINFIELD, N.J., July 21, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Evrysdi® (risdiplam) marketing authorization to include infants under two months of age in the European Union (EU). A final decision regarding the approval is expected from the European Commission later this year.

Key Points: 
  • A final decision regarding the approval is expected from the European Commission later this year.
  • "The CHMP opinion represents another important milestone in the development of Evrysdi," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics.
  • "Presymptomatic babies are an important patient group that deserve access to oral, at-home administered treatments early in the disease."
  • Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

PTC Therapeutics to Host Conference Call to Discuss Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, July 20, 2023
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SOUTH PLAINFIELD, N.J., July 20, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will host a webcast conference call to report its second quarter 2023 financial results and provide an update on the company's business and outlook on Thursday, Aug. 3, at 4:30 p.m.

Key Points: 
  • SOUTH PLAINFIELD, N.J., July 20, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will host a webcast conference call to report its second quarter 2023 financial results and provide an update on the company's business and outlook on Thursday, Aug. 3, at 4:30 p.m.
  • To access the call by phone, please click here to register and you will be provided with dial-in details.
  • To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call.
  • The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations .