Actelion

Aerovate Therapeutics Announces Full-Year 2023 Financial Results and Business Highlights

Retrieved on: 
Monday, March 25, 2024

Cash, cash equivalents and short-term investments totaled $122.4 million as of December 31, 2023, compared to $135.2 million as of September 30, 2023.

Key Points: 
  • Cash, cash equivalents and short-term investments totaled $122.4 million as of December 31, 2023, compared to $135.2 million as of September 30, 2023.
  • The decrease was primarily driven by operational costs for the three-month period ended December 31, 2023.
  • Net loss: Net loss for the year ended December 31, 2023 was $75.5 million as compared to $51.5 million for the year ended December 31, 2022.
  • Net loss included stock-based compensation expense of $11.9 million and $5.5 million for the years ended December 31, 2023 and December 31, 2022, respectively.

Juvisé Pharmaceuticals Acquires Multiple Sclerosis Drug PONVORY® (ex-US/Canada) and Opens Its Capital to Bpifrance and Pemberton

Retrieved on: 
Tuesday, March 26, 2024

To fund this acquisition, the French sovereign fund Bpifrance and Pemberton Asset Management (‘Pemberton’), a leading European private credit manager, have acquired a minority stake in Juvisé Pharmaceuticals.

Key Points: 
  • To fund this acquisition, the French sovereign fund Bpifrance and Pemberton Asset Management (‘Pemberton’), a leading European private credit manager, have acquired a minority stake in Juvisé Pharmaceuticals.
  • “We are very excited about Ponvory® and its potential to have a very positive impact on the lives of patients with multiple sclerosis” announces Frédéric Mascha, founder and President of Juvisé Pharmaceuticals.
  • Juvisé Pharmaceuticals will work closely with Johnson & Johnson to ensure a seamless transition and continuous availability of Ponvory® for patients.
  • Finally, Juvisé Pharmaceuticals will assume the worldwide manufacturing duties for Ponvory® from sites based in France and Switzerland.

Quince Therapeutics Appoints Former Reata Pharmaceuticals Chief R&D Officer Dr. Rajiv Patni to its Board of Directors

Retrieved on: 
Thursday, February 15, 2024

“We are pleased to welcome a proven clinical development leader of Dr. Rajiv Patni’s caliber to our Board of Directors,” said David Lamond, chairperson of Quince’s Board of Directors.

Key Points: 
  • “We are pleased to welcome a proven clinical development leader of Dr. Rajiv Patni’s caliber to our Board of Directors,” said David Lamond, chairperson of Quince’s Board of Directors.
  • Most recently, he served as Chief Research and Development Officer at Reata Pharmaceuticals, a commercial-stage company recently acquired by Biogen.
  • Previously, Dr. Patni also served as Chief Medical Officer at several successful public, small-cap, and commercial-stage biopharmaceutical companies – Global Blood Therapeutics, Portola Pharmaceuticals, and Adamas Pharmaceuticals.
  • Earlier in his career, Dr. Patni held roles of increasing responsibility at Pfizer, Roche, and Actelion.

Launch of GIO Therapeutics, founded by Cumulus Oncology, to develop therapeutics targeting G protein-coupled receptors to treat cancer and inflammation

Retrieved on: 
Thursday, February 1, 2024

Edinburgh, Scotland, 1 February 2024 – Cumulus Oncology (a biotech creation company) today proudly unveils the inauguration of GIO Therapeutics AG, based in Basel, Switzerland.

Key Points: 
  • Edinburgh, Scotland, 1 February 2024 – Cumulus Oncology (a biotech creation company) today proudly unveils the inauguration of GIO Therapeutics AG, based in Basel, Switzerland.
  • This newly established biotech company specialises in the development of pharmaceuticals targeting G protein-coupled receptors (GPCR).
  • Heading GIO Therapeutics is Dr Xavier Leroy who has been appointed as Chief Executive Officer.
  • Dr Xavier Leroy, CEO of GIO Therapeutics commented: “While GPCRs are well-known drug targets, their potential in cancer therapeutics is currently underutilised.

Vanda Pharmaceuticals Announces a U.S. Patent Allowance for PONVORY® (ponesimod) in the U.S.

Retrieved on: 
Friday, January 26, 2024

WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses.

Key Points: 
  • WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses.
  • When issued, this patent is anticipated to expire on October 10, 2042.
  • Upon issuance, Vanda intends to list this patent in the U.S. Food and Drug Administration publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
  • Vanda acquired rights to U.S. and Canadian rights to PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.

BioXcel Therapeutics Strengthens Clinical Development Leadership to Advance Late-Stage Programs

Retrieved on: 
Monday, December 11, 2023

NEW HAVEN, Conn., Dec. 11, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced a key executive promotion and a clinical advisor appointment as part of the Company’s strategic reprioritization focused on the advancement of its late-stage clinical programs and emerging pipeline candidates.

Key Points: 
  • Vincent J. O’Neill, M.D., Senior Vice President and Chief Research & Development Officer of OnkosXcel Therapeutics, has been promoted to Executive Vice President, Chief of Product Development and Medical Officer of BioXcel Therapeutics.
  • Additionally, Rajiv Patni, M.D., has been appointed to the newly created position of Strategic Clinical Advisor to the BioXcel Therapeutics Chief Executive Officer and Board of Directors.
  • Prior to joining BioXcel Therapeutics, Dr. O’Neill held senior leadership roles at several leading global pharmaceutical companies, including Sanofi, Genentech, and GlaxoSmithKline.
  • “I look forward to working with the BioXcel leadership team in continuing to address the unmet medical needs of patients and caregivers and advance the Company’s product-development goals.”

Santhera Appoints Executive Committee Members as it Transitions into Commercial Stage

Retrieved on: 
Thursday, December 7, 2023

Both will join the six-member Executive Committee effective January 1, 2024.

Key Points: 
  • Both will join the six-member Executive Committee effective January 1, 2024.
  • “Santhera is transitioning to the commercial phase and will make AGAMREE® (vamorolone) available to patients in Europe starting in Germany in early 2024, subject to approval by the European Commission.
  • Notably, he was instrumental in establishing Santhera’s European commercial operations and successfully launching the rare disease product RAXONE® in Europe which was later divested to Chiesi Group.
  • Before joining Santhera, Geert Jan held positions as Medical Director, Business Unit Director and General Manager in start-up teams in Serono, Actelion and InterMune.

Pharvaris Appoints Stefan Abele, Ph.D., as Chief Technical Operations Officer

Retrieved on: 
Wednesday, November 15, 2023

ZUG, Switzerland, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the appointment of Stefan Abele, Ph.D., as Chief Technical Operations Officer.

Key Points: 
  • ZUG, Switzerland, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the appointment of Stefan Abele, Ph.D., as Chief Technical Operations Officer.
  • In this role, he will be responsible for all chemistry, manufacturing, and controls (CMC) activities, supply chain, and program management as Pharvaris progresses into late-stage clinical development.
  • Dr. Abele joins Pharvaris with more than 20 years of experience in process development, end-to-end Active Pharmaceutical Ingredients (API) supply chain, cross-functional CMC activities, GMP manufacturing, global vendor management, and people leadership.
  • “Stefan joins Pharvaris at a transformative time as we prepare to transition into a late-stage clinical company and prepare for commercialization in the coming years,” said Berndt Modig, Chief Executive Officer of Pharvaris.

Gossamer Bio Appoints Bob Smith as Chief Commercial Officer

Retrieved on: 
Tuesday, December 5, 2023

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced the appointment of Bob Smith as its Chief Commercial Officer.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced the appointment of Bob Smith as its Chief Commercial Officer.
  • “We are proud to welcome Bob Smith to the Gossamer team and his 30 years of expertise at this critical time in our company’s history,” said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio.
  • “With Bob’s arrival, Gossamer is well-positioned to transition itself from a pre-commercial, clinical-stage biotechnology company to a fully integrated commercial organization focused on bringing seralutinib to patients with pulmonary hypertension.
  • As the principal sales leader, Mr. Smith managed all U.S. sales operations, including sales, training, sales operations, patient & professional advocacy, key customer engagement and territory management.

Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to PONVORY® (ponesimod), a Selective S1P1R Modulator Approved for Patients with Relapsing Multiple Sclerosis

Retrieved on: 
Thursday, December 7, 2023

WASHINGTON, Dec. 7, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.

Key Points: 
  • WASHINGTON, Dec. 7, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.
  • PONVORY® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
  • PONVORY® has a proven safety profile with over 10 years of data.
  • Stifel acted as exclusive financial advisor to Vanda with respect to this acquisition.