Cold agglutinin disease

Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024

Cost of sales was $19.9 million for the fourth quarter of 2023, compared to $2.9 million for the fourth quarter of 2022, respectively.

Key Points: 
  • Cost of sales was $19.9 million for the fourth quarter of 2023, compared to $2.9 million for the fourth quarter of 2022, respectively.
  • R&D expenses were $69.3 million for the fourth quarter of 2023, compared to $99.4 million for the fourth quarter of 2023.
  • G&A expenses were $141.7 million for the fourth quarter of 2023, compared to $84.4 million for the fourth quarter of 2022.
  • Apellis will host a conference call and webcast to discuss its fourth quarter and year end 2023 financial results and business highlights today, February 27, 2024, at 8:30 a.m.

Annexon Outlines 2024 Priorities with Late-Stage Clinical Milestones Across Upstream Complement Portfolio for Autoimmune, Ophthalmic and Neurodegenerative Diseases

Retrieved on: 
Monday, January 8, 2024

BRISBANE, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for people living with devastating inflammatory-related diseases, today outlined its strategic priorities for 2024 with late-stage clinical milestones, including ANX005 for Guillain-Barré syndrome (GBS), ANX007 for geographic atrophy (GA) and its first-in-kind oral small molecule complement inhibitor, ANX1502, for a range of autoimmune indications.

Key Points: 
  • The study completed enrollment in 2023 and the company is on-track to report Phase 3 data in the first half of 2024.
  • Annexon also plans to initiate the ARROW clinical trial, an injection-controlled head-to-head study against SYFOVRE® (pegcetacoplan injection) in late 2024.
  • A live webcast of the event can be accessed under the ‘Events & Presentations’ section on the Investors page at www.annexonbio.com.
  • A replay of the webcast will be archived on the Annexon website for 30 days following the presentation.

Annexon Reports Phase 1 Results for ANX1502, its Oral Small Molecule Inhibitor of the Classical Complement Pathway

Retrieved on: 
Wednesday, December 20, 2023

BRISBANE, Calif., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for people living with devastating inflammation-related diseases, today reported results from the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) healthy volunteer study of ANX1502, a first-in-kind oral, selective small molecule inhibitor that targets the active form of C1s responsible for propagating classical pathway activation in association with C1q. ANX1502 achieved target serum levels and demonstrated pharmacokinetic (PK) measures that support advancement into a proof-of-concept clinical study to assess pharmacodynamics (PD) and efficacy in patients with cold agglutinin disease (CAD) in 2024.

Key Points: 
  • “After more than a decade of groundbreaking research targeting the early classical complement pathway, we are excited to have reached an important step in the clinical development of ANX1502, our first-in-kind small molecule complement inhibitor that we believe can have meaningful impact on a range of autoimmune conditions,” said Ted Yednock, Ph.D., chief innovation officer of Annexon.
  • “We’re very encouraged by the results from our Phase 1 SAD/MAD trial showing that ANX1502 was well tolerated and achieved target drug levels with supportive impact on a key biomarker in healthy volunteers.
  • Results of the study were as follows:
    Across all doses evaluated, ANX1502 was generally well tolerated with mild to moderate treatment-emergent adverse events (TEAEs).
  • No serious adverse events were reported, and there were no significant clinical or lab findings.

Electra Therapeutics Appoints Kathy Dong, PharmD, MBA, as President and Chief Executive Officer

Retrieved on: 
Monday, December 11, 2023

Electra Therapeutics, Inc. , a clinical stage biotechnology company developing antibody therapies against novel targets for immunological diseases and cancer, today announced the appointment of Kathy Dong, PharmD, MBA, as President and Chief Executive Officer.

Key Points: 
  • Electra Therapeutics, Inc. , a clinical stage biotechnology company developing antibody therapies against novel targets for immunological diseases and cancer, today announced the appointment of Kathy Dong, PharmD, MBA, as President and Chief Executive Officer.
  • View the full release here: https://www.businesswire.com/news/home/20231211224486/en/
    Electra President and CEO Kathy Dong PharmD, MBA (Photo: Business Wire)
    “We are excited to have Kathy take on the role of CEO of Electra.
  • Dr. Rosenthal will continue to serve as a member of Electra’s board of directors and as Chief Executive Officer of Star Therapeutics, the company that spun out Electra.
  • Previously, she was Chief Operating Officer of Star Therapeutics since 2019, where she held strategic and operational responsibilities across the Star portfolio, including building Electra Therapeutics and Vega Therapeutics from discovery stage into the clinic.

BioCryst R&D Day Highlights New Diversified Pipeline of First-in-Class/Best-in-Class Therapies with Five Programs Expected in Clinical Development in Next 24 Months

Retrieved on: 
Friday, November 3, 2023

A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .

Key Points: 
  • A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .
  • The team is excited to share our approach, and our expanded pipeline of new programs, at our R&D Day,” said Jon Stonehouse, president and chief executive officer of BioCryst.
  • The disease is caused by the deficiency of a natural inhibitor (SPINK5) of KLK5, a serine protease responsible for regulating skin shedding.
  • Netherton syndrome can be life threatening, especially during infancy when patients are vulnerable to dehydration and recurrent infections.

Apellis Pharmaceuticals Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 1, 2023

Delivered approximately 37,000 commercial vials and 10,000 samples of SYFOVRE to physician practices in the third quarter 2023.

Key Points: 
  • Delivered approximately 37,000 commercial vials and 10,000 samples of SYFOVRE to physician practices in the third quarter 2023.
  • EMPAVELI for the treatment of PNH:
    Generated $23.9 million in EMPAVELI U.S. net product revenue in the third quarter 2023.
  • In August 2023, Apellis announced a corporate restructuring to drive growth of SYFOVRE and EMPAVELI, positioning Apellis for long-term success.
  • Apellis will host a conference call and webcast to discuss its third quarter 2023 financial results and business highlights today, November 1, 2023, at 8:00 a.m.

Alpine Immune Sciences Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 14, 2023

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the second quarter ended June 30, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the second quarter ended June 30, 2023.
  • “During the first half of 2023 we achieved several important milestones in the development of povetacicept, our potentially best-in-class dual BAFF/APRIL inhibitor being advanced in multiple autoimmune diseases.
  • Continue to enroll patients in RUBY-3, a phase 1b/2a, open-label study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy.
  • The respective increases of $0.8 million and $1.4 million were primarily attributable to increases in personnel costs.

Apellis Pharmaceuticals Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, July 31, 2023

EMPAVELI for the treatment of PNH:

Key Points: 
  • EMPAVELI for the treatment of PNH:
    Apellis reported $22.3 million in EMPAVELI U.S. net product revenue for the second quarter 2023.
  • Cost of sales were $8.4 million for the second quarter 2023, compared to $0.1 million for same period in 2022.
  • Apellis reported a net loss of $122.0 million for the second quarter 2023, compared to a net loss of $156.0 million for the same period in 2022.
  • Apellis will host a conference call and webcast to discuss its second quarter 2023 financial results and business highlights today, July 31, 2023, at 8:30 a.m.

Alpine Immune Sciences Reports First Quarter 2023 Financial Results

Retrieved on: 
Thursday, May 11, 2023

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2023.
  • Collaboration revenue for the first quarter ended March 31, 2023 was $9.4 million compared to $13.6 million for the first quarter ended March 31, 2022.
  • Research and development expenses for the first quarter ended March 31, 2023 were $19.6 million compared to $16.3 million for the first quarter ended March 31, 2022.
  • General and administrative expenses for the first quarter ended March 31, 2023 were $5.4 million compared to $4.8 million for the first quarter ended March 31, 2022.

Apellis Pharmaceuticals Reports First Quarter 2023 Financial Results

Retrieved on: 
Thursday, May 4, 2023

EMPAVELI for the treatment of PNH:

Key Points: 
  • EMPAVELI for the treatment of PNH:
    Apellis recorded $20.4 million in EMPAVELI U.S. net product revenue for the first quarter 2023.
  • Cost of sales were $7.8 million for the first quarter 2023, compared to $1.2 million for same period in 2022.
  • Apellis reported a net loss of $177.8 million for the first quarter 2023, compared to a net loss of $138.9 million for the same period in 2022.
  • Apellis will host a conference call and webcast to discuss its first quarter 2023 financial results and business highlights today, May 4, 2023, at 4:30 p.m.