IgA nephropathy

Alpine Immune Sciences Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 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 third quarter ended September 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 third quarter ended September 30, 2023.
  • “Following our data presentation, we executed a follow-on equity offering of $150 million to bolster our balance sheet.
  • Cash Position and Runway: As of September 30, 2023, Alpine’s cash and investments totaled $227.2 million compared to $273.4 million as of December 31, 2022.
  • The respective increases of $0.8 million and $2.3 million were primarily attributable to increases in personnel and legal costs.

Kira Pharmaceuticals Presents Positive Results of KP104 Phase 2 Study in Complement-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) at the 2023 ASH Annual Meeting

Retrieved on: 
Thursday, December 14, 2023

The interim results support the advancement of KP104 to Phase 3 studies as an optimal and safe treatment for PNH patients to address currently unmet medical needs.

Key Points: 
  • The interim results support the advancement of KP104 to Phase 3 studies as an optimal and safe treatment for PNH patients to address currently unmet medical needs.
  • The presentation has also been selected to be featured in the 2024 Highlights of ASH.
  • Kira Pharmaceuticals is committed to advancing KP104 as an innovative therapy for patients with PNH and other complement-mediated diseases.
  • Title: KP104, a bifunctional C5 antibody/factor H fusion protein, effectively controls both intravascular and extravascular hemolysis: interim results from a phase 2 study in complement inhibitor-naïve PNH patients

Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®

Retrieved on: 
Monday, December 11, 2023

STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.

Key Points: 
  • STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.
  • "  This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043.
  • The patent, when issued, will be Calliditas' second patent for TARPEYO in the United States.

Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®

Retrieved on: 
Monday, December 11, 2023

STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.

Key Points: 
  • STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.
  • "  This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043.
  • The patent, when issued, will be Calliditas' second patent for TARPEYO in the United States.

Everest Medicines Announces Acceptance of Nefecon® New Drug Applications for the Treatment of Primary IgA Nephropathy in Adult Patients in South Korea

Retrieved on: 
Wednesday, November 29, 2023

Nefecon® was the first ever targeted treatment for IgAN approved in the United States, European Union and China.

Key Points: 
  • Nefecon® was the first ever targeted treatment for IgAN approved in the United States, European Union and China.
  • Everest expects to receive NDA approval in South Korea in 2024.
  • South Korea's MFDS granted Global Innovative product on Fast Track (GIFT) designation to Nefecon® earlier this year.
  • The primary endpoint, time-weighted average of eGFR over 2 years, showed a statistically significant and clinically meaningful benefit of Nefecon® over placebo (p-value

Calliditas' partner Everest Medicines announces China NMPA's approval of Nefecon® for the treatment of primary IgA nephropathy

Retrieved on: 
Friday, November 24, 2023

China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.

Key Points: 
  • China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.
  • There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.
  • Everest also announced that, in addition to Nefecon's approval in mainland China and Macau, it expects a decision on New Drug Application (NDA) approval in Singapore and Hong Kong in the near term.
  • This approval triggers a milestone payment of five million USD to Calliditas, which will be included as revenue in the fourth quarter.

Calliditas' partner Everest Medicines announces China NMPA's approval of Nefecon® for the treatment of primary IgA nephropathy

Retrieved on: 
Friday, November 24, 2023

China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.

Key Points: 
  • China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.
  • There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.
  • Everest also announced that, in addition to Nefecon's approval in mainland China and Macau, it expects a decision on New Drug Application (NDA) approval in Singapore and Hong Kong in the near term.
  • This approval triggers a milestone payment of five million USD to Calliditas, which will be included as revenue in the fourth quarter.

Vera Therapeutics Provides Business Update and Reports Third Quarter Financial Results

Retrieved on: 
Thursday, November 9, 2023

“Vera presented additional positive data from the Phase 2b ORIGIN trial at Kidney Week 2023, which support the potential of atacicept as a disease-modifying treatment for patients with IgAN.

Key Points: 
  • “Vera presented additional positive data from the Phase 2b ORIGIN trial at Kidney Week 2023, which support the potential of atacicept as a disease-modifying treatment for patients with IgAN.
  • We showed that patients on atacicept achieved durable and significant Gd-IgA1 reduction over 36 weeks regardless of baseline quartile.
  • High serum levels of galactose-deficient IgA1 (Gd-IgA1) are associated with greater risk of end-stage renal disease or death.
  • Vera reported $159.9 million in cash, cash equivalents, and marketable securities as of September 30, 2023.

Calliditas Interim Report January - September 2023

Retrieved on: 
Tuesday, November 7, 2023

Operating loss amounted to SEK 159.6 million and SEK 36.2 million for the three months ended September 30, 2023, and 2022, respectively.

Key Points: 
  • Operating loss amounted to SEK 159.6 million and SEK 36.2 million for the three months ended September 30, 2023, and 2022, respectively.
  • Significant Events in Q3 2023, in Summary
    On July 13 Calliditas announced supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib.
  • Calliditas invites investors, analysts and press to a presentation of the Quarterly Report 2023 at 14:30 pm.
  • Calliditas' CEO Renee Aguiar-Lucander will present the report together with CFO Fredrik Johansson, CMO Richard Philipson and President North America Andrew Udell.

Calliditas Interim Report January - September 2023

Retrieved on: 
Tuesday, November 7, 2023

Operating loss amounted to SEK 159.6 million and SEK 36.2 million for the three months ended September 30, 2023, and 2022, respectively.

Key Points: 
  • Operating loss amounted to SEK 159.6 million and SEK 36.2 million for the three months ended September 30, 2023, and 2022, respectively.
  • Significant Events in Q3 2023, in Summary
    On July 13 Calliditas announced supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib.
  • Calliditas invites investors, analysts and press to a presentation of the Quarterly Report 2023 at 14:30 pm.
  • Calliditas' CEO Renee Aguiar-Lucander will present the report together with CFO Fredrik Johansson, CMO Richard Philipson and President North America Andrew Udell.