Novartis Discontinues Mid-Stage Lupus Trial In Latest Pipeline Setback

The multi-location study aimed to evaluate the efficacy, safety, and tolerability of iptacopan (LNP023) in addition to standard-of-care treatment in lupus.

  • Iptacopan is sold under the brand name Fabhalta and is approved by the FDA for Paroxysmal Nocturnal Hemoglobinuria, Primary Immunoglobulin A Nephropathy, and C3 Glomerulopathy.
  • Novartis has faced multiple clinical setbacks over the past several weeks, including trial failures and development discontinuations.
  • According to data from Koyfin, 8 of the 23 analysts rate the stock a ‘buy’ or ‘strong buy,’ while 13 rate it a ‘hold’ and only two rate it ‘sell.’

Shares of Novartis (NVS) closed little changed on Friday after the company decided to discontinue its mid-stage trial of iptacopan in lupus nephritis.

According to a federal clinical trials registry update, the company has concluded the study over ‘strategic considerations.’ It is unclear if the discontinuation was spurred by efficacy or safety concerns.

The multi-location study aimed to evaluate the efficacy, safety, and tolerability of iptacopan (LNP023) in addition to standard-of-care treatment. The company decided to conclude the study after completing the first part, as per the database.

Iptacopan is sold under the brand name Fabhalta and is approved by the FDA for Paroxysmal Nocturnal Hemoglobinuria, Primary Immunoglobulin A Nephropathy, and C3 Glomerulopathy.

Latest Pipeline Setback For Novartis

Novartis has faced multiple clinical setbacks over the past several weeks. Last month, the company said that its late-stage trial of Pelacarsen, being developed as a treatment to lower elevated lipoprotein(a) or Lp(a) and reduce the risk of major cardiovascular events, missed its primary goal. The company also said that its late-stage trial of del-desiran in myotonic dystrophy type 1 (DM1) missed its primary endpoint.

Besides the late-stage drug failures, the company also discontinued development of VHB937 in mid-September after a mid-stage study missed primary and secondary goals.  Prior to that, in August, Novartis paused multiple autoimmune and neurology trials after three fatal cases of immune effector cell-associated hemophagocytic syndrome (IEC-HS) in patients taking its experimental therapy Rap-cel.  

According to data from Koyfin, 8 of the 23 analysts rate the stock a ‘buy’ or ‘strong buy,’ while 13 rate it a ‘hold’ and only two rate it ‘sell.’

How Did NVS Retail Traders React?

On Stocktwits, retail sentiment around NVS stock stayed within the ‘bearish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.

NVS stock has gained 9% year-to-date. 

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