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Rigel (RIGL) to Not Pursue the WAIHA Program, Cut Jobs
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Shares of Rigel Pharmaceuticals, Inc. (RIGL - Free Report) are down 13.16% in after-hours trading on Oct 10 after the company announced an update on fostamatinib for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA).
Rigel does not expect to file a supplemental new drug application (sNDA) for this indication at this time following guidance from the FDA review of data from the phase III FORWARD trial of fostamatinib for wAIHA.
Please note that in June 2022, Rigel announced dismal top-line efficacy and safety data from the FORWARD study of fostamatinib in patients with wAIHA. The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. The safety profile was consistent with prior clinical experience, and no new safety issues were identified. Rigel then stated that it will discuss these findings with the FDA to determine the path forward in wAIHA.
Concurrently, Rigel announced that it will cut its workforce by 16%, which in turn will wipe out 30 positions primarily in development and administration to reduce operating expenses ranging from $7-$8 million annually, starting in 2023. Consequently, Rigel expects to recognize a one-time cash severance-related charge of approximately $1.5 million in the fourth quarter of 2022.
Shares of Rigel have plunged 60.7% so far this year compared with the industry’s decline of 29.6%.
Image Source: Zacks Investment Research
We note that fostamatinib is already approved in the United States under the brand name Tavalisse for treating adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
A potential label expansion would have boosted the sales potential of the drug.
Fostamatinib is also currently being evaluated in a phase III study for the treatment of hospitalized high-risk patients with COVID-19; and a National Institute of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) sponsored phase III study (ACTIV-4 Host Tissue Trial) for the treatment of COVID-19 in hospitalized patients.
Other programs include an interleukin receptor-associated kinase (IRAK) inhibitor program and a receptor-interacting serine/threonine-protein kinase (RIPK1) inhibitor program in clinical development with partner Eli Lilly and Company (LLY - Free Report) .
Rigel entered into a global exclusive license agreement and strategic collaboration with Lilly in February 2021 to develop and commercialize R552, a RIPK1 inhibitor, to treat non-central nervous system (non-CNS) diseases.
Loss estimates for BOLT have narrowed to $2.31 from $2.87 in the past 90 days. Earnings surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average beat being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 90 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.
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Rigel (RIGL) to Not Pursue the WAIHA Program, Cut Jobs
Shares of Rigel Pharmaceuticals, Inc. (RIGL - Free Report) are down 13.16% in after-hours trading on Oct 10 after the company announced an update on fostamatinib for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA).
Rigel does not expect to file a supplemental new drug application (sNDA) for this indication at this time following guidance from the FDA review of data from the phase III FORWARD trial of fostamatinib for wAIHA.
Please note that in June 2022, Rigel announced dismal top-line efficacy and safety data from the FORWARD study of fostamatinib in patients with wAIHA. The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. The safety profile was consistent with prior clinical experience, and no new safety issues were identified. Rigel then stated that it will discuss these findings with the FDA to determine the path forward in wAIHA.
Concurrently, Rigel announced that it will cut its workforce by 16%, which in turn will wipe out 30 positions primarily in development and administration to reduce operating expenses ranging from $7-$8 million annually, starting in 2023. Consequently, Rigel expects to recognize a one-time cash severance-related charge of approximately $1.5 million in the fourth quarter of 2022.
Shares of Rigel have plunged 60.7% so far this year compared with the industry’s decline of 29.6%.
Image Source: Zacks Investment Research
We note that fostamatinib is already approved in the United States under the brand name Tavalisse for treating adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
A potential label expansion would have boosted the sales potential of the drug.
Fostamatinib is also currently being evaluated in a phase III study for the treatment of hospitalized high-risk patients with COVID-19; and a National Institute of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) sponsored phase III study (ACTIV-4 Host Tissue Trial) for the treatment of COVID-19 in hospitalized patients.
Other programs include an interleukin receptor-associated kinase (IRAK) inhibitor program and a receptor-interacting serine/threonine-protein kinase (RIPK1) inhibitor program in clinical development with partner Eli Lilly and Company (LLY - Free Report) .
Rigel entered into a global exclusive license agreement and strategic collaboration with Lilly in February 2021 to develop and commercialize R552, a RIPK1 inhibitor, to treat non-central nervous system (non-CNS) diseases.
Rigel currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.31 from $2.87 in the past 90 days. Earnings surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average beat being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 90 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.