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BioCryst (BCRX) Down as it Discontinues Developing PNH Drug
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Shares of BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) were down 3.22% after the company announced that it will discontinue the development of BCX9930.
BCX9930 is a novel, oral, potent, and selective small molecule inhibitor of Factor D that was being evaluated for paroxysmal nocturnal hemoglobinuria (PNH) and other disorders.
The company decided to shelve the development of the candidate based on new competitive data that was recently presented at the American Society of Hematology (ASH) annual meeting and the limitations of optimizing the dosing of BCX9930 for increased efficacy. The company believes that BCX9930 is unlikely to meet the new standard of care.
In April 2022, BioCryst voluntarily paused enrollment in clinical trials of BCX9930 due to observed elevations in serum creatinine in some patients, indicating drug-related kidney injury. The FDA subsequently placed the program on a partial clinical hold. On Aug 4, 2022, the regulatory body lifted its partial clinical hold. The company then resumed enrollment in global clinical trials under revised protocols at a reduced dose of 400 mg twice daily of BCX9930. This includes the REDEEM-1 and REDEEM-2 pivotal trials in patients with PNH and the RENEW proof-of-concept trial in patients with C3 glomerulopathy (C3G), immunoglobulin A nephropathy (IgAN) and primary membranous nephropathy (PMN).
The temporary halt in enrolment in the program earlier this year allowed the company to reduce its 2022 operating expense guidance by approximately $100 million, primarily from reduced research and development (R&D) expenses.
BioCryst Pharmaceuticals’ shares have declined 21.9% compared with the industry’s decrease of 30.7%.
Image Source: Zacks Investment Research
Consequently, the company will now focus on its complement inhibitor development efforts on BCX10013, a potential once-daily, oral Factor D (alternative pathway) inhibitor currently in clinical development. BioCryst expects to report preliminary data from healthy volunteers receiving single ascending doses and multiple ascending doses of BCX10013 in the first quarter of next year. The preclinical and early clinical profile from approximately 90 healthy volunteers suggests that BCX10013 could have the properties of a once-daily, oral therapy.
BioCryst now expects that 2023 R&D expenses will be similar to 2022 as the company focuses its investment on BCX10013 and other programs. The company plans to provide guidance on the same in the first quarter of 2023.
BioCryst is also evaluating oral medicines directed at other targets across the classical, lectin and terminal pathways of the complement system.
The company has an approved drug - Orladeyo in its portfolio - an oral, once-daily treatment for the prevention of hereditary angioedema (HAE) attacks. The drug is approved in the United States and is receiving approval in additional countries.
The company earlier decided to stop the BCX9250 program as it believed that patients with fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease, were likely to benefit from other oral ALK-2 inhibitors that were substantially ahead of BCX9250 in development and the program required additional $100 million of investment.
Earnings estimates for Gilead Sciences have increased 48 cents in the last 60 days to $7.09. Gilead has surpassed earnings estimates in three of the past four quarters with an average positive beat of 0.36%.
Earnings estimates for Vir Biotechnology have increased $1.28 in the last 60 days to $4.03. Vir has surpassed earnings estimates in three of the past four quarters with an average positive beat of 3182.4%.
Loss estimates for VistaGen have narrowed one cent in the last 60 days to 28 cents. VTGN has surpassed earnings estimates in two of the past four quarters with an average negative beat of 1.74%.
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BioCryst (BCRX) Down as it Discontinues Developing PNH Drug
Shares of BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) were down 3.22% after the company announced that it will discontinue the development of BCX9930.
BCX9930 is a novel, oral, potent, and selective small molecule inhibitor of Factor D that was being evaluated for paroxysmal nocturnal hemoglobinuria (PNH) and other disorders.
The company decided to shelve the development of the candidate based on new competitive data that was recently presented at the American Society of Hematology (ASH) annual meeting and the limitations of optimizing the dosing of BCX9930 for increased efficacy. The company believes that BCX9930 is unlikely to meet the new standard of care.
In April 2022, BioCryst voluntarily paused enrollment in clinical trials of BCX9930 due to observed elevations in serum creatinine in some patients, indicating drug-related kidney injury. The FDA subsequently placed the program on a partial clinical hold. On Aug 4, 2022, the regulatory body lifted its partial clinical hold. The company then resumed enrollment in global clinical trials under revised protocols at a reduced dose of 400 mg twice daily of BCX9930. This includes the REDEEM-1 and REDEEM-2 pivotal trials in patients with PNH and the RENEW proof-of-concept trial in patients with C3 glomerulopathy (C3G), immunoglobulin A nephropathy (IgAN) and primary membranous nephropathy (PMN).
The temporary halt in enrolment in the program earlier this year allowed the company to reduce its 2022 operating expense guidance by approximately $100 million, primarily from reduced research and development (R&D) expenses.
BioCryst Pharmaceuticals’ shares have declined 21.9% compared with the industry’s decrease of 30.7%.
Image Source: Zacks Investment Research
Consequently, the company will now focus on its complement inhibitor development efforts on BCX10013, a potential once-daily, oral Factor D (alternative pathway) inhibitor currently in clinical development. BioCryst expects to report preliminary data from healthy volunteers receiving single ascending doses and multiple ascending doses of BCX10013 in the first quarter of next year. The preclinical and early clinical profile from approximately 90 healthy volunteers suggests that BCX10013 could have the properties of a once-daily, oral therapy.
BioCryst now expects that 2023 R&D expenses will be similar to 2022 as the company focuses its investment on BCX10013 and other programs. The company plans to provide guidance on the same in the first quarter of 2023.
BioCryst is also evaluating oral medicines directed at other targets across the classical, lectin and terminal pathways of the complement system.
The company has an approved drug - Orladeyo in its portfolio - an oral, once-daily treatment for the prevention of hereditary angioedema (HAE) attacks. The drug is approved in the United States and is receiving approval in additional countries.
The company earlier decided to stop the BCX9250 program as it believed that patients with fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease, were likely to benefit from other oral ALK-2 inhibitors that were substantially ahead of BCX9250 in development and the program required additional $100 million of investment.
BioCryst Pharmaceuticals currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the sector are Gilead Sciences, Inc. (GILD - Free Report) , Vir Biotechnology (VIR - Free Report) and VistaGen Therapeutics (VTGN - Free Report) . All three companies carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for Gilead Sciences have increased 48 cents in the last 60 days to $7.09. Gilead has surpassed earnings estimates in three of the past four quarters with an average positive beat of 0.36%.
Earnings estimates for Vir Biotechnology have increased $1.28 in the last 60 days to $4.03. Vir has surpassed earnings estimates in three of the past four quarters with an average positive beat of 3182.4%.
Loss estimates for VistaGen have narrowed one cent in the last 60 days to 28 cents. VTGN has surpassed earnings estimates in two of the past four quarters with an average negative beat of 1.74%.