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Biotech Stock Roundup: BMY's Study Update, INCY's Drug Label Expansion, MRNA News
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Drug approvals and other regulatory updates are in focus in the biotech sector. COVID-19 vaccine news is also back in the spotlight.
Recap of the Week’s Most Important Stories:
Bristol Myers Milvexian Study Update: Bristol Myers (BMY - Free Report) announced disappointing results from the mid-stage AXIOMATIC-SSP dose-ranging study of experimental candidate milvexian. Milvexian is a potential first-in-class oral factor XIa (FXIa) inhibitor (anti-thrombotic) being studied for the prevention and treatment of major thrombotic conditions. The candidate is being developed in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
AXIOMATIC-SSP evaluated the efficacy and safety of milvexian for the prevention of new symptomatic ischemic stroke or new covert brain infarction in patients receiving aspirin and clopidogrel following an acute ischemic stroke or transient ischemic attack (TIA). Approximately 1,242 patients were randomized to receive one of seven regimens of oral milvexian given twice- or once-daily or to receive 40 mg of subcutaneous enoxaparin once-daily.
Study results showed an approximate 30% relative risk reduction in recurrent symptomatic ischemic strokes. It also reflected a favorable safety profile in three arms (either 25, 50 or 100 mg) compared to placebo when used in combination with background antiplatelet therapy in patients with an acute non-cardioembolic ischemic stroke or transient ischemic attack.
The primary objective of this study was to detect a dose response for the composite endpoint of symptomatic ischemic stroke + MRI detected covert brain infarction across a 16-fold dose range. However, a dose response was not observed. In patients treated with milvexian, no fatal bleeding and no increase in symptomatic intracranial hemorrhage were observed.
Incyte’s Drug Label Expansion: Incyte (INCY - Free Report) announced that the FDA has approved a label expansion of cholangiocarcinoma drug Pemazyre (pemigatinib) for treating adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. Pemazyre was granted accelerated approval by the FDA in 2020 for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
The latest FDA approval was based on data from the phase II FIGHT-203 study, a multicenter open-label, single-arm trial that evaluated the safety and efficacy of Pemazyre in 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement. The supplemental new drug application (sNDA) for Pemazyre for treating adults with relapsed or refractory MLNs with FGFR1 rearrangement was analyzed by the FDA under Priority Review.
Jounce Down on Study Update: Jounce Therapeuticsannounced that the phase II SELECT trial was unsuccessful. The study is evaluating vopratelimab (vopra), Jounce’s inducible costimulator (ICOS) agonist, in combination with pimivalimab (pimi) versus pimivalimab alone in immunotherapy naïve, second-line non-small cell lung cancer (NSCLC) patients.
The study evaluated two pulsatile and differentiated doses of vopra in the combination groups against pimi monotherapy, using as the primary endpoint the mean percent change from baseline in tumor size in all measurable lesions, averaged over 9 and 18 weeks as assessed by central independent radiology review.
However, the SELECT study did not meet its primary endpoint as it was powered to detect a 20% absolute difference in the pooled combo doses compared to pimi monotherapy. The actual difference was 7%.
Nevertheless, encouraging trends in improved mean tumor change over 9 and 18 weeks and secondary endpoints of overall response rate (ORR) and progression-free survival (PFS) were observed in the low dose vopratelimab arm in combination with pimivalimab compared to pimivalimab alone. Pimivalimab monotherapy continues to demonstrate safety and clinical activity.
Despite these observations, management decided that the SELECT results do not support moving into registration studies as had been their previous goal. Shares of Jounce were in response to the study update.
Regulatory Updates From Moderna: Moderna (MRNA - Free Report) announced that its Omicron bivalent booster candidate, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), was granted provisional approval in Australia by the Therapeutic Goods Administration (TGA) as a booster dose in adults above 18 years of age.
In addition, Swissmedic has granted temporary authorization to use Spikevax Bivalent Original/Omicron (mRNA-1273.214), for active immunization to prevent COVID-19 infection for individuals aged 18 years and older.
Earlier, Moderna announced that it has filed lawsuits against rivals Pfizer (PFE - Free Report) and BioNTech, alleging that their COVID-19 vaccine, Comirnaty, infringes on patents related to its mRNA technology platform (filed between 2010 and 2016). The complaints will be filed in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.
Moderna alleges Pfizer and BioNTech copied two key features of its patented technologies, which are critical to the success of mRNA vaccines. Moderna claims Pfizer/BioNTech’s vaccine used the same mRNA chemical modification as Spikevax and they copied its method to encode for the full-length spike protein in a lipid nanoparticle formulation for coronavirus.
Performance
The Nasdaq Biotechnology Index has lost 3.45% in the past five trading sessions. Among the biotech giants, Bristol Myers has lost 7.65% during the period. Over the past six months, shares of Vertex have surged 22.32%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD, BLUE, AXSM’s Drug Approvals, FHTX Study Update & More)
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What's Next in Biotech?
Stay tuned for earnings and other updates.
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Biotech Stock Roundup: BMY's Study Update, INCY's Drug Label Expansion, MRNA News
Drug approvals and other regulatory updates are in focus in the biotech sector. COVID-19 vaccine news is also back in the spotlight.
Recap of the Week’s Most Important Stories:
Bristol Myers Milvexian Study Update: Bristol Myers (BMY - Free Report) announced disappointing results from the mid-stage AXIOMATIC-SSP dose-ranging study of experimental candidate milvexian. Milvexian is a potential first-in-class oral factor XIa (FXIa) inhibitor (anti-thrombotic) being studied for the prevention and treatment of major thrombotic conditions. The candidate is being developed in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
AXIOMATIC-SSP evaluated the efficacy and safety of milvexian for the prevention of new symptomatic ischemic stroke or new covert brain infarction in patients receiving aspirin and clopidogrel following an acute ischemic stroke or transient ischemic attack (TIA). Approximately 1,242 patients were randomized to receive one of seven regimens of oral milvexian given twice- or once-daily or to receive 40 mg of subcutaneous enoxaparin once-daily.
Study results showed an approximate 30% relative risk reduction in recurrent symptomatic ischemic strokes. It also reflected a favorable safety profile in three arms (either 25, 50 or 100 mg) compared to placebo when used in combination with background antiplatelet therapy in patients with an acute non-cardioembolic ischemic stroke or transient ischemic attack.
The primary objective of this study was to detect a dose response for the composite endpoint of symptomatic ischemic stroke + MRI detected covert brain infarction across a 16-fold dose range. However, a dose response was not observed. In patients treated with milvexian, no fatal bleeding and no increase in symptomatic intracranial hemorrhage were observed.
Incyte’s Drug Label Expansion: Incyte (INCY - Free Report) announced that the FDA has approved a label expansion of cholangiocarcinoma drug Pemazyre (pemigatinib) for treating adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. Pemazyre was granted accelerated approval by the FDA in 2020 for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
The latest FDA approval was based on data from the phase II FIGHT-203 study, a multicenter open-label, single-arm trial that evaluated the safety and efficacy of Pemazyre in 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement. The supplemental new drug application (sNDA) for Pemazyre for treating adults with relapsed or refractory MLNs with FGFR1 rearrangement was analyzed by the FDA under Priority Review.
Jounce Down on Study Update: Jounce Therapeutics announced that the phase II SELECT trial was unsuccessful. The study is evaluating vopratelimab (vopra), Jounce’s inducible costimulator (ICOS) agonist, in combination with pimivalimab (pimi) versus pimivalimab alone in immunotherapy naïve, second-line non-small cell lung cancer (NSCLC) patients.
The study evaluated two pulsatile and differentiated doses of vopra in the combination groups against pimi monotherapy, using as the primary endpoint the mean percent change from baseline in tumor size in all measurable lesions, averaged over 9 and 18 weeks as assessed by central independent radiology review.
However, the SELECT study did not meet its primary endpoint as it was powered to detect a 20% absolute difference in the pooled combo doses compared to pimi monotherapy. The actual difference was 7%.
Nevertheless, encouraging trends in improved mean tumor change over 9 and 18 weeks and secondary endpoints of overall response rate (ORR) and progression-free survival (PFS) were observed in the low dose vopratelimab arm in combination with pimivalimab compared to pimivalimab alone. Pimivalimab monotherapy continues to demonstrate safety and clinical activity.
Despite these observations, management decided that the SELECT results do not support moving into registration studies as had been their previous goal. Shares of Jounce were in response to the study update.
Regulatory Updates From Moderna: Moderna (MRNA - Free Report) announced that its Omicron bivalent booster candidate, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), was granted provisional approval in Australia by the Therapeutic Goods Administration (TGA) as a booster dose in adults above 18 years of age.
In addition, Swissmedic has granted temporary authorization to use Spikevax Bivalent Original/Omicron (mRNA-1273.214), for active immunization to prevent COVID-19 infection for individuals aged 18 years and older.
Earlier, Moderna announced that it has filed lawsuits against rivals Pfizer (PFE - Free Report) and BioNTech, alleging that their COVID-19 vaccine, Comirnaty, infringes on patents related to its mRNA technology platform (filed between 2010 and 2016). The complaints will be filed in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.
Moderna alleges Pfizer and BioNTech copied two key features of its patented technologies, which are critical to the success of mRNA vaccines. Moderna claims Pfizer/BioNTech’s vaccine used the same mRNA chemical modification as Spikevax and they copied its method to encode for the full-length spike protein in a lipid nanoparticle formulation for coronavirus.
Performance
The Nasdaq Biotechnology Index has lost 3.45% in the past five trading sessions. Among the biotech giants, Bristol Myers has lost 7.65% during the period. Over the past six months, shares of Vertex have surged 22.32%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD, BLUE, AXSM’s Drug Approvals, FHTX Study Update & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for earnings and other updates.