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Roche Obtains Approval For its Rare Blood Disorder Drug in the EU
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Roche (RHHBY - Free Report) announced that the European Commission (EC) approved PiaSky (crovalimab) for treating patients suffering from paroxysmal nocturnal hemoglobinuria (PNH).
PiaSky is a novel recycling monoclonal antibody that inhibits the complement protein C5. Per Roche, the drug is the first monthly subcutaneous (SC) treatment for people with PNH.
The EC approved the drug for adults and adolescents (12 years of age or older with a weight of 40 kg and above) suffering from PNH who are either new to or have been previously treated with C5 inhibitors.
Roche’s shares have gained 15.2% year to date compared with the industry’s growth of 27.1%.
Image Source: Zacks Investment Research
Positive Study Results Help RHHBY
The approval is based on results from the phase III COMMODORE 2 study in people with PNH who have not been previously treated with C5 inhibitors. Results of the study demonstrated that PiaSky, administered as SC injections every four weeks, achieved disease control and was well-tolerated.
The study also showed that SC PiaSky once a month was equivalent to intravenous eculizumab every two weeks.
Eculizumab, an existing standard of care C5 inhibitor, is marketed as Soliris by Astrazeneca (AZN - Free Report) .
The application included supportive data from two additional late-stage studies, the COMMODORE 1 study, in people with PNH switching from currently approved C5 inhibitors and the COMMODORE 3 study in people new to C5 inhibitor treatment in China.
PiaSky is also approved in the United States and Japan, based on results of the COMMODORE studies.
Roche’s Development Program For Crovalimabin
Roche is also evaluating crovalimabin, a broad clinical development program, including five phase III studies and three earlier phase studies in complement-mediated diseases, including PNH, atypical hemolytic uremic syndrome and sickle cell disease.
PNH is a rare and life-threatening blood condition wherein red blood cells are destroyed by the complement system – part of the innate immune system. The condition causes symptoms such as anemia, fatigue and blood clots, and potentially leading to kidney disease.
How Does the PNH Drug Approval Help RHHBY?
Approval of new drugs and label expansion of the existing ones will further strengthen Roche’s strong and diverse portfolio.
Drugs like Vabysmo, Ocrevus, Hemlibra and Polivy fuel RHHBY’s top line as the company faces competition from biosimilars for established drugs like Avastin, MabThera/Rituxan and Herceptin.
AZN also has another PNH drug in its portfolio- Ultomiris. Both Soliris and Ultomiris were added to AZN’s portfolio through the acquisition of erstwhile Alexion.
Earnings estimates for 2024 have risen from $13.71 to $15.77 per share in the past 30 days. For 2025, the bottom-line estimate has been increased from $19.42 to $22.79 over the same timeframe. Year to date, Lilly’s shares have risen 65%.
In the past 60 days, estimates for EXEL’s 2024 earnings per share have moved north to $1.79 from $1.39. Year to date, shares of EXEL have risen 6.2%.
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Roche Obtains Approval For its Rare Blood Disorder Drug in the EU
Roche (RHHBY - Free Report) announced that the European Commission (EC) approved PiaSky (crovalimab) for treating patients suffering from paroxysmal nocturnal hemoglobinuria (PNH).
PiaSky is a novel recycling monoclonal antibody that inhibits the complement protein C5. Per Roche, the drug is the first monthly subcutaneous (SC) treatment for people with PNH.
The EC approved the drug for adults and adolescents (12 years of age or older with a weight of 40 kg and above) suffering from PNH who are either new to or have been previously treated with C5 inhibitors.
Roche’s shares have gained 15.2% year to date compared with the industry’s growth of 27.1%.
Image Source: Zacks Investment Research
Positive Study Results Help RHHBY
The approval is based on results from the phase III COMMODORE 2 study in people with PNH who have not been previously treated with C5 inhibitors. Results of the study demonstrated that PiaSky, administered as SC injections every four weeks, achieved disease control and was well-tolerated.
The study also showed that SC PiaSky once a month was equivalent to intravenous eculizumab every two weeks.
Eculizumab, an existing standard of care C5 inhibitor, is marketed as Soliris by Astrazeneca (AZN - Free Report) .
The application included supportive data from two additional late-stage studies, the COMMODORE 1 study, in people with PNH switching from currently approved C5 inhibitors and the COMMODORE 3 study in people new to C5 inhibitor treatment in China.
PiaSky is also approved in the United States and Japan, based on results of the COMMODORE studies.
Roche’s Development Program For Crovalimabin
Roche is also evaluating crovalimabin, a broad clinical development program, including five phase III studies and three earlier phase studies in complement-mediated diseases, including PNH, atypical hemolytic uremic syndrome and sickle cell disease.
PNH is a rare and life-threatening blood condition wherein red blood cells are destroyed by the complement system – part of the innate immune system. The condition causes symptoms such as anemia, fatigue and blood clots, and potentially leading to kidney disease.
How Does the PNH Drug Approval Help RHHBY?
Approval of new drugs and label expansion of the existing ones will further strengthen Roche’s strong and diverse portfolio.
Drugs like Vabysmo, Ocrevus, Hemlibra and Polivy fuel RHHBY’s top line as the company faces competition from biosimilars for established drugs like Avastin, MabThera/Rituxan and Herceptin.
AZN also has another PNH drug in its portfolio- Ultomiris. Both Soliris and Ultomiris were added to AZN’s portfolio through the acquisition of erstwhile Alexion.
Zacks Rank & Other Stocks to Consider
Roche currently carries a Zacks Rank #2 (Buy).
Some top-ranked stocks from the drug/biotech industry are Eli Lilly (LLY - Free Report) and Exelixis (EXEL - Free Report) , both carrying the same rank as Roche at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for 2024 have risen from $13.71 to $15.77 per share in the past 30 days. For 2025, the bottom-line estimate has been increased from $19.42 to $22.79 over the same timeframe. Year to date, Lilly’s shares have risen 65%.
In the past 60 days, estimates for EXEL’s 2024 earnings per share have moved north to $1.79 from $1.39. Year to date, shares of EXEL have risen 6.2%.