We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche (RHHBY - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has recommended the approval of the SC formulation of Tecentriq, the immuno-oncology drug.
The CHMP recommended Tecentriq SC for all indications for which the intravenous (“IV”) has been previously approved, including certain types of lung, liver, bladder and breast cancer.
The SC formulation can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for an IV infusion, freeing up time for patients, healthcare teams and caregivers. The SC formulation has been developed to provide patients with an alternative to the IV administration of Tecentriq and the potential for treatment outside the hospital setting. The ease of administration and shorter duration of treatment are key advantages.
The positive opinion of the CHMP is based on data from the phase IB/III IMscin001 study, evaluating the pharmacokinetics, safety and efficacy of Tecentriq SC compared with Tecentriq IV in patients with previously treated locally advanced or metastatic non-small cell lung cancer (“NSCLC”) for whom prior platinum therapy has failed.
Part 2 of the study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood. The safety and efficacy profiles were consistent with the IV formulation.
A potential approval will make Tecentriq SC the first injectable programmed death ligand-1 (PD-L1) cancer immunotherapy in the EU, reducing treatment time by approximately 80%.
The SC formulation is authorized in Great Britain. Tecentriq is Roche’s fourth subcutaneous cancer therapy.
Tecentriq SC combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.
Tecentriq is approved for the treatment of a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer and hepatocellular carcinoma. It is also used either alone or in combination with targeted therapies and/or chemotherapies for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer, BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma.
Tecentriq sales were up 11% year-over-year to CHF 2.8 billion in the first nine months of 2023.
Roche has lost 14.4% year-to-date against the industry’s growth of 3.9%.
Image Source: Zacks Investment Research
Roche’s performance in the third quarter and the first nine months of 2023 was impacted by a sharp decline in COVID-19 test sales and exchange rate fluctuations, even though the diagnostics base business and newer drugs maintained their growth.
New drugs, namely Ocrevus, Hemlibra, Evrysdi and Tecentriq, boosted growth and the uptake of the new eye drug Vabysmo (launched at the beginning of 2022) was outstanding.
However, competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin hurt sales.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 30.9% year to date.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in all of the last four quarters. The company has delivered an earnings surprise of 67.19% on average.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Shutterstock
Roche (RHHBY) Tecentriq SC Receives Positive CHMP Opinion
Roche (RHHBY - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has recommended the approval of the SC formulation of Tecentriq, the immuno-oncology drug.
The CHMP recommended Tecentriq SC for all indications for which the intravenous (“IV”) has been previously approved, including certain types of lung, liver, bladder and breast cancer.
The SC formulation can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for an IV infusion, freeing up time for patients, healthcare teams and caregivers. The SC formulation has been developed to provide patients with an alternative to the IV administration of Tecentriq and the potential for treatment outside the hospital setting. The ease of administration and shorter duration of treatment are key advantages.
The positive opinion of the CHMP is based on data from the phase IB/III IMscin001 study, evaluating the pharmacokinetics, safety and efficacy of Tecentriq SC compared with Tecentriq IV in patients with previously treated locally advanced or metastatic non-small cell lung cancer (“NSCLC”) for whom prior platinum therapy has failed.
Part 2 of the study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood. The safety and efficacy profiles were consistent with the IV formulation.
A potential approval will make Tecentriq SC the first injectable programmed death ligand-1 (PD-L1) cancer immunotherapy in the EU, reducing treatment time by approximately 80%.
The SC formulation is authorized in Great Britain. Tecentriq is Roche’s fourth subcutaneous cancer therapy.
Tecentriq SC combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.
Tecentriq is approved for the treatment of a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer and hepatocellular carcinoma. It is also used either alone or in combination with targeted therapies and/or chemotherapies for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer, BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma.
Tecentriq sales were up 11% year-over-year to CHF 2.8 billion in the first nine months of 2023.
Roche has lost 14.4% year-to-date against the industry’s growth of 3.9%.
Image Source: Zacks Investment Research
Roche’s performance in the third quarter and the first nine months of 2023 was impacted by a sharp decline in COVID-19 test sales and exchange rate fluctuations, even though the diagnostics base business and newer drugs maintained their growth.
New drugs, namely Ocrevus, Hemlibra, Evrysdi and Tecentriq, boosted growth and the uptake of the new eye drug Vabysmo (launched at the beginning of 2022) was outstanding.
However, competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin hurt sales.
Zacks Rank & Stock to Consider
Roche currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the overall healthcare sector are Dynavax Technologies (DVAX - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 30.9% year to date.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in all of the last four quarters. The company has delivered an earnings surprise of 67.19% on average.