News

Roche RHHBY announced that the European Commission has granted marketing authorization to subcutaneous ("SC”) (under the skin) injection of the cancer immunotherapy drug Tecentriq (atezolizumab).

The authorization applies to all approved indications of intravenous (“IV”) formulation of Tecentriq and makes it the European Union’s first programmed death ligand-1 (PD-L1) cancer immunotherapy for subcutaneous injection.

Tecentriq IV is approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (“NSCLC”), small cell lung cancer and hepatocellular carcinoma.

Tecentriq IV is also approved in countries around the world, 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.

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 new subcutaneous injection will cut treatment time to approximately seven minutes, with most injections taking between four and eight minutes.

Tecentriq SC combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.

The approval is based on pivotal data from the phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood when administered subcutaneously and a safety and efficacy profile consistent with the IV formulation.

The SC formulation is authorized in Great Britain.

Tecentriq sales increased 11% year over year to CHF 2.8 billion in the first nine months of 2023.

Roche has lost 6.6% in the past six months against the industry’s growth of 15.1%.

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RHHBY’s new drugs, namely Ocrevus, Hemlibra, Evrysdi, Phesgo, Polivy and Tecentriq, have put up a stellar performance. The uptake of the new eye drug, Vabysmo, has been outstanding. The company’s efforts to develop new drugs to combat the decline in legacy drugs are encouraging.

Last month, Roche announced that it will acquire the privately owned U.S.-based company Carmot Therapeutics, Inc. for $2.7 billion in a bid to foray into the lucrative obesity market. The acquisition will provide Roche access to Carmot’s differentiated portfolio of incretins, including CT-388, CT-996 and CT-868.

However, lower COVID-19-product-related sales have significantly impacted its top line, even though the diagnostics base business and newer drugs maintain growth.

Zacks Rank & Stocks to Consider

Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are Regeneron Pharmaceuticals REGN, Sarepta Therapeutics SRPT and Acadia ACAD.

Regeneron currently sports a Zacks Rank #1 (Strong Buy) and Acadia and Sarepta carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Regeneron’s 2024 earnings have risen from $41.57 per share to $43.66 per share. REGN’s stock has gained 28.5% in the past year. The company beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 12.34%.

Loss estimates for Sarepta for 2023 have narrowed to $6.62 from $9.19 in the past 60 days, while earnings estimates for 2024 have increased to $1.99 from 46 cents in the past 60 days.

The loss per share estimate for Acadia has narrowed to 33 cents from 41 cents for 2023. The bottom-line estimate for 2024 is pinned at $1.04. ACAD's shares have jumped 59.3% in the past year.

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