Johnson & Johnson JNJ announced that the European Commission granted conditional marketing authorisation (CMA) to its off-the-shelf bispecific antibody, Tecvayli (teclistamab) as monotherapy for the treatment of patients with relapsed and refractory multiple myeloma.
The conditional approval is for patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and those who demonstrated disease progression on the last therapy. This marks the first approval for Tecvayli in any country.
The EC grants CMA to drugs that target diseases, which have significant unmet need based on less comprehensive data than it normally asks for. The benefits of these drugs should outweigh their risks and the applicant must provide comprehensive clinical data later.
Tecvayli’s approval was based on data from the phase I/II MajesTEC-1 study, which showed that treatment with teclistamab resulted in deep and durable responses. In the study, after a median of five prior lines of therapy, treatment with a weekly subcutaneous injection of teclistamab led to an overall response rate (ORR) of 63% with 39.4% of the patients achieving a complete response (CR) or better. The median duration of progression-free survival was 11.3 months while median overall survival was 18.3 months.
This year so far, J&J’s shares have declined 3.3% compared with the industry’s decline of 0.9%.
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The European approval for Tecvayli follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) last month recommending CMA for Tecvayli. Tecvayli is under review in the United States.
In a separate press release, J&J announced that it has hired Larry Merlo as non-executive chair designate of the board of the planned new Consumer Health company to be formed on its separation. J&J plans to separate its Consumer Health segment into a new publicly-traded company, leaving behind a new J&J with its Pharmaceuticals and Medical Device units. The separation is expected to be executed in 2023.
Merlo previously served as president and CEO of CVS Health Corporation CVS. Merlo’s tenureat CVS Health has given him in-depth knowledge of health and consumer trends that will be an advantage for the new Consumer Health company. Merlo served as president and CEO of CVS Health from 2011 to 2021.
In May, J&J had announced the appointment of Thibaut Mongon as chief executive officer designate.
Zacks Rank and Stocks to Consider
J&J currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the drugs/biotech sector are Bolt Biotherapeutics BOLT, and Merck MRK, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Bolt Biotherapeutics’ 2022 bottom line have narrowed from a loss of $2.87 per share to $2.25 per share over the past 30 days. Loss estimates for 2023 have narrowed from $2.76 per share to $2.14 per share over the same time frame. Shares of Bolt Biotherapeutics have declined 60% this year so far.
Earnings of Bolt Biotherapeutics beat estimates in two of the last four quarters, while missing in one and matching the same in one. The stock delivered a four-quarter surprise of 2.39%, on average.
Merck’s earnings per share estimates for 2023 have increased from $7.16 per share to $7.17 per share in the past 30 days. Merck’s stock is up 17.4% in the year-to-date period.
Merck beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 16.79%, on average.
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