Back to top

Image: Bigstock

Sanofi's (SNY) Studies on BTK Inhibitor Put on Hold by FDA

Read MoreHide Full Article

Shares of Sanofi (SNY - Free Report) were down 5% on Jun 30 after management announced that the FDA has placed a partial clinical hold on the company’s phase III studies, evaluating its investigational Bruton’s tyrosine kinase (“BTK”) inhibitor, tolebrutinib, in multiple sclerosis (MS) and myasthenia gravis indications. The drug is yet to be approved or evaluated by any regulatory agency in the world.

The partial hold was placed after the FDA identified cases of drug-induced liver injury in some study participants who were administered tolebrutinib. Per Sanofi, the majority of the impacted study participants were determined to have concurrent complications known historically to predispose to drug-induced liver injury. However, the liver injury was shown to be reversible in participants following the discontinuation of treatment with tolebrutinib.

Based on this assessment, the FDA paused new enrollment in the phase III studies. In fact, patients who have been enrolled in the study for less than 60 days shall discontinue treatment with the drug. Only those patients who have completed at least 60 days in the study can continue treatment with the drug.

The company had also discussed this issue with the FDA and based on these discussions, revised the study protocols in May 2022. These revisions included changes in enrollment criteria, which now excluded participation of patients with pre-existing risk factors for hepatic dysfunction. Sanofi continues to follow these revised protocols for enrolling participants outside the United States.

Sanofi is currently working with the study investigators to evaluate the effectiveness of the safety measures of the drug. Per Sanofi, more than 2000 study participants undergoing treatment with tolebrutinibfor as long as three years have been enrolled in the MS program.

Shares of Sanofi have lost 0.1% in the year so far against the industry’s 4.8% rise.

Zacks Investment Research
Image Source: Zacks Investment Research

We note that tolebrutinib was added to Sanofi’s pipeline, following its acquisition of Principia Biopharma in 2020. SNY acquired Principia for $100 per share in cash for an aggregate equity value of approximately $3.68 billion. The acquisition had also added another BTK inhibitor, rilzabrutinib. Last September, Sanofi announced data from a late-stage study, which evaluated this candidate in pemphigus. The study failed to achieved primary or key secondary endpoints.

Rilzabrutinib is also being evaluated in a phase III study for immune thrombocytopenia, a blood disorder that causes a high risk of bleeding events. Sanofi is also conducting phase II studies evaluating the candidate for the autoimmune condition IgG4 disease as well as immunological diseases, including asthma, atopic dermatitis, chronic spontaneous urticaria and warm autoimmune hemolytic anemia.

Zacks Rank & Stocks to Consider

Sanofi currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the overall healthcare sector are Merck (MRK - Free Report) , Novo Nordisk (NVO - Free Report) Sesen Bio (SESN - Free Report) . While Sesen Bio sports a Zacks Rank #1 (Strong Buy) at present, both Merck and Novo Nordisk carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Sesen Bio’s 2022 bottom line have declined from a loss of 46 cents to 44 cents in the past 60 days. Share prices of Sesen Bio have fallen 0.6% in the year-to-date period.

Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.9%. In the last reported quarter, Sesen Bio delivered an earnings surprise of 100%.

Estimates for Merck’s 2022 bottom line have increased from $7.28 to $7.32 in the past 60 days. Share prices of Merck have risen 19% in the year-to-date period.

Earnings of Merck beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 13.4%. In the last reported quarter, Merck delivered an earnings surprise of 18.2%.

Estimates for Novo Nordisk’s 2022 bottom line have increased from $3.38 to $3.52 in the past 60 days. Estimates for 2023 have increased from $3.91 to $4.24 in the past 60 days. Share prices of Novo Nordisk have declined 0.5% in the year-to-date period.

Earnings of Novo Nordisk beat estimates in each of the last four quarters, the average surprise being 7.6%. In the last reported quarter, Novo Nordisk delivered an earnings surprise of 10.6%.


In-Depth Zacks Research for the Tickers Above


Normally $25 each - click below to receive one report FREE:


Sanofi (SNY) - free report >>

Novo Nordisk AS (NVO) - free report >>

Merck & Co., Inc. (MRK) - free report >>

SESEN BIO, INC. (SESN) - free report >>