Sanofi (SNY) Terminates Pompe Disease Deal as FTC Objects

SNY NVO PBYI CTMX

Sanofi (SNY - Free Report) announced that it is canceling its previously announced licensing agreement with private biotech Maze Therapeutics for the latter’s Pompe Disease candidate, MZE001. Sanofi decided to terminate the deal due to the Federal Trade Commission’s (FTC) announcement that it is seeking a preliminary injunction against the deal. The FTC has issued an administrative complaint and authorized a lawsuit in federal court.

MZE001 is a glycogen synthase 1 (GYS1) inhibitor, which recently completed phase I development for Pompe disease, a rare degenerative muscle disorder. If eventually approved, MZE001 would become the first oral medication available for Pompe disease patients.

Sanofi already has a Pompe disease product in its portfolio called Nexviazyme (avalglucosidase alfa), an enzyme replacement therapy, which is approved for late-onset Pompe disease.

Sanofi’s stock has declined 2.6% so far this year against the industry’s rise of 4.3%.

 

The FTC decided to block the deal, valued at up to $755 million, as it believes that Sanofi’s exclusive licensing deal will eliminate future competition in the Pompe disease market. The FTC explained that Sanofi’s Pompe disease product is intravenously administered, whereas Maze’s MZE001 is an oral tablet taken twice daily and holds the potential to significantly reduce patient burden. If approved, it would have been a significant threat to Sanofi’s market share for Nexviazyme as it may see much higher demand due to its benefit of lower treatment burden.

The proposed acquisition would have allowed Sanofi to price its Pompe disease drugs higher, leveraging its monopoly position. This may have deprived patients of lower-priced medicines.

Sanofi believes that the FTC’s decision could result in a long litigation and thus terminated the deal.

Zacks Rank & Stocks to Consider

Sanofi currently has a Zacks Rank #3 (Hold).

Some better-ranked drug/biotech companies worth considering are Novo Nordisk (NVO - Free Report) , Puma Biotech (PBYI - Free Report) and CytomX Therapeutics (CTMX - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each currently. You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62 over the past 60 days. Estimates for 2024 have jumped from $2.95 per share to $3.14 over the same timeframe. NVO’s stock has surged 42.4% year to date.

Earnings of Novo Nordisk beat estimates in two of the last four quarters, missed in one and matched estimates in one, delivering an earnings surprise of 0.58% on average.

Estimates for Puma Biotech’s 2023 earnings per share have increased from 67 cents to 72 cents over the past 60 days. Estimates for 2024 have jumped from 55 cents per share to 64 cents over the same timeframe. PBYI’s stock has declined 10.2% year to date.

Earnings of Puma Biotech beat estimates in three of the last four quarters and missed in one, delivering an earnings surprise of 76.55% on average.

In the past 30 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to earnings of 2 cents per share. During the same period, loss per share estimates for 2024 have narrowed from 51 cents to 6 cents. Year to date, shares of CTMX have declined 13.1%.

CTMX’s earnings beat estimates in three of the last four quarters and missed in one, delivering an earnings surprise of 45.44% on average

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