Sanofi SNY and partner, Alnylam Pharmaceuticals ALNY, announced that the FDA has approved Qfitlia (fitusiran) as the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors in the United States.

Hemophilia A and B are rare, lifelong congenital bleeding disorders that impair the blood's ability to clot, causing excessive bleeding and spontaneous joint bleeds. These can lead to joint damage, chronic pain, which takes a significant toll on the patients’ quality of life.

This FDA approval is based on positive data from the phase III ATLAS studies of Qfitlia, which showed clinically significant bleed protection, as measured by annualized bleeding rates (ABR), in hemophilia patients with or without inhibitors.

Year to date, SNY stock has gained 15% compared with the industry’s 3.4% growth.

Image Source: Zacks Investment Research

Per the company, current hemophilia treatment options often require patients to choose between effective bleed control and convenient dosing schedules, resulting in compromises in disease management. Qfitlia offers a novel solution by protecting those with hemophilia while reducing dosing frequency for patients and their families.

Qfitlia enhances thrombin generation to restore hemostasis in people with hemophilia by reducing AT, a protein that inhibits blood clotting. Utilizing small-interfering RNA technology, Qfitlia allows for low-frequency treatment, subcutaneous administration, and low-volume injections.

Sanofi initially signed an agreement with Alnylam in 2014, which granted SNY global rights to co-develop and co-commercialize Qfitlia. Later, in 2018, the licensing agreement was amended, which granted Sanofi global development and commercialization rights to Qfitlia, while Alnylam became eligible to receive tiered royalties of 15%-30% on global net sales. Qfitlia is the sixth Alnylam-discovered medicine using its RNAi therapeutic platform to be approved to date.

Detailed Results From SNY’s Phase III ATLAS Clinical Program

In Sanofi’s ATLAS clinical development program, Qfitlia demonstrated substantial effectiveness in reducing bleed rates across various patient subgroups, requiring as few as six injections per year. Notable findings include a 71% reduction in ABR for patients without inhibitors who were treated with Qfitlia prophylaxis compared to those receiving clotting factor concentrate on-demand. For patients with inhibitors, Qfitlia showed a 73% reduction in ABR compared to those receiving bypassing agents on-demand.

Further analysis in the open-label extension study, under the ATLAS Clinical Program, revealed that the median observed ABR was 3.8 in patients without inhibitors and 1.9 in patients with inhibitors. The median annualized spontaneous bleeding rate was observed to be 1.9 in both patient groups. Additionally, nearly half of the patients in the open-label extension study reported experiencing one or fewer bleeds, with 31% having zero bleeds and 47% having one or fewer. The drug also demonstrated an acceptable safety and tolerability profile in the phase III studies.

Along with Qfitlia’s approval, the FDA also cleared Siemens Healthineers’ INNOVANCE Antithrombin assay as a companion diagnostic to measure AT levels in patients using Qfitlia. Through the Qfitlia Testing Program with Labcorp, this diagnostic will be available at no cost to patients prescribed Qfitlia.

Per Sanofi, Qfitlia offers the fewest doses among all prophylactic therapies and will be priced similarly to other hemophilia treatments. The FDA has granted Qfitlia Orphan Drug Designation for hemophilia A and B, Fast Track Designation for hemophilia A and B with or without factor VIII or IX inhibitors and Breakthrough Therapy Designation for hemophilia B with factor IX inhibitors. Similar regulatory filings for the drug are also under review in several other geographies.

Sanofi Price and Consensus

Sanofi price-consensus-chart | Sanofi Quote

SNY’s Zacks Rank & Stocks to Consider

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

Some better-ranked stocks from the sector are Bayer BAYRY and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, estimates for Bayer’s earnings per share have increased from $1.14 to $1.19 for 2025. During the same time, earnings per share have increased from $1.23 to $1.28 for 2026. Year to date, shares of Bayer have gained 23.4%.

BAYRY’s earnings matched estimates in two of the trailing three quarters while missing the same on the remaining occasion, the average negative surprise being 19.61%.

In the past 30 days, the estimate for Corcept Therapeutics’ 2025 earnings per share has declined from $1.95 to $1.87. The estimate for 2026 earnings per share has declined from $3.25 to $3.11. Year to date, shares of Corcept Therapeutics have gained 126.7%.

CORT’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 20.08%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Sanofi (SNY) : Free Stock Analysis Report

Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report

Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report

Corcept Therapeutics Incorporated (CORT) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research