Sanofi ( SNY Quick Quote SNY - Free Report) announced that a pivotal phase II/III study — STAGED-PKD — evaluating its pipeline candidate, venglustat, in patients with autosomal dominant polycystic kidney disease (ADPKD) failed to meet its futility criteria. The company discontinued the clinical program in ADPKD following failure to meet its futility criteria.
An independent analysis was done for annualized rate of change in total kidney volume (TKV) in patients receiving venglustat compared to placebo. Data showed that treatment with the candidate did not provide a meaningful reduction in TKV growth rate, the primary endpoint of stage 1 of STAGED-PKD study. We note that venglustat slows disease progression by inhibiting abnormal glycosphingolipid (GSL) accumulation. However, interim analysis of the pivotal study showed that reduction of GSL may not prevent kidney cyst growth and thus modulating the GSL pathway may be insufficient to restore kidney function in adults affected by ADPKD.
Meanwhile, Sanofi continues to develop venglustat in lysosomal storage diseases, which includes Gaucher disease type 3, Fabry disease and GM2 Gangliosidosist, where GSL plays an important role in regulating the diseases.
Shares of Sanofi were down 0.9% in pre-market trading on Jun 1 following the news. However, the company’s shares have increased 10% so far this year compared with the
industry’s increase of 5.8%. Image Source: Zacks Investment Research
Apart from venglustat, this France-based pharma giant has multiple pipeline candidates targeting several indications. Sanofi primarily focuses on Specialty Care therapy areas — like oncology, immunology, rare disease and rare blood disorder — and Vaccines. Key pipeline candidates includes dupilumab, avalglucosidase alfa, amcenestrant and fitusiran. Please note that a regulatory application seeking approval for avalglucosidase alfa in Pompe Disease is under review with the FDA. A decision is expected in August 2021.
Key vaccine candidates include a COVID-19 vaccine and nirsevimab vaccine for respiratory syncytial virus.
We remind investors that Sanofi and its partner
Glaxo ( GSK Quick Quote GSK - Free Report) initiated enrollment in a global, pivotal phase III study to evaluate their adjuvanted recombinant-protein COVID-19 vaccine candidate. The companies anticipate that their adjuvanted COVID-19 vaccine candidate may receive an approval/authorization in the fourth quarter of 2021, subject to the late-stage study data readout and regulatory review.
Apart from its recombinant COVID-19 vaccine candidate, Sanofi is also developing a mRNA-based vaccine candidate, MRT5500, for COVID-19 in partnership with
Translate Bio ( TBIO Quick Quote TBIO - Free Report) . A phase I/II study is currently evaluating MRT5500. Zacks Rank and Stock to Consider
Sanofi currently has a Zacks Rank #3 (Hold).
Bayer AG ( BAYRY Quick Quote BAYRY - Free Report) is a better-ranked large pharma company, carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Bayer’s earnings estimates have been revised 4% upward for 2021 and 5.8% upward for 2022 over the past 30 days. The stock has risen 8% year to date.
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