FibroGen (FGEN) Pamrevlumab Fails DMD Study, Stock Down 8%
Shares of FibroGen FGEN were down 8.4% on Jun 7 after management announced that the phase III LELANTOS-1 study did not achieve its primary endpoint of Performance of the Upper Limb 2.0 (PUL 2.0) score.
FibroGen did not disclose any study data along with the above announcement. Management intends to do so at a future date.
The LELANTOS-1 study is evaluating the combination of pamrevlumab plus systemic corticosteroidsin non-ambulatory DMD patients aged 12 years and older.
The company plans to report top-line data from another phase III study (LELANTOS-2), evaluating pamrevlumab plus systemic corticosteroidsin non-ambulatory DMD patients aged 12 years and older
In the year so far, shares of FibroGen have increased 6.9% against the industry’s 0.5 fall.
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Apart from DMD, FibroGen is evaluating pamrevlumab in multiple indications. While the drug is being separate phase III studies for the treatment of idiopathic pulmonary fibrosis (“IPF”) and locally advanced unresectable pancreatic cancer (“LAPC”), it is also being evaluated in a phase II/III study for metastatic pancreatic cancer.
The DMD market is currently dominated by Sarepta Therapeutics SRPT that markets three drugs — Exondys 51, Vyondys 53 and Amondys 45 — all of which have been approved by the FDA in DMD indication. These drugs can potentially address nearly a third of all patients with DMD in the United States.
The FDA is currently reviewing Sarepta’s biologics license application (“BLA”) seeking accelerated approval for the latter’s DMD gene therapy SRP-9001. A final decision on Sarepta’s BLA is expected before Jun 22, 2023. Sarepta developed SRP-9001 in collaboration with Roche.
This failure of the LELANTOS-1 study comes just a month after the company announced that it failed to achieve primary endpoint in the phase III MATTERHORN study, evaluating roxadustat for treating anemia in patients with transfusion-dependent lower risk myelodysplastic syndromes (“MDS”). Currently, roxadustat is approved in China, Europe and Japan for treating anemia of chronic kidney disease (“CKD”) in non-dialysis-dependent and dialysis-dependent adult patients. The drug is yet to be approved in the United States.
Zacks Rank & Stock to Consider
FibroGen currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Novo Nordisk NVO and Novartis NVS. While Novo Nordisk sports a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the consensus estimate for Novo Nordisk’s 2023 and 2024 earnings per share has increased from $4.51 to $5.07 and $5.26 to $5.91, respectively. Shares of Novo Nordisk are up 18.8% in the year-to-date period.
Earnings of Novo Nordisk beat estimates in two of the last four quarters, met the mark one occasion while missing the mark on another. On an average, the company witnessed an average earnings surprise of 0.35%. In the last reported quarter, Novo Nordisk’s earnings met estimates.
In the past 60 days, estimates for Novartis’ 2023 and 2024 earnings per share have increased from $6.57 to $6.72 and $7.08 to $7.26, respectively. Shares of Novartis are up 9.9% in the year-to-date period.
Earnings of Novartis beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.15%. In the last reported quarter, Novartis’ earnings beat estimates by 10.32%.
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