Regeneron Pharmaceuticals, Inc. REGN announced that the FDA has issued a complete response letter (CRL) to its biologics license application seeking approval for the 8 mg dose strength of aflibercept for treating several retinopathic conditions. These include wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).
Regeneron has reported that the cause for the CRL is only an ongoing review of inspection findings at a third-party filler. The company reaffirmed that the CRL was not levied due to issues with the clinical efficacy or safety, trial design and labeling or drug substance manufacturing of aflibercept 8 mg. Furthermore, the company also stated that the FDA had not requested any additional clinical data or studies for the drug candidate.
REGN intends to work closely with the FDA as well as the third-party filler to make aflibercept 8 mg available to patients with wAMD, DME and DR at the earliest.
Shares were down 9% on the news despite no reported issues with the efficacy or safety of the drug candidate itself. Year to date, shares of Regeneron have lost 0.8% compared with the industry’s fall of 9%.
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We would like to remind the investors that REGN is jointly developing aflibercept 8 mg with Bayer AG BAYRY. Currently, Bayer and Regeneron jointly market Eylea (aflibercept) inside and outside the United States as part of the collaboration agreement. Per the terms of the agreement, Bayer holds the license to exclusive marketing rights of Eylea outside of the United States and the profits from its sales are shared equally between the companies.
Regeneron retains exclusive commercial rights to Eylea Injection and aflibercept 8 mg in the United States.
It is important to note that REGN’s Eylea is a leader in the treatment of wAMD, DME and macular edema following retinal vein occlusion (RVO), which includes macular edema following central RVO and macular edema following branch RVO. The FDA recently approved Eylea to treat preterm infants with retinopathy of prematurity.
Aflibercept 8 mg is currently not approved for use in any country. Regulatory filings are under review in the EU and Japan along with the United States. Regeneron also intends to submit applications for approvals in additional countries.
In a separate press release, REGN reported positive top-line data from its pivotal PHOTON study of aflibercept 8 mg in patients with DME at the end of two years (96 weeks). The total patient population was divided into three cohorts, receiving aflibercept 8 mg doses in intervals of either 12 weeks or 16 weeks, after initially receiving three monthly doses of aflibercept 8 mg, or Eylea every 8 weeks.
The objective of the pivotal PHOTON study is to evaluate the non-inferiority of aflibercept 8 mg 12-week and aflibercept 8 mg 16-week, compared with an 8-week dosing regimen of Eylea Injection after five initial monthly doses.
Results from the study demonstrated that 89% of all aflibercept 8 mg patients maintained ≥12-week dosing intervals through two years compared with 93% through one year. Furthermore, 83% of the patients, assigned to a 16-week dosing regimen at baseline, maintained ≥16-week dosing intervals through two years compared with89% through one year. It was also observed that a significant number of patients fulfilled the extension criteria for even longer dosing intervals, including 43% for ≥20-week intervals and 27% for 24-week intervals.
In conclusion, visual gains from treatment with aflibercept 8 mg and its safety profile were observed to be consistent with the established profile of Eylea 2 mg Injection.
Regeneron also expects to report two-year data from its pivotal PULSAR study for aflibercept 8 mg in wAMD in the third quarter of 2023. Results from both the PHOTON and PULSAR studies are scheduled to be presented at a future medical conference.
Regeneron Pharmaceuticals, Inc. Price and Consensus
Regeneron Pharmaceuticals, Inc. Price and Consensus
Regeneron Pharmaceuticals, Inc. price-consensus-chart | Regeneron Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Regeneron currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Adaptimmune Therapeutics ADAP and Akero Therapeutics AKRO, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has narrowed from 63 cents to 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 59 cents to 56 cents. Year to date, shares of ADAP have fallen by 38.2%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.96 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.40 to $3.27. Year to date, shares of AKRO have lost 17.1%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
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