Shares of
Reata Pharmaceuticals, Inc.
RETA
have gained 12.6% so far this year, primarily supported by the commercial prospects of its lead pipeline candidate, omaveloxolone. The
Zacks Medical – Biomedical and Genetics
industry has declined 22.1% in the same period.
Image Source: Zacks Investment Research
Please note that Reata has two key pipeline candidates — bardoxolone and omaveloxolone. While the company is developing bardoxolone as a potential treatment for kidney disorders, omaveloxolone has been developed as a treatment for Friedreich’s ataxia, an inherited disorder that affects some of the body’s nerves.
Earlier this month, the company announced that the FDA has accepted its new drug application (“NDA”) for omaveloxolone and also granted priority review, which will shorten the review period of the NDA.
Friedreich’s ataxia patients do not have an effective treatment option. A shorter review period also implies a significant need for a treatment option for this patient population. Reata estimates that 5,000 patients in the United States and 22,000 globally are affected by this nerve disorder.
A decision from the FDA on the potential approval of omaveloxolone is expected by Nov 30, 2022. Following a potential approval, omaveloxolone will become the first FDA-approved therapy for the rare, genetic neuromuscular disorder, Friedreich’s ataxia. Reata expects to launch the candidate in early 2023. The Zacks Consensus Estimates for 2023 total revenues is pegged at $50 million.
However, Reata’s prospects were hurt in February by the negative regulatory update on bardoxolone. The FDA issued a Complete Response Letter (“CRL”) to the NDA for bardoxolone. The company’s NDA for bardoxolone, seeking approval as a potential treatment for chronic kidney disease (CKD) caused by Alport syndrome, was accepted by the FDA in April 2021. However, an advisory committee voted against the approval for bardoxolone in December last year as it noted that the benefits of treatment with bardoxolone do not seem to outweigh its risks. The committee did not believe that clinical data provided with the NDA supported the effectiveness of the candidate in slowing the progression of CKD in patients with Alport syndrome.
The CRL from the FDA is expected to further delay the approval for bardoxolone in the United States.
After a period of regulatory setbacks, Omaveloxolone is nearing approval, which is likely attracting investors, following the CRL-led downturn for its other candidate, bardoxolone.
Reata Pharmaceuticals, Inc. Price
Reata Pharmaceuticals, Inc. price
|
Reata Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Reata currently carries a Zacks Rank #3 (Hold). Some better-ranked biotech/drug stocks are
ProPhase Labs
PRPH
,
Sesen Bio
SESN
and
Alkermes
ALKS
. While ProPhase and Sesen Bio sport a Zacks Rank #1 (Strong Buy), Alkermes carries a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank stocks here
.
The Zacks Consensus Estimate for ProPhase’s 2022 bottom line has improved from earnings of 27 cents per share to 55 cents per share over the past 60 days. PRPH stock is up 18.2% this year so far.
ProPhase exceeded earnings expectations in two of the last four quarters, while missing the same twice. The company has a negative four-quarter earnings surprise of 130.56%, on average.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has narrowed from 33 cents to 31 cents per share in the past 60 days. Shares of SESN have declined 35.6% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 69 cents to 60 cents in the past 60 days. Shares of ALKS have risen 31.3% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 362.62%.
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