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Recursion Stock Down Despite Meeting Goal in Brain Disease Study

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Recursion Pharmaceuticals (RXRX - Free Report) shares plunged 16.6% on Sept. 3 after announcing mixed results from a mid-stage study evaluating the safety, tolerability and efficacy of its lead candidate, REC-994, an orally bioavailable, superoxide scavenger small molecule, for symptomatic cerebral cavernous malformation (CCM) patients.

Recursion’s SYCAMORE Study Meets Primary Goal but Efficacy Lags

Recursion reported that its phase II SYCAMORE study met the primary endpoint of safety and tolerability in CCM patients treated with REC-994. However, the results lacked significant efficacy as treatment with placebo and both 200mg and 400mg doses of REC-994 demonstrated a similar adverse event profile after 12 months of treatment.

Additionally, MRI-based secondary efficacy endpoints indicated a tendency for reduced lesion volume and hemosiderin ring size in patients receiving the 400mg dose of the candidate compared with those on placebo. However, no improvements were reported by patients or doctors at the 12-month mark. Detailed results from the SYCAMORE study will be presented at an upcoming medical conference.

Recursion expects to meet with the FDA soon to discuss plans regarding study design, including exploring study duration, higher doses and a larger cohort of CCM patients for an additional clinical study of REC-994.

Year to date, shares of Recursion have plunged 38.4% compared with the industry’s 2.9% decline.

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CCM is a rare neurovascular condition that causes abnormal collection of small blood vessels leading to lesion formations in the brain. Per Recursion, approximately 360,000 symptomatic individuals suffer from this disease in the United States and EU and more than 1 million patients worldwide. 

CCM lesions often cause seizures and headaches, worsening neurological issues and possibly fatal hemorrhagic strokes in patients suffering from this condition. The only available treatments are non-drug options like microsurgical resection and stereotactic radiosurgery. However, these procedures are not always possible due to the location of the lesions and may not fully cure the condition. This represents a huge unmet medical need.

Other Candidates in Recursion’s Clinical-Stage Pipeline

Recursion currently does not have a marketed product in its commercial portfolio. The company has ongoing collaboration agreements with pharma giants like Roche and Bayer to develop candidates for several oncology indications with differentiated mechanisms of action. RXRX also collaborated with NVIDIA Corporation, the worldwide leader in visual computing technologies, to build a next-generation platform for the company to develop novel therapies.

Recursion’s other pipeline candidates include REC-2282 and REC-4881 for treating neurofibromatosis type II (NF2) and familial adenomatous polyposis (FAP), respectively. Two doses of REC-2282 are being evaluated in Part 1 of the mid to late-stage POPLAR study for the NF2 indication. Recursion expects to share phase II safety and preliminary efficacy data from the POPLAR study in the fourth quarter of 2024.

An early to mid-stage TUPELO study is evaluating REC-4881 for patients with FAP. The company expects to report phase II safety and preliminary efficacy data in the first half of 2025.

Recursion is also evaluating REC-4881 in a phase II LILAC study for the treatment of patients with unresectable, locally advanced or metastatic cancer with AXIN1 or APC mutations. Top-line data from this additional study of REC-4881 is also expected in the first half of 2025.

The company also expects to initiate a separate phase II study in 2024 to evaluate another investigational candidate, REC-3964, to treat clostridioides difficile infection.

Zacks Rank & Stocks to Consider

Recursion currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6.4%.

ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.

In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 50.6%.

KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.

In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 20%.

FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.

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