Buy rating reaffirmed on Chimerix stock with potential 3Q25 launch for ONC201

On Tuesday, H.C. Wainwright reaffirmed its Buy rating and $11.00 price target for Chimerix shares (NASDAQ:CMRX). The stock, currently trading at $3.44, has shown remarkable momentum with a 257.4% return year-to-date.

According to InvestingPro data, analyst targets range from $6 to $11, suggesting significant potential upside from current levels. The firm's analyst highlighted the recent submission of a New Drug Application (NDA) by Chimerix to the U.S. Food and Drug Administration (FDA) for accelerated approval of dordaviprone (ONC201) for the treatment of patients with recurrent H3 K27M-mutant diffuse glioma.

Dordaviprone is described as a highly selective antagonist of the dopamine receptor D2 and a caseinolytic protease agonist, which can effectively penetrate the blood-brain barrier. The drug has previously received Fast Track Designation from the FDA for the treatment of adult recurrent H3 K27M-mutant high-grade glioma and has also been granted Rare Pediatric Disease Designation for the treatment of H3 K27M-mutant glioma.

Chimerix is optimistic about the potential for a Priority Review Voucher (PRV) and a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025. The company has applied for a Rare Pediatric PRV as part of the NDA submission. The value of PRVs has been underscored by a recent sale of one for $150 million, though the analyst noted that the potential financial impact of a PRV is not currently factored into their financial model for Chimerix.

The analyst estimates that annually there are approximately 2,000 patients in the U.S. and around 5,000 patients in the top seven global markets affected by H3 K27M-mutant diffuse midline glioma (DMG). The absence of proven effective therapies for patients suffering from this condition was emphasized. With a current market capitalization of $309.38 million, InvestingPro analysis reveals the company maintains a strong balance sheet with more cash than debt, though it's currently unprofitable with an EBITDA of -$92.73 million in the last twelve months.

Looking ahead, H.C. Wainwright forecasts a potential launch for dordaviprone in the third quarter of 2025, with projected sales of $6 million for that year. The firm's stance on Chimerix stock remains positive with a reiterated Buy rating and a maintained price target of $11.00.

InvestingPro subscribers can access 15 additional investment tips and a comprehensive Pro Research Report for deeper insights into Chimerix's financial health, which is currently rated as 'FAIR' with a score of 2.49 out of 5.

In other recent news, Chimerix Inc (NASDAQ:CMRX). has been making notable strides in its operations and corporate governance. The firm has released its Q3 2024 financial results, revealing a net loss of $22.9 million, an improvement from the $24 million loss in the same quarter the previous year. The company's cash position remains robust with $152 million, projected to sustain operations until Q4 2026.

Simultaneously, Chimerix has updated its Officer Severance Benefit Plan. The Compensation Committee of Chimerix's Board of Directors approved the plan, extending its term for an additional three years from November 12, 2024.

In terms of product development, Chimerix is nearing full enrollment for its global Phase 3 ACTION study of Dordaviprone and is close to completing Phase 1 dose escalation studies for ONC206. The company plans to file a New Drug Application (NDA) for provisional approval of Dordaviprone in Australia by the end of the year. This aligns with Chimerix's preparation for potential commercialization of Dordaviprone, targeting a global market opportunity exceeding $750 million.

These developments reflect Chimerix's ongoing commitment to advancing its clinical programs and preparing for potential commercial launches. The company's focus remains on delivering its pipeline products to market, with the near-term possibility of introducing Dordaviprone as a new therapy for patients with high unmet medical needs.

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