SEOUL (dpa-AFX) - The biotechnology sector is a high-risk investment arena, and investing in these companies requires considerable patience. Drug developers can spend years - even decades - and billions of dollars bringing a new therapy to market.
While some drugs sail through the FDA approval process, others face a long and often complex regulatory journey, with some ultimately receiving a Complete Response Letter (CRL). Here are the companies that received CRLs from the FDA in July.
Ascelia Pharma
Ascelia Pharma AB (publ)(ACE.ST) was issued a Complete Response Letter by the FDA on July 2, 2026, for its New Drug Application for Orviglance.
Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent in development for liver magnetic resonance (MR) imaging in patients with impaired kidney function.
In the Complete Response Letter, the FDA informed the company that it was unable to approve the Orviglance NDA in its present form and requested additional clinical data and product documentation.
To gain a better understanding of the FDA's concerns in detail, the company requested a Type A meeting with the agency and has been assigned a meeting date of September 9, 2026.
ACE.ST is currently trading on Nasdaq Stockholm at 0.59 Swedish Krona, down 6.02%.
Elevar Therapeutics
Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. (028300.KQ), received its third complete response letter (CRL) on July 10, 2026, for the new drug application of Rivoceranib, in combination with Camrelizumab, as first-line treatment in patients with unresectable or metastatic hepatocellular carcinoma(uHCC).
Hepatocellular carcinoma is the most common form of liver cancer, often linked to chronic liver inflammation, which may be from viral and non-viral causes.
The FDA declined to approve the drug, citing deficiencies identified during a cGMP inspection of a manufacturing site, though it noted that Phase 3 CARES-310 clinical trial results remain strong. Elevar is reviewing the letter and will work with the agency to determine next steps.
The first CRL, issued in May 2024, cited GMP deficiencies at the Hengrui Pharma facility manufacturing camrelizumab, along with incomplete Bioresearch Monitoring inspections due to FDA travel restrictions. The second CRL, in March 2025, requested additional information unrelated to clinical efficacy or safety concerns.
Rivoceranib, also known as apatinib, is an oral VEGFR-2-targeting tyrosine kinase inhibitor. In January 2023, the combination of rivoceranib (apatinib) and camrelizumab was approved in China as a first-line treatment for unresectable hepatocellular carcinoma (uHCC). Rivoceranib is marketed under the brand name Aitan in China by Jiangsu Hengrui Pharma.
Jiangsu Hengrui Pharmaceuticals holds Chinese rights to the rivoceranib-camrelizumab combination while Elevar/HLB holds rights for the rest of the world, including the U.S.
Apiject Systems Corp
ApiJect Systems Corp, a subsidiary of private company ApiJect Holdings, Inc., received a Complete Response Letter (CRL) from the FDA on July 21, 2026, for its New Drug Application for a glycopyrrolate injection solution as adjunctive therapy for peptic ulcers in adults.
The FDA identified deficiencies in human factors testing, device-related quality, and labeling and naming. Human factors testing identified a use-related error involving needle selection, as well as one use difficulty and one use error associated with needles stored in their carton.
The agency placed the labeling on hold until other issues are resolved, and recommended consulting labeling resources, including the FDA's Safety-Related Labeling Changes and Pregnancy and Lactation Labeling guidance.
The FDA also requested complete clinical study data, case reports, a safety summary, and English translations of any foreign labeling. The proposed brand name was conditionally acceptable and must be resubmitted.
ApiJect has one year to address the deficiencies and resubmit, or the application may be considered withdrawn, though a meeting with the FDA can be requested first. The product cannot be marketed until final approval is granted.
Osteal Therapeutics
Osteal Therapeutics was issued a Complete Response Letter by the FDA on July 29, 2026, for its New Drug Application for the Nexchange Kit to treat patients with periprosthetic joint infections (PJI) around the hip and knee.
Nexchange Kit is a drug-device combination designed to treat periprosthetic joint infection (PJI) in just seven days before reimplantation of a permanent prosthesis, potentially shortening treatment compared with the traditional two-stage exchange arthroplasty. The approach combines purpose-built drug-delivery technology with the cyclic, local, expedited antibiotic-irrigation regimen (CLEAR) protocol.
The FDA rejected the application because the clinical trials failed to provide sufficient evidence addressing the serious risk of fungal prosthetic joint infections. Specifically, the studies suffered from small sample sizes, short follow-up periods, inconsistent execution, and clinical endpoints that did not align with meaningful health outcomes.
The company has been asked to provide updated regulatory paperwork, including foreign label translations, and is recommended to hold a pre-submission meeting first to address safety concerns.
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