On April 10, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the company received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.

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Replimune disagrees with the FDA about whether the data set, upon which breakthrough therapy designation was awarded, is sufficient to allow this promising medicine to be made available to advanced cancer patients. In the IGNYTE trial, patients with confirmed progression on an anti-PD-1 based regimen who received RP1 plus nivolumab had a 34% response rate with a median duration of 24.8 months with a favorable safety profile.

"It is deeply disappointing that the FDA has not exercised regulatory flexibility to meet patients’ needs given the data supporting strong efficacy and the favorable safety profile. Approximately 8,500 Americans with advanced melanoma die every year. The country’s foremost melanoma specialists stood behind the RP1 data. Patients and caregivers pleaded for urgency. All of it was met with inconsistent communication and a fragmented and slow-moving regulatory process which clearly puts U.S. innovation at risk," said Sushil Patel, Ph.D., CEO of Replimune. "As we previously communicated, without timely accelerated approval, the development of RP1 will not be viable. We are devastated for our committed employees who have worked tirelessly for patients but at this point we have no choice but to eliminate jobs, including substantially scaling back our U.S. based manufacturing operations. A treatment desperately needed by patients will not be available. Not because the medicine failed. Because the system did."

Inconsistent agency process and communication thwarts innovation
With the CRL, the company learned that a different review team was appointed for the resubmission and replaced the prior team who had interacted with the company. A senior member of the prior review team stated publicly that the "BLA clinical team thought the applicant had provided adequate evidence to support contribution of effect of RP1 plus nivolumab but leadership did not agree." The new team did not meet with the company during the review process despite the company offering.

In the CRL, the agency appears to have contradicted their positions expressed at the September 2025 Type A meeting, including on the following points:

After testimony from melanoma experts, the agency did not raise further concerns about the heterogeneity of the patient population in IGNYTE and acknowledged that randomizing patients to an anti-PD1 only arm in the confirmatory study was not feasible.
Following an agency suggestion, the company submitted a proposal for a descriptive analysis from IGNYTE-3 supporting contribution of components. The company also included data from IGNYTE showing median progression free survival on RP1 plus nivolumab was 30.6 months compared to 4.4 months on their prior PD-1 based regimen. The company requested feedback, however, the FDA did not respond and subsequently accepted the resubmission as a complete response to the July 2025 CRL.
The FDA raised several points related to tumor assessment methodology. As requested by the FDA, responses in IGNYTE were assessed using RECIST 1.1 without modifications. In addition, the company provided detailed analyses showing no material difference in response rates between injected and non-injected lesions. The company also provided a comprehensive analysis which showed that biopsies and surgical interventions did not impact tumor response.
Prior to the original BLA submission, standard regulatory meetings were conducted to discuss trial design, patient population, and the BLA package requirements. While a randomized controlled trial was preferred, the FDA suggested in the March 2021 Type B minutes that if the data was sufficiently compelling, a single arm trial could be acceptable for consideration under accelerated approval. At the subsequent pre-BLA meeting, the FDA stated "we do not object to your proposal to submit a BLA based primarily on data from the cohort of patients (n=140) in the Phase 2 IGNYTE trial who had advanced melanoma and progressed while being treated with prior anti-PD-1 based therapy." The company subsequently submitted a BLA which was accepted with breakthrough therapy designation and granted priority review. Based on feedback from the FDA, the company initiated a resource-intensive global Phase 3 trial, IGNYTE-3, to satisfy the regulatory requirement that a confirmatory study be underway for an accelerated approval.

About Melanoma
Melanoma is the fifth most common cancer, with approximately 112,000 new cases estimated in the U.S. in 2026, and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment. Melanoma is considered advanced when the cancer spreads beyond the primary tumor to other parts of the body.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, APR 10, 2026, View Source [SID1234664299])

On April 10, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported final overall survival data from its pivotal Phase 3 ROSELLA trial of Lifyorli (relacorilant) combined with the chemotherapeutic agent nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women’s Cancer. The SGO presentation slides can be found here.

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These data were simultaneously published in The Lancet: "Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial."

Lifyorli plus nab-paclitaxel has now been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen for patients with platinum-resistant ovarian cancer. Lifyorli, in combination with nab-paclitaxel, was approved by the U.S. Food and Drug Administration (FDA) in March 2026 for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA).

The ROSELLA trial met its dual primary endpoints of overall and progression-free survival, regardless of biomarker status and without an increased safety burden. Patients treated with Lifyorli in addition to nab-paclitaxel chemotherapy experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004). Median overall survival was 4.1 months longer for patients who received Lifyorli, compared to patients receiving nab-paclitaxel alone (16.0 v. 11.9 months). Patients who received Lifyorli in addition to nab-paclitaxel also experienced a 30 percent reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.0076), as assessed by blinded independent central review compared to patients treated with nab-paclitaxel alone.

The combination of Lifyorli with nab-paclitaxel was well-tolerated. Adverse events in the combination arm were comparable to those in the nab-paclitaxel monotherapy arm. The prescribing information for Lifyorli includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity. The most common adverse reactions experienced by more than 20 percent of patients (including laboratory abnormalities) were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

"The safety and efficacy findings from ROSELLA are remarkable," said Alexander B. Olawaiye, M.D., Professor and Vice Chair of Diversity and Inclusion at Magee-Women’s Hospital of the University of Pittsburgh, Principal Investigator in the ROSELLA trial, SGO presenter and Lancet publication author. "They give hope to patients and oncologists now that we have a new preferred regimen in this devastating and difficult-to-treat cancer."

"Patients with platinum-resistant ovarian cancer need more good treatment options. Relacorilant provides one. It significantly extends overall survival, with very little added toxicity," said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X in Milan, and Full Professor of Obstetrics and Gynaecology at Humanitas University, Pieve Emanuele, Lancet publication senior author and European Network of Gynaecological Oncological Trial groups (ENGOT) investigator in the ROSELLA trial. "This regimen is firmly positioned as a new standard-of-care treatment for patients in the United States. We anticipate regulatory approval in Europe soon."

"ROSELLA’s positive findings affirm our confidence that selective glucocorticoid receptor (GR) antagonists, such as relacorilant, may help treat any patient whose tumor type expresses the GR," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "With our recent FDA approval, we are now focused on delivering this therapy to patients and continuing cortisol modulation research in solid tumors that express GR across many different treatment settings. We are grateful for the patients and investigators who make our trials possible."

ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The ROSELLA trial was conducted in collaboration with The GOG Foundation, Inc. (GOG-F) (GOG-3073), the European Network of Gynaecological Oncological Trial groups (ENGOT) (ENGOT-ov72), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT) (APGOT-Ov10), the Latin American Cooperative Oncology Group (LACOG) (LACOG-0223) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) (ANZGOG-221/2023).

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

About Lifyorli

Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement for Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.

Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support at 1-85-LIFYORLI (1-855-439-6754).

LIFYORLI Indication & Usage

LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab.

IMPORTANT SAFETY INFORMATION

Contraindications:

LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids.

Warnings and Precautions:

Neutropenia and Severe Infections

LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy.

Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.

Adrenal Insufficiency

LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity.

Exacerbation of Conditions Treated with Glucocorticoids

Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both.

Embryo-Fetal Toxicity

LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.

Adverse Reactions:

Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%).

Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued.

The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Drug Interactions:

Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness.
CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.
CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.
CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates.
Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates.
Use in Specific Populations:

Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose.
Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients.
Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST).
Please see the full Prescribing Information for additional Important Safety Information.

(Press release, Corcept Therapeutics, APR 10, 2026, https://ir.corcept.com/news-releases/news-release-details/corcept-presents-complete-data-pivotal-rosella-trial-sgo-late [SID1234664298])

On April 10, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported the Company will host a conference call and webcast to review the interim futility analysis from its pivotal, randomized Phase 2 ALPHA3 trial with cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation large B-cell lymphoma (LBCL) on Monday, April 13, 2026.

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The live conference call and webcast will take place at 5:30 a.m. PT / 8:30 a.m. ET. Please use this link to register. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section.

(Press release, Allogene, APR 10, 2026, View Source [SID1234664297])

On April 10, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported a brief update regarding mitazalimab.

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In parallel with ongoing partnering activities, Alligator is exploring alternative opportunities for phase 3 development of mitazalimab in first line metastatic pancreatic cancer. As part of these efforts, Alligator has signed a letter-of-intent with the French non-for-profit clinical cancer research organization Unicancer. Consequently, the parties are collaborating to establish the feasibility of, and prepare for, a global investigator sponsored Phase 3 study.

No development decisions have been taken at this time, and any such activities remain at an exploratory stage.

(Press release, Alligator Bioscience, APR 10, 2026, View Source [SID1234664296])

On April 9, 2026 Aveta Biomics, together with researchers from the VA Greater Los Angeles Healthcare System (VAGLAHS), reported new Phase 2A subpopulation data for APG-157 in head and neck squamous cell carcinoma (HNSCC) from patients at one of the clinical trial sites, which will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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HNSCC is a disease with limited durable treatment options, driven by multiple biological mechanisms, including persistent HPV16 infection in a growing subset of patients and chronic NF-κB-mediated immune suppression across the broader population. APG-157, an oral immunotherapy, is designed to address these drivers simultaneously.

The new analysis reveals distinct yet complementary effects across patient subpopulations. In HPV-positive patients, APG-157 reduces HPV16 expression in both tumor tissue and saliva, supporting antiviral activity. Across the broader population, treatment is associated with activation of systemic immune responses, including expansion of B and T cells.

These preliminary translational findings contain TWO CLINICALLY SIGNIFICANT observations that, to our knowledge, no therapy in HNSCC has previously reported. First, it showed a reduction in HPV viral load, addressing the root viral driver of disease in HPV-positive patients. Second, activation of gigaxonin and its downstream modulation of Snail and E-cadherin, pointing to a novel mechanism for reducing metastatic potential. While the confirmation in larger studies is the next step, these findings point to mechanisms of real clinical significance.

"The multiple mechanisms of action of APG-157 demonstrate strong potential, particularly in head and neck cancers that respond poorly to currently available chemotherapy and immunotherapy agents," said Dr. Marilene Wang, Professor of Head and Neck Surgery at the David Geffen School of Medicine at UCLA and lead investigator.

"APG-157 appears to activate gigaxonin, a novel regulator linked to NF-κB degradation, and modulates EMT markers with decreased Snail and increased E-cadherin, consistent with a less invasive, lower-metastatic-risk phenotype," added Dr. Eri S. Srivatsan, professor of surgery and senior Author at the David Geffen School of Medicine at UCLA and VAGLAHS.

These findings build on data previously presented at ASCO (Free ASCO Whitepaper) 2025 and ESMO (Free ESMO Whitepaper) 2025, adding further mechanistic depth to the emerging clinical profile.
The implications of these early observations may extend beyond HNSCC. HPV16 is a key driver of multiple anogenital cancers globally, and NF-κB activation is a hallmark across many solid tumors.

"These early findings of reduced HPV viral load may extend to other HPV-driven cancers, including cervical cancer. The observed shift toward a less invasive phenotype also suggests broader potential across solid tumors where reducing metastatic risk remains a key unmet need," said Dr. Selda Samakoglu, Chief Medical Officer of Aveta Biomics.

PRESENTATION DETAILS
• Title: Downregulation of HPV 16 and NF-κB and upregulation of gigaxonin and immune markers in APG-157 treated head and neck cancer: A phase 2A clinical investigation
• Presenter: Dr. Saroj Basak, Research Scientist, VAGLAHS
• Session: Biomarkers Predictive of Therapeutic Benefit
• Date: April 21, 2026
• Time: 9:00 AM – 12:00 PM
• Location: Section 42

(Press release, Aveta Biomics, APR 9, 2026, View Source [SID1234664535])