On April 30, 2026 Cytodyn presented its corporate presentation.

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(Presentation, CytoDyn, APR 30, 2026, View Source [SID1234664964])

On April 30, 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 its results for the quarter ended March 31, 2026.

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Financial Results

Corcept’s first quarter 2026 revenue was $164.9 million, compared to $157.2 million in the first quarter of 2025. First quarter 2026 operating expenses were $214.5 million, compared to $153.8 million in the same period last year, due to increased spending to prepare for the launch of Lifyorli to treat patients with platinum-resistant ovarian cancer and to invest in growth initiatives in our Cushing’s syndrome business. Net loss per common share (diluted) was $0.30 in the first quarter of 2026, compared to net income per common share (diluted) of $0.17 in the first quarter of 2025. Corcept expects to return to profitability in the second quarter of 2026.

Cash and investments were $515.4 million at March 31, 2026, compared to $532.4 million at December 31, 2025.

"This quarter’s results include a significant milestone: With the FDA’s approval of Lifyorli (relacorilant) to treat women with platinum-resistant ovarian cancer more than three months before its PDUFA date, this is the last quarter for which our financial results will reflect the sales of just one medication. In April, Lifyorli, in combination with nab-paclitaxel, was added to NCCN Guidelines as a preferred regimen and uptake has been vigorous.

In February, our Cushing’s syndrome business completed its transition to our new pharmacy vendor, which is successfully fulfilling the increasing demand for Korlym and our authorized generic. March and April marked all-time highs in the number of patients starting treatment.

We have increased our 2026 revenue guidance to $950 – $1,050 million," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Clinical Development

"The FDA’s approval of Lifyorli in platinum-resistant ovarian cancer is welcome news for women with this difficult-to-treat disease. It also underscores the potential of our oncology program, which we believe will produce medications to treat many tumor types and a broad array of combination therapies. We expect results from our BELLA trial combining relacorilant with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer by the end of this year, with results from our studies of relacorilant in patients with platinum-sensitive ovarian, endometrial, cervical and pancreatic cancers available by the end of next year. Our Phase 1b SYNERGY study combining our proprietary, selective glucocorticoid receptor antagonist, nenocorilant, with the PD-1 checkpoint inhibitor nivolumab will also produce results next year," said Dr. Belanoff.

"We are engaged with the FDA to determine the best path forward for our New Drug Application (NDA) for relacorilant in Cushing’s syndrome and are confident that the ultimate outcome will be approval.

In addition, results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH), are expected by the end of this year. We also plan to start a Phase 3 trial of dazucorilant in patients with ALS later this year. The goal of this trial will be simple – replicate the significant survival benefits observed in our Phase 2 DAZALS study," added Dr. Belanoff.

Hypercortisolism (Cushing’s Syndrome)

New Drug Application – Engaged with FDA to determine best path forward for relacorilant to treat patients with Cushing’s syndrome
GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in The Lancet Diabetes & Endocrinology (Pivonello et al, February 2026)
CATALYST – Findings referenced in the March 2026 update of the American Association of Clinical Endocrinology (AACE) Consensus Statement Algorithm for Management of Adults with Type 2 Diabetes
MOMENTUM – Prevalence of hypercortisolism was 27.3 percent in 1,086 patients with resistant hypertension – Results presented at the American College of Cardiology (ACC) in March
"Our studies have shown that patients with hypercortisolism who receive relacorilant experience clinically and statistically significant improvements in multiple signs and symptoms of the disease, without the off-target effects and adverse reactions associated with currently available treatments," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Relacorilant has the potential to become the new standard of care."

"The need for better treatments for patients with hypercortisolism is urgent. Our CATALYST and MOMENTUM studies demonstrate that hypercortisolism is an underlying driver of disease for many patients with diabetes and hypertension, whose disease doesn’t respond to standard-of-care treatments. These findings will lead to increased screening and improved treatment," added Dr. Guyer.

Oncology

Relacorilant in Combination with Chemotherapy

FDA approved Lifyorli (relacorilant) plus nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer in March 2026
Lifyorli plus nab-paclitaxel added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen in April 2026
Marketing Authorization Application (MAA) – European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of this year
ROSELLA – Both dual primary endpoints (progression-free and overall survival) met – Complete results presented at the Society of Gynecologic Oncology (SGO) meeting in April and published in The Lancet (Lorusso et al, April 2026)
BELLA Part A – Enrollment completed in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer – Results expected by the end of this year
BELLA Part B – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor
BELLA Part C – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy)
STELLA – Initiated Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy), conducted in collaboration with ARCAGY-GINECO
TRIDENT – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 60 patients with pancreatic cancer
Nenocorilant in Combination with Immunotherapy

SYNERGY – Enrollment continues in Phase 1b dose-finding trial of nenocorilant plus nivolumab in 30 patients with a variety of solid tumors
Relacorilant in Combination with Androgen Deprivation Therapy

Prostate cancer – Enrollment continues in randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in 90 patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
"The FDA approved Lifyorli because the addition of Lifyorli to nab-paclitaxel in our Phase 3 ROSELLA trial reduced the risk of death in patients with platinum-resistant ovarian cancer by 35 percent, with no need for a biomarker selection. These outstanding results, along with pre-clinical and clinical data that we and our academic collaborators have generated, validate the thesis that glucocorticoid receptor antagonism may help patients with a wide variety of tumor types and may be useful in combination with a wide variety of chemo- or immuno-therapies. Our development program is dedicated to proving this idea," added Dr. Guyer.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 175 patients with biopsy-confirmed or presumed MASH – Results expected by the end of this year
"In our Phase 1b study, miricorilant rapidly reduced liver fat while improving fibrosis, liver enzymes and other markers of liver health, including key metabolic and lipid measures. We look forward to building on these promising findings in our Phase 2b MONARCH study, with results expected by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – Exploratory analyses showed that patients who received dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009) – This benefit persisted into the study’s second year with an 87 percent reduction in risk of death (hazard ratio: 0.13, p-value: < 0.0001)
Phase 3 trial – Planned to begin later this year
"Elevated cortisol activity is associated with ALS. In our Phase 2 DAZALS study, patients who received dazucorilant exhibited a profound reduction in early mortality, at a stage when many patients with ALS still retain significant function and quality of life," said Dr. Guyer. "Our ongoing dose-titration study aims to improve gastrointestinal tolerability to inform the path forward in this program."

Conference Call

We will hold a conference call on April 30, 2026, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

(Press release, Corcept Therapeutics, APR 30, 2026, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-financial-results-3 [SID1234664963])

On April 30, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported positive clinical data from its Phase 2a study of namodenoson in patients with advanced pancreatic cancer.

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The data from the fully enrolled study demonstrate preliminary evidence of clinical activity, including durable disease stabilization in a heavily pretreated patient population, in addition to the previously reported favorable safety profile.

Key findings include:

● Stable disease observed in >30% of evaluable patients

● Prolonged treatment duration includes one patient extending beyond 16 months.

● 35% of patients remain on therapy and follow up

● Favorable safety and tolerability profile consistent with prior reports

The prolonged treatment duration observed in several patients suggests a potential for durable clinical benefit in this difficult-to-treat population.

"As we continue to analyse the data, we are encouraged by the emerging signal of durable disease stabilization observed in this study," said Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. "Importantly, a meaningful proportion of patients remain on therapy for extended periods, supporting the continued clinical development of namodenoson in pancreatic cancer."

As a substantial proportion of patients remain on treatment, full efficacy analyses, including progression-free survival and overall survival, top-line results are expected in the coming months and will be presented in a forthcoming clinical conference.

About Namodenoson

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

About Pancreatic Cancer Phase 2a Study

The Phase 2a study of namodenoson is an open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of namodenoson in this population. All patients receive oral namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. 20 evaluable patients were enrolled to the study. The primary objective of this trial is to characterize the safety profile of namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases.

(Press release, Can-Fite BioPharma, APR 30, 2026, View Source [SID1234664962])

On April 30, 2026 Bristol Myers Squibb (NYSE: BMY) reported first quarter 2026 financial results.

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Visit the company’s Investor Relations website at View Source to view the detailed first quarter 2026 earnings press release and investor presentation.

The company will host a conference call and live audio webcast for analysts and investors at 8:00 a.m. ET today, April 30, 2026, which is accessible here. Company executives will review financial results with the investment community during the call.

A replay of the webcast will be available at View Source approximately three hours after the conference call concludes.

(Press release, Bristol-Myers Squibb, APR 30, 2026, View Source [SID1234664961])

On April 30, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the first quarter ended March 31, 2026, and provided recent corporate updates.

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"The data we reported in the first quarter continues to provide further validation of the potential of our Bicycle technology to deliver oncology therapeutics with improved benefit/risk profiles compared to existing modalities," said Bicycle CEO Kevin Lee, Ph.D. "We are excited by the emerging profile of our EphA2 drug conjugate, nuzefatide pevedotin, which we have now tested in over 150 patients to date, both as a monotherapy and in combination with a checkpoint inhibitor. Nuzefatide has been shown to be generally well tolerated at clinically active doses, in contrast to previous attempts to drug this target with other modalities. We believe these data, together with those presented at AACR (Free AACR Whitepaper), provide a strong rationale for advancing the development of nuzefatide in pancreatic cancer, and we are pleased to have recently dosed our first patient in our Phase 2 trial. In addition to this, the preliminary data we have reported from our Duravelo-2 program demonstrate zelenectide pevedotin to also be clinically active with a differentiated safety profile, providing convincing evidence that Bicycle drug conjugates may exhibit a fundamentally different tolerability profile to that seen with antibody-based approaches, and support our mission of helping patients not only to live longer but also to live well."

Dr. Lee added: "Following a strategic reprioritization in the first quarter, we are converting the Duravelo-2 trial into a randomized Phase 2 trial, allowing us to focus our internal resources on our emerging pipeline of next-generation therapeutics, including nuzefatide and Bicycle-based radiotherapeutics and imaging agents. We look forward to presenting initial dose selection data from our Duravelo-2 trial at the upcoming 2026 ASCO (Free ASCO Whitepaper) Annual Meeting and will continue to evaluate the best path for this program as the data continues to mature."

First Quarter 2026 and Recent Events

Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 demonstrates significant opportunities for nuzefatide pevedotin (nuzefatide), formerly BT5528, a potentially first-in-class EphA2 targeting Bicycle Drug Conjugate (BDC), in EphA2 expressing cancers.
Nuzefatide Phase 1/2 data show a differentiated safety profile in combination with nivolumab in metastatic urothelial cancer (mUC) patients as well as promising anti-tumor activity. As of the February 9, 2026 data cutoff, results from the Phase 1/2 trial evaluating nuzefatide 6.5mg/m2 once every two weeks (Q2W) plus nivolumab 480mg once every four weeks (Q4W) in 14 patients with mUC who had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed:
40% confirmed overall response rate (ORR) (4/10) among patients with EphA2+ tumors and 100% confirmed ORR (3/3) among patients with EphA2+ tumors that were monomethyl auristatin E (MMAE)-naïve.
Patients who achieved a partial response (PR) or at least 16 weeks of stable disease (SD) were on treatment for a minimum of 56 weeks and most continued on treatment at the time of the data cut-off.
Nuzefatide in combination with nivolumab was generally well tolerated with no Grade ≥3 treatment-related adverse events (TRAEs) of clinical interest and no TRAEs of hemorrhage observed. Only one dose-limiting toxicity of Grade 3 fatigue that lasted for five days was reported and improved to Grade 1 without dose reduction.
Preclinical assessment of nuzefatide anti-tumor activity in patient-derived xenograft (PDX) models of pancreatic ductal adenocarcinoma (PDAC). Expression of EphA2 was found in all 16 PDAC PDX models. Of the 14 PDAC PDX models assessed for anti-tumor activity, 10 models were sensitive to nuzefatide, six of which showed high sensitivity.
Preclinical assessment of nuzefatide anti-tumor activity in cell-line-derived xenograft (CDX) models of head and neck squamous cell carcinoma (HNSCC). Nuzefatide demonstrated potent preclinical anti-tumor activity in EphA2-expressing CDX models of HNSCC.
Altogether, Bicycle Therapeutics believes that these data highlight significant opportunities for nuzefatide in EphA2 expressing cancers, including pancreatic cancer.

In March 2026, Bicycle Therapeutics began enrolling a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent PDAC, and the first patient was successfully dosed in April 2026. Bicycle Therapeutics has determined 8mg/m2 Q2W as the preferred dose for the trial.

Additional human imaging data of a Bicycle Imaging Agent (BIA) targeting EphA2 in patients with PDAC presented at AACR (Free AACR Whitepaper) Annual Meeting 2026. The German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), presented human imaging data conducted with a Bicycle molecule targeting EphA2 labelled with gallium-68 (EphA2 BIA). Seven patients with histologically confirmed PDAC underwent PET/CT imaging up to three hours post injection of the EphA2 BIA. Data demonstrated rapid tumor uptake in six out of seven patients with excretion primarily via the kidneys. EphA2 BIA PET imaging successfully detected multiple liver, bone, lymph node, and peritoneal metastases.
These data are representative of the results seen in 15 out of 18 patients with PDAC who have undergone EphA2 BIA imaging to date. Bicycle Therapeutics believes these data validate the potential of EphA2 as a novel target in the treatment of cancer, demonstrate the translatability of preclinical data and highlight the potential of Bicycle molecules for targeted radioligand therapies and radiopharmaceutical imaging.

Promising Duravelo-2 data and multiple potential regulatory pathways provide a range of options for a Phase 3 trial and potential commercialization of zelenectide pevedotin (zelenectide) in mUC. Initial dose selection data from the Duravelo-2 trial demonstrate response rates comparable to those published for existing standards of care, with physician assessed ORR of 65%, blinded independent central review (BICR) confirmed ORR of 58% at the 27-week cutoff and a differentiated safety profile. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62%. Zelenectide at 6mg/m2 two weeks on, one week off demonstrated a differentiated safety profile with only one patient discontinuing therapy due to a TRAE at the 27-week cutoff.
While Bicycle Therapeutics evaluates preliminary regulatory feedback from the European Medicines Agency, U.S. Food and Drug Administration (FDA), and Medicines and Healthcare products Regulatory Agency, and the potential paths for this program, the company is converting the ongoing Duravelo-2 trial to a randomized Phase 2 trial and deprioritized the program for internal development.

Bicycle Therapeutics will present initial Duravelo-2 dose selection data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2 in Chicago.

Strategic reprioritization focuses on promising pipeline of next-generation therapeutics. In March 2026, Bicycle Therapeutics initiated a strategic reprioritization in order to focus its resources on its promising pipeline of next-generation therapeutics, including nuzefatide, as well as its emerging Bicycle conjugate pipeline, including BRCs. As part of the reprioritization, Bicycle Therapeutics seeks to discontinue the Phase 1/2 Duravelo-3 trial for zelenectide in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for zelenectide in NECTIN4-amplified non-small cell lung cancer. Enrollment for these trials is closed, and patients currently enrolled will complete their course of treatment. In addition, Bicycle Therapeutics announced a workforce reduction pursuant to which it expects to reduce its workforce by approximately 30%. Anticipated annual operational savings related to the workforce reduction and strategic reprioritization are expected to reduce annual operating expenses by approximately 50% based on the company’s current plans. These actions are expected to extend Bicycle Therapeutics’ cash runway by approximately two years, into 2030.
First Quarter 2026 Financial Results

Cash and cash equivalents were $559.5 million as of March 31, 2026, compared to $628.1 million as of December 31, 2025. The decrease in cash and cash equivalents is primarily due to cash used in operations, including cash payments for clinical program activities.
Collaboration revenue was $0.9 million for the three months ended March 31, 2026, compared to $10.0 million for the three months ended March 31, 2025. The decrease in collaboration revenue of $9.1 million was primarily due to the termination of our collaboration programs with Genentech and Novartis.
Research and development (R&D) expenses were $48.9 million for the three months ended March 31, 2026, compared to $59.1 million for the three months ended March 31, 2025. The decrease in expense of $10.2 million was primarily due to decreased clinical program expenses for zelenectide and share-based compensation due to our workforce reduction, offset by lower U.K. R&D tax credits period over period.
General and administrative (G&A) expenses were $17.5 million for the three months ended March 31, 2026, compared to $21.1 million for the three months ended March 31, 2025. The decrease in expense of $3.6 million was primarily due to decreased professional and consulting fees and decreased share-based compensation due to our workforce reduction.
Net loss was $60.8 million, or $(0.87) basic and diluted net loss per share, for the three months ended March 31, 2026, compared to net loss of $60.8 million, or $(0.88) basic and diluted net loss per share, for the three months ended March 31, 2025.

(Press release, Bicycle Therapeutics, APR 30, 2026, View Source [SID1234664960])