Roche Holding AG Basel American Depositary Shares (RHHBY)

Oncotelic Therapeutics (OTCQB: OTLC) is emerging as a key example of how scientific progress is increasingly being reflected as measurable financial value across the biotechnology sector, supported by evolving fair-value accounting practices under U.S. GAAP. Operating at the intersection of oncology and AI-driven drug development, the company highlights this shift through its diversified pipeline and strategic holdings, including a 45% stake in GMP Bio valued at over $1 billion, alongside peers such as Autolus Therapeutics plc (NASDAQ: AUTL), Wave Life Sciences Ltd. (NASDAQ: WVE), IO Biotech Inc. (OTC: IOBTQ), and Roche Holding AG (OTC: RHHBY), as the industry transitions toward valuing clinical progress as an asset class.

AUSTIN, Texas, April 22, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: The biotechnology industry is experiencing a subtle yet meaningful transformation that is redefining how value is interpreted within a sector long associated with extended development cycles and inherent uncertainty. As therapeutic candidates advance toward commercialization, scientific achievement is no longer viewed purely as an expense tied to research and development but rather as something that can be quantified as a financial asset. This transition is supported by fair-value accounting principles under U.S. GAAP, which enable life sciences companies to incorporate clinical progress, probability of success and expected commercialization timelines into measurable balance sheet value. Companies at the forefront of this shift, including Oncotelic Therapeutics Inc. (OTCQB: OTLC) (profile), are actively leveraging this evolving framework. Operating at the intersection of oncology therapeutics and AI-driven drug development, Oncotelic demonstrates how scientific advancement can influence financial positioning. Through a diversified pipeline and strategic holdings, including a 45% interest in GMP Bio, which was recently assessed at more than $1 billion in enterprise value, the company illustrates how innovation can be reflected in tangible economic terms. As the industry increasingly aligns valuation with development progress rather than current revenue, Oncotelic represents a compelling example of science emerging as a recognized asset class. The company is part of a broader group of organizations developing advanced therapies at the genetic and molecular level, including Autolus Therapeutics plc (NASDAQ: AUTL), Wave Life Sciences Ltd. (NASDAQ: WVE), IO Biotech Inc. (OTC: IOBTQ) and Roche Holding AG (OTC: RHHBY).

Sixth paragraph, fifth sentence of release issued April 20, 2026 at 10 p.m. PT/April 21, 2026 at 1 a.m. ET, should read: In addition, treatment with Gazyva plus standard therapy, versus placebo plus standard therapy, more than doubled the remission rate at 52 weeks (Definition of Remission in SLE (DORIS) - 33.8% versus 13.8%, adjusted difference 19.9%, 95% CI: 10.6-29.2).

Agreement Focused on Developing DACs With Payloads For Two Oncology Targets, With an Option for a Third Target

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today results from the Phase III persevERA Breast Cancer study evaluating investigational giredestrant in combination with palbociclib for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. The adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of each individual treatment.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that a detailed analysis of the Phase III ALLEGORY trial of Gazyva® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) was published in the New England Journal of Medicine (NEJM). The study demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint. Over three quarters (76.7%) of people treated with Gazyva plus standard therapy achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at 52 weeks, compared to 53.5% with placebo plus standard therapy (adjusted difference 23.1%, 95% confidence interval [CI]: 12.5-33.6, p<0.001). These data are also being presented today at the 15th European Lupus meeting, SLEuro 2026.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline results from the Phase II ZUPREME-1 trial evaluating investigational petrelintide versus placebo in 493 people living with overweight and obesity (mean BMI of 37 kg/m²) in a gender-balanced trial population. The study met its primary endpoint, demonstrating that once-weekly subcutaneous injections of petrelintide (escalated every fourth week ) resulted in statistically significant and clinically meaningful weight loss from baseline after 28 weeks in all five treatment arms compared to placebo.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the pivotal Phase III study (FENhance 1) of fenebrutinib in RMS met its primary endpoint, showing clinically meaningful and statistically significant results. The study demonstrated that fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, markedly reduced the annualized relapse rate (ARR) by 51% compared to teriflunomide over a period of at least 96 weeks of treatment, consistent with FENhance 2 results showing a 59% reduction in ARR. Together, these results equate to approximately one relapse every 17 years. Secondary endpoints in both RMS studies show statistically significant and clinically meaningful reductions in brain lesions. Additionally, all progression endpoints show favorable trends for fenebrutinib.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the combination regimen of Venclexta® (venetoclax) plus acalabrutinib for the treatment of previously untreated adults with chronic lymphocytic leukemia (CLL), based on results from the Phase III AMPLIFY study.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by December 18, 2026. Giredestrant plus everolimus could be the first and only oral selective estrogen receptor degrader (SERD) combination approved in the post-cyclin-dependent kinase (CDK)4/6 inhibitor setting.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with Gazyva® (obinutuzumab). Results show that significantly more people achieved complete remission at two years (104 weeks) with Gazyva versus tacrolimus. Safety was in line with the well-characterized profile of Gazyva and no new safety signals were identified.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new late-breaking data from the Phase III FENtrepid study showing the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib met its primary endpoint of non-inferiority compared to Ocrevus® (ocrelizumab) in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS). Fenebrutinib showed a 12% reduction in the risk of disability progression compared to Ocrevus, the only approved medicine for PPMS, as measured by the time to onset of 12-week composite confirmed disability progression (cCDP12) (hazard ratio [HR] 0.88; 95% confidence interval [CI]: 0.75, 1.03) with curves separating as early as 24 weeks. A consistent treatment effect on cCDP12 was observed across patient subgroups and for the entire treatment duration.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline results from CT388-103, a Phase II clinical trial of CT-388, an investigational dual GLP-1/GIP receptor agonist being developed for the treatment of obesity. The study found that once-weekly subcutaneous injections of CT-388 (titrated up to 24 mg) resulted in significant and clinically meaningful placebo-adjusted weight loss of 22.5% (efficacy estimand) without reaching a weight loss plateau at 48 weeks. A clear dose-response relationship on the weight loss was observed. For the treatment-regimen estimand, the placebo-adjusted weight loss achieved with CT-388 was 18.3% (p-value < 0.001). At week 48 for the 24 mg dose, 95.7% of CT-388 treated participants achieved a weight loss of ≥5%, 87% achieved ≥10%, 47.8% achieved ≥20%, and 26.1% achieved ≥30%. 73% of participants who were pre-diabetic at baseline and treated with CT-388 at 24 mg achieved normal blood glucose levels at week 48 compared to 7.5% in the placebo group.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced an expansion of its initial investment in a new Holly Springs, North Carolina manufacturing facility. The increased investment will more than double the total commitment for the company’s first-ever East Coast manufacturing facility to approximately $2 billion. The expansion builds on the company’s May 2025 investment announcement, as well as the project’s August 2025 groundbreaking, and reflects Genentech’s continued confidence in the region’s community, workforce, and long-term growth potential.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced an agreement with the U.S. government that lowers costs for state Medicaid programs, encourages other wealthy countries to reward innovation, and increases opportunities for direct patient access.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive data from the Phase III lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer. At the pre-specified interim analysis, adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% (invasive disease-free survival [iDFS]) compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014). The lidERA results are being presented at the 2025 San Antonio Breast Cancer Symposium and are included in the official press program.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data highlighting the potential of Lunsumio® (mosunetuzumab-axgb) in earlier treatment lines for people living with different types of lymphoma, presented at the 67th American Society of Hematology Annual Meeting and Exposition, December 6-9, 2025 in Orlando, Florida.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive Phase III results from the lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer. The study met its primary endpoint at a pre-planned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant versus standard-of-care endocrine therapy. lidERA is the first Phase III trial of a selective estrogen receptor degrader (SERD) to demonstrate a significant benefit in the adjuvant setting. The majority of breast cancer cases are diagnosed at an early stage.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the first Phase III (FENhance 2) of two pivotal, similarly-designed Phase III studies (FENhance 1 and 2) in patients with relapsing multiple sclerosis (RMS) met its primary endpoint. Fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, significantly reduced the annualized relapse rate (ARR) compared to teriflunomide over a period of at least 96 weeks of treatment.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 6-9, 2025 in Orlando, Florida.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today statistically significant and clinically meaningful results from the Phase III ALLEGORY study of Gazyva® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) on standard therapy. The study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva versus standard therapy. SRI is a tool that assesses changes in disease severity, symptoms and physical condition to indicate whether treatment is effective at controlling disease activity. All key secondary endpoints were also met. No new safety signals were identified, and safety was in line with the well-characterized profile of Gazyva.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from the Phase III INShore study of Gazyva® (obinutuzumab) in children and young adults (aged ≥ 2-25 years) with idiopathic nephrotic syndrome (INS). The study met its primary endpoint, with more people achieving sustained complete remission at one year (week 52) with Gazyva compared with mycophenolate mofetil (MMF). Sustained complete remission was defined by the absence of relapses during the study together with a low amount of protein in the urine (protein to creatine of 0.2 or less) at week 52. Certain important key secondary endpoints were also met. No new safety signals were identified and safety was in line with the well-characterized profile of Gazyva in adults.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III IMvigor011 study evaluating Tecentriq® (atezolizumab) as an adjuvant treatment for people with muscle-invasive bladder cancer (MIBC) who are at risk of recurrence after surgery (cystectomy) and have detectable circulating tumor DNA (ctDNA). In this ctDNA-guided setting, Tecentriq reduced the risk of death (overall survival, OS) by 41% and the risk of disease recurrence or death (disease-free survival, DFS) by 36%, both compared with placebo. This ctDNA-guided approach, using Natera’s Signatera™ ctDNA Molecular Residual Disease (MRD) test, spared people at low risk of recurrence from unnecessary treatment and side effects. The safety profile was consistent with previous studies of Tecentriq.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. Following four initial doses in the first year, Gazyva can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.