ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech announced that the FDA's Oncologic Drugs Advisory Committee voted 7 to 2 to maintain the accelerated approval of Tecentriq (atezolizumab) in combination with chemotherapy for adults suffering from unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) expressing PD-L1. While the committee's recommendation is significant for treatment accessibility, the continued approval is contingent upon further collaboration with the FDA, particularly after the IMpassion131 study failed to meet its primary endpoint. Genentech remains focused on further developing Tecentriq for various cancers.

On April 28, 2021, Roche announced that the FDA Oncologic Drugs Advisory Committee voted 7 to 2 to maintain the accelerated approval of Tecentriq (atezolizumab) with chemotherapy for treating adults with triple-negative breast cancer (mTNBC) expressing PD-L1. The decision follows an industry review of accelerated approvals with unmet primary endpoints. While Tecentriq was initially approved in March 2019 based on positive PFS results, its continued approval hinges on subsequent study results. Roche aims to collaborate with the FDA on next steps for Tecentriq.

Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended ENSPRYNG (satralizumab) for the treatment of anti-aquaporin-4 antibody seropositive neuromyelitis optica spectrum disorder (NMOSD) in adults and adolescents aged 12 and older. If approved, it will be the first subcutaneous treatment option available in the EU for this condition. ENSPRYNG has shown significant efficacy in reducing relapse rates in pivotal Phase III trials, demonstrating a favorable safety profile. A final decision from the European Commission is anticipated soon.

Roche has received FDA approval for the VENTANA MMR RxDx Panel, the first predictive test for endometrial cancer aimed at identifying patients eligible for JEMPERLI (dostarlimab-gxly) therapy. This approval is critical as it addresses the needs of women with advanced or recurrent endometrial cancer, a condition leading to approximately 90,000 deaths annually worldwide. This companion diagnostic enhances personalized healthcare strategies by enabling targeted treatment options, thereby potentially increasing the effectiveness of immunotherapy.

Roche's wholly owned subsidiary, Geronimo Acquisition Corp., has successfully completed its tender offer for GenMark Diagnostics, acquiring approximately 61.2 million shares (82.89% of total shares) at USD 24.05 per share. The tender offer expired on April 21, 2021, and Roche will merge Geronimo Acquisition Corp. with GenMark without a stockholder vote. Following the merger, GenMark will become a wholly owned Roche subsidiary, and its shares will cease trading on NASDAQ. Roche aims to enhance its molecular diagnostics portfolio with GenMark's technology to combat infectious diseases.

Roche reported a 3% rise in group sales (CHF 14.9 billion) for Q1 2021, driven by a robust 55% increase in the Diagnostics Division, largely due to COVID-19 testing. However, the Pharmaceuticals Division faced a 9% decline in sales (CHF 10.6 billion), primarily due to biosimilar competition, notably a CHF 1.6 billion reduction linked to established cancer treatments. The company confirmed its 2021 outlook, emphasizing the successful launch of new medicines and strong phase III trial results for Tecentriq and faricimab.

Roche's OCREVUS® demonstrates promising results in managing multiple sclerosis (MS), as revealed in recent analyses presented at the American Academy of Neurology Annual Meeting. The open-label Phase IIIb ENSEMBLE study showed that 85% of treatment-naïve, early-stage relapsing-remitting MS patients achieved no evidence of disease activity. Additionally, post-hoc analysis from the Phase III ORATORIO study indicated that OCREVUS significantly slowed T2 lesion accumulation in primary progressive MS. Moreover, a U.S. claims analysis highlighted high adherence and persistence rates for OCREVUS compared to other therapies.

Roche (OTCQX: RHHBY) released new data from the FIREFISH study, showing significant improvements in infants with Type 1 spinal muscular atrophy (SMA) treated with Evrysdi over 24 months. Key findings include:

• 61% of infants could sit unsupported for 5 seconds after 24 months.
• Improvement in survival rates: 93% alive after 24 months and 83% free from permanent ventilation.
• Consistent safety profile with common adverse events being upper respiratory tract infections.

The study's findings highlight Evrysdi's transformative potential in treating SMA.

Roche has received FDA approval for Xolair® (omalizumab) prefilled syringes for self-injection. This approval allows suitable patients to administer their treatment from home, enhancing flexibility and convenience, particularly for high-risk individuals during the COVID-19 pandemic. Xolair targets immunoglobulin E (IgE) and is used for moderate to severe allergic asthma, chronic idiopathic urticaria, and nasal polyps. Since its launch in 2003, around 460,000 patients have been treated with Xolair in the U.S.