Roche Hldg - RHHBY STOCK NEWS

Genentech announced that the FDA Oncologic Drugs Advisory Committee voted 10-1 to maintain the accelerated approval of Tecentriq (atezolizumab) for treating adults with locally advanced or metastatic urothelial carcinoma not eligible for cisplatin chemotherapy and with high PD-L1 expression. This meeting is part of an industry review of accelerated approvals. The FDA has yet to announce a final decision. Tecentriq, approved since 2017, has shown significant efficacy for specific bladder cancer patients, with ongoing studies in various cancers.

On April 28, 2021, Roche (OTCQX: RHHBY) announced that the FDA's Oncologic Drugs Advisory Committee voted 10-1 to maintain the accelerated approval of Tecentriq® for metastatic bladder cancer patients not eligible for cisplatin chemotherapy. This endorsement highlights the significant unmet medical need in this patient population. Roche is committed to advancing Tecentriq's clinical development, having received a similar positive recommendation for triple-negative breast cancer. The FDA's final decision on Tecentriq is pending.

On April 28, 2021, Roche announced five new intended uses for its cardiac biomarkers, Elecsys® cTnT-hs and NT-proBNP, enhancing cardiovascular disease diagnosis and management.

These biomarkers aim to identify cardiovascular risks, improve early diagnosis, and support timely treatments, potentially reducing healthcare costs. Notably, new applications include assessing risks for patients with type-2 diabetes and Atrial Fibrillation.

With over 200 million adults undergoing major non-cardiac surgery annually, these innovations could help predict heart attack risks in surgical patients.

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.