Roche Hldg - RHHBY STOCK NEWS

Genentech announced positive topline results from two Phase III studies, TENAYA and LUCERNE, for its bispecific antibody faricimab in treating neovascular age-related macular degeneration (nAMD). Both studies met their primary endpoint, demonstrating that faricimab injections at intervals up to 16 weeks achieved comparable visual acuity to aflibercept given every 8 weeks. Approximately 45% of participants receiving faricimab were treated every 16 weeks, marking a significant milestone in treatment durability. Faricimab was generally well tolerated with no new safety concerns.

Genentech, part of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the FDA has accepted its supplemental New Drug Application (sNDA) for Esbriet^® (pirfenidone) to treat unclassifiable interstitial lung disease (UILD) and granted Priority Review. A decision is expected by May 2021. This sNDA is based on a Phase II trial, the first randomized controlled study for UILD, indicating Esbriet may benefit patients. The treatment has previously received Orphan Drug and Breakthrough Therapy Designations from the FDA.

Genentech has received Breakthrough Therapy Designation (BTD) from the FDA for tiragolumab, an innovative cancer immunotherapy targeting TIGIT, in combination with Tecentriq for treating metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. This marks the first anti-TIGIT molecule to receive BTD, based on promising results from the Phase II CITYSCAPE trial, which demonstrated improved overall response rates and progression-free survival. Genentech plans to further develop tiragolumab across multiple cancer types, aiming for significant advancements in treatment.

Genentech has received FDA approval for a shorter two-hour infusion time for Ocrevus (ocrelizumab) for patients with relapsing or primary progressive multiple sclerosis (MS) without prior serious infusion reactions. This decision follows data from the ENSEMBLE PLUS study, showing comparable infusion reaction rates between the two-hour and previous 3.5-hour infusions. Ocrevus is already the most prescribed MS medication in the U.S., with dosing every six months and approved in 94 countries.

Roche has announced the full FDA approval of Venclexta (venetoclax) in combination with azacitidine or decitabine for treating newly diagnosed acute myeloid leukemia (AML) in adults 75 and older or those unable to undergo intensive chemotherapy. This approval is based on phase III trials, VIALE-A and VIALE-C, with VIALE-A showing a 34% reduction in death risk compared to azacitidine alone. Venclexta’s approval was expedited under the FDA’s Real-Time Oncology Review and Project Orbis initiatives, enhancing its global availability.

Roche reported a 1% sales increase in the first nine months of 2020, reaching CHF 44.0 billion, despite a 5% decline in Swiss francs due to currency appreciation. The Pharmaceuticals Division saw a slight decrease of 1% in sales, while the Diagnostics Division grew by 9%, primarily driven by COVID-19 testing. Key FDA approvals included Enspryng and Evrysdi for rare diseases, with ongoing strong demand for newly launched medicines. Roche maintains its 2020 outlook with expected growth in sales and core earnings. Challenges include competition from biosimilars and ongoing impacts from the COVID-19 pandemic.

Roche announced the upcoming launch of the Elecsys® SARS-CoV-2 Antigen test, aimed at diagnosing SARS-CoV-2 infections. Set for release by the end of 2020, this test will be available in CE-marked markets and seeks FDA Emergency Use Authorization. The Elecsys test is designed to run on cobas e immunochemistry analyzers, providing results in 18 minutes with a throughput of up to 300 tests per hour. This addition to Roche's diagnostic portfolio aims to enhance global testing capacity in response to COVID-19.

A federal judge in Maryland ruled that Hoffman-La Roche (RHHBY) must respond to whistleblower allegations of falsifying claims regarding Tamiflu's effectiveness and inducing the government to stockpile the drug. The lawsuit, filed under the False Claims Act, could lead to penalties exceeding $4 billion due to Roche's alleged misleading claims that influenced government purchases. Despite warnings from the FDA about unsupported claims, Roche received over $1.4 billion from the government between 2005 and 2009 for Tamiflu stockpiles. The case highlights the importance of safeguarding taxpayer interests against corporate fraud.

Roche's press release highlights promising 2-year data from the FIREFISH study of Evrysdi for treating spinal muscular atrophy (SMA) in infants. At the 2-year mark, 88% of infants treated were alive and did not require permanent ventilation. Additionally, 59% could sit unsupported for at least 5 seconds. There were no new safety concerns identified. Earlier, the FDA approved Evrysdi for SMA in patients aged 2 months and older. Roche remains optimistic about the ongoing assessments of survival and motor function for this innovative treatment.