Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

The phase IIb PADOVA study, evaluating Roche's prasinezumab in people with early-stage Parkinson's disease, misses the primary endpoint.

Roche's Prasinezumab Misses Goal in Parkinson's Disease Study

An experimental Parkinson's drug missed its primary goal in a mid-stage trial, Roche said, in what is the second setback this week for candidate treatments for the neurodegenerative condition.

Roche's Parkinson's Drug Candidate Misses Key Goal in Mid-Stage Study

Basel, 19 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the Phase IIb PADOVA study investigating prasinezumab in 586 people with early-stage Parkinson's disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01] and p=0.0657, missing statistical significance. In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99]. Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Prasinezumab continues to be well tolerated and no new safety signals were observed in the study.

Roche's Phase IIb study of prasinezumab missed primary endpoint, but suggests possible benefit in early-stage Parkinson's disease

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the Phase IIb PADOVA study investigating prasinezumab in 586 people with early-stage Parkinson's disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01] and p=0.0657, missing statistical sign.

Genentech's Phase IIb Study of Prasinezumab Missed Primary Endpoint, but Suggests Possible Benefit in Early-Stage Parkinson's Disease

Basel, 18 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE mark approval for its cobas® Mass Spec solution including the cobas® i 601 analyser and the first Ionify® reagent pack of four assays for steroid hormones2. The CE mark is the first milestone in the global launch of the cobas Mass Spec solution, using in-house innovation to bring automated, integrated and standardised clinical mass spectrometry testing to routine laboratories worldwide. Following launch, the cobas Mass Spec solution will roll out a menu offering of more than 60 analytes for testing of steroid hormones, vitamin D metabolites, immunosuppressant drugs (ISD), therapeutic drug monitoring (TDM) and drugs of abuse testing (DAT).

Roche transforms mass spectrometry diagnostics with launch of cobas® Mass Spec solution

RHHBY wins approval for prefilled syringe of ophthalmology drug Vabysmo for three retinal conditions that can cause blindness.

Roche Gets Approval for Vabysmo PFS in EU for Three Retinal Diseases

Basel, 13 December 2024– Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet' age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect more than nine million people in the European Union (EU) and can have a devastating impact – physically, emotionally, and economically – on those affected, their families and caregivers.1-5

Roche's Vabysmo prefilled syringe (PFS) approved in the EU for three retinal conditions that can cause blindness

Basel, 13 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE certification of the new cobas® 6800/8800 systems 2.0. The update significantly enhances the efficiency of laboratories by optimising resources, reducing downtime, consolidating test menus, and increasing throughput. These improvements ultimately promise a more streamlined diagnostics experience for healthcare professionals and their patients.

Roche receives CE Mark for new and updated molecular cobas 6800/8800 systems, enhancing laboratory efficiency and testing capabilities

Basel, 10 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody programme were presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, 7-10 December 2024. With more than 20 bispecific antibody abstracts accepted for presentation, data showcase the benefits of fixed-duration Columvi® (glofitamab) and Lunsumio® (mosunetuzumab) across different types of aggressive and indolent lymphomas. This research supports Roche's efforts to continue innovating for patients by advancing treatment standards at earlier stages of disease while exploring additional forms of administration that could further improve the patient experience. “The data being presented at ASH offer further evidence that Columvi and Lunsumio can provide lasting remissions for people with advanced lymphoma,” said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. “The results underscore our ambition to transform the treatment of B-cell malignancies with a range of innovative therapeutic options.”

New and updated data for Roche's fixed-duration Columvi and Lunsumio at ASH 2024 reinforce their potential to improve outcomes for people with lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody program were presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, 2024. With more than 20 bispecific antibody abstracts accepted for presentation, data showcase the benefits of fixed-duration Columvi® (glofitamab-gxbm.

New and Updated Data for Genentech's Fixed-Duration Columvi and Lunsumio at ASH 2024 Reinforce Their Potential to Improve Outcomes for People With Lymphoma

Basel, 9 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has commenced a tender offer for all of the outstanding shares of common stock of Poseida Therapeutics, Inc. (Poseida) (NASDAQ: PSTX) at a price of $9.00 per share in cash, plus a non-tradeable contingent value right (CVR) to receive certain contingent payments of up to an aggregate of $4.00 per share in cash. The tender offer is being made pursuant to the previously announced merger agreement dated as of November 25, 2024 among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Blue Giant Acquisition Corp., a wholly owned subsidiary of Roche Holdings, Inc., and Poseida.

Roche commences tender offer for all shares of Poseida Therapeutics, Inc. for $9.00 per share in cash, plus a non-tradeable contingent value right for up to $4.00 per share in cash

Basel, 8 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from a five-year follow-up of the pivotal phase III POLARIX study evaluating Polivy® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (DLBCL). Data were presented in an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, 7-10 December 2024 in San Diego, US. This latest analysis conducted after a median follow-up of 60.9 months, includes descriptive data on primary and secondary endpoints, as well as safety results.1

Five-year results confirm Roche's Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from a five-year follow-up of the pivotal Phase III POLARIX study evaluating Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (DLBCL). Data were presented in an oral session at the 66th American Society of Hematology (ASH) Annu.

Five-Year Results Confirm Genentech's Polivy Combination Therapy as New Standard of Care for Previously Untreated Aggressive Lymphoma

The FDA accepts RHHBY's sBLA seeking the label expansion of Columvi to include the treatment of second-line R/R DLBCL for review.

FDA Accepts Roche's Columvi sBLA for Expanded Use in Lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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 supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy an.

FDA Accepts Supplemental Biologics License Application for Genentech's Columvi Combination for People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Basel, 5 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant. The FDA is expected to make a decision on approval by 20 July 2025.

FDA accepts supplemental Biologics License Application for Roche's Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Poseida Therapeutics

Shares of Poseida Therapeutics Inc (NASDAQ: PSTX) more than tripled this morning after Roche Holding (SWX: ROG) said it will buy the clinical-stage biopharmaceutical company for about $1.5 billion. Roche's offer values each share of Poseida Therapeutics at $9.0 that translates to a more than 200% premium on their previous close.

Poseida shares triple on Tuesday, boosted by Roche collaboration

RHHBY is all set to acquire Poseida Therapeutics, Inc. and ramp up its pipeline with off-the-shelf cell therapies.

Roche to Acquire CAR-T Cell Therapy Focused Poseida for $1.5B

On Tuesday, Roche Holdings AG RHHBY agreed to acquire Poseida Therapeutics, Inc. PSTX for an equity value of approximately $1.5 billion on a fully diluted basis.

Roche's Proposed Acquisition Of Poseida Therapeutics Poised To Establish New Core Capability In Cell Therapy For Cancer And Autoimmune Diseases: Details

A Roche study into using a combination of tiragolumab and tecentriq to treat a form of lung cancer in a phase III trial did not achieve the desired success, the Swiss pharmaceuticals maker said on Tuesday.

Roche records setback in phase III study of two lung cancer drugs

Roche will acquire California-based biopharmafirm Poseida Therapeutics for $9 per share at closing, for a total equity value of $1 billion, the Swiss company said on Tuesday.

Roche to acquire US-based Poseida Therapeutics

Basel, 26 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc. (“Poseida”, NASDAQ: PSTX), a public clinical-stage biopharmaceutical company pioneering donor-derived CAR-T cell therapies. Based in San Diego, California, Poseida's R&D portfolio includes pre-clinical and clinical-stage off-the-shelf (also referred to as allogeneic) CAR-T therapies across several therapeutic areas including haematological malignancies, solid tumours, and autoimmune disease, as well as manufacturing capabilities and technology platforms.

Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy candidates and related platform technologies

Poseida stockholders to receive up to $13.00 per share in cash, comprised of $9.00 per share in cash at closing and a non-tradeable contingent value right (CVR) to receive up to an aggregate of $4.00 per share in cash; transaction represents total equity value of up to $1.5 billion Poseida to join the Roche Group and advance its innovative pipeline of non-viral, TSCM-rich CAR-T therapies and genetic medicines as part of Roche's Pharmaceuticals Division SAN DIEGO , Nov. 26, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX) ("Poseida"), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer, autoimmune and rare diseases, today announced that it has entered into a merger agreement to be acquired by Roche Holdings, Inc. ("Roche") at a price of $9.00 per share in cash at closing, plus a non-tradeable CVR to receive certain contingent payments of up to an aggregate of $4.00 per share in cash upon achievement of specific milestones. This corresponds to a total equity value of approximately $1.5 billion on a fully diluted basis.

Poseida Therapeutics, Inc. Announces Agreement to be Acquired by Roche Holdings, Inc.

Basel, 26 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) reports an update on the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Roche reports update on Phase III SKYSCRAPER-01 study results

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reports an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 is a global Phase III, randomized, double-blinded study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 5.

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