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Roche Holding

ROCHE HLDG LTD SPONS

Roche is a Swiss biopharmaceutical and diagnostic company. The firm's bestselling pharmaceutical products include a variety of oncology therapies from acquired partner Genentech, and its diagnostics group was bolstered by the acquisition of Ventana in 2008. Oncology products account for 50% of pharmaceutical sales, and centralized and point-of-care diagnostics for more than half of diagnostic-related sales.

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RHHBY

TEVA

Piper Sandler analyst maintains an Overweight rating on Teva, citing positive feedback on duvakitug&#39;s potential in treating IBD.

Teva&#39;s Duvakitug Set To Shake Up IBD Treatment, Analyst Highlights Competitive Data

Collapsing,Dna,Molecules,On,A,Blurred,Background.

Biotech

Health Care

SRPT

Sarepta&#39;s EMBARK study confirms Elevidys offers sustained Duchenne treatment benefits, including motor function improvement and minimal muscle pathology progression.

Sarepta Therapeutics&#39; Duchenne Gene Therapy Shows Sustained Benefits And Disease Stabilization At Two Years

Doctor,Hand,Hold,And,Offer,To,Patient,Medical,Marijuana,And

Cannabis

Medical marijuana reduces benzodiazepine prescriptions, saving patients from potential risks. This threatens big pharma&#39;s profits.

Legal Marijuana Linked To Drop In Anxiety Medications: What It Means For Pharma Giants

ROCHE HOLDING LTD S/ADR by Roche Holding Ltd

Roche Holding AG

Piper Sandler analyst David Amsellem reiterated the Overweight rating on Teva Pharmaceutical Industries Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) <a href="https://www.benzinga.com/quote/TEVA/analyst-ratings">with a price forecast of $30.</a>
Amsellem writes that he hosted a call with a top gastroenterologist who treats many ulcerative colitis and Crohn&#8217;s disease patients. The doctor specializes in managing treatment-experienced and refractory cases at a major referral center.
From the call, the analyst notes that feedback on Teva's/Sanofi's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) anti-TL1A antagonist duvakitug, along with the broader anti-TL1A class, suggests these agents could play a significant role in treating both ulcerative colitis and Crohn&#8217;s disease, which is supported by competitive data.
Amsellem highlights that according to the featured expert, biomarkers are crucial, and they are particularly interested in studies/data stratified by biomarkers.
The analyst will closely follow what Teva shares on this at the upcoming ECCO meeting.
Both Merck &amp; Company, Inc. and Roche Holding Ltd are also stratifying their anti-TL1A studies by biomarkers.
The expert considers that biomarkers could greatly benefit the broader inflammatory bowel disease (IBD) field if they are easy to assess and help predict clinical response.
While Teva/Sanofi&#8217;s all-comers Phase III program for duvakitug is commercially reasonable, the goal is to address a wide ulcerative colitis and Crohn&#8217;s disease patient audience.
Price Action: TEVA shares are trading lower by 1.47% to $21.46 at last check Tuesday.
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Photo by Ralf Liebhold via Shutterstock.

Teva's Duvakitug Set To Shake Up IBD Treatment, Analyst Highlights Competitive Data

– Updated overall survival (OS) results – a key secondary endpoint – reinforce the significant benefit of the ItovebiTM (inavolisib)-based regimen for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting –
– Primary analysis showed the Itovebi-based regimen reached statistical significance, more than doubling progression-free survival in this patient population –
– Full OS results from the Phase III INAVO120 study will be presented at an upcoming medical meeting –

RHHBF

RHHVF

Roche's Genentech Reports Significant Survival Benefit With Itovebi In Advanced HR-Positive Breast Cancer Patients

On Monday, Sarepta Therapeutics Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) released topline results from Part 2 of EMBARK (Study SRP-9001-301) Phase 3 clinical study of Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with <a target="_blank" href="https://www.benzinga.com/quote/SRPT" rel="noreferrer noopener">Duchenne muscular dystrophy</a>.
Crossover-treated patients who received a placebo in Part 1, crossed over at 52 weeks and were treated with Elevidys in Part 2 improved 2.34 points from baseline compared to matched external controls on the North Star Ambulatory Assessment (NSAA) 52 weeks after treatment. NSAA measures functional motor abilities in <a href="https://www.benzinga.com/pressreleases/25/01/b43220537/sarepta-therapeutics-announces-results-from-part-2-of-the-embark-study-demonstrating-sustained-ben" target="_blank" rel="noreferrer noopener">children with Duchenne</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/42883730/solid-biosciences-outpaces-competitors-in-duchenne-gene-therapy-development" rel="noreferrer noopener">Solid Biosciences Outpaces Competitors In Duchenne Gene Therapy Development</a>
Despite being one year older (average age 7.18 years) than those treated in Part 1 (average age 5.98 years), crossover-treated patients showed clinically meaningful and statistically significant functional benefit for NSAA, Time to Rise (TTR) and 10-meter walk/run (10MWR) function tests compared with a pre-specified, propensity-weighted external control group (EC).
Individuals treated in part one of EMBARK (n=63) showed clinically meaningful and statistically significant improvements on the NSAA sustained two years after treatment with Elevidys. Functional motor improvements include:
<ul>
<li>+2.88 points (improvement) on NSAA.</li>
<li>-2.06 seconds (improvement) on Time to Rise.</li>
<li>-1.36 seconds (improvement) on 10MWR.</li>
</ul>
Muscle biopsies from a subset of patients taken 64 weeks after dosing in part one showed consistent and sustained expression of micro-dystrophin. Muscle pathology on MRI continues to show minimal progression in underlying muscle pathology and remains highly consistent with the functional benefits shown.
No new safety signals were observed.
As part of a collaboration agreement signed in 2019, Sarepta is working with Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>). Sarepta is responsible for regulatory approval and commercializing Elevidys in the U.S. and manufacturing.
Roche is responsible for regulatory approvals and bringing Elevidys to patients across the rest of the world.
Price Action: SRPT stock closed at $116.46 on Friday.
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Sarepta Therapeutics' Duchenne Gene Therapy Shows Sustained Benefits And Disease Stabilization At Two Years

In states where both medical and recreational marijuana are legal, patients are filling fewer prescriptions for medications commonly used <a href="https://www.benzinga.com/topic/anxiety">to treat anxiety</a>, according to a recent study published in JAMA Network Open.
The findings consistently showed that increased access to marijuana correlates with reductions in benzodiazepine prescription fills, which refer to the number of prescriptions picked up by patients, not the number written by doctors. 
Lead <a href="https://spp.gatech.edu/people/person/ashley-bradford">author</a> Ashley Bradford, PhD, of the Georgia Institute of Technology, <a href="https://www.painnewsnetwork.org/stories/2025/1/19/prescriptions-for-anti-anxiety-meds-decline-in-states-where-marijuana-is-legal#google_vignette">noted</a> that the research is particularly relevant given that nearly 23% of U.S. adults reported having a diagnosable mental health disorder in 2021, but only 65% of them received treatment.
Expanding cannabis access offers an alternative treatment avenue, especially as many <a href="https://www.benzinga.com/cannabis/laws">state medical marijuana laws</a> allow patients with mental health conditions like post-traumatic stress disorder (PTSD) to use medical cannabis. The Food and Drug Administration <a href="https://www.benzinga.com/24/11/42100354/fda-approves-cannabis-trial-for-veterans-with-ptsd-after-years-of-delays">approved a clinical trial in November 2024</a> to assess the efficacy of smoked medical marijuana in treating PTSD among military veterans.
The <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2823248?resultClick=3">findings</a> have significant implications for insurance providers, prescribers, patients and pharmaceutical companies that produce benzodiazepines, which, like opioids, carry risks. In 2020, benzodiazepines contributed to 14% of total opioid overdose deaths, said Bradford, who added that the substitution of marijuana for medications with high misuse potential could also have far-reaching public health benefits.
<h2 class="wp-block-heading">Could Cannabis For Anxiety Cut Into Big Pharma's Bottom Line?</h2>
Bradford&#8217;s research focused on medications like Valium, Xanax and Ativan, which are brand names for diazepam, alprazolam and lorazepam, respectively. Xanax and Lorazepam are produced by Pfizer, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Wyeth Pharmaceuticals, which <a href="https://www.investopedia.com/companies-owned-by-pfizer-5211303">Pfizer acquired in 2009</a>.
The most common drug, Valium, produced by the Hoffmann-La Roche pharmaceutical company – now <a href="https://www.benzinga.com/24/12/42721437/roche-ceo-reassures-no-job-cuts-despite-drug-development-challenges-reports">Roche Holdings</a> (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) &nbsp;&#8211; was introduced in 1963 and gained popularity as a sedative almost immediately. Between 1969 and 1982, "Mother's Little Helper" as the Rolling Stones called it in their 1966 hit song, Valium was the <a href="https://drugabuse.com/benzodiazepines/valium/history-and-statistics/">most prescribed drug in the US</a>. Sales peaked in 1978 with more than 2.3 billion pills sold that year. 
Roche, with a market value of $244.27 billion, is among the <a href="https://www.visualcapitalist.com/cp/worlds-50-largest-pharmaceutical-companies/">largest pharmaceutical companies</a> in the world.
According to <a href="https://my.clevelandclinic.org/health/treatments/24570-benzodiazepines-benzos">the</a> Cleveland Clinic, benzodiazepines are still among the most commonly prescribed medications and are notably &#8220;habit-forming.&#8221; 
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Photo: Shutterstock

On Thursday, Outlook Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OTLK#NASDAQ">OTLK</a>) completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT evaluating ONS-5010 in wet age-related macular <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g43023003/outlook-therapeutics-announces-complete-twelve-week-efficacy-and-safety-results-of-norse-eight-cli" rel="noreferrer noopener">degeneration (wet AMD) patients</a>.
ONS-5010 demonstrated non-inferiority to Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) / Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Lucentis (ranibizumab) at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025.
The difference in the mean between ONS-5010 and ranibizumab was -1.009 best corrected visual acuity (BCVA) letters.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37893076/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-higher-on-friday" rel="noreferrer noopener">Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Higher On Friday?</a>
BCVA measures how well a person can see after wearing corrective lenses, such as glasses or contact lenses.
In the intent-to-treat (ITT) population, NORSE EIGHT demonstrated a mean 5.5 letter improvement in BCVA in the ONS-5010 arm and 6.5 letter improvement in BCVA in the ranibizumab arm.
As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment (SPA) with the U.S. <a target="_blank" href="https://www.benzinga.com/24/11/42214804/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-lower-on-wednesday" rel="noreferrer noopener">Food and Drug Administration (FDA)</a>.
However, BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity.
Overall, in NORSE EIGHT, ONS-5010 demonstrated mean visual acuity improvements of +3.3 letters at week 4, +4.2 letters at week 8, and +5.5 letters at week 12.
ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab.
ONS-5010/LYTENAVA (bevacizumab gamma) has been approved in the European Union and the United Kingdom. Outlook Therapeutics intends to begin launching in Europe in the first half of calendar 2025.
The company also entered into agreements for warrant inducement transactions expected to result in up to $20.4 million in gross proceeds.
The company will use the proceeds to fund its ONS-5010 clinical development programs, the European commercial launch of LYTENAVA, and working capital and general corporate purposes.
Price Action: OTLK stock is down 9.78% at $2.06 at last check Thursday.
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Financing

Offerings

OTLK

Outlook Therapeutics Vision Loss Drug At Par With Novartis Drug

<ul>
<li>The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2</li>
<li>The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients.</li>
<li>B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is one of the most common cancers in the US.3</li>
</ul>

Roche's VENTANA ISH Test Secures FDA Clearance For Accurate B-Cell Lymphoma Diagnosis

<ul>
<li>The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. &nbsp;</li>
<li>This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab. &nbsp;</li>
<li>Primary diagnosis in digital pathology helps enhance diagnostic accuracy, consistency, and speed by providing high-resolution images and advanced analysis tools.</li>
</ul>

Roche's Digital Pathology Dx System Expands With FDA Approval Of High-Capacity VENTANA DP 600 Scanner

Under the agreement, Innovent has granted Roche exclusive global rights to develop, manufacture and commercialize IBI3009. The two parties will jointly focus on the early-stage development of this ADC candidate, after which Roche will take over full development. Innovent will receive an upfront payment of US$80 million and is eligible to receive up to US$1 billion in development and commercial milestone payments, along with tiered royalties on net sales.

IVBIY

Reported Wednesday, Roche And Innovent Forge Exclusive Global License Deal To Develop DLL3-Targeting ADC For Advanced Lung Cancer

On Monday, Sangamo Therapeutics, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGMO#NASDAQ">SGMO</a>) regained the development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy product candidate for moderately severe to severe hemophilia A that it has co-developed with and licensed to Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>).
Pfizer decided to terminate the global collaboration and license agreement <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/b42733065/sangamo-therapeutics-to-regain-full-rights-to-hemophilia-a-gene-therapy-program-following-pfizers-" rel="noreferrer noopener">between the parties</a>. Sangamo intends to explore all options to advance the program, including seeking a potential new collaboration partner.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41310468/fda-approves-pfizers-second-hemophilia-drug-with-six-months" rel="noreferrer noopener">FDA Approves Pfizer&#8217;s Second Hemophilia Drug With Six Months</a>
In July 2024, Pfizer announced topline results from the Phase 3 AFFINE trial of giroctocogene fitelparvovec, which demonstrated that the trial met the primary and key secondary objectives of superiority <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39937203/sangamo-stock-spikes-as-pfizer-partnership-meets-goal-in-late-stage-study" rel="noreferrer noopener">compared to prophylaxis</a>.
&#8220;&#8230;we believe it is well positioned for regulatory submissions and potential commercialization,&#8221; said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. &#8220;While we were surprised and extremely disappointed by Pfizer&#8217;s decision to end our collaboration so close to the anticipated BLA and MAA submissions&#8230;&#8221;
The collaboration and license agreement with Pfizer will terminate effective April 21, 2025. All trial participants will continue to be monitored as planned during the transition period.
Sangamo believes that its recently announced partnerships with Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Genentech and Astellas Pharma Inc (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ALPMF#OTC">ALPMF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ALPMY#OTC">ALPMY</a>) and advanced business development discussions for its Fabry gene therapy program will allow it to chart a path forward for its neurology genomic medicine pipeline.
The company prepares to initiate the expected enrollment of patients in the Phase 1/2 study of ST-503 for idiopathic small fiber neuropathy in mid-2025 and file an anticipated Clinical Trial Authorisation submission for the prion disease program in Q4 2025, each subject to securing additional funding.
Price Action: SGMO stock is down 54.70% at $1.106 during the premarket session at last check Tuesday.
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ALPMF

ALPMY

SGMO

Sangamo Therapeutics Stock Plunges As Pfizer Terminates Hemophilia Gene Therapy Pact

Swiss pharmaceutical giant Roche Holding AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) reportedly has no plans for job cuts despite facing recent challenges in its drug development pipeline.
CEO Thomas Schinecker, in an interview with NZZ am Sonntag, reassured that worker numbers are constant to slightly increasing, reported Reuters.
He also emphasized healthy business and not having a growth problem either. Meanwhile, the report noted Schinecker&nbsp;saying that the company&#8217;s research and development budget remains stable without expansion.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42597251/roche-prothena-partnered-mid-stage-parkinsons-trial-misses-primary-endpoint-but-cling-on-signs-of-clinical-benefits" rel="noreferrer noopener">Roche-Prothena Partnered Mid-Stage Parkinson&#8217;s Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits</a>
Schinecker also provided insights into Roche&#8217;s pipeline, estimating that the company&#8217;s anti-obesity drug could hit the market by 2029 or earlier, per the report.
Addressing the broader economic landscape, Schinecker acknowledged challenges in Europe and China, contrasting them with moderate growth in the U.S.
Price Action: RHHBY shares closed at $35.07 on Friday.

Media

Roche CEO Reassures No Job Cuts Despite Challenges: Report

On Thursday, Prothena Corporation plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTA#NASDAQ">PRTA</a>) released results from the Phase 2b PADOVA study of prasinezumab in early-<a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/b42568873/roches-phase-iib-study-of-prasinezumab-missed-primary-endpoint-but-suggests-possible-clinical-bene" rel="noreferrer noopener">stage Parkinson&#8217;s disease</a>.
Partner Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) conducted the 586-subject study investigating prasinezumab in early-stage Parkinson&#8217;s disease patients who had been treated for a minimum of 18 months while on stable symptomatic treatment.
Prasinezumab <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2024-12-19" rel="noreferrer noopener">showed</a> a potential clinical effect in the primary endpoint of time to confirmed motor progression with an HR=0.84 and p=0.0657, missing statistical significance.
The companies said the effect of prasinezumab was more pronounced in a pre-specified analysis in the population treated with levodopa (75% of participants), HR=0.79 and nominal p=0.0431.
Pre-specified supplementary covariate-adjusted analyses of these endpoints demonstrated nominally significant effects on the primary endpoint (HR=0.81; nominal p=0.0334) and in the levodopa subgroup (HR=0.76; nominal p=0.0175).
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.
The Phase 2 PASADENA and Phase 2b PADOVA open-label extension studies will continue to explore the observed effects in both studies.
Roche will continue to evaluate the data and work together with health authorities to determine the next steps.
Full results from the PADOVA study will be presented at an upcoming medical meeting.
Price Action: PRTA stock is up 32.40% at $15.83 at the last check on Thursday.
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PRTA

Roche-Prothena Partnered Mid-Stage Parkinson's Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits

&#x2A;– PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints –– Prasinezumab continues to be well tolerated and no new safety signals were observed
&#x2A;– PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints –
– Prasinezumab continues to be well tolerated and no new safety signals were observed –
– Genentech is further evaluating the data and will work together with health authorities to determine next steps –

Genentech's Prasinezumab Phase IIb Study Misses Primary Endpoint But Shows Potential In Early Parkinson's Disease

Teva Pharmaceutical Industries Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and <a href="https://www.benzinga.com/24/12/42531132/why-are-teva-and-sanofi-stocks-trading-higher-on-tuesday" target="_blank" rel="noreferrer noopener">Crohn&#8217;s disease (CD)</a>.
In the RELIEVE UCCD study, 36.2% (low-dose) and 47.8% (high-dose) of patients with ulcerative colitis treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14.
BofA Securities raised the price target for Teva to $25 from $23 <a target="_blank" href="https://www.benzinga.com/quote/TEVA/analyst-ratings" rel="noreferrer noopener">with a Buy rating</a>, reflecting a strong Phase 2 data update for duvakitug in inflammatory bowel disorders (IBD).
Based on the strength of the data and the emerging product prole, the analyst forecasts nominal peak sales of ~$2 billion (booked by partner), with Teva booking half the profits.
Given the anticipated impact on profits by 2030, BofA factors in the long-term strength of Teva&#8217;s innovative portfolio by applying a valuation multiple of 9.25x to 2025 estimated EV/EBITDA.
Partnership milestone payments provide reliable cash flow, and the analyst sees potential for the stock to gain value as the company shifts toward growth-focused execution.
The TL1a drug class has emerged over the last two years, led by Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Prometheus&#8217; strong Phase 2 data, which was followed by similar data from Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) competitor asset.
BofA writes that TL1a was a class of drug that could offer a very good safety profile, on par with market-leading Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) Entyvio, plus a high rate of efficacy across all major patient subgroups.
Data update from Teva in around 240 patients in Phase 2 showed 16%-27% placebo-adjusted MAYO remission scores in the UC population, with the high dose compared favorably to competitors.
TEVA Price Action: Teva Pharmaceutical stock is up 3.23% at $21.56 at publication Wednesday.
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Photo: Courtey Teva Pharmaceutical Industries

Teva Pharmaceutical Releases Impressive Phase 2 Candidate Data For Gastro-Related Diseases

During 2000–2020, the U.K.'s National Health Service (NHS) faced significant trade-offs in prioritizing new drug treatments, as resources allocated to these medications often came at the expense of broader population health gains.
Lancet research revealed that while newly approved drugs directly benefit certain patients, the overall impact on population health was negative due to the high costs and resulting resource reallocation.
A retrospective analysis reviewed technology appraisals conducted by the National Institute for Health and Care Excellence (NICE) on 332 drugs.
Of these, 276 (83%) received positive recommendations, and most were appraised within five years of regulatory approval.
The study ultimately included 183 drugs after excluding ineligible cases. While these drugs generated an estimated 3.75 million quality-adjusted life years (QALYs) across 19.82 million patients, their cost to the NHS—totaling $94.93 billion (75.1 billion pounds)—led to an estimated net loss of 1.25 million QALYs.
For example, oncology drugs demonstrated a median cost-effectiveness ratio (ICER) of 30,000 pounds per QALY gained, significantly higher than the 6,478 pounds for anti-infective drugs.
Additionally, the ICER for new drug recommendations rose by 32% from 2000 to 2020, reflecting increased financial pressures on the NHS.
Despite potential long-term benefits from price reductions after patent expiration, these effects were limited. Only 19% of the studied drugs had generic or biosimilar alternatives by 2020.
For new drugs to contribute positively to population health, their initial costs would have required a median reduction of 42%.
The ongoing debate around NICE's cost-effectiveness threshold remains central to policy discussions.
A 2024 agreement retained the current threshold until 2029, but experts argue for alignment with the Department of Health and Social Care's estimate of health-opportunity costs.
Such an adjustment could ensure the NHS achieves better value for its investments in new drugs without compromising care quality in other areas.
Balancing innovation with equitable health outcomes requires nuanced policy solutions. The study <a target="_blank" href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02352-3/fulltext" rel="noreferrer noopener">suggests</a> a lower cost-effectiveness threshold, closer to 15,000 pounds per QALY, could better align spending with health gains.
However, opposition from the pharmaceutical industry underscores the challenges of reforming pricing policies while fostering innovation.
This approach highlights how benefiting one group of patients may require deprioritizing others as existing NHS services and treatments are displaced to fund new drugs.
For instance, in 2010, NICE approved Roche Holding AG's (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Herceptin (trastuzumab) for metastatic gastric cancer, deeming an ICER of 43,206 pounds per QALY gained as cost-effective.
Framing this as 2.88 QALYs forgone for every QALY gained clarifies the value placed on patients receiving the treatment versus those who might lose out on care.
At a population level, using trastuzumab in this context resulted in an estimated 4,000 QALYs lost between 2010 and 2020.
However, adopting this perspective could pose challenges for policymakers due to the established 20,000–30,000 pounds per QALY threshold.
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United Kingdom's National Health Service Drug Spending Priorities Questioned in New Analysis

– Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing –
– First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration time –
– Positive results for Genentech's two bispecifics antibodies validate the company's efforts to provide multiple treatment options that suit the diverse needs of lymphoma patients and healthcare providers –

Reported Earlier, Roche's Genentech Presents Long-Term Data at ASH 2024 Highlighting Durable Remissions With Fixed-Duration Columvi And Lunsumio

<ul>
<li>– Exploratory long-term follow-up analysis of the Phase III POLARIX study indicated a positive trend in overall survival in favor of Polivy in combination with R-CHP for people with first-line diffuse large B-cell lymphoma (DLBCL) –</li>
<li>– Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems –</li>
<li>– These encouraging five-year results continue to highlight the potential of this Polivy combination to improve outcomes in first-line DLBCL, an area that previously had little advancement in nearly two decades –</li>
</ul>

Reported Sunday, Roche's Genentech Showcases Polivy's Transformative Impact On Frontline DLBCL Treatment: Five-Year POLARIX Trial Results Presented At ASH 2024

<ul>
<li>Application is based on data from the Phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival&nbsp;</li>
<li>This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progression&nbsp;</li>
<li>Improving survival outcomes is needed for people with an aggressive disease like relapsed or refractory DLBCL, especially those who aren't eligible for transplant&nbsp;</li>
<li>The FDA is expected to make a decision on approval by July 20, 2025.</li>
</ul>

FDA Accepts Genentech's sBLA For Columvi Combination Therapy For Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

Outlook Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OTLK#NASDAQ">OTLK</a>) revealed preliminary topline results of NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42210551/outlook-therapeutics-announces-preliminary-topline-results-of-norse-eight-clinical-trial" rel="noreferrer noopener">wet AMD patients</a>.
In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified noninferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA.
The pre-specified noninferiority endpoint was measured by mean change in best corrected visual acuity (BCVA) from baseline to week 8.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37893076/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-higher-on-friday" rel="noreferrer noopener">Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Higher On Friday?</a>
The difference in the means between the ONS-5010 and Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Lucentis (ranibizumab) in the NORSE EIGHT trial was -2.257 BCVA letters, while the lower bound of the pre-specified noninferiority margin in the SPA was -3.5; the hypothesis of noninferiority was not met (p&gt;0.025).&nbsp;
In the intent-to-treat (ITT) primary dataset, NORSE EIGHT demonstrated a mean +4.2 letter improvement in BCVA in the ONS-5010 arm and +6.3 letter improvement in BCVA in the ranibizumab arm.
However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010.
Data analysis is ongoing as month 3 data from NORSE EIGHT are being collected. The data is expected to be available in January 2025.
Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics plans to resubmit the U.S. marketing application for ONS-5010 in the first quarter of calendar 2025.
ONS-5010/Lytenava (bevacizumab gamma) has already been granted Marketing Authorization in the European Union and the U.K.
Outlook Therapeutics intends to continue efforts to launch in Europe in 2025, either directly or with a licensing partner.
If approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/Lytenava (bevacizumab-vikg) directly in the U.S. It is also assessing partnering options for Lytenava (bevacizumab gamma) in Europe and other regions <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g40706252/outlook-therapeutics-announces-completion-of-enrollment-in-norse-eight-clinical-trial" rel="noreferrer noopener">outside of the U.S.</a>
Price Action: OTLK stock is down 80% at $0.97 during the premarket session at last check Wednesday.
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Photo by Amanda Dalbjörn on Unsplash.

Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Lower On Wednesday?

On Tuesday, Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) agreed to acquire Poseida Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTX#NASDAQ">PSTX</a>) for an equity value of approximately&nbsp;$1.5 billion&nbsp;on a <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/n42180905/poseida-therapeutics-inc-announces-agreement-to-be-acquired-by-roche-holdings-inc" rel="noreferrer noopener">fully diluted basis</a>.
The deal consideration includes $9.00&nbsp;per share in cash plus a non-tradeable CVR to receive certain contingent payments of up to an aggregate of&nbsp;$4.00&nbsp;per share in cash upon achievement of specific milestones.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41505575/roches-q3-sales-surge-led-by-ocrevus-vabysmo-urges-regulators-to-block-novo-holdings-16-5b-catale" rel="noreferrer noopener">Roche&#8217;s Q3 Sales Surge Led By Ocrevus, Vabysmo, Urges Regulators To Block Novo Holdings&#8217; $16.5B Catalent Acquisition</a>
The proposed acquisition will establish a new core capability for&nbsp;Roche in allogeneic cell therapy, with lead opportunities focused on CAR-T programs covered by the existing strategic collaboration between Poseida and Roche in hematologic malignancies.
It will include CAR-T programs for solid tumors and autoimmune diseases, Poseida&#8217;s genetic engineering platform, and related preclinical medicines.
The acquisition <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2024-11-26b" rel="noreferrer noopener">supports</a> Roche&#8217;s Pharma Strategy and allows for a range of potentially first and best-in-class therapies across oncology, immunology, and neurology, uniquely positioning Roche in the new field of donor-derived off-the-shelf cell therapies.
In its third-quarter earnings release, Poseida said it has three programs under Roche collaboration announced in August 2022, including P-BCMA-ALLO1, an allogeneic CAR-T therapy in Phase 1/1b&nbsp;development for multiple myeloma, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T candidate in Phase 1 development for <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/n41823822/poseida-therapeutics-provides-updates-and-financial-results-for-the-third-quarter-of-2024" rel="noreferrer noopener">B-cell malignancies</a>.&nbsp;
In October, Poseida Therapeutics nominated a new development candidate under its collaboration with Roche. The nomination triggered a&nbsp;$15 million&nbsp;milestone payment from Roche to Poseida.
The new candidate is an allogeneic, dual CAR-T therapy targeting known antigens expressed in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/n41378041/poseida-therapeutics-announces-nomination-of-new-car-t-development-candidate-under-collaboration-w" rel="noreferrer noopener">hematologic malignancies</a>.
The transaction is expected to close in the first quarter of 2025.
Concurrently, Roche <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2024-11-26" rel="noreferrer noopener">revealed</a> an update on the Phase 3 SKYSCRAPER-01 study of tiragolumab combined with Tecentriq (atezolizumab) compared to Tecentriq alone for PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).&nbsp;
The 534-patient study did not reach the primary endpoint of overall survival at the final analysis.
The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.
Roche regularly evaluates its research programs to see if changes are needed to support ongoing studies. The same approach will be applied to this program, with more data from Phase 3 trials in various settings or tumor types expected next year.
Price Action: PSTX stock is up 227.3% at $9.36 during the premarket session at last check Tuesday.
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PSTX

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

SKYSCRAPER-01 is a global Phase III, randomized, double-blinded study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit, or unacceptable toxicity. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.

Roche's Genentech Provides Update On SKYSCRAPER-01 Phase III Study In PD-L1-High NSCLC Patients

Press Releases

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

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

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Innovent Enters into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate

Roche's momentum in digital pathology continues with FDA clearance on its high-volume slide scanner

Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma

Dyno Therapeutics Announces Exercise of Option by Roche for Next-Generation AAV Vector for Neurological Gene Therapy

Genentech's Itovebi Demonstrated Statistically Significant and Clinically Meaningful Overall Survival Benefit in a Certain Type of HR-Positive Advanced Breast Cancer

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