Pfizer Stock Price, News & Analysis

ViiV Healthcare has announced groundbreaking results from implementation studies for their HIV prevention injectable Apretude and treatment injectable Cabenuva at CROI 2025. The studies demonstrated remarkable effectiveness with zero HIV acquisitions reported in nearly 4,000 people using Apretude for prevention.

The PILLAR study, involving 201 participants across 17 U.S. clinics, showed zero HIV cases over 12 months, with 72% persistence rate. The ImPrEP CAB Brazil study of 1,447 participants demonstrated superior PrEP coverage with Apretude (96.2%) compared to oral PrEP (64.1%).

For Cabenuva treatment, real-world data from the OPERA analysis (n=2,485) showed 95% of patients maintained viral suppression, with only 1% experiencing confirmed virologic failure. The Trio Health cohort (n=928) similarly demonstrated 95% viral suppression maintenance, with 89% of injections administered on schedule.

ViiV Healthcare announced positive results from its phase IIb EMBRACE study evaluating N6LS (VH3810109), a broadly neutralising antibody for HIV treatment. When administered every four months in combination with monthly cabotegravir long-acting (CAB LA), N6LS effectively maintained viral suppression in HIV patients stable on treatment.

Key findings at the six-month endpoint showed that 96% of participants receiving N6LS 60mg/kg intravenously and 88% receiving 3000mg subcutaneously maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. The treatment was generally well-tolerated, though subcutaneous administration showed more frequent infusion site reactions (14%) compared to none with IV administration.

Based on these favorable results, ViiV Healthcare will advance development of a six-month IV formulation of N6LS in combination with CAB LA in an EMBRACE part two trial.

ViiV Healthcare announced positive results from two phase IIa studies of investigational HIV therapies at CROI 2025. The studies focused on VH4524184 (VH184), a third-generation integrase inhibitor, and VH4011499 (VH499), a capsid inhibitor, both showing promise as long-acting injectable treatments.

VH184 demonstrated significant antiviral activity across three doses (10mg, 50mg, 300mg) in 22 treatment-naive adults. The 300mg dose achieved the maximum viral load decline of -2.69 log10 copies/mL. All side effects were mild to moderate with no serious adverse events.

VH499 showed positive results in 23 treatment-naive adults across doses of 25mg, 100mg, and 250mg. The highest dose (250mg) achieved a -2.2 log10 copies/mL decrease in HIV-1 viral load. The treatment was well-tolerated with only mild to moderate adverse events reported.

FoRx Therapeutics has appointed Dr. Jens Würthner as Chief Medical Officer, bringing over 20 years of clinical development expertise in oncology therapeutics. Dr. Würthner's experience includes successful drug development at companies like Novartis, GlaxoSmithKline, AstraZeneca, and ADC Therapeutics, where he oversaw the development of loncastuximab teserine (Zynlonta).

The company also provided an update on FORX-428, their lead development candidate targeting solid tumors. This PARG (Poly(ADP-ribose) glycohydrolase) inhibitor is progressing toward IND submission by mid-2025. Recent developments include:

• Completion of GLP toxicological testing
• Identification of predictive biomarkers for patient selection
• Promising animal studies showing strong anti-tumor efficacy and good tolerability

Akeso announced that its partner Summit Therapeutics (NASDAQ: SMMT) has entered a clinical trial collaboration with Pfizer (NYSE: PFE) to evaluate ivonescimab, a novel PD-1/VEGF bispecific antibody, in combination with several of Pfizer's antibody drug conjugates (ADCs) across multiple solid tumor settings.

The collaboration aims to accelerate development of potentially landscape-changing combinations to improve standards of care for cancer patients with serious unmet needs. Each study will evaluate ivonescimab plus one of Pfizer's vedotin ADCs in distinct solid tumor settings to determine safety profiles and potential anti-tumor activity.

Under the agreement, Summit will provide ivonescimab while Pfizer will conduct the studies, with oversight from both companies. Both parties retain rights to their respective products. The studies are planned to begin in mid-2025, with further details to be announced later.

Pfizer (NYSE: PFE) has announced a public webcast featuring a discussion with Albert Bourla, Chairman and CEO, at the TD Cowen 45th Annual Health Care Conference on March 3, 2025, at 10:30 a.m. EST.

The webcast will be accessible through www.pfizer.com/investors, with registration details available immediately. A transcript and replay will be posted within 24 hours after the live discussion and remain accessible for at least 90 days.

The discussion may include forward-looking statements about Pfizer's operating performance, product pipeline, business strategy, COVID-19 response, and ESG priorities. These statements are subject to risks and uncertainties as detailed in Pfizer's Annual Report on Form 10-K and subsequent SEC filings.

Summit Therapeutics (NASDAQ: SMMT) has announced a clinical trial collaboration with Pfizer (NYSE: PFE) to evaluate ivonescimab, a novel PD-1/VEGF bispecific antibody, in combination with Pfizer's antibody drug conjugates (ADCs) across multiple solid tumor settings.

The collaboration aims to assess ivonescimab with several of Pfizer's vedotin-based ADCs in distinct solid tumor settings to determine safety profiles and potential anti-tumor activity. Summit will provide ivonescimab while Pfizer will conduct the studies, with both companies overseeing the trials. Both parties maintain their respective product rights.

The clinical trials are scheduled to begin in mid-2024, with further details to be announced later. The partnership focuses on developing novel mechanisms beyond current available treatments, particularly targeting non-small cell lung cancer and other solid tumors.

Pfizer (NYSE: PFE) announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA® in combination with XTANDI® for metastatic castration-resistant prostate cancer (mCRPC). The study showed significant improvement in overall survival across two patient cohorts:

In unselected patients (Cohort 1), the combination therapy achieved a median overall survival of 45.8 months versus 37.0 months with XTANDI and placebo, representing a 20% reduction in death risk and nearly 9-month survival gain. In HRR-mutated patients (Cohort 2), median overall survival was 45.1 months versus 31.1 months with XTANDI and placebo, showing a 38% reduction in death risk and 14-month survival improvement.

The safety profile aligned with known characteristics of both medicines, with common adverse events including anemia, neutropenia, and fatigue. The data has been shared with FDA, EMA, and other global health authorities for potential label updates.

Pfizer (NYSE: PFE) has received FDA approval for ADCETRIS® combination therapy for treating relapsed/refractory large B-cell lymphoma (LBCL). The approval is based on the Phase 3 ECHELON-3 trial results, which showed the ADCETRIS regimen reduced death risk by 37% compared to standard treatment.

The therapy is specifically approved for adult patients with LBCL who have undergone two or more lines of systemic therapy and are not eligible for stem cell transplantation or CAR-T therapy. This marks ADCETRIS's eighth FDA-approved indication.

The ECHELON-3 study demonstrated significant improvement in overall survival, with benefits consistent across CD30 expression levels. More than 3,500 patients annually in the U.S. experience treatment failure after two prior therapy lines for this aggressive form of non-Hodgkin lymphoma.