PFIZER (PFE) Company Report

In the Phase 3 EV-304 trial, perioperative PADCEV (enfortumab vedotin) plus pembrolizumab cut the risk of recurrence or death by 47% versus neoadjuvant gemcitabine/cisplatin (HR 0.53; 95% CI 0.41–0.70; 1-sided p<.0001).
The regimen yielded a 55.8% pathological complete response at surgery versus 32.5% with standard chemotherapy (difference 23.4%; 95% CI 16.7–29.8; 1-sided p<.0001).
Overall survival was improved, with a 35% reduction in risk of death (HR 0.65; 95% CI 0.48–0.89; 1-sided p=.0029).
Safety was consistent with prior data, with grade ≥3 adverse events in 75.7% of patients versus 67.2% in the chemotherapy arm, and no new safety signals.

9 hours ago

Press Release

Pfizer publishes report on the oral small-molecule GLP-1 patent race

PFE

PatentVest released its “The Oral Small-Molecule GLP-1 Race: Beyond Orforglipron” Pulse report, analyzing 50 oral GLP-1 programs and reviewing 1,200+ patent documents across 26 clinical-stage assets.
The report highlights a $71 billion injectable GLP-1 market with under 5% patient reach, prompting 50 oral programs aiming for 12–16% weight-loss efficacy to capture the remaining market.
Since 2023, $47 billion has been committed to GLP-1 deals; with semaglutide’s patent cliff in 2031 and tirzepatide’s in 2036, long-term exclusivity hinges on patent depth and defensibility.
Leading programs from Eli Lilly, Novo Nordisk, Pfizer, Roche, AstraZeneca, Gilead and others are assessed for patent scope—from genus claims to method-of-use coverage—to forecast which assets can secure 20-year franchises.

1 day ago

Press Release

Pfizer’s ViiV Healthcare presents pipeline data for two investigational HIV therapies

PFE

New Projects/Investments

In a phase 1 study, VH184, a third-generation integrase inhibitor, maintained steady drug levels through Month 7, supporting up to twice-yearly dosing.
In vitro data show VH184 has improved potency and an enhanced resistance profile versus bictegravir against resistant HIV strains, indicating a higher barrier to resistance.
VH499, an investigational capsid inhibitor, was well tolerated in phase 1 trials and maintained stable drug levels for up to six months, supporting ultra-long-acting twice-yearly dosing.
ViiV Healthcare plans to advance VH184 into phase 2b studies to optimize dosing schedules and further assess its twice-yearly regimen potential.

2 days ago

Press Release

Pfizer granted full FDA approval for BRAFTOVI regimen in first-line metastatic colorectal cancer

PFE

Product Launch

The U.S. FDA granted full approval to Pfizer’s BRAFTOVI® (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for adult patients with metastatic colorectal cancer harboring a BRAF V600E mutation, making it the only approved targeted first-line regimen in this setting.
Phase 3 BREAKWATER trial data showed a 51% reduction in risk of death (HR 0.49) and a 47% reduction in risk of progression or death (HR 0.53) versus chemotherapy (± bevacizumab), with median overall survival of 30.3 months versus 15.1 months and median progression-free survival of 12.8 months versus 7.1 months.
Full approval follows December 2024’s accelerated approval and is based on the trial’s dual primary endpoints (ORR and PFS) plus key overall survival data, and allows flexibility to use BRAFTOVI with cetuximab alongside different fluorouracil-based regimens such as mFOLFOX6 and FOLFIRI.

3 days ago

Press Release

Pfizer secures FDA approval for Braftovi regimen in BRAF V600E mCRC

PFE

Product Launch

The FDA granted full approval to encorafenib (Braftovi) combined with cetuximab and fluorouracil-based chemotherapy for adults with metastatic colorectal cancer harboring a BRAF V600E mutation, building on an accelerated approval from December 2024.
Approval was based on the global Phase 3 BREAKWATER trial, which demonstrated a median progression-free survival of 12.8 months for the encorafenib + cetuximab + mFOLFOX6 arm.
In the randomized portion of BREAKWATER, 236 patients received the Braftovi combination versus 243 patients in the control arm, with primary endpoints of PFS, objective response rate, and overall survival.
Regulators require confirmation of the BRAF V600E mutation using an FDA-approved test (Qiagen Therascreen BRAF V600E RGQ PCR Kit), and BREAKWATER data were presented at the 2026 ASCO Gastrointestinal Cancers Symposium.

3 days ago

Morningstar

Beam Therapeutics reports Q4 and full-year 2025 results and launches PKU program

PFE

Earnings

Debt Issuance

New Projects/Investments

Announced a new liver-targeted genetic disease program, BEAM-304, to correct PAH gene mutations in PKU patients with an IND filing expected in 2026.
Entered a $500 million non-dilutive credit facility with Sixth Street—$100 million funded at close, $300 million tied to milestones and $100 million optional—with a minimum $200 million drawdown, extending cash runway into mid-2029.
Reported $1.25 billion in cash, cash equivalents and marketable securities at December 31, 2025; full-year R&D expenses of $409.6 million, G&A expenses of $113.8 million, and a net loss of $80.0 million; Q4 net income was $244.3 million ($2.37 per share).
Expecting updated Phase 1/2 data for BEAM-302 by end of Q1 2026 and planning a BLA submission for risto-cel in sickle cell disease as early as year-end 2026.

4 days ago

Press Release

Pfizer secures China commercialization rights for ecnoglutide

PFE

New Projects/Investments

Pfizer obtained exclusive China commercialization rights for the GLP-1 therapy ecnoglutide in a deal worth up to $495 million, with Hangzhou Sciwind Biosciences retaining marketing authorization.
Ecnoglutide is approved in China for adults with type 2 diabetes and is under regulatory review for chronic weight management; Chinese trials showed 15.1% placebo-adjusted weight loss, 92.8% of patients achieved clinically meaningful weight reduction, and over 80% reached HbA1c below 7%.
Under the agreement, Sciwind will oversee R&D, registration, manufacturing, and supply, while Pfizer’s payments include an upfront fee plus regulatory- and sales-based milestones.
The collaboration accelerates Pfizer’s strategic footprint in China’s metabolic field and positions it to compete in the growing weight-loss market against Novo Nordisk, Eli Lilly, and local rivals.

4 days ago

Bloomberg

Traws Pharma completes Phase 2 ratutrelvir study and updates tivoxavir marboxil prophylaxis plans

PFE

New Projects/Investments

Phase 2 data show ratutrelvir 600 mg daily for 10 days had fewer treatment-related adverse events (10% vs 23.3%) and comparable time to sustained symptom resolution versus PAXLOVID® in eligible and ineligible COVID-19 patients (HR 1.31; p=0.018)
The absence of viral rebound and a favorable tolerability profile support further evaluation of ratutrelvir for acute COVID-19 and potential Long COVID prevention
Preclinical studies of tivoxavir marboxil tablets demonstrated 30% increased exposure over the prototype, with modelling predicting 28-day, once-monthly influenza prophylactic coverage
The FDA has placed the US IND for tivoxavir marboxil on clinical hold over mutagenicity concerns, with formal feedback expected by March 16, 2026; non-US studies remain on track

Feb 19, 2026, 12:30 PM

Press Release

Pfizer reports BREAKWATER trial success in metastatic colorectal cancer

PFE

Pfizer’s BRAFTOVI plus cetuximab and FOLFIRI regimen achieved a statistically significant improvement in progression-free survival in Cohort 3 of the Phase 3 BREAKWATER trial.
The regimen delivered a 60.9% objective response rate vs. 40.0% with control, and a secondary analysis indicated an overall survival improvement.
The safety profile was consistent with known effects, with no new safety signals identified.
Pfizer plans to submit detailed BREAKWATER data to the FDA to support potential approval, building on earlier accelerated approval for a related BRAFTOVI combination.

Feb 17, 2026, 11:54 AM

Morningstar

Pfizer reports improved PFS in BRAFTOVI metastatic CRC trial

PFE

Pfizer’s investigational BRAFTOVI regimen (encorafenib + cetuximab + FOLFIRI) in Cohort 3 of the Phase 3 BREAKWATER trial showed a statistically significant and clinically meaningful improvement in progression-free survival in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.
Overall survival, a descriptive secondary endpoint, also demonstrated clinically meaningful prolongation with the BRAFTOVI regimen versus FOLFIRI ± bevacizumab.
Safety findings for the triplet were consistent with known profiles of each component, with no new safety signals identified at the time of analysis.

Feb 17, 2026, 11:45 AM

Press Release