BioNTech

The FDA placed a partial clinical hold on the phase 3 PRESERVE-003 trial evaluating gotistobart vs docetaxel in metastatic NSCLC due to varying results across disease cohorts. BioNTech and OncoC4 halted enrollment and will determine next steps for gotistobart in NSCLC, while other trials evaluating the drug in different indications are unaffected.

Innovative cancer therapies like mRNA-based treatments and CAR T-cell therapy are transforming research, leveraging the immune system to fight cancer effectively. Nonclinical studies are crucial for evaluating efficacy and safety before clinical trials, focusing on potential toxicities and immune responses. CAR T-cell therapy, approved for certain hematologic cancers, is being explored for solid tumors and next-generation enhancements. mRNA-based therapies, including cancer vaccines and immune modulators, show promise in early trials, with ongoing research addressing delivery challenges and immune response management. Future directions include personalized cancer vaccines and expanded CAR T-cell applications for solid tumors.

FDA places partial clinical hold on BioNTech and OncoC4's Phase III PRESERVE-003 trial of gotistobart due to varying results in squamous and non-squamous NSCLC patients. Enrolment is paused, but ongoing treatment for enrolled patients continues. Other gotistobart trials remain unaffected.

Astellas secures FDA approval for Vyloy, its first-in-class CLDN18.2-targeting cancer therapy, for certain gastric cancers. Vyloy, already approved in Japan, EU, and GB, demonstrated reduced risk of disease progression or death in SPOTLIGHT and GLOW trials. The FDA also cleared a CLDN18.2 diagnostic test from Roche for patient eligibility.

Pfizer CEO Dr. Albert Bourla's bold bet on a Covid-19 vaccine paid off, making Pfizer a household name and generating billions in sales. However, Pfizer's stock price has since dropped due to miscalculated vaccine demand and underperforming post-pandemic goals. Activist investor Starboard Value has taken a $1 billion stake in Pfizer, criticizing Bourla's leadership. Despite this, Bourla enjoys support from Pfizer's board and has implemented cost-cutting measures and reorganization efforts. Pfizer's post-pandemic slump, miscalculated demand, and underperforming new drug launches have led to a significant drop in stock value. Starboard's campaign against Bourla has become personal, accusing Pfizer of pressuring former executives to support Bourla. Bourla's ambitious goals and risks during the pandemic have been both praised and criticized, with some acquisitions yet to yield results.

Vontobel Holding Ltd. reduced its BioNTech SE stake by 62.5% in Q3, selling 28,574 shares. Other investors also adjusted their holdings, with GAMMA Investing LLC increasing its position by 21.7%. BioNTech's stock opened at $111.77 on Friday, with a market cap of $26.57 billion. The company reported a Q3 EPS of ($3.36), missing estimates by ($1.34). Analysts have upgraded their ratings, with a current consensus of 'Moderate Buy' and a target price of $131.92.

European stock markets mostly closed higher; construction production in the EU increased in August; UK retail sales rose in September; French business launches declined; Novo Nordisk's acquisition of Catalent faces opposition; EMA recommends approval for Novo Nordisk's Alhemo; Nokia appoints new officers; BioNTech's lung cancer trial put on hold.