BioNTech’s Cancer Drug Misses A Key Trial Goal – Citi Says Survival Data Could Preserve ‘A Meaningful Development Path’

• The trial will continue to assess its remaining primary goal of overall survival.
• Citi maintained its ‘Buy’ rating and $125 price target, according to The Fly.
• The firm said additional benefits over Keytruda are hard to showcase since head and neck cancer can be difficult to treat with immunotherapy.

Shares of BioNTech (BNTX) fell more than 5.5% on Tuesday after the biotech company reported disappointing results from a late-stage head and neck cancer trial, with its experimental mRNA treatment failing to significantly delay disease progression.

However, the company said the study would continue to assess whether the treatment can help patients live longer.

BNTX shares were headed for their fifth decline in six sessions.

What Did The Trial Show?

BioNTech’s Phase 2/3 Ahead-Merit trial is evaluating BNT113 alongside Merck’s (MRK) Keytruda in patients with advanced head and neck cancer linked to HPV16, a high-risk form of human papillomavirus.

The combination failed to significantly improve progression-free survival, indicating no clear advantage over Keytruda alone in delaying cancer progression or death.

However, the trial’s other primary goal is overall survival, which measures how long patients live. BioNTech Chief Medical Officer Özlem Türeci said the results support continued testing, as immune responses may take time to produce lasting benefits.

“The analysis of the second dual primary endpoint, overall survival, will be critical to fully assess the potential of this approach to deliver durable benefit for patients with HPV-driven head and neck cancer,” Türeci said.

Citi Sees A Path Forward

Despite the trial update, Citi maintained its ‘Buy’ rating and $125 price target, according to The Fly. This implies a 39% upside potential from current levels.

The firm noted that head and neck cancer can be difficult to treat with immunotherapy, making it challenging to demonstrate additional benefits over Keytruda.

However, Citi highlighted that the trial could still be considered successful if the treatment significantly improves overall survival, "preserving a meaningful development path," despite the initial setback.

BioNTech’s Pipeline Includes 14 Oncology Trials

BioNTech has 14 oncology trials underway as of August. Its pipeline includes Pumitamig, an experimental cancer immunotherapy being developed with Bristol Myers Squibb (BMY), and antibody-drug conjugates to deliver cancer-killing medicines directly to tumors.

The company reported about €16.63 billion ($18.62 billion) in cash, cash equivalents, and security investments as of June 30.

Retail’s Take On BNTX

Retail sentiment on Stocktwits surrounding BNTX remained ‘neutral’ over the past 24 hours.

The stock is down more than 6% so far this year.

(Exchange Rate: €1 = $1.12)

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