BioNTech’s Melanoma Treatment Candidate Bags FDA Fast Track Designation


BioNTech SE’s (BNTX) BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma, has been granted Fast Track designation by the U.S. Food and Drug Administration.

Currently, BioNTech’s vaccine candidate is being investigated in a Phase 2 trial in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma. (See BioNTech stock chart on TipRanks)

The Fast Track designation has been given to BNT111 based on preclinical and clinical data that reflect on its potential to overcome current limitations in the treatment of inoperable therapy-resistant advanced-stage melanoma.

The ongoing trial on the candidate is investigating BNT111 in combination with Libtayo® (cemiplimab), an anti-PD-1 monoclonal antibody being co-developed by Regeneron and Sanofi.

The M.D., Co-founder and Chief Medical Officer of BioNTech, Özlem Türeci, said, “With the Fast Track status and support by the FDA, we aim to expedite the further development of the BNT111 program to provide a new therapeutic option for patients with life-threatening, hard-to-treat melanoma.”

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Consensus Rating

On November 11, Goldman Sachs analyst Chris Shibutani reiterated a Hold rating on the stock and lowered the price target to $289 from $433. The new price target implies 0.3% downside potential to current levels.

Shibutani said, “While vaccine marketplace trends continue to provide tailwinds for mRNA-vaccine manufacturers, more hesitant management commentary around the endemic phase booster markets prompts a downward revision of our revenue projections in FY2023 and beyond.”

Consensus among analysts is a Moderate Buy based on 4 Buys and 7 Holds. The average BioNTech price target of $307.91 implies 6.3% upside potential.

Smart Score

According to the TipRanks’ Smart Score rating system, BioNTech gets a 7 out of 10, which indicates that the stock is likely to perform in line with market averages.

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