Affimed N.V. AFMD announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its pipeline candidate, acimtamig (AFM13).
The regulatory body granted the RMAT designation to acimtamig in combination with Artiva Biotherapeutic’s ARTV AlloNK (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL).
Despite the FDA’s RMAT designation, shares of Affimed were down 6.5% on Dec. 5 following the announcement of the news. The stock, however, rebounded in after-hour trading and was up 5.6%.
The RMAT designation provides the candidate with increased opportunities to meet FDA officials, as well as arrange early meetings to discuss potential surrogate or intermediate endpoints. It opens up early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application.
Year to date, shares of Affimed have plunged 62.9% compared with the industry’s decline of 8%.
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More on AFMD's Acimtamig Combo Therapy
Acimtamig in combination with Artiva’s AlloNK (AB101) is currently being evaluated in the ongoing multi-cohort phase II LuminICE-203 study.
AFMD announced promising early efficacy data from cohorts 1 and 2 of the LuminICE-203 study earlier this year. Data from the same showed that treatment with the acimtamig combo demonstrated an overall response rate of 83.3% and a complete response rate of 50%, with a well-managed safety profile.
The FDA’s RMAT designation to the combo of acimtamig and Artiva’s AlloNK (AB101) was based on this early efficacy data from the LuminICE-203 study.
Per the company, besides HL, the combination of acimtamig and AlloNK also has applicability in other CD30-positive lymphomas, such as peripheral T-cell lymphoma.
The successful development of the combo therapy should provide a big boost to Affimed, given the need for new therapies in R/R HL, especially in double refractory HL, for which there are currently no approved therapies.
AFMD's Zacks Rank & Key Picks
Affimed currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Loss per share estimates for 2025 have narrowed from $1.54 to 79 cents during the same time. Year to date, shares of SPRO have declined 21.1%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 49%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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