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RallyBio (RLYB) Partners With J&J & Gets $6.6M Funding, Stock Up

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Rallybio Corporation’s (RLYB - Free Report) shares surged 82.8% on Apr 11, after the company announced that it has collaborated with J&J (JNJ - Free Report) to develop complementary therapeutic approaches aimed at reducing the risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Additionally, the company also received an equity investment of $6.6 million from J&J as part of the deal. 

RallyBio is presently developing RLYB212, a novel human monoclonal anti-HPA-1a antibody, to prevent pregnant individuals from alloimmunizing, which curbs the risk of FNAIT and its potentially devastating consequences in their fetuses and newborns.

Alloimmunising is a form of an immune response to foreign antigens upon exposure to genetically different cells or tissues.

Per the terms of the collaboration agreement, JNJ is seeking to raise awareness of its own FNAIT clinical program in connection with Rallybio’s separate ongoing FNAIT natural history study on investigational therapeutic candidate, RLYB212, by providing funding to the latter. RLYB is further eligible to receive additional payments under the collaboration.

Year to date, shares of the company have climbed 24.7% against the industry’s 6% decline.

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Management stated that the development program of RLYB212 is currently the only investigational therapy under clinical development to address the needs of pregnant individuals at risk of FNAIT who have not alloimmunized.

Rallybio’s FNAIT natural history study is designed to report a preliminary dataset for HPA-1a alloimmunization frequency in a diverse population, which is intended to support a future RLYB212 registration study. However, pregnant individuals who are already alloimmunized are neither eligible for inclusion in the natural history study nor for potential preventative treatment with Rallybio’s RLYB212.

Being alloimmunized signifies that such patients already have the alloantibodies that can cause FNAIT.

On the other hand, J&J is currently developing its own investigational monoclonal antibody targeting FcRn, nipocalimab, in a phase III study in pregnant individuals who are already alloimmunized. Hence, preventative treatment with RLYB212 in this study population will not be ideal.

The complementary clinical programs of J&J and RallyBio together, if successful, will provide pregnant individuals at risk of developing FNAIT with a potential treatment option, regardless of their alloimmunization status.

RallyBio is currently gearing up to initiate a phase II dose confirmation study for RLYB212 in pregnant individuals at higher risk of alloimmunization and FNAIT in the second half of 2024.

Zacks Rank & Stocks to Consider

Rallybio currently carries a Zacks Rank #3 (Hold). 

Some better-ranked stocks from the drug/biotech industry are FibroGen (FGEN - Free Report) and Annovis Bio (ANVS - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have rallied 53.4%.

FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.

In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 34.8%.

ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.

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