Rallybio Stock Plunges After Program For Pediatric Bleeding Disorder Disappoints
Rallybio Discontinues RLYB212 Program: Rallybio Corporation has halted the RLYB212 program aimed at preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT) due to insufficient pharmacokinetic data indicating that the drug could not achieve necessary target concentrations for efficacy.
Focus on Other Programs: The company is shifting its focus to advancing RLYB116, a C5 inhibitor for complement-driven diseases, with plans to initiate a confirmatory clinical study in 2025, while also developing other preclinical programs like REV102 for hypophosphatasia.
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Rallybio Corp. Performance: Rallybio Corp. rose 12.84% to $0.71 after reporting a third-quarter net income of $16.0 million, reversing a loss from the previous year, although revenue slightly declined.
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Cellectis S.A. Recovery: Cellectis S.A. increased by 6.58% to $3.40 after reporting a third-quarter net income of $589 thousand, a significant improvement from a loss in the prior year, with revenues more than doubling.

RLYB116 Study Progress: Rallybio has completed dosing for Cohort 1 in the RLYB116 Phase 1 confirmatory PK/PD study, with data expected in Q4 2025, targeting immune platelet transfusion refractoriness and refractory antiphospholipid syndrome.
Financial Highlights: The company generated $20 million from the sale of its interest in REV102, extending its cash runway through 2027, and reported a net income of $16 million for Q3 2025, a significant improvement from a net loss in the same period last year.

Biotech Stock Movements: Several biotech and medical device stocks experienced significant after-hours gains, with Reviva Pharmaceuticals (RVPH) leading the surge with an 18.27% increase, driven by high trading volume and recent catalysts related to its lead candidate brilaroxazine.
Company Updates and Guidance: Penumbra Inc. (PEN) and Palisade Bio Inc. (PALI) also saw notable increases, with PEN benefiting from executive changes and positive revenue guidance, while PALI's rise was linked to a successful public offering and clinical updates.

RLYB116 Study Progress: Rallybio Corporation has completed dosing for the first cohort in a Phase 1 study of RLYB116, a C5 inhibitor, showing promising pharmacokinetic and pharmacodynamic results, along with a favorable safety profile.
Future Plans and Market Potential: The company plans to escalate dosing to a second cohort and aims to target two hematologic conditions, immune platelet transfusion refractoriness and refractory antiphospholipid syndrome, which present a combined market opportunity of $5 billion.

Rallybio's Agreement with Recursion Pharmaceuticals: Rallybio has agreed to sell its interest in the preclinical drug REV102 to Recursion Pharmaceuticals for up to $25 million, which includes an upfront payment of $7.5 million and potential milestone payments.
Financial Impact on Rallybio: The deal is expected to extend Rallybio's cash runway into mid-2027, and they will also receive royalties on future sales of REV102 by Recursion.
Rallybio Corporation's Sale of REV102: Rallybio has agreed to sell its interest in the ENPP1 inhibitor REV102 to Recursion Pharmaceuticals for up to $25 million, which includes an upfront payment of $7.5 million, extending Rallybio's cash runway into mid-2027.
Impact on Stock Prices: Following the announcement, Rallybio's stock rose by 36.8% to $0.47, while Recursion's stock increased by 0.81% to $4.97 during premarket trading.






