Rallybio LLC

The capital will be used to progress Candid’s T-cell engager portfolio through key milestones. Credit: Vshivkova / Shutterstock.com. US-based biotechnology company Rallybio has entered a definitive agreement to acquire Candid Therapeutics through a merger transaction. Following completion, the combined entity will operate as Candid Therapeutics and list on Nasdaq under the “CDRX” ticker symbol. As part of the merger, Candid has secured more than $505m in gross proceeds from a concurrent private financing round. The round is supported by institutional investors such as RA Capital Management; Venrock Healthcare Capital Partners; accounts advised by entities such as Cormorant Asset Management, Foresite Capital, and Janus Henderson Investors; additional mutual funds and others. The combined cash balance at closing is projected to fund operations through 2030. The capital will be used to progress Candid’s T-cell engager (TCE) portfolio through key milestones. This includes planned initiation and clinical data readouts from Phase II studies for cizutamig, a TCE targeting B-cell maturation antigen (BCMA), in myasthenia gravis and interstitial lung disease. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Both companies’ boards have unanimously approved the transaction, which is set to close by mid-2026, subject to customary closing conditions, including shareholder approval and regulatory clearances. After the transaction is finalised, it is anticipated that the existing equityholders of Rallybio will hold 3.65% of the new merged entity. Meanwhile, the equityholders of Candid, including those investors involved in the financing, are projected to own around 96.35% of the company. The combined company expects pro-forma cash of around $700m at closing. Candid chairman, president and CEO Dr Ken Song will lead the new entity. Rallybio co-founder and CEO Dr Stephen Uden said: “We are pleased to announce this transaction, which we believe represents a compelling opportunity for Rallybio stockholders to participate in the future value creation of a well-capitalised, clinical-stage company with a differentiated and broad portfolio of TCE drug candidates. “Candid’s clinical data in myasthenia gravis and across its autoimmune pipeline, combined with the strong endorsement of leading healthcare investors, further substantiates the merit of this transaction.” In April 2024, Rallybio announced a collaboration with Johnson & Johnson to advance complementary therapeutic solutions for foetal and neonatal alloimmune thrombocytopenia (FNAIT).

Two more members named to CDC vaccine panelCandid goes public in reverse merger with RallyBioNovo to boost ex-US oral GLP-1 capacityAardvark hits pause on Prader-Willi studyTwo more members named to CDC vaccine panelHealth and Human Services Secretary Robert F. Kennedy Jr. has appointed two more doctors to the Centers for Disease Control and Prevention's vaccine panel. The Advisory Committee on Immunization Practices (ACIP) now includes Sean Downing, a Florida-based physician trained in internal medicine and paediatrics, and Angelina Farella, a paediatrician based in Texas.After abruptly firing all 17 members of ACIP last year, Kennedy — a long-time critic of vaccines — has been reconstituting the panel, most recently adding two new members this past January.Similar to other new ACIP members, Farella has a past of spreading vaccine misinformation. She was a member of America's Frontline Doctors, a group that promoted the use of ivermectin and hydroxychloroquine to treat COVID-19, and also falsely claimed the vaccines were not effective in preventing infection and instead had killed 45,000 people in the US.In a 2021 interview, Farella also suggested there appeared to be a gag order on what could be discussed regarding treatment of COVID-19. "We can use all kinds of things to treat this virus," she said. "But you know what? There has been an absolute blackout on what primary care physicians can do to treat and get these patients well. That's how you crush a pandemic. Not by vaccinating."ACIP is scheduled to next meet March 18-19 and will discuss COVID-19 vaccine injury recommendations.-Anna BratulicCandid goes public in reverse merger with RallyBioA year and a half after launching, Candid Therapeutics has found a pathway to go public via a reverse merger with RallyBio. As part of the deal, the biotech raised $505 million in a private financing from Venrock Healthcare Capital Partners, RA Capital Management, Janus Henderson Investors, accounts advised by T. Rowe Price Associates, venBio Partners, Viking Global Investors, Cormorant Asset Management, Foresite Capital, Soleus Capital, TCGX and Vivo Capital. The funds, expected to give the newly public company a cash runway through 2030, will help support the development of Candid's pipeline of T-cell engagers (TCEs), gained through aggressive deal-making. At its debut, the company acquired Vignette Bio, securing ex-China rights to cizutamig (formerly) CND106, a BCMA/CD3 bispecific developed by EpimAb, and also took over TRC 2004, gaining ex-China rights to CND261, a CD20/CD3 bispecific from Genor Biopharma, originally designed by Ab Studio. The capital will support Phase II studies evaluating cizutamig in myasthenia gravis and interstitial lung disease secondary to rheumatological diseases.Candid has also inked TCE agreements with Ab Studio, Nona Biosciences, EpimAb Biotherapeutics and WuXi Biologics.-Elizabeth EatonNovo to boost ex-US oral GLP-1 capacityNovo Nordisk will invest €432 million ($506 million) in its tabletting facility in Monksland, Athlone, Ireland to increase manufacturing capacity for current and future oral GLP-1 treatments. The move will allow the site to serve as a critical hub for markets outside the US, according to the company. Construction will be finalised gradually from the end of 2027 through 2028."This investment, a historic milestone for Novo Nordisk in Ireland, marks our continued commitment to Ireland," said Kasper Bødker Mejlvang, EVP of CMC and product supply.-Matthew DennisAardvark hits pause on Prader-Willi studyAardvark Therapeutics said it voluntarily paused its Phase III HERO trial of ARD-101 in patients with Prader-Willi Syndrome (PWS) after detecting "reversible cardiac observations" at above-target doses in a separate healthy volunteer study.Oppenheimer analyst Leland Gershell noted that the doses were two times higher than what PWS patients received in the HERO study, though that didn't sway investors. Company shares were down 56% on Monday.ARD-101 is a gut-restricted small molecule that activates intestinal bitter taste receptors, stimulating enteroendocrine cells to release gut hormones such as GLP-1 and cholecystokinin (CCK), which engage gut-brain pathways to mediate appetite.The HERO study had been evaluating ARD-101 for hyperphagia, the hallmark insatiable hunger experienced by patients with PWS. Enrollment and dosing in both the pivotal trial and its open-label extension have been halted while Aardvark conducts a safety review. As a result, the company no longer anticipates announcing topline HERO data in the third quarter, adding it intends to provide further guidance next quarter. -Anna Bratulic

Rallybio Corporation has agreed to acquire Candid Therapeutics through an all-stock reverse merger that will create a Nasdaq-listed company operating under the Candid name and trading under the ticker CDRX. The transaction is accompanied by a USD 505 million private financing, positioning the combined company to advance a pipeline of T-cell engager (TCE) therapeutics targeting B-cell lineage antigens across more than ten autoimmune diseases. Under the merger agreement, Candid shareholders will receive newly issued shares of Rallybio common stock, with the exchange ratio determined at closing based on relative company valuations. No cash consideration will be paid between the parties. Following completion of the deal, Candid equityholders—including participants in the new financing—will own about 96.35% of the combined company, while existing Rallybio shareholders will retain approximately 3.65%, assuming Rallybio contributes USD 37.5 million in net cash at closing. The USD 505 million financing, which was oversubscribed and upsized, includes participation from investors such as Venrock Healthcare Capital Partners, RA Capital Management, Janus Henderson Investors, T. Rowe Price Associates, venBio Partners, Viking Global Investors, Cormorant Asset Management, Foresite Capital, Soleus Capital, TCGX, and Vivo Capital. Combined with Rallybio’s balance sheet and Candid’s existing capital, the merged company expects a pro forma cash position of roughly USD 700 million, providing runway through 2030. Rallybio shareholders will also receive contingent value rights tied to proceeds from the previously announced sale of interests in REV102 and potential divestitures of other legacy assets. The transaction, unanimously approved by both boards, is expected to close in mid-2026, pending shareholder approval, SEC registration effectiveness, and Hart-Scott-Rodino antitrust clearance. Candid’s pipeline focuses on multi-specific antibodies designed to redirect endogenous T cells to eliminate pathogenic B-cell populations. These TCEs bind CD3 on T cells and a target antigen on B-lineage cells, triggering cytotoxic killing through perforin- and granzyme-mediated mechanisms. The company’s lead program, cizutamig, is a BCMA×CD3 bispecific antibody targeting plasma cells and plasmablasts that produce autoantibodies. Unlike conventional anti-CD20 antibodies—which spare long-lived plasma cells—BCMA targeting aims to directly eliminate the cellular source of autoantibody production. As of the merger announcement, 87 patients had received cizutamig, including 47 with autoimmune diseases, with early studies reporting low rates of mild cytokine release syndrome. Phase II trials in myasthenia gravis and autoimmune-associated interstitial lung disease are planned for 2026. Additional programs include: CND261, a CD20×CD3 bispecific antibody, evaluated in more than 100 patients across oncology and autoimmune studies. CND319, a trispecific CD19×CD20×CD3 antibody designed to broaden B-cell depletion and reduce antigen-escape risk, with first-in-human trials planned for mid-2026. The platform aims to achieve deeper tissue B-cell depletion than conventional anti-CD20 antibodies such as rituximab and ocrelizumab.