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What’s in Today’s Brief? (May 4th Preview)
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Corporate M&A in immunology
UCB announced it will acquire Candid for $2.2B, placing a large bet on Candid’s antibody assets aimed at autoimmune diseases. The deal centers on a portfolio of bispecific and related biologic programs that UCB views as part of the next wave of immunological care. The transaction highlights how mid- and late-stage antibody platform strategies are being consolidated to accelerate pipeline buildouts in autoimmune indications, where demand for more targeted immunomodulation remains high. UCB’s move also signals continued investor and industry focus on bispecific mechanisms of action as developers seek deeper penetration of immunotherapy beyond oncology.
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Oncology pipeline: RET+ NSCLC durability update
Rigel Pharmaceuticals published final data from its Phase 1/2 ARROW trial of pralsetinib (Gavreto) in metastatic RET fusion-positive NSCLC in the Journal of Clinical Oncology. The update adds 42 months of follow-up to previously reported results. In patients with measurable disease (n=259), the overall response rate was 70%, including 7% complete responses and 63% partial responses, with no new safety signals reported and no hypersensitivity reactions in patients receiving prior immunotherapies. Company and investigator commentary emphasized durable benefit, including patients with baseline measurable CNS metastases, reinforcing pralsetinib’s positioning as an early-biomarker-driven option.
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Regulatory decision: FDA rejection of melanoma oncolytic therapy
Replimune’s RP1 oncolytic immunotherapy has faced additional regulatory setbacks after the FDA rejected the therapy twice, despite prior breakthrough-style emphasis in its clinical development. The engineered herpesvirus is injected directly into melanoma tumors to trigger localized immune activation. The rejection is particularly consequential for patients with limited second-line options after standard treatments fail; an estimated 110,000 new melanoma cases are diagnosed annually in the U.S., and survival drops sharply once disease spreads. Replimune CEO Sushil Patel criticized the agency’s behavior as unusual, underscoring how even therapies with earlier trial momentum can face high hurdles when late-stage evidence or regulatory requirements don’t align.
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Equity market shock: adverse-event disclosure weighs on Erasca
Erasca shares fell after the company disclosed a patient death tied to an adverse event in a previously shared dose-escalation dataset for ERAS-0015. The disclosure surfaced in investor materials and followed preliminary positive, though early, efficacy signals from pooled Phase I trials in RAS/MAPK-driven solid tumors. The drug is being developed as an oral pan-RAS molecular glue targeting KRAS G12X–mutant NSCLC and PDAC. Reported unconfirmed overall response rates ranged up to 62%–75% in KRAS G12X NSCLC cohorts and 40%–50% in second-line KRAS G12X PDAC. The company said the fatality resulted after grade 3 pneumonitis progressed to grade 5 following supportive care withdrawal at the patient’s direction, prompting investors to reassess risk even as Erasca characterized pneumonitis as a rare class effect.
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Biotech IPO market: April fundraising surge
Four biotech IPOs raised $1.5B in April, the biggest monthly tally in more than five years, according to Renaissance Capital. The new listings included Hemab Therapeutics and Seaport Therapeutics, each with upsized offerings. The month’s volume suggests renewed appetite for public-market biotech risk as investors prioritize companies with credible pipelines and near-term value catalysts. For issuers, the strong reception can translate into broader capital-raising flexibility, while for the sector it reinforces that market liquidity remains a key lever for pipeline execution.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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