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BioCryst Pharmaceuticals has entered into a license agreement with an Irish affiliate of Neopharmed Gentili, granting the latter exclusive rights to commercialize navenibart for hereditary angioedema (HAE) in the EU
As per the deal, BioCryst will receive $70M upfront & up to $275M in regulatory & sales milestone payments as well as tiered royalties…
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Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor
The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…
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Esperion Therapeutics & ARCHIMED have entered a definitive agreement under which ARCHIMED-managed funds will acquire Esperion, delisting it from NASDAQ
As per the deal, Esperion’s shareholders will receive $3.16/share in cash, plus the right to participate in CVR of ~$100M tied to future sales, valuing the transaction at up to ~$1.1B in fully diluted…
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The EC has approved label expansion of Imcivree to incl. treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment; commercial launch is expected in 2027
Approval was supported 120-patient cohort data from the global P-III (TRANSCEND) trial assessing setmelanotide (n=81) vs PBO…
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FDA approved Veppanu to treat adults with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer who received ≥1L of endocrine therapy, prior to PDUFA date of Jun 5, 2026; Arvinas & Pfizer plan to select a third-party partner for commercialization
NDA was backed by P-III (VERITAC-2) trial assessing Veppanu alone vs fulvestrant in mentioned pts…
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UCB has entered into a definitive agreement to acquire Candid Therapeutics, expanding its immunology pipeline with novel T-cell engagers (TCE)
As per the deal, UCB will acquire Candid for $2B upfront & ~$200M in potential future milestone payments; closing is expected by end of Q2 or early Q3’26
Acquisition will add cizutamig, a BCMA…
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The US FDA has approved initiation of the P-III (OASIS) trial evaluating OsteoAdapt SP as an alternative to autologous & allograft bone graft in TLIF, ALIF, and LLIF procedures for symptomatic degenerative lumbosacral spine disease
This approval builds on prior clinical experience in ~100 participants & expanded enrollment in Australia & Israel, while the…
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Cue Biopharma has entered into an exclusive license agreement with Ascendant Health Sciences to develop, manufacture and commercialize Ascendant-221 for the treatment of allergic diseases
As per the deal, Cue will obtain global rights (excl. Greater China) to develop & commercialize Ascendant-221 in exchange for $15M upfront license fee, ~$676.5M in development, regulatory &…
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The US FDA has approved Auvelity (dextromethorphan HBr & bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease
Approval was supported by an extensive clinical program incl. P-III (ADVANCE-1 & ACCORD-2), where ADVANCE-1 evaluated Auvelity vs PBO or bupropion over 5wks., while ACCORD-2 assessed Auvelity vs PBO in known responders
In…
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Health Canada has granted NOC to Bevqolva (bevacizumab), a biosimilar version of Genentech’s Avastin
Bevacizumab, a humanized mAb, inhibits angiogenesis by blocking VEGF-A to slow tumor vascular growth in cancers like colorectal and lung. Marketed by Roche/Genentech as Avastin, it is available in 100 mg and 400 mg formulations
In 2025, Bevqolva received MHRA approval and was launched in the…

