Clinical data reported by a handful of biopharmas on Dec. 19 sent stocks soaring or plunging, as company leaders laid out next-step plans. Investors showed enthusiasm for Omeros Corp.’s narsoplimab to treat hematopoietic stem cell-transplant-associated thrombotic microangiopathy (TA-TMA), and Roche AG’s Parkinson’s prospect prasinezumab, which is partnered with Prothena Corp. plc.
The potential for TL1A-targeting duvakitug to impact unmet needs of patients with ulcerative colitis (UC) and Crohn’s disease (CD), and to provide antifibrotic effects for a host of other diseases, boosted shares of Teva Pharmaceutical Industries Ltd. and Sanofi SA by 26.5% and 6.7%, respectively, as the partners released what analysts called “best-in-class” results from the phase IIb Relieve UCCD study and prepare for a phase III trial in 2025.
A year after manufacturing issues resulted in a complete response letter for cosibelimab, the U.S. FDA approved Checkpoint Therapeutics Inc.’s drug, branded Unloxcyt, as the first anti-PD-L1 antibody for use in metastatic or locally advanced cutaneous squamous cell carcinoma patients who are not candidates for curative surgery or curative radiation.
Disappointing readouts from separate phase II studies in atopic dermatitis sank shares of Q32 Bio Inc. and Anaptysbio Inc., as their respective antibody candidates failed to impress in a highly competitive space.
Citryll BV has closed an €85 million (US$89.8 million) series B, enabling it to take CIT-013, an antibody designed to block pathological neutrophil extracellular traps that drive a wide range of immune-mediated inflammatory diseases, into phase IIa development.
The U.S. FDA added hidradenitis suppurativa to the label for UCB SA’s Bimzelx (bimekizumab-bkzx), throwing renewed light on the indication, a chronic disease that causes painful, boil-like lumps that appear under the skin. Regulators cleared the humanized IL-17A and IL-17F antagonist for adults with moderate to severe HS, marking the drug’s fifth approval.
The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
Amgen Inc. has shrugged off a Cantor Fitzgerald analyst report that wiped about $12 billion from the company’s market cap. The Nov. 12 analyst report noted supplemental data from the company’s phase I study of obesity drug Maritide showing bone mineral density loss in patients.
Eli Lilly and Co.’s chief scientific officer, Daniel Skovronsky, called peresolimab, the PD-1 agonist previously in the works by the firm for rheumatoid arthritis (RA), a “really interesting mechanism” – but not interesting enough.
OSE Therapeutics SA has reported positive data for lusvertikimab in a phase II trial in ulcerative colitis, boosting the monoclonal antibody’s prospects of becoming the first anti-interleukin-7 therapy to reach the market.
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