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Moonwalk Biosciences secures $70m Series B for adipose-targeted RNAi
Moonwalk Biosciences has secured $70 million to advance MW101 toward human testing, taking disclosed financing since launch to $127 million as the biotech pursues an adipose-targeted alternative to appetite-based obesity therapies.
Immutep (NASDAQ: IMMP) jumps 15% as efti review points to manufacturing differences
Immutep has identified potentially relevant structural differences between 200-litre and 2,000-litre efti manufacturing batches after the TACTI-004 failure, prompting a return to 200-litre production and a narrower clinical strategy.
Eloxx Pharmaceuticals (NASDAQ: ELOX) starts 24-patient EXACT trial of exaluren
Eloxx Pharmaceuticals has dosed the first two patients in its 24-person Phase 2b EXACT study of exaluren, testing whether nonsense mutation readthrough can restore functional kidney protein in Alport syndrome.
Biohaven faces FDA partial clinical hold on new opakalim epilepsy enrollment
Biohaven has paused new enrollment across parts of its BHV-7000 epilepsy programme after an FDA partial clinical hold tied to incomplete metabolite data, while dosing continues in more than 600 randomized patients and one pivotal study remains fully enrolled.
CSL Seqirus reports stronger immune response with enhanced flu vaccine in adults over 50
CSL Seqirus has published pivotal Phase III results from 7,699 adults showing superior immune responses versus an adjuvanted egg-based flu vaccine, while the study design leaves real-world comparative effectiveness as a separate question.
Intellia’s $400m OrbiMed facility gains relevance as lonvo-z wins FDA Priority Review
Intellia secured an OrbiMed facility of up to $400 million on September 4 and drew $75 million upfront. Four days later, the FDA accepted lonvo-z for Priority Review with a March 10, 2027 decision date, bringing the next $75 million regulatory tranche into sharper focus.
Seismic Pharmaceuticals begins 600-patient global Phase III study of istaroxime
Seismic Pharmaceuticals has enrolled the first patient in its approximately 600-person global RESCUE HF-CS Phase III study of istaroxime, moving a programme with extensive Phase II experience into its pivotal test.
Gan & Lee Pharmaceuticals doses first participant with once-weekly oral GLP-1 candidate
Gan & Lee Pharmaceuticals has dosed the first participant in a 112-person Phase I study of GZC8072, an oral peptide GLP-1 receptor agonist designed for once-weekly administration, putting pharmacokinetics and tolerability ahead of any near-term weight-loss claims.
CordenPharma commits €80m to expand sterile injectable capacity in Italy
CordenPharma is committing €80 million to expand its Caponago sterile injectable operation, including new property and filling lines, as outsourcing demand grows across peptides, GLP-1 medicines, biologics and other complex injectable therapies.
EMD Serono acquires two PostEra AI-designed fertility drug programmes
EMD Serono has acquired two preclinical fertility programmes created using PostEra’s Proton AI platform, giving Merck KGaA control of oral FSHR and LHCGR agonist candidates that could challenge injectable treatment models if clinical development succeeds.