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  • Biotech & Pharma Updates | February 6 - 9, 2025

Biotech & Pharma Updates | February 6 - 9, 2025

Bain Capital acquires Mitsubishi Tanabe Pharma for $3.3B, CSL Behring's Hemgenix delivers positive four year Ph3 follow-up data, Sionna Therapeutics raises $191M in IPO to fuel cystic fibrosis drugs, Olix Pharmaceuticals & Eli Lilly part on developing MASH hopefuly OLX702A (targeting MARC1 gene), Bioluminescence Ventures abruptly shuts down after 15 months and raising $477M + 33 more stories

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

FDA approves Pfizer and AbbVie's Emblaveo (targeting Gram-negative bacteria) for complicated intra-abdominal infections in adults
Small molecule, antibiotic, infectious disease, intra-abdominal infections - Read more

Keymed Biosciences' Stapokibart (targeting IL-4Rα) lands Chinese NMPA approval for seasonal allergic rhinitis
Monoclonal antibody, seasonal allergic rhinitis - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Genentech's Gazyva (targeting CD20) delivers positive Ph3 data in lupus nephritis
Monoclonal antibody, lupus nephritis - Read more

Novo Nordisk's Mim8 (targeting Factor IXa, Factor X) delivers a Ph3 win for children with hemophilia A
Bispecific antibody, hemophilia A - Read more

Eli Lilly's showcases positive long-term Ph3 data for Omvoh (targeting IL-23p19), sustained two-year efficacy in treating moderate to severe Crohn's disease
Monoclonal antibody, Crohn's disease - Read more

Sangamo Therapeutics touts positive Ph1/2 data for Fabry disease gene therapy isaralgagene civaparvovec (cDNA for human alpha-galactosidase A)
Gene therapy, Fabry disease, recombinant AAV - Read more

InFlectis BioScience showcases “promising” Ph2 results for IFB-088 (targeting stress-induced PPP1R15A/PP1c phosphatase complex) in bulbar-onset amyotrophic lateral sclerosis
Small molecule, bulbar-onset amyotrophic lateral sclerosis (ALS) - Read more

Annexin Pharmaceuticals' touts “promising“ Ph2a data for ANXV (targeting cell membrane phosphatidylserine) in retinal vein occlusion patients
Recombinant protein, retinal vein occlusion - Read more

4D Molecular Therapeutics' 4D-150 delivers positive Ph2b data in wet AMD
Fusion protein, RNAi, wet age-related macular degeneration (wet AMD) - Read more

CSL Behring's reports positive four year data from Hemgenix (delivering F9 gene) Ph3 trial, with sustained factor IX activity and safety in hemophilia B patients
Gene therapy, hemophilia B, AAV - Read more

eGenesis reports successful second xenotransplant of genetically engineered pig kidney in patient with end-stage kidney disease
Organ transplant, engineered pig kidney, genetically engineered organ, renal disease, kidney failure - Read more

THE GOOD
Earnings & Finances

Eisai's Alzheimer's drug Leqembi shows modest US growth, while experiencing stronger sales performance in Japan and other markets
Monoclonal antibody, Alzheimer's disease - Read more

THE GOOD
Fundraises

RenovoRx $12.1M public offering, developing targeted cancer therapies and commercializing FDA-cleared RenovoCath delivery platform
Medical device, chemotherapy, pancreatic cancer, drug delivery, catheter - Read more

Entero Therapeutics $2M revolving loan, GI disease therapy developer
Small molecule, enzyme, celiac disease, gastroparesis, cystic fibrosis, chronic pancreatitis with exocrine pancreatic insufficiency - Read more

Coeptis $10M Series A preferred financing round, developing cell therapies and “AI-driven tools”
Cell therapy, COVID-19, cancer, NK cell, allogeneic cell therapy, AI - Read more

Cure Rare Disease $5.69M grant from California Institute for Regenerative Medicine grant, developing ASO therapy for rare neurodegenerative disorder SCA3
Antisense oligonucleotide, spinocerebellar ataxia type 3, rare disease - Read more

THE GOOD
IPOs

Sionna Therapeutics raises $191M in IPO to develop cystic fibrosis drugs
Small molecule, cystric fibrosis - Read more

Aardvark Therapeutics announces $100M IPO ambitions, offering 5.9M shares at $16-18 each for metabolic disease treatments
Small molecule, obesity, metabolic disease - Read more

THE GOOD
Mergers & Acquisition

Bain Capital acquires Mitsubishi Tanabe Pharma for $3.4B, sold because parent company Mitsubishi Chemical Group is unable to “provide the large-scale investment in R&D necessary to drive growth”
Big pharma acquisition - Read more

Valeo Pharma closes share purchase agreement with Xediton Pharmaceuticals as part of merger
Small molecule, cancer, Parkinson's disease, ocular hypertension - Read more

THE GOOD
Partnerships

Olix Pharmaceuticals, Eli Lilly drug development partnership for OLX702A (targeting MARC1 gene), against MASH and other metabolic diseases
Asymmetric siRNA (asiRNA), metabolic dysfunction-associated steatohepatitis (MASH), metabolic disorder - Read more

LG AI Research, Seoul National University partner to develop AI model for protein structure prediction in drug discovery
Protein modelling, AI, drug development, drug design - Read more

G2GBio, Boehringer Ingelheim partner to develop long-acting injectable drugs using InnoLAMP delivery platform technology
Peptide, drug delivery, injectable, long-acting therapy - Read more

Framatome, IBA partner to develop cyclotron network for Astatine-211 production in cancer therapy applications
Radiopharm, radioisotope manufacturing, radionuclide, precision oncology - Read more

THE GOOD
Strategic Plans

Eli Lilly plans to expand testing of its incretin drugs beyond obesity into neurology and immunology applications starting 2025
GLP-1, obesity, neurology, immunology - Read more

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Pliant Therapeutics pauses Ph2b/3 trial of bexotegrast (αvβ6, αvβ1 integrin inhibitor) for idiopathic pulmonary fibrosis
Small molecule, idiopathic pulmonary fibrosis - Read more

THE BAD
Company Shutdown

Bioluminescence Ventures shutting down after 15 months, despite raising $477M for early-stage biotech investments
Venture capital, biotech investing - Read more [Paywall]

THE BAD
Earnings & Finances

Illumina reports 2% revenue drop amid China tensions, as country adds company to watchlist in retaliation for US tariffs
Next-generation sequencing, geopolitics, US-China relations - Read more

THE BAD
Lawsuits

Sanofi and AstraZeneca support Teva's appeal to rehear case about delisting inhaler patents in FDA's Orange Book
Inhaler, drug patent, patent dispute - Read more [Paywall]

Regeneron sues Sanofi for allegedly withholding crucial Dupixent sales information, including pricing details and contracts with pharmacy benefit managers
Monoclonal antibody, agreement breach, pharmacy benefit managers, drug pricing, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, chronic obstructive pulmonary disease (COPD) - Read more

THE BAD
Strategic Plans

Bristol Myers Squibb drops allergy drug cendakimab (targeting IL-13) despite successful Phase 3 trial, while slowing down development push for BMS-986322 (TYK2 inhibitor) in plaque psoriasis
Monoclonal antibody, eosinophilic esophagitis, small molecule, plaque psoriasis, commercialization - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Marketing

Senators ask FDA to review Hims' Super Bowl weight loss drug ad for potentially misleading viewers by omitting safety information
Obesity, drug marketing, misleading advertising, side effects - Read more [Paywall]

THE UGLY
Politics & Policy

White House reportedly planning mass layoffs at HHS, targeting probationary workers, though administration denies imminent executive order
Federal health agency, public staffing cuts, Health and Human Services - Read more

NIH drastically cuts indirect research funding to universities from 50% to 15%, affecting administrative and facility expenses
Federal research funding, indirect research funding, National Institute of Health - Read more [Paywall]

NIH halts diversity grant program for PhD students following Trump's executive orders banning federal DEI initiatives
DEI, National Institute of Health, federal research grants - Read more [Paywall]

Howard Hughes Medical Institute unexpectedly terminates $60M diversity program for science students, despite previous $2B commitment to inclusion in academia
DEI, research grant - Read more [Paywall]

THE UGLY
Regulatory

FDA faces potential staff exodus under Trump administration's push for federal workers to leave, threatening drug reviews and public health
Public health agency, Food & Drug Administration (FDA) - Read more [Paywall]

THE UGLY
Warning Letters, Form 483

Belgian regulator recommends blocking Maithili Life Sciences' API production after finding 24 compliance issues at Indian facility.
Active pharmaceutical ingredient (API), non-compliance report - Read more [Paywall]

You’re all caught up on the latest Pharma & Biotech News!

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