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Lots of news covered today as we skipped an edition last week - scroll down!

THE GOOD
Approvals & Labels

Bristol Myers Squibb's Breyanzi (targeting CD-19) receives European Commission approval for relapsed/refractory follicular lymphoma after two systemic therapies
Cell therapy, follicular lymphoma, CAR-T - Read more

Innovent's Sycume (anti-IGF-1R) lands NMPA approval in China for thyroid eye disease
Monoclonal antibody, thyroid eye disease - Read more

European Commission approves Otsuka Pharmaceutical and Lundbeck's Rxulti (serotonin-dopamine activity modulator), an antipsychotic for schizophrenia in adolescents 13+ years old
Small molecule, schizophrenia - Read more

THE GOOD
Business Development

SOTIO Biotech in-licenses Synaffix's technology to develop two bispecific antibody-drug conjugates
Bispecific ADC, solid tumor, prostate cancer - Read more

PranaX licenses MD Anderson's stem cell-derived exosome technology to develop anti-aging and regenerative medicine products
Exosome, stem cell-derived therapy, aging - Read more

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THE GOOD
Clinical Trials

Amgen touts positive Ph3 data for Uplizna (anti-CD19) in generalized myasthenia gravis
Monoclonal antibody, myasthenia gravis - Read more

Blue Earth Therapeutics' Lutetium (¹⁷⁷Lu) rhPSMA-10.1 Injection shows promising radiation dosimetry in Ph1 trial for metastatic castrate resistant prostate cancer
Radiopharm, radioligand, prostate cancer - Read more

INOVIO's Covid-19 dMAb, encoding AstraZeneca's cilgavimab and tixagevimab (both(targeting S protein of SARS-CoV-2), maintained relevant levels in all Ph1 participants for 72 weeks
DNA-encoded monoclonal antibody (dMAbs), COVID-19 - Read more

Akebia plans Ph3 Valor trial for Vafseo (HIF-PHI inhibitor), in late-stage chronic kidney disease anemia patients not on dialysis
Small molecule, chronic kidney disease anemia, pipeline strategy - Read more

Altimmune to test pemvidutide (GLP-1/glucagon agonist) in Ph2 trials for alcohol use disorder and alcohol-related liver disease
Pipeline strategy, peptide, GLP-1, alcohol use disorder, liver disease - Read more

THE GOOD
Company Launches

MeiraGTx spins off Parkinson's and obesity gene therapies to Hologen Neuro AI, a joint venture leveraging artificial intelligence
Gene therapy, Parkinson’s disease, CNS disorder, obesity, AI, drug discovery, drug development - Read more

THE GOOD
Earnings & Finances

Dogwood Therapeutics converts $19.5M debt to equity as major shareholder exchanges loan for preferred shares, strengthening balance sheet
Small molecule, pain, non-opioid pain - Read more

Zevra's Miplyffa for Niemann-Pick disease exceeds sales projections five weeks after launch, securing 109 prescription enrollments
Small molecule, Niemann-Pick disease type C - Read more

Recipharm reports record 2024 revenue of €827M ($902M)
CDMO (Contract Development & Manufacturing Organization), biologics manufacturing - Read more [Paywall]

THE GOOD
Fundraises

Perfuze raises €22M ($24M) additional funding for catheter-based stroke treatment technology development
Medical device, ischemic stroke - Read more

Cage Pharma aiming for $35M Series A to develop drugs that “starve” cancer cells
Small molecule, cancer, prospective fundraise - Read more [Paywall]

Neural Therapeutics $519k Series A, pyschedelic-based therapies receiving CSE listing approval under ticker "NURL"
Small molecule, psychedelics, mental health - Read more

Strolll raises £10.35M ($13.5M) Series A to expand augmented reality rehabilitation platform for neurological disorders
Digital therapeutics, Parkinson's disease, stroke, multiple sclerosis (MS), augmented reality - Read more

Accropeutics $12M Series B, Chinese-based clinical-stage biotech developing therapeutics for immune mediated diseases
Small molecule, ulcerative colitis, psoriasis - Read more

Montara Therapeutics $28M seed extension, developing safer drug combinations for CNS disorders and rare epilepsy
CNS disorder, epilepsy, small molecule, drug delivery, combo therapy - Read more

Tarsus Pharmaceuticals $125M Public Offering, developing treatments for eye care and infectious disease prevention
Small molecule, demodex blepharitis, ocular rosacea, Lyme disease - Read more

Illexcor Therapeutics (undisclosed investment), developing oral therapies for sickle cell disease
Small molecule, sickle cell disease - Read more

C2N Diagnostics $10M investment from various Samsung operating companies, scaling clinical lab services and brain health diagnostics solutions.
Biomarker, Alzheimer's disease, dementia, disease screening, diagnostics - Read more

ImmuONE raises £600K ($754K), developing 3D human lung model as alternative to animal testing for multiple industries
Non-animal models, 3D human lung model - Read more

THE GOOD
IPOs

Bluejay Therapeutics plans potential IPO next month, aiming for up to $150M in proceeds to drive viral and liver disease treatment development
Monoclonal antibody, hepatitis B, hepatitis D - Read more

Boston Pharmaceuticals explores IPO (or acquisition) for its monthly MASH drug after successful mid-stage trial
Metabolic dysfunction-associated steatohepatitis (MASH), fusion protein - Read more [Paywall]

THE GOOD
Lawsuits

Allarity Therapeutics settles with SEC over past disclosures related to FDA interactions concerning dovitinib (RTK inhibitor) NDA
Securities lawsuit, small molecule, cancer - Read more

THE GOOD
Mergers & Acquisition

Clario acquires WCG's neuroscience eCOA business to strengthen expertise in neurology, psychiatry and rare diseases
Electronic clinical outcome assessment, neuroscience - Read more

Azurity Pharmaceuticals acquires specialty pharma Covis
Specialty pharmaceuticals - Read more

THE GOOD
Partnerships

BioCity Biopharma, Merck & Co., clinical collaboration to test BC3195 (targeting CDH3) with Keytruda (targeting PD-1) in advanced solid tumors
Monoclonal antibody, antibody-drug conjugate (ADC), cancer, solid tumor, clinical development - Read more

ENCell, Cell Resources Corporation (part of Alfresa Group) partner for CGT CDMO operations and EN001 development in Japan
CDMO, cell therapy, gene therapy, cell therapy manufacturing, gene therapy manufacturing, mesenchymal stem cell, DMD, market access - Read more

THE GOOD
Politics & Policy

Trump administration withdraws CDC nominee Dave Weldon before Senate hearing, reportedly due to his controversial vaccine criticism
Centers for Disease Control and Prevention (CDC), political appointee - Read more

THE GOOD
Product Launches

Celltrion launches FDA-approved Steqeyma (targeting IL-12, IL23; Stelara biosimilar (Janssen) for psoriasis and inflammatory bowel disease.
Monoclonal antibody, biosimilar, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis - Read more

THE GOOD
Public Health

FDA recommends flu vaccine strains for 2025-2026 season after interagency meeting, aiming for timely production despite initial advisory cancellation
Food & Drug Administration (FDA), vaccine, influenza, advisory committee - Read more

THE GOOD
Regulatory

RFK Jr. held roundtable with FDA officials and stem cell representatives to discuss reducing regulatory barriers for treatments
Stem cell-derived therapy, drug approval process, drug access - Read more [Paywall]

THE GOOD
Research

Retrospective register study provides evidence for Avextra Pharma’s THC/CBD extract as a tratement for chemotherapy-induced neuropathic pain
Small molecule, cannabinoid, chemotherapy-induced neuropathic Pain - Read more

Bayer and Hurdle validate saliva-based InflammAge biomarker to measure chronic inflammation
Biomarker, aging - Read more

Already FDA-approved avapritinib shows promise in treating aggressive brain cancer by targeting PDGFRA alterations (administered through expanded access program)
Small molecule, glioma, asset salvaging - Read more

THE GOOD
Strategic Plan

New GoodRx CEO Wendy Barnes aims to revive struggling company by expanding brand-name drug access offerings
Drug pricing, pharmacy - Read more [Paywall]

Medigene files patent for novel NK cell-specific TCR construct enabling TCR function without CD3 co-expression
Patent applications, cancer, TCR-based therapy, natural killer (NK) cells, TCR-NK cell therapy, cell therapy, allogeneic cell therapy - Read more

Takeda prioritizes thoracic, gastrointestinal (GI), and hematology-focused indication while de-emphasizing cell therapy deals
Pipeline strategy, cancer, cell therapy, small molecule, antibody-drug conjugate (ADC), biologic, allogeneic cell therapy - Read more

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THE BAD
Lawsuits

Court denies Regeneron's patent stay request for Eylea, allowing Amgen's biosimilar sales to continue
Fusion protein, biosimilar, wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion, age-related macular degeneration (AMD), biosimilar suit - Read more

THE BAD
Layoffs

GRO Biosciences exploring strategic options and reduces research staff despite recent $60M Series B
Non-standard amino acids - Read more

Sutro Biopharma cuts 50% of staff, deprioritizes lead ADC luvelta despite promising data in ovarian cancer
Antibody-drug conjugate (ADC), ovarian cancer - Read more

THE BAD
Mergers & Acquisitions

Acelyrin implements poison pill defense against Tang Capital's takeover attempt, protecting its planned merger with Alumis
M&A strategy, monoclonal antibody, thyroid eye disease, hostile takeover, small molecule, psoriasis, lupus erythematosus - Read more

THE BAD
Politics & Policy

UK plan to double drug rebates to NHS on name-brand drugs to 32.2%, industry group not happy
National Health Service (NHS), drug pricing - Read more [Paywall]

THE BAD
Regulatory

Center for Medicare and Medicaid Innovation ending select payment models by 2025 following review, expecting $750M savings though replacement strategy TBD
Centers for Medicare and Medicaid Services (CMS), drug pricing - Read more

THE BAD
Strategic Plans

Pfizer halts Phase I oral STING agonist trial for business reasons, as developers explore new approaches beyond oncology
siRNA, pipeline strategy, cancer, solid tumor - Read more

THE UGLY
Lawsuits

Harvard doctors sue Trump administration for removing LGBTQ+ and transgender health research from government website
LGBTQ+, censorship, US Department of Health & Human Services (HHS) - Read more

THE UGLY
Politics & Policy

NIH reportedly cancels over 40 grants studying vaccine hesitancy, continuing its cuts after targeting DEI and LGBTQ+ research
National Institute of Health (NIH), vaccine hesitancy - Read more

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

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