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THE GOOD
Approvals & Labels

AbbVie’s Elahere nabs EU approval in ovarian cancer
Antibody-drug conjugate, ovarian cancer - Read more

AstraZeneca’s Tagrisso lands EU CHMP recommendation for unresectable lung cancer
Small molecule, lung cancer - Read more

REGENX’s DMD gene therapy could still land accelerated approval as biotech aligns with FDA on expanded pivotal study
Gene therapy, Duchenne’s muscular dystrophy (DMD) - Read more

THE GOOD
Business Development

Avenzo Therapeutics buys exclusive ex-China licensing option for VelaVigo bispecific ADC
Bispecific antibody-drug conjugate, cancer - Read more

AstraZeneca exercises licensing option for Quell Therapeutics cell therapy, latter to gain $10M milestone
Cell therapy, type 1 diabetes, Treg cell therapy - Read more

Keymed Biosciences out-licenses bispecific CM366 ex-China global rights to Platina Medicines (Ouro Medicines division)
Bispecific antibody, multiple myeloma, cancer - Read more

Aclaris Therapeutics buys ex-China rights to BSI-045B and BSI-502 from Biosion
Monoclonal antibody, atopic dermatitis, asthma, chronic rhinosinusitis, bispecific antibody - Read more

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THE GOOD
Clinical Trials

Intellia Therapeutics touts promising Ph1 data for CRISPR therapy in rare heart disorder
CRISPR, transthyretin amyloidosis, gene editing - Read more

Eli Lilly’s tirzepatide reduces risk of worsening heart failure according to Ph3 data in patients with heart failure and obesity
GLP-1, heart failure, obesity - Read more

Cybin reports positive Ph2 data for CYB003 in major depressive disorder, though concerns about functional unblinding prevention in Ph3 trials drive stock lower
Small molecule, major depressive disorder, psychedelic - Read more

TenNor Therapeutics touts positive topline Ph3 data for rifasutenizol in H. pylori infections
Small molecule, H. pylori infection - Read more

Inventiva Pharma’s lanifibranor + empagliflozin hits primary efficacy endpoint in Ph2 in patients with MASH and type 2 diabetes
Small molecule, metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes - Read more

Alnylam Pharmaceuticals grants peek at healthy volunteer Ph1 data for Nucresiran RNAi therapy in transthyretin amyloidosis
RNAi, transthyretin amyloidosis - Read more

Rocket Pharmaceuticals touts long-term Ph1 data for gene therapy RP-A501 in Danon disease
Gene therapy, Danon disease, AAV - Read more

Emmecell’s EO2002 delivers “significant improvement” in corneal edema according to Ph1 extension study
Cell therapy, corneal edema, cell delivery tech - Read more

THE GOOD
Company Launches

Trogenix emerges from stealth with £15M ($19M) and therapies with “one-and-done” aggressive tumor fighting potential
Engineered DNA, glioblastoma, cancer - Read more

THE GOOD
Fundraises

Atlas Ventures aims for a $450M 14th biotech fund
Venture capital, biotech investing - Read more [Paywall]

Impact Therapeutics RMB 250M ($34.5M) Series D++, commercialization of senaparib
Small molecule, solid tumor, lung cancer - Read more [Press release in Chinese]

C Ray Therapeutics $100M+ Series A+, CRO & CDMO services
CDMO, CRO, manufacturing, research services - Read more

SRTD biotech undisclosed Seed raise, RNA medicines for liver diseases
RNA, liver disease - Read more

Zai Labs closes public offering, $230M approximate gross proceeds
Small molecule, oncology, immunology - Read more

ReCode Therapeutics $15M funding from Cystic Fibrosis Foundation
CRISPR, cystic fibrosis, DNA writing, lipid nanoparticles - Read more

THE GOOD
Investments

Sanofi’s €40M ($42.2M) expansion plans for kidney transplant rejection, type 1 diabetes meds manufacturing facility
Polyclonal antibody, kidney transplant rejection, monoclonal antibody, type 1 diabetes - Read more

THE GOOD
Mergers & Acquisitions

Grifols may be taken private with €7B ($7.4B) bid from Brookfield Asset Management
Plasma-based medicines, primary immunodeficiencies - Read more

THE GOOD
Partnerships

Novartis, Ratio Therapeutics $745M radiotherapy development partnership
Radiopharm, drug discovery, drug development - Read more

HCW Biologics, WY Biotech licensing, R&D, and co-development partnership for one of former’s product candidates, indication(s) not disclosed
Biologic, fusion protein, antibody, drug discovery, drug development - Read more

THE GOOD
Product Launches

Novo Nordisk’s Wegovy officially launches in China at a fraction of the US price ($193.27 compared to $1,349 - both for a month’s supply)
GLP-1, obesity - Read more

THE GOOD
Regulatory

FDA posts new draft guidance for CGT developers
Regulatory guidance, cell therapy, gene therapy - Read more [Paywall]

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THE BAD
Clinical Trials

Neurogene stock drops even further as NGN-401 gene therapy recipient that had a serious adverse event now in “critical condition”
Gene therapy, Rett syndrome - Read more

THE BAD
Layoffs

CSL Behring shuts down Pasadena, CA cell & gene therapy R&D hub, about 60 layoffs
Cell therapy, gene therapy, research & development - Read more

Gilead cuts 100+ roles at California HQ
Small molecule, antiviral, human immunodeficiency virus - Read more

THE BAD
Strategic Plans

Eisai discontinues Ph3 trial of Dravet syndrome adjunctive treatment lorcaserin, citing recruitment challenges
Small molecule, Dravet syndrome - Read more [Paywall]

THE BAD
Withdrawals & Recalls

VBI Vaccines issues voluntary recall of hep B vaccine PreHevbrio as part of shuttering proceedings
Vaccine, hepatitis B - Read more

THE UGLY
No Ugly News Today!

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