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THE GOOD
Approvals & Labels

Gilead's seladelpar (PPAR-delta agonist) receives CHMP positive opinion for treating primary biliary cholangitis with or without UDCA in adults.
Small molecule, primary biliary cholangitis - Read more

Eli Lilly's Mounjaro (tirzepatide) data for obstructive sleep apnea in obesity added to label by EMA; no separate approval granted by regulators
GLP-1, obesity, obstructive sleep apnea - Read more

Organon (Dermavant Sciences) Vtama (AhR agonist) 1% cream for topical treatment of atopic dermatitis lands expanded label into children aged 2 and older by FDA
Small molecule, atopic dermatitis, eczema, topical - Read more

CHMP issues positive opinion for Bayer, BridgeBio’s acoramidis (TTR stabilizer), to treat transthyretin amyloid cardiomyopathy (ATTR-CM), based on ATTRibute-CM study
Small molecule, transthyretin amyloid cardiomyopathy - Read more

CHMP issues positive opinion for Geron's Rytelo (oligonucleotide telomerase inhibitor) to treat transfusion-dependent anemia in low-risk myelodysplastic syndromes (LR-MDS)
Small molecule, transfusion-dependent anemia in low-risk myelodysplastic syndromes - Read more

Galderma’s Nemluvio (interleukin-31 inhibitor) lands second indication from FDA, approved for moderate-to-severe atopic dermatitis in patients 12 years and older
Small molecule, atopic dermatitis, eczema, topical - Read more

Merck & Co.’s Welireg (HIF-2α inhibitor) lands CHMP positive opinion for von Hippel-Lindau disease who require therapy for associated types of solid tumors, and renal cell carcinoma
Small molecule, von Hippel-Lindau disease, solid tumors, renal cell carcinoma, cancer - Read more

THE GOOD
Business Development

Novavax's pediatric COVID-19 vaccine (partnered with Sanofi) hits Ph2/3 clinical trial milestone, triggering $50 million payment
Vaccine, COVID-19, infectious disease - Read more

Newron Pharmaceuticals secures €44M ($46.1M) from EA Pharma (Eisai subsidiary) for development and commercialization rights of evenamide (voltage-gated sodium channel inhibitor) in select Asian markets, plus royalties
Small molecule, schizophrenia - Read more

Oxford Vacmedix finalizes licensing deal with Dx&Vx for OVM-200 (targeting survivin) in South Korea, China, and India
Cancer vaccine, lung cancer, prostate cancer, and ovarian cancer - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Repare Therapeutics touts “positive” Ph1 lunresertib (PKMYT1 inhibitor) and camonsertib (ATR kinase inhibitor) data in endometrial and platinum-resistant ovarian cancer; despite this, stock drops by over 50%
Small molecule, endometrial cancer, ovarian cancer - Read more

Incyclix Bio’s INX-315 (CDK2 inhibitor) shows promise in CDK4/6 inhibitor-resistant breast cancer and CCNE1-amplified tumors according to interim Ph1/2 data
Small molecule, breast cancer, ovarian cancer - Read more

Akeso’s ivonescimab (targeting PD-1, VEGF) improves outcomes in EGFR-mutant non-small cell lung cancer with brain metastasis according to new Ph3 data
Bispecific antibody, lung cancer, brain metastasis - Read more [Press release in Chinese]

Alphamab Oncology’s KN046 (targeting PD-L1, CTLA-4) combined with axitinib (VEGFR and kinase inhibitor) shows efficacy in advanced non-small-cell lung cancer according to Ph2 data
Bispecific antibody, lung cancer, small molecule - Read more

RemeGen’s disitamab vedotin (targeting HER2 shows “significant” efficacy in Ph3 study of HER2-positive advanced breast cancer with liver metastasis
Antibody-drug conjugate, breast cancer, liver metastasis - Read more

BioNTech’s gotistobart (CTLA-4 target-preserving anti-CTLA-4) Phase III trial resumes for squamous non-small cell lung cancer after FDA hold
Monoclonal antibody, lung cancer - Read more

THE GOOD
Fundraises

Turn Therapeutics $75M investment commitment, focused on advanced wound and dermatology solutions, to support a public listing
Drug delivery, wound care, dermatology - Read more

Alessa Therapeutics $15M Seed raose, focused on developing localized drug delivery implants for treating prostate cancer
Small molecule, prostate cancer, drug delivery - Read more

INOVIO Pharmaceuticals $30M public offering, focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases
DNA, human papillomavirus, cancer, infectious disease - Read more

Candel Therapeutics $80M public offering, to support development of prostate cancer therapy CAN-2409 and general corporate purposes
Adenoviral immunotherapy, prostate cancer - Read more

THE GOOD
Lawsuits

FDA defends mifepristone safety restrictions, citing evidence to mitigate risks, in response to lawsuit challenges
Small molecule, abortion - Read more [Paywalll]

THE GOOD
Mergers & Acquisitions

AbbVie will pay $200M to acquire Nimble Therapeutics and its oral peptide drug pipeline for immune diseases
Peptide, generalized myasthenia gravis, irritable bowel syndrome, psoriasis - Read more

Private equity firms, including Blackstone and Bain Capital, are considering acquiring Mitsubishi Tanabe Pharma for $3-3.5B
Small molecule, central nervous system, immuno-inflammation, cancer, amyotrophic lateral sclerosis - Read more

THE GOOD
Patient Access

U.S. CMS (behind Medicare) warns Medicare Advantage insurers against denying coverage for Biogen's Qalsody (targeting SOD1 mRNA) for ALS treatment
Antisense oligonucleotide, amyotrophic lateral sclerosis - Read more

THE GOOD
Public Health

CDC finds no evidence of H5N1 bird flu in suspected California child case, despite initial flu A test result
Infectious disease, bird flu, H5N1 - Read more [Paywall]

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THE BAD
Clinical Trials

Bicycle Therapeutics’ zelnectide pevedotin (targeting Nectin-4) shows a 60% response rate in metastatic urothelial cancer, but results are weaker than what investors expected; stock drops
Small molecule, urothelial cancer, Bicycle Toxin conjugate - Read more

Incyte discontinues zilurgisertib (ALK-2 inhibitor) program for myelofibrosis-related anemia after failing to improve symptoms in Phase 1/2 trial
Small molecule, myelofibrosis-related anemia, cancer - Read more

Boundless Bio discontinues Phase 1/2 trial of BBI-825 (RNR inhibitor) in colorectal cancer, citing lack of dose-proportional exposure and increased competition
Small molecule, colorectal cancer - Read more

THE BAD
Patient Access

South African regulators accept Vertex Pharmaceutical's access plan for cystic fibrosis meds, angering activists over inequity
Small molecule, cystic fibrosis - Read more [Paywall]

THE BAD
Withdrawals & Recalls

Takeda withdraws Alofisel from EU markets after confirmatory Ph3 trial failure and inadequate sales performance tied to write-down triggered by aforementioned Ph3 failure
Mesenchymal stem cell therapy, complex anal fistulas, Crohn's disease - Read more 

THE UGLY
Lawsuits

McKinsey agrees to pay $650 million to settle DOJ charges over its role in Purdue's opioid sales
Small molecule, opioid epidemic - Read more

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