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  • Biotech & Pharma Updates | September 30 - October 1, 2024

Biotech & Pharma Updates | September 30 - October 1, 2024

Kailera launches with $400M and big obesity dreams, Biohaven’s $250M public offering, SK pharmteco drops $260M for new manufacturing site, Zephyrm Bioscience files for Hong Kong stock exchange IPO, BioMarin signs RNA R&D deal with CAMP4, FDA and FTC both urged by US senators to do more (in different ways), J&J, Bayer, Pfizer all post new layoffs (totally 500 jobs), Gritstone bio considers the dreaded “strategic alternatives” as cash pile dwindles, Amgen casually forgets to mention $10.7B in back taxes to investors; class-action suit ensues

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

GE Healthcare nets FDA approval for Flyrcado PET imaging agent
Small molecule, radioimaging, cardiac, PET scan - Read more

THE GOOD
Clinical Trials

Enliven Therapeutics touts positive Ph1 results for ELVN-001 in leukaemia
Small molecule, chronic myeloid leukaemia, cancer - Read more

Santhera Pharmaceuticals posts “promising” top-line results for DMD-associated cardiac complications med
Small molecule, Duchenne’s muscular dystrophy, cardiomyopathy - Read more

Cytokinetics presents additional Ph3 data analyses for aficamten in cardiomyopathy
Small molecule, symptomatic obstructive hypertrophic cardiomyopathy - Read more

Myrtelle touts “significant biomarker change” in Canavan disease patients treated with rAAV-Olig001-ASPA in Ph1/2 trial
Gene therapy, Canavan disease - Read more

Clinical trial recruitment portal European Clinical Trials Information Network launches
Clinical trial recruitment, decentralized clinical trials - Read more

THE GOOD
Company Launches

Kailera Therapeutics launches with $400M and obesity dreams, four assets from Jiangsu Hengrui Pharmaceuticals
GLP-1/GIP, obesity - Read more

Florey Biosciences launches with pre-seed funding to tackle gut microbiome dysfunction caused by antibiotic use
Genentically modified yeast, microbiome dysfunction - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Cartherics private financing round, AUD 15M ($10M)
Cell therapy, solid tumor, ovarian cancer, natural killer cell - Read more 

Biohaven $250M public offering
Bispecific antibody, small molecule, inflammation, cancer - Read more

Vicore Pharma to receive SEK 100M ($9.7M) strategic raise from Sanofi
Small molecule, idiopathic pulmonary fibrosis - Read more

IN8Bio $12.4M private placement
Cell therapy, acute myeloid leukemia, cancer, gamma-delta T cell - Read more

Vaxess receives NIH grant
GLP-1, type 2 diabetes - Read more

THE GOOD
Investments

SK pharmteco commits $260M for new South Korea-based small molecule, peptide plant
CDMO, small molecule, peptide manufacturing - Read more

Piramal Pharma Solutions earmarks Lexington, KY facility expansion to tune of $80M
CDMO, antibody-drug conjugate, fill-finish, manufacturing - Read more

THE GOOD
IPOs

Zephyrm Bioscience files IPO on Hong Kong Stock Exchange
Cell therapy, acute graft-versus-host disease, interstitial lung disease - Read more

THE GOOD
Mergers & Acquisitions

Tharimmune announce intent to acquire Intract Pharma
Biologics, drug delivery, gastrointestinal tract - Read more

Life science procurement and supplier orchestration software Science Exchange acquired by Waud Capital Partners
Life science procurement - Read more

THE GOOD
Partnerships

BioMarin Pharmaceutical signs R&D deal with CAMP4 Therapeutics
RNA, drug discovery, suboptimal protein expression - Read more

Metsera, Amneal sign drug development and supply agreement, including new peptide synthesis & sterile fill-finish facility build
GLP-1, obesity, metabolic disease, drug development - Read more

Lupin nabs Canada distribution rights to Aytu BioPharma’s ADHD meds
Small molecule, attention deficit hyperactivity disorder, sale & distribution - Read more

Shionogi lands Japan distribution and sales rights to Nxera Pharma’s Quviviq insomnia med
Small molecule, insomnia, sales & distribution - Read more

PDRadiopharma (PeptiDream subsidiary), Curium partner on clinical development through commercialization for radiopharm assets 177Lu-PSMA-I&T and 64Cu-PSMA-I&T
Radiopharm, prostrate cancer, drug development - Read more

Sun Pharmaceutical Industries signs worldwide licensing agreement for Philogen’s anti-cancer immunotherapy Fibromun
Antibody fusion protein, sarcoma, glioblastoma, cancer - Read more

THE GOOD
Politics & Policy

US Senator Bill Cassidy (R-LA) pushes FDA to provide concrete guidance regarding patent inclusion in Orange Book, calls FTC Orange Book patent actions “an extraordinary abdication of [FDA] authority”
Drug patents, federal trade commission - Read more

FTC urged by US Senators to expand PBM investigations into “additional anti-competitive practices”
Pharmacy benefit manager, prescription drugs, drug pricing - Read more

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⬇️ The Bad News ⬇️

THE BAD
Earnings & Finances

Activist investor EcoR1 Capital now controls 10% of Galapagos’ outstanding share
Cell therapy, lymphoma, leukemia, cancer, CAR-T - Read more

THE BAD
Layoffs

Spate of layoffs, nearly 500 jobs, disclosed by Johnson & Johnson, Bayer (New Jersey sites, 231 and 57 positions respectively), and Pfizer (Ireland sites, 210 positions)
Big pharma layoffs - Read more

Shattuck Labs cuts 40% of staff as part of strategic reorg
Monoclonal antibody, cancer, inflammatory bowel disease - Read more

THE BAD
Strategic Plans

CVS Health considers corporate break-up as investor pressure mounts
Consumer health, health insurance - Read more [Paywall]

Gritstone bio is exploring the dreaded “strategic alternatives” as cash dwindles
Cancer vaccine, colorectal cancer - Read more

IGM Biosciences makes rapid pivot to autoimmunity, investor aren’t pleased
Bispecific T-cell engager, rheumatoid arthritis, systemic lupus erythematosus, myositis, autoimmune - Read more

ViiV Healthcare halts development of HIV antiviral asset VH3739937
Small molecule, human immunodeficiency virus - Read more [Paywall]

⬇️ The Ugly News ⬇️

THE UGLY
Lawsuits

Amgen forced to face the tax liability music, as New York judge denies dismissal request for $10.7B back tax class action lawsuit
Back taxes, tax liability - Read more

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

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