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- Biotech & Pharma Updates | December 2 - 3, 2024
Biotech & Pharma Updates | December 2 - 3, 2024
Maze Therapeutics $115M Series D fuels kidney disease ambitions, Gilead buys ADC discovery option from Tubulis, Janux T-cell engager Ph1b dose escalation data launches stock 50%, GSK's hep B vaccine hopeful sputters in Ph1/2, insult to injury as Applied Therapeutics handed FDA warning letter + 29 more stories

Maze Therapeutics nabs $115M Series D, fuel for small molecule kidney disease-focused lead assets. | Source: Alice in Wonderland
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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Eli Lilly removes BMI from weight loss drug labels, providing additional leeway to prescribing physicians
GLP-1, obesity - Read more [Paywall]
THE GOOD
Business Development
Coherus Biosciences sells Udenyca (targeting TIGIT; Neulasta biosimilar, Amgen) franchise to Intas Pharmaceuticals
Recombinant human granulocyte colony-stimulating factor, cancer - Read more
Ipsen buys global licensing rights to Biomunex Pharmaceuticals’ bispecific BMX-502 (mucosal-associated invariant T cell activating)
Bispecific antibody, cancer - Read more
Takeda buys ex-China rights to Keros Therapeutics’ elritercept (activin inhibitor)
Monoclonal antibody, anemia associated with myelodysplastic syndromes and myelofibrosis, cancer - Read more
Gilead pays $20M for an option for yet-to-be discovered solid tumor ADC (topoisomerase I inhibitor-based) from Tubulis
Antibody-drug conjugate, solid tumor, cancer - Read more
Elevar Therapeutics buys global licensing rights to Relay Therapeutics’ lirafugratinib (fibroblast growth factor receptor 2 inhibitor)
Small molecule, cholangiocarcinoma, solid tumor, cancer - Read more
BridgeBio exercises option to license Unnatural Products’ discovered macrocyclic peptide
Peptide, rare disease, cancer - Read more
CSL Seqirus lands bird flu vaccine supply deal with UK
Vaccine, bird flu (H5N1), pandemic preparedness - Read more
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⬇️ More Good News ⬇️
THE GOOD
Clinical Trials
Janux Therapeutics’ positive Ph1b dose escalation data of JANX007 T-cell engager (PSMA, CD3, albumin binding) launches stock 50%
Trispecific antibody, prostate cancer - Read more
InventisBio touts positive Ph2 data for D-2570 (TYK2 Inhibitor) in plaque psoriasis
Small molecule, plaque psoriasis - Read more
Cartesian Therapeutics showcases positive updated Ph2 data for Descartes-08 (targeting BCMA) in generalized myasthenia gravis
Cell therapy, generalized myasthenia gravis, mRNA CAR-T - Read more
Revolution Medicines provides updates on its RAS(ON) inhibitor portfolio
Small molecule, pancreatic ductal adenocarcinoma, lung cancer, colorectal cancer - Read more
Tern Pharmaceuticals touts early positive Ph1 data for TERN-701 (BCR-ABL inhibitor) in myeloid leukemia
Small molecule, myeloid leukemia, cancer - Read more
THE GOOD
Fundraises
Revolution Medicines $750M public offering
Small molecule, pancreatic ductal adenocarcinoma, lung cancer, colorectal cancer - Read more
Maze Therapeutics $115M Series D
Small molecule, kidney disease, focal segmental glomerulosclerosis, phenylketonuria - Read more
Orakl Oncology €11M ($11.5M) Seed raise, AI-powered drug development platform
Drug development, techbio, AI - Read more
Orikine Bio €800k ($839k) research funding grant
Bi-specific antibody, autoimmune disease, inflammatory disease - Read more
THE GOOD
Investments
Reckitt plans Mucinex production site expansion to the tune of $200M
Consumer health, cold & flu, over-the-counter - Read more
THE GOOD
Lawsuits
Kiromic BioPharma and SEC reach settlement in clinical hold disclosure trial
Cell therapy, solid tumor, cancer, gamma delta T-cell, allogeneic - Read more
THE GOOD
Mergers & Acquisitions
GE Healthcare to fully acquire Nihon Medi-Physics by buying remaining 50% stake from co-owner Sumitomo Chemical
Radiopharm, radiodiagnostics, molecular imaging agents - Read more
THE GOOD
Partnerships
Bristol Myers Squibb, AI Proteins AI-powered miniprotein drug discovery and development pact, undisclosed targets
Biologics, miniprotein, AI - Read more
Genentech, Cour Pharmaceuticals sign strategic collab for tolerogenic nanoparticle development in autoimmune diseases
Tolerogenic nanoparticle, autoimmune - Read more
Ono Pharmaceutical, Congruence Therapeutics small molecule correctors drug discovery partnership focused on oncology
Small molecule, cancer, drug discovery - Read more
Aptose Biosciences, National Cancer Institute sign R&D partnership focused on tuspetinib (FLT3 inhibitor) in myeloid leukemia and myelodysplastic syndrome
Small molecule, myeloid leukemia, myelodysplastic syndrome, cancer, research & development - Read more
Celltrion, BioMe microbiome-targeting drug development collab
Microbiome-based live biotherapeutic, multidrug-resistant bacterial infection - Read more
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⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
GSK’s hepatitis B therapeutic vaccine hopeful misses Ph1/2 efficacy endpoint, trial terminated
Vaccine, hepatitis B, liver disease - Read more
Kinevant Sciences’ namilumab (anti-GM-CSF) fails in pulmonary sarcoidosis Ph2
Monoclonal antibody, pulmonary sarcoidosis - Read more
Trevi Therapeutics’ human abuse potential study for Haduvio (Nalbuphine opioid analgesic extended release formulation) in chronic cough disappoints investor despite demonstrating statistically significant lower 'drug liking'
Small molecule, chronic cough - Read more
THE BAD
Patient Access
American Diabetes Association warns against using compound versions of popular weight-loss meds
GLP-1, obesity, diabetes, compounding - Read more
THE BAD
Politics & Policy
Pfizer, Eli Lilly push back (and avoid answering detailed questions) on government scrutiny aimed at their telehealth platforms and potential “anti-kickback statute” violations
Telehealth, direct-to-consumer, kickbacks - Read more
THE BAD
Strategic Plans
Orexo ditches GAIA-partnered depression treating app
Virtual health, depression, prescription app - Read more [Paywall]
⬇️ The Ugly News ⬇️
THE UGLY
Politics & Policy
RFK Jr. made $20k a week (total $326k) from his anti-vax non-profit Children’s Health Defense prior to his presidential run
Anti-vaccine, conspiracy theory - Read more
THE UGLY
Warnings Letters, Form 483s
Applied Therapeutics handed FDA warning letter (in addition to last week’s CRL) regarding govorestat (aldose reductase inhibitor) clinical trial conduct
Small molecule, classic galactosemia - Read more
You’re all caught up on the latest Pharma & Biotech News!

Anybody else participating in Whamageddon this holiday season? | Gif: joluijten on Giphy
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