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  • Biotech & Pharma Updates | November 11 - 12, 2024

Biotech & Pharma Updates | November 11 - 12, 2024

Trace Neuroscience launches with $101M and ALS therapy goals, Apollo Therapeutics buys ex-China rights to Sunshine Lake Pharma diabetes clinical asset, Alentis Therapeutics $181.4M Series D to accelerate ADC pipeline, AstraZeneca plans $3.5B & 1000+ jobs investment in the US, Roche & Flare Therapeutics collaborate on cancer drug discovery, Intercept Pharmaceutical’s full Ocaliva approval rejected by FDA, Neurogene stock collapses after Rett syndrome gene therapy serious adverse event, Bayer’s CEO calls Q3 earnings “not pretty”, Pfizer considers hospital drugs business divestiture as activist investor pressure continues, AstraZeneca’s CEO says they didn’t “lose oversight” regarding Chinese executive criminal investigations

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⬇️ The Good News ⬇️

THE GOOD
Business Development

Apollo Therapeutics buys ex-China rights to APL-1888 clinical asset from Sunshine Lake Pharma
Bispecific fusion protein, GLP-1, type 2 diabetes - Read more

THE GOOD
Clinical Trials

Triumvira Immunologics touts “promising” preliminary Ph1/2 data for solid tumor cell therapy TAC01-CLDN18.2
Cell therapy, solid tumor, pancreatic cancer, allogeneic T cell - Read more

Merck & Co., AstraZeneca showcase positive topline Ph3 data for Koselugo in neurofibromatosis type 1 with symptomatic inoperable plexiform neurofibromas
Small molecule, neurofibromatosis type 1 (NF1), symptomatic inoperable plexiform neurofibromas - Read more

Insilico Medicine’s AI-designed small molecule ISM001-055 delivers positive Ph2a topline data
Small molecule, idiopathic pulmonary fibrosis - Read more

Merck KGaA, Abbisko’s pimicotinib delivers the Ph3 goods in tenosynovial giant cell tumours
Small molecule, tenosynovial giant cell tumor, cancer - Read more

THE GOOD
Company Launches

Trace Neuroscience launches with $101M, goal to address ALS via “replacing broken genetic machinery“
Antisense oligonucleotide, amyotrophic lateral sclerosis - Read more

THE GOOD
Earnings & Finances

Altimmune’s stock rockets up 30% on positive business update
Synthetic peptide, metabolic dysfunction-associated steatohepatitis (MASH), liver disease - Read more

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⬇️ More Good News ⬇️

THE GOOD
Fundraises

Alentis Therapeutics $181.4M Series D to accelerate ADC pipeline
Antibody-drug conjugate, solid tumor, cancer - Read more

Zuraca Therapeutics $20M Series B, targeting noctural hypoglycemia events in type 1 diabetes
Small molecule, nocturnal hypoglycemia events, type 1 diabetes - Read more

Vittoria Biotherapeutics $25M Private financing, autologous T cell therapy targeting lymphoma
Cell therapy, lymphoma, cancer, autologous T cell - Read more

AdipoPharma undisclosed raise, developing a whole body insulin sensitizer to treat insulin resistance
Synthetic peptide, insulin resistance, diabetes - Read more

Novel Microdevices $2.68M follow-on funding from NIH for infectious disease rapid diagnostics
Diagnostics, rapid testing, infectious disease, RT-PCR - Read more

THE GOOD
Investments

AstraZeneca plans $3.5B in US investments by EOY 2026, creation of “more than a thousand” new jobs
Facility build, capacity expansion, manufacturing - Read more

Lonza plans Visp bioconjugation site expansion for ADC manufacturing
Antibody-drug conjugate, manufacturing, capacity expansion - Read more

Future Fields announces new Edmonton, Canada protein biomanufacturing facility
Biomanufacturing, protein manufacturing - Read more

THE GOOD
Mergers & Acquisitions

Cardinal Health to acquire majority stake in GI Alliance + fully acquire Advanced Diabetes Supply Group
Healthcare, pharmaceutical and specialty product supplier, gastroenterology, diabetes - Read more 

THE GOOD
Partnerships

Novartis, Schrödinger partner on computationally-driven drug discovery & design, up to $2.3B biobucks
Small molecule, drug discovery, computational drug design - Read more

Roche, Flare Therapeutics cancer drug discovery collaboration
Small molecule, drug discovery, chemoproteomics, structural biology screening, cancer - Read more

GSK, Vesalius Therapeutics neurodegenerative disorder drug discovery collaboration
Small molecule, Parkinson’s disease, neurodegenerative disorder - Read more

Optic, Vindur Tx partner on cancer drug discovery, utilizing formers BIOPTIC AI platform
Small molecule, AI, drug discovery - Read more

Repare Therapeutics collabs with US National Cancer Institute on camonsertib development
Small molecule, drug development, lung cancer - Read more

THE GOOD
Product Launches

Sanofi, OpenAI, Formation Bio launch AI-powered clinical trial recruitment tool
Software, AI, clinical trial recruitment - Read more

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⬇️ The Bad News ⬇️

THE BAD
Approvals & Labels

Intercept Pharmaceuticals’ full Ocaliva approval slapped down by FDA
Small molecule, primary biliary cholangitis - Read more

AstraZeneca, Daiichi Sankyo withdraw dato-dxd ADC approval application with FDA, resubmit with narrower patient criteria
Antibody-drug conjugate, lung cancer - Read more

THE BAD
Clinical Trials

Syndax Pharmaceuticals stock slides by 25% on new Ph2 revumenib data, despite hitting primary endpoint
Small molecule, myeloid leukemia, cancer - Read more

Neurogene stock falls by 35% after reporting gene therapy NGN-401 high dose serious adverse event
Gene therapy, Rett syndrome, AAV - Read more

THE BAD
Earnings & Finances

Bayer’s own CEO calls Q3 earnings “not pretty”, 37% decline earnings per share YoY
Big pharma, consumer health - Read more

THE BAD
Lawsuits

Johnson & Johnson sues the US HRSA over 340B drug pricing interpretation
340B drug pricing program - Read more [Paywall]

THE BAD
Layoffs

Orna Therapeutics cuts undisclosed number of roles
RNA, autoimmune diseases, sickle cell, CRISPR - Read more [Paywall]

THE BAD
Mergers & Acquisitions

US DOJ sues to block UnitedHealth’s $3.3B acquisition of Amedisys
Home health, hospice - Read more

THE BAD
Strategic Plans

Pfizer considering divestiture of hospital drugs business as activist investor Starboard Value continues putting on pressure
Sterile injectables, antibiotics, hospital drugs - Read more

Bayer cuts development of Parkinson’s disease gene therapy BV-101
Gene therapy, Parkinson’s disease, AAV - Read more

Centessa Pharmaceuticals ditches Ph2 hemophilia B hopeful SerpinPC after recent Pfizer Hympavzi approval
Recombinant protein, hemophilia B - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Criminal Acts

AstraZeneca’s CEO argues that they didn’t “lose oversight” regarding recent Chinese executive investigations
Illegal importation, insurance fraud - Read more

THE UGLY
Politics & Policy

FDA Commissioner warns of “political risks” to agency as new administration looms
Regulatory oversight - Read more [Paywall]

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

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