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- Biotech & Pharma Updates | January 26 - 27, 2025
Biotech & Pharma Updates | January 26 - 27, 2025
Sarepta's Elevidys gene therapy delivers positive Ph3 results in Duchenne muscular dystrophy, a pulitzer-prize winning cancer physician + a LinkedIn co-founder join forces (with a $24.6M seed raise) to launch an AI-powered drug discovery engine (Manas AI), Allakos' AK006 flops in Ph1 chronic spontanous urticaria trial, CDC abruptly halts all collaboration with the WHO thus scuttling any hopes of a transition period + 22 more stories

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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
FDA approves monthly Leqembi (Eisai, Biogen) maintenance dosing for Alzheimer's disease
Monoclonal antibody, Alzheimer’s disease - Read more
Janssen's Lazcluze (EGFR inhibitor) plus Rybrevant (targeting EGFRxMET) approved in Europe for as first-line treatment for EGFR-mutated non-small cell lung cancer
Small molecule, lung cancer, monoclonal antibody - Read more
THE GOOD
Business Development
Nippon Shinyaku pays $36M upfront for US rights to AB2 Bio's rare disease drug tadekinig alfa (IL-8 inhibitor), with $650M in potential milestones
Recombinant protein, autoimmune, hyperinflammatory syndrome, NLRC4 mutation, XIAP deficiency - Read more
Takeda reacquires Japanese rights to depression drug osavampator (AMPA receptor agonist) from Neurocrine Biosciences after initial out-licensing in 2020
Small molecule, depression, major depressive disorder, anhedonia - Read more
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THE GOOD
Clinical Trials
Sarepta Therapeutics' Elevidys gene therapy delivers positive Ph3 results in Duchenne muscular dystrophy, potentially vindicating last year’s controversial accelerated approval
Gene therapy, Duchenne muscular dystrophy, AAV - Read more
Akero Therapeutics' efruxifermin (targeting FGF21) shows improved fibrosis reduction in Ph2b trial for metabolic dysfunction-associated steatohepatitis with cirrhosis
Fusion protein, metabolic dysfunction-associated steatohepatitis (MASH), liver cirrhosis - Read more
Veru's enobosarm (androgen receptor modulator) combined with Wegovy showed better lean mass preservation in obesity trial versus Wegovy alone
Small molecule, obesity, lean mass preservation, GLP-1 - Read more
Pfizer's Ph3 trial of Braftovi (targeting BRAF V600E mutant) plus cetuximab (targeting EGFR) and mFOLFOX6 shows improved response in BRAF V600E mutated metastatic colorectal cancer patients
Small molecule, colorectal cancer, monoclonal antibody - Read more
⬇️ More Good News ⬇️
THE GOOD
Company Launches
Manas AI launches with $24.6M Seed raise and AI-powered cancer drug discovery ambitions; backed by Pulitzer-winning science author Siddhartha Mukherjee and LinkedIn Co-Founder Reid Hoffman
Small molecule, cancer, drug discovery, AI - Read more
THE GOOD
Earnings & Finances
To Pfizer’s relief, activist investor Starboard Value declines to nominate any board members ahead of Jan. 25 deadline
Activist investor - Read more
THE GOOD
IPOs
Maze Therapeutics plots $131M IPO to fuel kidney disease ambitions
Small molecule, APOL1 kidney disease, chronic kidney disease, phenylketonuria - Read more
Pending lawsuit be damned as Aurion Biotech pursues NYSE listing as "AURN"
Cell therapy, corneal edema, corneal endothelial dysfunction, allogeneic corneal endothelial cells - Read more
Weight-loss company Metsera prices IPO, seeking $289M to support Phase III ambitions
GLP-1, obesity - Read more
THE GOOD
Lawsuits
Hawaii's lawsuit against major pharmacy benefit managers over unfair drug pricing practices survives dismissal attempt in federal court
Pharmacy benefit manager, drug pricing - Read more
Pfizer pays $59.7M settlement over acquisition Biohaven's illegal kickbacks to doctors for prescribing migraine drug Nurtec ODT
Small molecule, migraine, kickbacks - Read more
THE GOOD
Partnerships
Oxford University, GSK launch £50M ($62M) research collaboration to explore potential for preventative cancer vaccines
Cancer vaccine, research partnership - Read more
Agenus seeks pharma partnerships to advance anti-CTLA-4 cancer drug combo after FDA setback
Monoclonal antibody, colorectal cancer - Read more [Paywall]
CStone Pharmaceuticals partners with SteinCares to commercialize cancer drug sugemalimab (anti-PD-L1) across ten Latin American countries
Monoclonal antibody, cancer, solid tumor - Read more
THE GOOD
Public Health
NIH staff can continue research but face restrictions on public communications during Trump administration's temporary freeze on federal agencies
Research funding, public communications - Read more [Paywall]
THE GOOD
Research
Study shows Found's telehealth program achieved significant weight loss using generic drugs and coaching for 66,000 patients
Virtual care, coaching, weight loss, obesity, generic - Read more
Lantern Pharma's AI platform identifies 82 ADC targets and 729 potential payloads for cancer drug development
Antibody-drug conjugate, AI, cancer, drug development, drug discovery - Read more
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⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
Allakos discontinues AK006 development after Ph1 trial shows no clinical benefit for chronic spontaneous urticaria patients
Monoclonal antibody, urticaria, hives - Read more
THE BAD
Layoffs
Allakos cuts 75% of workforce after as AK006 (Siglec-6 agonist) flops in Ph1
Monoclonal antibody, urticaria, hives - Read more
Cell therapy biotech Affini-T Therapeutics reportedly conducted layoffs, with former employees posting about job losses on LinkedIn
Cell therapy, cancer, bispecific T-cell engager, autologus TCR-T cell therapy - Read more [Paywall]
THE BAD
Mergers & Acquisition
Sage Therapeutics rejects Biogen's $469 million takeover bid, opts for strategic review to explore better alternatives for shareholders
Small molecule, Alzheimer’s disease, Parkinson’s disease, major depressive disorder - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Public Health
CDC abruptly halts all collaboration with the WHO, scuttling any hopes of a transition period
Centers for Disease Control & Prevention, World Health Organization, public health, disease outbreaks, infectious disease - Read more [Paywall]
You’re all caught up on the latest Pharma & Biotech News!

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