All the top Biotech & Pharma news in one daily newsletter.

What to understand how these updates are formatted? Check-out the FAQ.

Have any feedback? I’d love to hear you from - connect with me on LinkedIn. 📣

Looking to reach an audience of 800+ biotech and pharma professionals? Let’s chat. 👍

THE GOOD
Approvals & Labels

Novo Nordisk’s Wegovy gets positive EMA CHMP opinion for label expansion to reflect reduced heart failure symptoms and improved physical function
GLP-1, obesity-related heart failure with preserved ejection fraction - Read more

Xspray Pharma plans to resubmit Dasynoc NDA after positive FDA meeting
Small molecule, myeloid leukemia, cancer - Read more

THE GOOD
Clinical Trials

Roche’s antiviral Xofluza posts positive Ph3 data, reduces influenza transmission after infection
Small molecule, antiviral, influenza - Read more

Edgewise Therapeutics’ cardiomyopathy candidate EDG-7500 posts encouraging interim Ph2 data, stock climbs 54%
Small molecule, hypertrophic cardiomyopathy - Read more

Aligos Therapeutics’ ALG-055009 Ph2 MASH trial delivers a midstage win, though investors aren’t impressed (stock drops 20%)
Small molecule, metabolic-dysfunction associated steatohepatitis (MASH) - Read more

4D Molecular Therapeutics touts positive Ph1/2 for wet AMD gene therapy 4D-150, but investors weren’t as impressed by the data (stock drops 25%)
Gene therapy, wet age-related macular degeneration (wet AMD) - Read more

Transcenta’s “encouraging” osemitamab Ph1 study of first-line triple combo therapy for rare esophageal cancer
Monoclonal antibody, gastroesophageal junction adenocarcinoma, cancer - Read more

Laekna’s “robust” Ph1 data for afuresertib in breast cancer
Small molecule, breast cancer - Read more

THE GOOD
Company Launches

GC Therapeutics launches with $75M and a bold plan to revolutionize off-the-shelf cell therapy production
Cell therapy, allogeneic/off-the-shelf - Read more

THE GOOD
Fundraises

Tanai Therapeutics additional financing from Novo Nordisk, BioGeneration Ventures
Small molecule(?), obesity - Read more 

Tiziani Life Sciences $4M grant from NIH
Monoclonal antibody, Alzheimer’s disease - Read more

Ascendis Pharma $300M public offering
Protein, small molecule, growth hormone deficiency, cancer - Read more

Neurexis Therapeutics’ $3M grant from NIH
Peptide, neuroprotection - Read more

Flourish Research majority investment from Genstar Capital
Clinical research organization (CRO) - Read more

PRESENTED BY ENMORE BIO
China's Largest Biotech Event: BIOCHINA 2025

BIOCHINA 2025 will take place from March 13-15, 2025, spanning 50,000 square meters and accommodating 30,000 participants across 3,000 biotech and biopharmaceutical companies with significant involvement from decision-makers - an ideal venue for fostering partnerships for business development and supply chain optimization.

Key topics will include cell and gene therapy, antibody drugs, and vaccines, with exhibits featuring pharmaceutical and biotech upstream suppliers, including CROs and CDMOs.

Register now and receive a 20% discount on your partnering registration! Promo code: TLDR

⬇️ The Good News (Cont’d) ⬇️

THE GOOD
IPOs

Upstream Bio files for NASDAQ IPO, lead asset verekitug against respiratory diseases
Monoclonal antibody, chronic rhinosinusitis with nasal polyps, asthma, chronic obstructive pulmonary disease - Read more

THE GOOD
Lawsuits

Axonics doesn’t infringe on a trio of Medtronic patents, decides California federal jury
Medical device, patent infringement - Read more

THE GOOD
Mergers & Acquisitions

Concentra Biosciences makes non-binding bid to acquire Singular Genomic Systems
Genomics, NGS, sequencing - Read more

THE GOOD
Partnerships

Basilea Pharmaceutica extends partnership with BARDA, up to $268M in funding
Small molecule, antifungal, antibacterial - Read more 

THE GOOD
Politics & Policy

US House takes steps to renew the FDA’s pediatric rare disease voucher program (PRV)
Pediatric rare disease priority review voucher program - Read more [Paywall]

THE GOOD
Public Health

Bavarian Nordic tapped by Gavi, the Vaccine Alliance and the UK for additional 650k mpox doses
Vaccine, monkeypox (mpox) - Read more

NIH builds up pandemic preparedness network as COVID-19, mpox continue spread
Pandemic preparedness, COVID-19, monkeypox (mpox) - Read more

ENJOYING THESE NEWSLETTERS?
Support TLDR Biotech🧬🦠🔬 

I’m offering this newsletter for free so it can get out to as many people as possible.

If you’re getting value out of these daily compilations, please consider a paid subscription (only $5/month) to support my continued work on this project.*

*Best of all, it’s a work-related news source that you can likely expense. 😉 

THE BAD
Approvals & Labels

Vanda Pharmaceuticals’ tradipitant rejected by FDA; decision delayed by 185 days
Small molecule, gastroparesis - Read more

THE BAD
Clinical Trials

GSK halts herpes Ph2 trial with GSK3943104 vaccine candidate after primary efficacy objective miss
Vaccine, herpes simplex virus - Read more

THE BAD
Earnings & Finances

The biotech market’s reaction to the US Feds’ rate cut? “Meh”
Small cap biotech, biotech stock market - Read more

Progyny loses Amazon as fertility benefits client, 13% of former’s revenue
Fertility benefits, fertility services - Read more [Paywall]

THE BAD
Layoffs

BioXcel Therapeutics lays off 28% of workforce
Small molecule, agitation associated with Alzheimer’s dementia - Read more

THE BAD
Strategic Plans

Achilles Therapeutics axes lead TIL-based therapy program
Cell therapy, tumor-infiltrating lymphocyte (TIL), cancer - Read more

THE UGLY
Research

Newer class of migraine meds (Pfizer’s Nurtec, AbbVie’s Ubrelvy, Eli Lilly’s Reyvow) are “no more effective…[than] tylenol, ibuprofen and aspirin”; clinical trial meta-analysis
Small molecule, migraine, headaches - Read more

THE UGLY
Warnings Letters, Form 483s

Granules India faces scolding by FDA over rampant production record control issues (eg. trucks full of scrapped, uncontrolled manufacturing-related documents)
Pharmaceutical manufacturing, generics - Read more

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

TLDR Biotech wants to hear from you! 📣

Have comments/questions/complaints about this newsletter?
Send me an email - I want your brutally honest feedback. 📝

Last thing - if you find the content useful and think a colleague would too, please share TLDR Biotech with them! ♻️

Disclaimer: Content, news, research, tools, and mention of stock or tradeable securities are for educational and illustrative purposes only and do not imply a recommendation or solicitation to buy or sell a particular security or to engage in any particular investment strategy. Read the full terms & conditions here.