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

Asahi Kasei's Hovilpri (pritelivir) wins FDA approval for drug-resistant herpes simplex virus lesions in immunocompromised patients following Ph3 success
Small molecule, infectious disease, helicase primase inhibitor, herpes simplex virus, immunocompromised patients - Read more

Foresee Pharmaceuticals' CAMCEVI (leuprolide mesylate) wins China NMPA approval for advanced prostate cancer
Small molecule, cancer, GnRH agonist, prostate cancer, hormone therapy - Read more

BARDA awards Kaléo $96M contract for 2-PAM auto-injector chemical threat preparedness, up to $341M total
Government contract, infectious disease, drug-device, manufacturing, regulatory, national stockpile - Read more

Roche, Rona Therapeutics license RNAi-based ALK7 obesity candidate for up to $1.16B
Licensing deal, obesity, RNAi, small molecule, milestone payments - Read more

Pfizer, Enodia Therapeutics partner on Sec61-targeting small-molecule drugs, deal topping $500M
Licensing deal, small molecule, drug discovery, AI/ML, milestone payments, royalties - Read more

NHS Blood and Transplant, Northwest Biotherapeutics collaborate to support DCVax-L personalised immunotherapy production across England
Manufacturing agreement, oncology, cell therapy, immunotherapy, commercialization - Read more

Lonza expands dual-payload ADC portfolio via exclusive license of Qurient Co. Ltd.'s CDK7 inhibitors
Licensing deal, antibody-drug conjugate, oncology, manufacturing, small molecule - Read more

Considering a continuous, automated approach to bioprocess and formulation analytics?

We can show you how - join CLADE and PAL System on October 21st to learn how to increase end-to-end analytical throughput and reduce human touchpoints across analytical workflows.

Ideal for: Biopharma analytical team leads, formulation and process development experts - register here.

Mirum Pharmaceuticals seeks FDA label expansion for Livmarli (maralixibat) targeting ultra-rare cholestatic liver diseases after Ph3 win
Small molecule, liver disease, ileal bile acid transporter inhibitor, cholestatic pruritus, paediatric, label expansion - Read more

Tortugas Neuroscience's (obuprazine) hits primary endpoint in Ph2b trial for acute schizophrenia
Small molecule, neurological, schizophrenia, D2/D3 partial agonist, antipsychotic - Read more

Bristol Myers Squibb's (admilparant) hits Ph3 primary endpoint in idiopathic pulmonary fibrosis despite confounding dose-response results
Small molecule, respiratory disease, LPA1 receptor antagonist, idiopathic pulmonary fibrosis, forced vital capacity - Read more

Bristol Myers Squibb's RYZ101 (RYZ101) meets Ph3 primary endpoint in somatostatin receptor-expressing gastroenteropancreatic neuroendocrine tumors
Radiopharmaceutical, cancer, small molecule, neuroendocrine tumors, actinium-225, somatostatin receptor - Read more

First Tracks Biotherapeutics' (ANB033) hits Ph1b primary endpoints protecting against gluten-induced intestinal damage in celiac disease
Antibody, autoimmune, monoclonal antibody, celiac disease, CD122 antagonist, IL-15 inhibition - Read more

Johnson & Johnson's Tremfya surpasses $2.4B in Q3, beating forecasts with 68.3% year-over-year growth
Monoclonal antibody, autoimmune, revenue impact, financial - Read more

Aspen Neuroscience files for IPO, Parkinson's personalized cell therapy developer
Cell therapy, Parkinson's disease, neurological, induced pluripotent stem cells, clinical-stage - Read more

City Therapeutics plans $175M IPO to advance trio of GalNAc-conjugated siRNA therapies
siRNA, rare disease, cardiovascular, clinical-stage, GalNAc conjugate - Read more

Bambusa Therapeutics files for $100M IPO, developing bispecific antibodies for inflammatory diseases
Autoimmune, bispecific antibody, clinical-stage, inflammation, rare disease - Read more

Desentum raises €28M ($31.4M) equity round to advance allergen immunotherapy programs targeting birch, peanut, cat allergies
Allergen immunotherapy, clinical-stage, genetically engineered biologics, autoimmune, rare disease - Read more

GSK pledges $800M to build biologics production facility and innovation hub in Pennsylvania
Biologics, oncology, manufacturing, major transaction - Read more

Alaunos Therapeutics acquires Velaris Therapeutics, raising $350M to advance PAH cardiopulmonary pipeline
Fc fusion protein, cardiovascular, major transaction, strategic - Read more

Roche's (vamikibart) FDA filing accepted for uveitic macular edema, decision expected July 2027 after Ph3 data
Protein therapy, autoimmune, monoclonal antibody, uveitic macular edema, IL-6 inhibitor, ophthalmology - Read more

AbbVie's AQUIPTA accepted by SMC for eligible migraine patients in NHS Scotland
Small molecule, migraine, regulatory, revenue impact - Read more

Alnylam UK's vutrisiran accepted by SMC, granting NHS Scotland patients access for ATTR-CM treatment
RNAi therapy, cardiovascular, rare disease, regulatory - Read more

Do you offer a biotech/pharma-focused product or service?

Or looking to get investor/analyst interest on your budding start-up?

Considering sponsoring TLDR Biotech to get in-front of an engaged audience of biotech & pharma-focused professionals.

Just reply to this email* or message me on LinkedIn to learn more.

*If you’re reading this on the web version, email [email protected]

Merck & Co.'s (remigromig) Ph2b/3 data reveals safety concerns, limited efficacy in diabetic macular edema vs. ranibizumab
Protein therapy, ophthalmology, trispecific antibody, diabetic macular edema, anti-VEGF, blood-retinal barrier - Read more

BioNTech's BNT113 (BNT113) misses Ph3 progression-free survival endpoint in HPV16-positive head and neck squamous cell carcinoma
mRNA vaccine, cancer, head and neck cancer, HPV16, combination therapy, PD-1 inhibitor - Read more

Syndax Pharmaceuticals' Niktimvo (axatilimab) fails Ph2 trial in idiopathic pulmonary fibrosis, prompting program discontinuation
Antibody, autoimmune, monoclonal antibody, idiopathic pulmonary fibrosis, CSF-1R, graft-versus-host disease - Read more

Par Health recalls two Brevital sodium IV bag lots over cellulose contamination risk
Small molecule, hospital/critical care, operational, product recall - Read more

Nurix discontinues zelebrudomide BTK degrader, prioritizes Roche-partnered bexobrutideg entering phase 3
Targeted protein degrader, oncology, strategic, competitive, major transaction - Read more

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

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

And lastly - connect with me on LinkedIn!

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