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

Ultragenyx wins FDA approval for Fayuvi (rebisufligene etisparvovec), first-ever gene therapy for Sanfilippo syndrome type A
Gene therapy, neurological, rare disease, Sanfilippo syndrome, mucopolysaccharidosis - Read more

Eli Lilly's Inluriyo (imlunestrant) plus Verzenio (abemaciclib) combo wins FDA approval for estrogen receptor-positive, HER2-negative breast cancer
Small molecule, cancer, oral SERD, breast cancer, ESR1 mutation, CDK4/6 inhibitor - Read more

Sandoz receives Health Canada approval for generic (semaglutide), expanding access for type 2 diabetes mellitus patients
Protein therapy, metabolic, GLP-1 receptor agonist, type 2 diabetes, semaglutide, generic medicine - Read more

IntraBio's Aqneursa (levacetylleucine) wins FDA label expansion for ataxia-telangiectasia following Ph3 success
Small molecule, neurological, amino acid derivative, ataxia-telangiectasia, ATM gene, pediatric - Read more

Novo acquires three early-stage obesity assets from Kallyope, financial terms undisclosed
Acquisition, obesity, small molecule, peptide, pipeline expansion - Read more

Bayer offloads cancer drug Stivarga to Grünenthal for up to $431M amid rising competition
Acquisition, oncology, small molecule, milestone payments, commercialization - Read more

Sandoz, mAbxience collaborate on emicizumab biosimilar targeting $5.7B haemophilia A market
Licensing deal, rare disease, biosimilar, antibody, commercialization - Read more

Specialised Therapeutics expands partnership with Incyte Biosciences International to commercialise ruxolitinib cream in Australia
Licensing deal, dermatology, small molecule, commercialization, regulatory - Read more

Cell and Gene Live is a one-day, investor & CEO summit dedicated exclusively to Cell and Gene therapy - the science, the manufacturing, and the investment driving advanced medicines forward. All happening on November 15, 2026.

(Hosted by Onyx at The Shard in London as part of London Life Sciences Week)

Speakers confirmed include:

• Steve Bates, OBE (Chair of the UK's Department of Life Sciences)
• Dr. Erik Wiklund (CEO of Circio)
• Edwin Stone (CEO of Cellular Origins)
+ many more!

Get your tickets here - for TLDR Biotech readers, use code ANIS20 at check-out for 20% off.

Alkermes' (ALKS 7290) orexin agonist shows Ph1b promise in attention deficit hyperactivity disorder, Ph2 enrolling
Small molecule, neurological, orexin agonist, ADHD, attention deficit hyperactivity disorder - Read more

Beacon Therapeutics' (laruparetigene zovaparvovec) Ph2/3 win paves way for FDA filing in X-linked retinitis pigmentosa
Gene therapy, neurological, retinal gene therapy, X-linked retinitis pigmentosa, RPGR target - Read more

Cue Biopharma's CUE-221 meets Ph2 primary endpoint in chronic spontaneous urticaria, advancing to Ph2b/3 trial
Antibody, autoimmune, monoclonal antibody, chronic spontaneous urticaria, IgE, omalizumab - Read more

Hansoh Pharma's HS-10374 (HS-10374) meets co-primary endpoints in Ph3 trial for moderate-to-severe plaque psoriasis
Small molecule, autoimmune, TYK2 inhibitor, plaque psoriasis, IL-23 pathway - Read more

Electra Therapeutics raises $350M in upsized IPO, advancing immune overactivation antibody ipsoprubart
Antibody, rare disease, autoimmune, clinical-stage - Read more

Retension Pharmaceuticals, TRex Bio plan IPOs to advance hypertension and autoimmune pipeline candidates
Autoimmune, small molecule, cardiovascular, clinical-stage, Treg modulation - Read more

Anew Labs raises $290M, AI-native drug discovery platform scaling computational biology infrastructure
AI/ML platform, drug discovery, computational biology, small molecule, platform-enabled - Read more

Novadip Biosciences raises €10.4M ($11.98M) convertible financing to advance regenerative medicine lead program
Regenerative medicine, cell therapy, rare disease, clinical-stage, orthopedics - Read more

Scinetics raises nearly $7M in first financing round, advancing AI for Science platform
AI/ML platform, scientific discovery, platform technology, AI-driven - Read more

AstraZeneca invests $30M to upgrade Wuxi, China facility, targeting 400M cardiovascular tablets annually by 2029
Small molecule, cardiovascular, operational, major transaction - Read more

Telix to acquire ITM for up to $2.35B, aiming to build radiopharmaceutical powerhouse
Radiopharmaceutical, oncology, major transaction, strategic - Read more

China unveils five-year plan targeting 25% of global innovative drug approvals by 2030
Pharmaceutical industry, multi-disease, strategic, revenue impact - Read more

Novo, Incyte lead September CHMP approvals with haemophilia, hidradenitis suppurativa drugs among dozen recommended
Monoclonal antibody, haemophilia, small molecule, oncology, 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]

Xenon Pharmaceuticals pauses Ph2/Ph3 enrollment of (azetukalner) in major depressive disorder amid neuropsychiatric adverse events
Small molecule, neurological, potassium channel modulator, epilepsy, depression, azetukalner - Read more

Bristol Myers Squibb discontinues Orum Therapeutics' ORM-6151 targeted degrader after Phase 1 AML data review
Acquisition, oncology, targeted protein degradation, antibody, milestone payments - Read more

Novo unveils Consumer Rx strategy, blockbuster pipeline ambitions at Capital Markets Day, but stock drops 8%
GLP-1, obesity, strategic, financial, competitive - 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