Rare Diseases

Major Cash Injection Advances Augustine’s HDAC6 Hopes

 
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The Belgian firm banks nearly €77.7m to push its Charcot-Marie-Tooth to proof-of-concept.

Alnylam Joins Competitive ATTR-CM Market With Amvuttra Approval

 

Amvuttra will target a substantially larger patient population with a new indication, but it is third to market behind Pfizer’s Vyndaqel and Bridge Bio’s Attruby and will cost more.

Roivant Phase III Batoclimab Trial Is Positive, But No Filing Planned

 

The company’s Immunovant announced positive data from a Phase III trial in myasthenia gravis but the focus is on next-generation drug IMVT-1402.

Sarepta Shares Plummet On News Of Elevidys Patient Death

 
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The gene therapy for Duchenne muscular dystrophy passed the blockbuster sales threshold in 2024. Analysts said the drug’s overall risk/benefit profile still appears solid.


Amgen Bullish On Uplizna As ‘New Standard Of Care’ In Myasthenia Gravis

 

In the crowded and competitive field of generalized myasthenia gravis, Amgen has faith that Uplizna’s twice-yearly administration will make it the treatment of choice.

Plaudits For MeiraGTx And Its Parkinson’s AI Pact

 
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A joint venture with AI specialist Hologen will bring in much-needed cash for the ambitious gene therapy firm.

Ionis Gets Tryngolza Launch Cash From Ono Via Sapablursen License

 
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Ono agreed to pay $280m up front for global rights to Ionis’s Phase II polycythemia vera candidate, which analysts say was de-risked by recent data reported for other PV drugs.

Zevra Seals PRV Sale And Banks $150m

 
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Having picked up Niemann-Pick disease type C drug Miplyffa for a song, the US rare disease specialist is singing all the way to the bank after selling the priority review voucher that came with its approval.


BridgeBio’s Attruby Off To A Strong Start – But Alnylam Awaits

 

Attruby is making fast inroads thanks to its edge over Pfizer’s established Vyndaqel, but will soon face competition from Alnylam.

Scrip Asks... What Does 2025 Hold For Biopharma? Part 6: Therapeutic Area Advances

 

Over 140 biopharma leaders share their views on developments to watch for in key therapeutic areas this year. Advances in multiple scientific fields are opening up new avenues for treatment.

Zealand Narrows Field Of Potential Partners For Petrelintide

 
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Amylin analogs could well match the weight loss seen with Novo Nordisk and Eli Lilly’s GLP-1-based blockbusters with less fewer tolerability issues. The Danish company believes petrelintide will lead the pack and is vetting potential big pharma partners very carefully.

Egetis Eager To Launch Ultra Rare Disease Drug Emcitate

 
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The Swedish company is celebrating approval for the first treatment for rare congenital disorder MCT8 deficiency and plans a launch in the near future.


Ipsen Pleased With Iqirvo Launch And Plots More Deals

 
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The Paris-headquartered group has been reflecting on a solid performance last year.

SpringWorks Gains New Approval Amid Merck KGaA Buyout Talks

 

After coming up blank with its in-house oncology efforts, the German conglomerate is mulling a deal to acquire the US specialist company which has just managed a new drug approval for mirdametinib.

Switzerland’s AB2 Bio Bags Nippon Shinyaku As Late-Stage IL-18 Inhibitor Partner

 
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CEO Djordje Filipovic tells Scrip that after talks with "multiple other potential partners,” the firm chose the Japanese group for its expertise and marketing capabilities in rare diseases” to be the licensing partner for tadekinig alfa in the US.

Leo Delves Into Rare Cancer Space With Junshi Deal

 
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The Danish drugmaker, best known for dermatology, has secured the European rights to Shanghai Junshi Biosciences’ cancer therapy toripalimab, which was the first Chinese PD-1/L1 checkpoint inhibitor to be approved in the US.


Scholar Rock Does Its Homework For Successful SMA Launch

 
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On the back of a stellar showing in Phase III, apitegromab is going to be filed in the US and Europe in the coming weeks for spinal muscular atrophy and CEO Jay Backstrom believes it will be a $2bn blockbuster.

Sarepta Bullish After Another Big Beat For Elevidys

 
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The US biotech’s Duchenne muscular dystrophy drug is “undoubtedly the most successful gene therapy launch in all of history,” according to CEO Doug Ingram. “We have barely scratched the surface of the opportunity in front of us.”

Double Whammy For ALS As AbbVie/Calico And Denali Drugs Fail

 
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Two treatments that target elF2B, a regulator of the integrated stress response that appears to be overactive in the progressive motor neurone disease, have missed their primary and secondary endpoints in a landmark platform trial.

Stock Watch: Biotech Investors Bid Good Riddance To 2024

 
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From gene therapies to small molecule drugs, investors seemed to have eschewed the risks of biotech company investment propositions in 2024 but last year’s disappointments provided good lessons going forward.