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NEWS

1ST Biotherapeutics Inks ~$314.8M Deal with SK Biopharmaceuticals for 1ST-104

Shots: 1ST Biotherapeutics SK Biopharmaceuticals have entered into an exclusive global licensing agreement & strategic equity investment partnership to advance 1ST-104 for the treatment of Parkinson's disease  As per the deal, 1STBIO will receive a $1.8M upfront payment, with the licensing agreement valued at ~$314.8M, incl. a $1.8M short-term milestone upon candidate selection & additional…
September 18, 2026

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EMA Marketing Authorization of New Drugs in August 2026

Shots:  The European Commission (EC) approved Daybu (trofinetide) and Hopledo (modified-release levodopa/carbidopa) for neurological disorders, expanding treatment options for Rett syndrome and Parkinson’s disease, respectively.  Daybu was approved for neurobehavioral symptoms of Rett syndrome in patients aged ≥5 years, while Hopledo was approved for adults with Parkinson’s disease and moderate to severe motor fluctuations.  The…
September 15, 2026

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NEWS

Zambon Secures the EC Approval for Hopledo to Treat Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The EC has approved Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Approval was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…
August 31, 2026

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NEWS

Jupiter Neurosciences Inks ~$100M Deal with PharmAla Biotech for Exclusive US Rights to ALA-002

Shots: Jupiter Neurosciences has entered into a definitive license agreement with PharmAla Biotech for perpetual exclusive US rights to ALA-002, a FDA NCE-designated, non-racemic MDMA formulation Jupiter Neurosciences will receive perpetual exclusive US rights to ALA-002 for $3.3M upfront ($1.5M cash + $1.8M JUNS common stock), with the deal valued at up to $100M, incl.…
July 22, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
July 21, 2026

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NEWS

Zambon’s Hopledo Receives the CHMP Positive Opinion for Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The CHMP has recommended Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Opinion was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…
June 30, 2026

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NEWS

Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao

Shots: Merz has granted Kvvit exclusive license to Inbrija (levodopa inhalation powder) in mainland China, Hong Kong, & Macao for intermittent treatment of OFF episodes in adults with Parkinson’s disease receiving levodopa/dopa-decarboxylase inhibitor Merz will supply Inbrija, oversee global quality & key regulatory activities, & act as Overseas Holder of the Drug Registration Certificate, while…
May 26, 2026

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NEWS

Tanabe Pharma Report the EC Approval of Onerji for Parkinson’s Disease (PD) 

Shots:  The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm   Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the…
April 27, 2026

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