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Tarsus Pharmaceuticals has entered into a definitive agreement to acquire Alkeus Pharmaceuticals, incl. its lead asset gildeuretinol (ALK-001), expanding Tarsus’ presence in retina care
As per the deal, Alkeus will receive ~$450M upfront ($270M cash + $180M in Tarsus stock priced at $61.38/share), plus ~$350M in regulatory & commercial milestones, & low single-digit tiered descending…
NEWS
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FDA approved mFLUSIVA against seasonal influenza for use in adults (≥50yrs); supply to select retailers to be available in coming wks. Regulatory review is ongoing in the EU, Canada & Australia, with flings in other countries planned during 2026
Approval in pts (50–64yrs.) was backed by a P-III trial (n=40,805; ≥50yrs.) assessing safety &…
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Alteogen has entered into an exclusive license agreement with a global pharmaceutical company to develop & commercialize a SC formulation of a biologic product utilizing ALT-B4 (berahyaluronidase alfa)
As per the deal, the company will acquire exclusive global rights to the SC formulation of a biologic product. In exchange, Alteogen will receive ~$365M, incl.…
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Schrödinger has entered into a strategic agreement with BMS to deploy Bunsen, its agentic AI co-scientist, across BMS's research organization, expanding the companies' long-standing partnership
As per the deal, Schrödinger will work with BMS to develop new Bunsen capabilities alongside its computational technologies for large-scale chemical exploration & RetroSynth, its AI-driven synthesis planning platform …
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The US FDA has granted 510(k) clearance to Revi Extend, the next-generation implant for Revi System to treat urgency urinary incontinence (UUI), with the new implant offering an extended lifespan of 15yrs.Limited US launch planned for Q4’26
Built on Implantable Tibial Neuromodulation (ITNM), Revi System is designed to reduce the long-term treatment burden through…
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The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. DEA scheduling decision is expected within 90 days, after which it will be available through a specialty pharmacy
Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in…
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Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer
The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…
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Natera has submitted an application to Japan's PMDA seeking approval of Signatera as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC)
The submission expands the company's presence in Japan, where Signatera became the country's first PMDA-approved molecular residual disease (MRD) test for colorectal cancer in Jun 2026
Application is supported by data from…
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The US FDA has accepted sBLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked MMP associated with masseter muscle activity in adults
sBLA was supported by 2 P-III (M21-416 and M21-417) studies, both of which met their 1EPs & showed improvements in the severity of MMP vs…
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SOPHiA GENETICS has entered a global collaboration with AstraZeneca to develop, validate, & commercialize two companion diagnostics (CDx) supporting precision oncology therapies
The multi-year collaboration will leverage SOPHiA’s decentralized clinical trial assays & CDx capabilities to advance development & commercialization of the CDx programs
As per the deal, SOPHiA GENETICS will develop its Solid Tumor…

