- Amended senior secured term loan includes $50 million funded at closing
- Agreement provides an additional $125 million in borrowing capacity under the expanded facility
Wednesday, June 17, 2026
Dyne amends Hercules Capital term loan, expanding non-dilutive debt facility to up to $400 m
Morgan Stanley downgrades ResMed to Equal Weight, cuts price target to $230 from $286
- Firm cites expectations of slower revenue growth as Philips re-enters the U.S. device market.
Ocular Therapeutix secures FDA alignment on 505(b)(2) NDA plan for AXPAXLI in wet AMD
targeting Q4 2026 submission
- NDA will rely on SOL-1 efficacy data plus interim safety data from the SOL-R trial.
- Company agreed with FDA on a new superiority endpoint versus aflibercept for SOL-R efficacy assessment.
- SOL-R efficacy data timing pushed back, with key readout now expected in 2028 under revised plan.
- Plan includes a streamlined single Phase 3 HELIOS-3 trial in diabetic retinopathy instead of multiple studies.
Novo Nordisk to seek regulatory approval for Wegovy pill in China soon, says CEO
Novo Nordisk plans to seek Chinese regulatory approval for its weight-loss pill "very soon," CEO Mike Doustdar said Tuesday, in a move to catch up with rival Eli Lilly in the world's second-largest pharmaceutical market
https://www.aol.com/articles/novo-nordisk-seek-regulatory-approval-060006000.html
GSK-Spero Utebzi OKd in the US for adults with complicated urinary tract infections
- First and only oral carbapenem antibiotic approved in the US
- Approval based on PIVOT-PO trial demonstrating non-inferiority compared to intravenous treatment1
- More than 3 million cases of cUTIs are treated annually in the US2 with up to a third of patients impacted by resistant infections3
- https://us.gsk.com/en-us/media/press-releases/utebzi-tebipenem-pivoxil-approved-in-the-us-for-adults-with-complicated-urinary-tract-infections-cutis/
Regenxbio, Replimune among gainers after FDA U-turn on UniQure
uniQure's positive FDA gene therapy feedback sparks sector rally, lifting REGENXBIO 22%
- RGNX shares surged ~21.79% to ~$8.00-$8.50 range on June 17 with elevated volume.
- Catalyst tied to uniQure (QURE +80%+ same day) after FDA indicated 3-year Phase 1/2 AMT-130 data can support accelerated approval BLA for Huntington's gene therapy.
- Positive regulatory signal for AAV gene therapies benefits peers like REGENXBIO with late-stage pipeline (RGX-202 for DMD, RGX-314 retinal therapy partnered with AbbVie).
- Builds on REGENXBIO's own May 2026 positive pivotal Phase 3 AFFINITY DUCHENNE topline for RGX-202 (met primary microdystrophin endpoint with strong functional trends).
- Recent conference comments (e.g., Ram Palanki at CTS) noted big pharma partnering interest in small-caps with clear regulatory path, strong safety, and transparency.
- High short interest (~14% of float) and options activity likely amplified the move via short covering and momentum buying.
- No standalone REGENXBIO press release on June 17; sector sympathy and rebound from post-earnings weakness appear primary drivers.
Merck adds to biopharma’s AI agenda with up to $510M+ Protillion pact
Merck will use Protillion Biosciences’ tech to design biologic therapies for therapies across undisclosed indications.
The next stop on biopharma’s AI train is Merck, which is bringing on California’s Protillion Biosciences to combine large-scale data generation and AI design to advance a suite of novel biologic therapies.
Merck is making an undisclosed upfront payment, according to a Tuesday release, as well as offering up to $510 million in R&D and commercial milestones. The companies did not name the specific targets or disease areas they plan on addressing, only saying that they will collaborate on “multiple therapies.”
For its investment, Merck will gain access to Protillion’s Prot-MaP technology, a “megascale data generation platform” that the biotech claims will provide training sets specifically tailored to protein design AI models.
This approach can simultaneously and quantitatively assess protein therapy candidates “at a massive scale” to find those that are likely to be specific to and have high affinity for their intended targets, as well as have “uncompromised manufacturability,” according to Protillion’s website.
Protillion’s tech “offers a compelling opportunity” for Merck’s drug development capabilities, Juan Alvarez, vice president of discovery biologics at Merck Research Laboratories, said in a statement. The platform has the “potential to transform the speed and precision with which we characterize protein landscapes and identify novel therapeutic candidates,” he added.
AI is quickly becoming a central force in biopharma as more and more companies—including the industry giants—integrate the technology into drug development processes. Eli Lilly in particular has been investing heavily in AI. In April, the pharma put up to $2.25 billion on the line to bring on Profluent Bio and its machine learning platform to design therapeutic enzymes for a variety of genetic targets.
Last month, Lilly struck again, along with Bristol Myers Squibb and Incyte, minting respective AI alliances to integrate machine learning models into different parts of their operations, such as data sharing and corporate and commercial functions.
Most recently, Alnylam earlier this month gave $30 million to Inceptive Nucleics, gaining access to a machine learning engine that learns the underlying biology behind diseases. Alnylam, which has earmarked a total of $2 billion for this agreement, will use Inceptive’s approach to optimize its siRNA design and selection.
The AI wave also saw the second largest financing round in biopharma history, with Alphabet’s Isomorphic Labs bringing in $2.1 billion in May, despite having no asset in the clinic yet.
https://www.biospace.com/deals/merck-adds-to-biopharmas-ai-agenda-with-up-to-510m-protillion-pact
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