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      Deals:

      AstraZeneca signed a potential $5 billion research deal with Chinese drugmaker CSPC.

      Eli Lilly is buying Verve Therapeutics for $1 billion upfront plus a CVR potentially worth another $300 million. 

      Supernus Pharmaceuticals acquired Sage Therapeutics in a $795 million deal.

      Processa Pharmaceuticals entered into a binding term sheet with Intact Therapeutics for an exclusive option to license PCS12852 in a deal that includes $452.5 million in total milestone payments.

      RNA biotech Ethris announced a strategic collaboration with Thermo Fisher Scientific.

      Lisata Therapeutics and GATC Health announced a strategic alliance.

      Synfini and O2nix Bio announced a strategic collaboration to develop novel cancer therapeutics targeting FTSJ1.

      FDA:

      Dyne Therapeutics received FDA clearance to seek accelerated approval for its drug to treat myotonic dystrophy type 1.

      The FDA announced the new Commissioner’s National Priority Voucher program that allows companies to shorten the review period of new drugs from 10-12 months to one to two.

      The FDA missed a deadline for deciding whether to approve a drug for a potentially life-threatening disorder because of “heavy workload and limited resources,” manufacturer KalVista Pharmaceuticals said.

      The agency approved Merck’s Keytruda for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score of at least 1.

      BioAegis Therapeutics received an FDA Fast Track Designation for recombinant human gelsolin for the treatment of acute respiratory distress syndrome.

      The FDA’s Office of Prescription Drug Promotion issued a warning letter to Sprout Pharmaceuticals to express concerns over an Instagram post from Sprout’s CEO about Addyi, the company’s prescription pill for hypoactive sexual desire disorder in women.

      UroGen won the FDA’s approval for its intravesical drug mitomycin for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer.

      FDA granted an Orphan Drug Designation to Medicovestor’s first-in-class ADC for pancreatic cancer.

      The FDA approved CSL Behring’s new drug Andembry, which treats hereditary angioedema. 

      Funding rounds:

      Sanofi successfully priced a €1.5 billion bond issue.

      Sanofi-backed Welsh biotech Draig Therapeutics secured $140 million in funding.

      A group of biopharma investors put $66 million into a San Diego startup called Actio Biosciences.

      SwordHealth will expand into the mental health market with a $40 million funding round from General Catalyst.

      Arima Genomics closed a $22 million Series C financing round led by Illumina Ventures.

      Processa Pharmaceuticals priced its $7 million public offering.

      Alzamend Neuro completed the closing of its $5 million private placement. 

      Layoffs:

      Vertex Pharmaceuticals laid off 125 of its employees after a failed type 1 diabetes cell therapy study and consolidation of its office locations.  

      Prothena plans “substantial” layoffs after a failed phase 3 trial of anti-amyloid antibodies in AL amyloidosis patients.  

      Industry news:

      The Supreme Court upheld a Tennessee law prohibiting gender affirming care for minors in a 6-3 vote.

      A $7.4 billion opioid settlement with Purdue Pharma has been approved by all 50 states and U.S. territories.

      Lilly announced it will begin selling the two strongest dosages of its weight loss drug Zepbound on its website, regardless of insurance.

      Anne Wojcicki regained control of 23andMe, the company she co-founded and led as CEO, through her nonprofit TTAM with a $305 million bid.

      Stagwell launched the Stagwell News Network.

      A federal judge deemed that some of the grant terminations by the National Institutes of Health are “void and illegal” in a hearing for two lawsuits against the Trump administration.

      Sarepta Therapeutics paused its clinical trial and shipments of its gene therapy drug Elevidys after a second patient death.

      AbbVie announced a setback in phase 3 of its blood cancer treatment trial testing the drug Venclexta.

      However, AbbVie‘s migraine drug met its main goal in head-to-head study with topiramate.

      Immuneering’s oral MEK inhibitor allowed 94% of first-line pancreatic cancer patients in a Phase 2a trial to survive six months.

      Dupixent bested Xolair in the first head-to-head respiratory trial between the two treatments.

      Xaira Therapeutics announced the release of its X-Atlas/Orion AI model, designed for data generation. 

      See last week’s edition of Rx Rundown.