While the emergence of immune checkpoint inhibitor (ICI) therapy in recent years has significantly improved cancer outcomes, some patients have been unable to experience the full therapeutic benefits of ICIs due to significant gastrointestinal inflammation linked to treatment. Seres Therapeutics Inc. is looking to change that with its live biotherapeutic candidate, SER-155, offering impressive findings from phase I data in ICI-related enterocolitis, or irEC.
Vera Therapeutics Inc. looks to get an almost five-month head start over a competitor, Vertex Pharmaceuticals Inc., as the U.S. FDA cleared its Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for treating immunoglobulin A nephropathy (IgAN). The accelerated approval, which came on the July 7 PDUFA date, indicates Trutakna for use in reducing proteinuria in adults with primary IgAN at risk for disease progression. The drug is administered once weekly via auto-injector.
Orca Bio Inc. is bringing to market a precision-engineered cell therapy approach designed to improve outcomes in patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) following U.S. FDA approval of Tregzi, a first-of-its-kind, personalized cell therapy.
One company was looking to add to its royalty stream and R&D portfolio. The other was seeking strategic alternatives in the wake of clinical misfires over the last few years. In an agreement aimed at satisfying both goals, Zymeworks Inc. will acquire Theravance Biopharma Inc., paying $17 per share, or about $929 million, though the transaction is structured in a way that minimizes the former’s current capital position.
Antares Therapeutics Inc. drew Novartis AG to the table for a potential $1.9 billion collaboration, including a $105 million up-front payment, to discover small-molecule programs against oncology targets considered to be undruggable. It’s Antares’ first partnership since spinning out of Scorpion Therapeutics Inc. about a year ago.
In a deal viewed as a big win for both companies, Abbvie Inc. is buying Apogee Therapeutics Inc. for $10.9 billion. The transaction calls for shareholders of Apogee to receive $135.11 per share in cash, marking a nearly 50% premium over Friday’s closing stock price, and puts lead candidate zumilokibart, a late-stage, half-life extended monoclonal antibody targeting IL-13 that has shown competitive phase II data in atopic dermatitis, in the hands of a pharma giant with a well-established immunology franchise.
Shares of Abcellera Biologics Inc. got a modest boost on news of a preclinical research collaboration with Jazz Pharmaceuticals plc aimed at developing next-generation T-cell engaging multispecific antibodies targeting gastrointestinal cancers and other solid tumors.
Another day, another about-face by the U.S. FDA on Uniqure NV’s Huntington’s disease gene therapy. But this latest shift brings good news for the company’s AMT-130, for which the FDA says three-year analysis data from the phase I/II study will be acceptable for an accelerated BLA filing, now expected to be submitted in the third quarter.
Despite some back-and-forth with the U.S. FDA regarding inclusion in the somewhat controversial Commissioner’s National Priority Voucher (CNPV) program, Sanofi SA’s Tzield (teplizumab) gained FDA clearance, expanding use of the CD3-directed monoclonal antibody as a disease-modifying therapy for patients with recently diagnosed stage 3 type 1 diabetes (T1D).
Less than two months after Kailera Therapeutics Inc. made headlines with biopharma’s largest IPO to date, Parabilis Medicines Inc. has come along and surpassed it. The oncology-focused firm priced its upsized IPO of 3.5 million shares at $20 apiece for gross proceeds of $670 million, an amount that could rise to $770 million should underwriters exercise their full 5-million-share overallotment option.
