Nearly a year after the first U.S. commercial launch of the multicancer molecular residual disease (MRD) detection platform Pathlight, developer Saga Diagnostics entered a definitive merger agreement under which Roche Holding AG subsidiary Foundation Medicine Inc. will take over the firm in return for up to $595 million in payments.
In what shakes out to be the largest follow-on stock offering in biopharma history, Revolution Medicines Inc., an oncology company that was the subject of buyout rumors earlier this year, priced 10.56 million shares to raise $1.5 billion just two days after wowing investors with top-line phase III data of its RAS inhibitor daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma.
Becoming the first and only fully FDA-approved treatment for focal segmental glomerulosclerosis (FSGS), Travere Therapeutics Inc.’s Filspari (sparsentan) has gained access to a second lucrative market with a regulatory package that validates proteinuria as a surrogate endpoint.
Replimune Group Inc. received another complete response letter (CRL) from the U.S. FDA for immunotherapy vusolimogene oderparepvec to treat advanced melanoma, sending shares plunging by more than 19% on the April 10 PDUFA date.
German company Tubulis GmbH, which emerged with a $12.3 million series A round and a next-generation antibody-drug conjugate (ADC) platform about six years ago, has commanded up to $5 billion in a buyout offer from Gilead Sciences Inc.
Eli Lilly and Co. plans to buy Centessa Pharmaceuticals plc for $6.3 billion in up-front cash and another potential $1.5 billion through contingent value rights, gaining access to a pipeline of orexin receptor 2 agonists for sleep disorders. The Indianapolis-based pharma is re-entering a field that has multibillion-dollar potential and one that could emulate the success seen with its obesity program. Centessa, of Boston and London, has a lead candidate, cleminorexton (formerly ORX-750), with positive phase IIa data in narcolepsy types 1 and 2 and idiopathic hypersomnia.
Just five months after raising a $70 million series A round, newly launched Excellergy Inc. agreed to a $2 billion M&A transaction that would bring its trifunctional allergic effector cell response inhibitors (ECRIs) to Novartis AG.
After previous setbacks with the program, investors largely brushed aside ocular-focused Kodiak Sciences Inc.’s anticipated phase III Glow2 data of tarcocimab tedromer in diabetic retinopathy (DR), so the positive top-line superiority results revealed March 26 caught many by surprise as it sets the company up for an accelerated multi-indication BLA submission.
The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.
For a company founded only four years ago, Quotient Therapeutics Inc. entered its third major deal, this time with Merck & Co. Inc. to find novel drug targets for inflammatory bowel disease (IBD) using its somatic genomics platform technology.