BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital.
Gene therapy biotech Kriya Therapeutics has acquired Tramontane Therapeutics, a startup focused on metabolic diseases. Tramontane brings a gene therapy that’s a potential one-time treatment for the fatty liver disease NASH.
Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some needed cash as it restructures in the wake of the Phase 3 failure of its lead program late last year.
Biotech startup Pheast Therapeutics is out of stealth taking a tack similar to that of cancer immunotherapy company Forty Seven, also a spinout from the Stanford University lab of Irving Weissman. While both companies get immune cells to eat tumors, Pheast’s technology has the potential to take the approach to a broader range of cancer types including those that have historically resisted immunotherapy.
A Kodiak Sciences drug failed to beat a Regeneron Pharmaceuticals product in a key test in the wet form of age-related macular degeneration. The biotech says the failure is due to a subset of undertreated patients, but the results raise the stakes for the drug, its lead product candidate, in other eye diseases.
ProKidney is going public in a SPAC merger that infuses the biotech with $825 million for Phase 3 tests and manufacturing of its autologous cell therapy for chronic kidney disease. More than slowing the decline in organ function, ProKidney says its cell therapy offers the potential to reverse injury caused by the condition.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
BridgeBio reported its drug acoramidis missed the main goal of a pivotal study in patients with transthyretin amyloidosis affecting the heart—the same type of patients helped by a currently approved blockbuster Pfizer drug. BridgeBio attributed the trial failure to a surprisingly strong placebo response, and it will continue the study, hoping for better outcomes on additional goals.
Medable recently raised $304 million, its fourth funding round in the past two years. The company’s software can be used to virtually consent patients into clinical trials and run telehealth visits as part of a trial.
Brightline focuses on providing virtual behavioral health solutions for kids. The startup plans to put the new funds to use by launching a coaching platform for families and to expand its services to more companies and health plans.
The FDA decision makes Nulibry the first drug approved to treat MoCD type A, a rare metabolic disease. It's also the first FDA-approved product for rare disease drug developer BridgeBio Pharma.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The Silicon Valley startup plans to start its registration-directed study of Limbix Spark in the earlier part of next year and - if successful - would anticipate FDA clearance in early 2022.
The Palo Alto-based startup provides tools to support family caregivers, and uses predictive analytics to help them develop personalized action plans.
In a interview, an executive from Medable said patients will likely demand to have the choice of whether to show up at trial sites or participate in studies remotely. The Covid-19 pandemic has accelerated a trend toward decentralized trials that was already underway before it began.
Late last month, Medable and LabCorp CRO Covance signed a deal to accelerate adoption of decentralized trials, a trend that has been helped along as Covid-19 has created challenges to conducting trials dependent on traditional brick-and-mortar sites.
Asset Management Ventures, a Silicon Valley-based health tech investment firm, is raising $150 million for a new fund, according to financial documents.
