Merck & Co. Inc. is getting the exclusive, global rights from Orion Corp. to develop the oral prostate therapy the two companies hammered out a deal for in 2022. Orion could now bring in up to $30 million in development milestones, as much as $625 million in regulatory milestone payments and up to $975 million in sales-based milestones. The deal adds up to $1.6 billion for Espoo, Finland-based Orion. ODM-208, a CYP11A1 inhibitor designed to suppress the hormone production that bolsters this type of cancer, is in a phase III study of heavily pretreated patients with metastatic castration-resistant prostate cancer.

Eisai forging ahead after Bristol Myers drops out of ADC deal

At a time when much of the biopharma space can’t seem to get enough of antibody-drug conjugates (ADC), Bristol Myers Squibb Co. is backing away from a potential $3 billion-plus collaboration with Eisai Co. Ltd., handing back full rights to the latter’s folate receptor alpha-targeting ADC, farletuzumab ecteribulin (FZEC), citing a portfolio reprioritization. Global rights to FZEC now reside with Tokyo-based Eisai, which said it intends to accelerate work on the candidate, which is in three clinical studies, including two phase II trials in gynecological cancers and non-small-cell lung cancer.

US Supreme Court scuttles Chevron doctrine in landmark reversal

In a ruling delivered June 28, the U.S. Supreme Court brought an end to four decades of a practice of judicial deference to federal government agencies in litigation, a practice that some argue has enabled regulatory mischief. The ruling would seem to elevate the prospects that industry will be able to overturn recent FDA rulemaking on key questions, but the concern going forward is that the courts lack the expertise to adjudicate some of the regulatory and scientific questions involved in these cases, a problem that may require congressional intervention to resolve.

EMA takes negative view on masitinib; Ocaliva and Translarna out

Two drugs were pushed back by the EMA last week, with a recommendation that Ocaliva, currently the only second-line standard of care for treating primary biliary cholangitis, be withdrawn from the market, and a refusal to grant conditional approval for masitinib in the treatment of amyotrophic lateral sclerosis. The EMA also doubled down on its earlier decision not to renew the conditional marketing authorization for Translarna (ataluren) for treating Duchenne muscular dystrophy, after being told by the European Commission to reassess the file in the light of real-world data.

Design, Sarepta, Wave rise amid overall neurological index decline

In the first five months of 2024, the BioWorld Neurological Diseases Index (BNDI) saw a 10.35% decline, underperforming both the Nasdaq Biotechnology Index, which rose by 0.7%, and the Dow Jones Industrial Average, which increased by 2.64%. This represents an additional drop for BNDI, which closed February with a 4.1% decline. As part of BNDI, 14 stocks saw declines, while three posted gains. Design Therapeutics Inc. rose by 53%, Sarepta Therapeutics Inc. increased by 35%, and Wave Life Sciences Ltd. climbed by 22%.

Yuhan nabs Ubix cancer drug for ₩150B; FDA nod for YH-35995 trial

Yuhan Corp., of Seoul, South Korea, has inked a ₩150 billion (US$108.6 million) deal with Korean biotech Ubix Therapeutics Inc. to gain exclusive global rights to UBX-103, Ubix’s oral small-molecule androgen receptor (AR) degrader for prostate cancer. Yuhan also announced July 1 that it gained the U.S. FDA’s nod to start a phase I study of a Gaucher disease drug candidate called YH-35995. For UBX-103, Seoul -based Ubix said it would out-license exclusive worldwide rights to the therapy candidate for ₩5 billion in an up-front payment and up to ₩145 billion in additional development, regulatory and commercial milestone payments, along with a high single-digit royalty payment based on net sales. 

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AB Science, Abbisko, Abbvie, Apellis, ARS, Attgeno, Benitec, Biontech, Capricor, Carisma, Cingulate, Daiichi Sankyo, EA Pharma, Eisai, Elicio, Eliem, Ensho, Eyenovia, Genmab, Immunis, Immutep, Innovent, Innoviva, Iovance, Janssen Cilag, Kiora, Lift, Limmatech, LSL, Merck, Mirum, Moderna, Pfizer, PTC, Recce, Redx, Regeneron, Rhythm, Roche, Rocket, Savara, Seagen, Shorla, Soleno, Waypoint, Zenas