The dark matter of long non-coding RNA (lncRNA) is shades brighter, after the signing of two major deals between biotech pioneers and big pharma in the past week. Haya Therapeutics SA announced Sept. 4 that is has sealed a multiyear agreement with Eli Lilly and Co., to apply its lncRNA platform technology to identify targets in obesity and related metabolic disorders. Lausanne, Switzerland-based Haya is getting an undisclosed up-front payment and could receive up to $1 billion in milestones, plus royalties. That followed on from a $547 million deal between Bayer AG and Nextrna Therapeutics Inc. to develop small-molecule inhibitors of lncRNA in oncology, announced on Aug. 29.

Phase II/III fizzle in Alzheimer’s wrecks Athira shares

Shares of Athira Pharma Inc. (NASDAQ:ATHA) plunged 77%, or $2.18, to trade at 65 cents after the Bothell, Wash-based firm disclosed top-line results from its phase II/III Lift-AD clinical trial of fosgonimeton, a hepatocyte growth factor-positive modulator, in patients with mild to moderate Alzheimer’s disease (AD). Neither the trial's primary endpoint – the Global Statistical Test, a combination of results from measures of cognition (ADAS-Cog11) and function (ADCS-ADL23) – nor its key secondary endpoints of ADAS-Cog11 and ADCS-ADL23 reached statistical significance in AD compared with placebo at 26 weeks. 

Third Circuit: Royalties not always tied to patent expiration

Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit yesterday ruled against a Merck KGaA subsidiary, saying it is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma. The precedential opinion noted that Ares Trading SA’s royalty obligation set out in a 2006 collaboration and licensing agreement it signed with Dyax Corp., now a part of Takeda Pharmaceutical Co. Ltd., was not calculated based on post-patent expiration use of inventions. Thus, the Supreme Court’s 2013 decision in Brulotte, which limits patent licensing royalties to the life of the patent, does not apply.

IPO class of 2024 shows value recovery despite mixed stock performance

Biopharma IPOs have faced tough conditions in recent years, but 2024 is showing signs of improvement in terms of value, while stumbling on overall performance. IPO values remain significantly lower than the peak years of 2020-2021 and are still below collective values seen in 2014-2019, however, this year's value marks a recovery compared to the challenging environment of 2023.

GBC 2024: Role of regulation for a changing biotech industry

Technological breakthroughs are changing the biopharmaceutical landscape and forcing regulators to think on their feet and facilitate (not impede) innovation, experts said at the Global Bio Conference (GBC) 2024. “Regulatory speed and agility are necessary amid emergencies to cater to unmet medical needs,” Choong May Ling, CEO of Singapore’s Health Sciences Authority, told audience members in Seoul, South Korea, on Sept. 4. “[This includes incorporating] adaptive clinical trials and real-world data (RWD) for a balanced and comprehensive assessment.” While new technologies advance the field of biomedicine, they also create a dilemma for health regulators around the world. 

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