Boehringer Ingelheim GmbH’s zongertinib enters the market as the first oral HER2-targeted therapy for patients with non-small-cell lung cancer (NSCLC), following an accelerated approval by the U.S. FDA. Branded Hernexeos, the drug is cleared for use in adults with unresectable disease or whose tumors have HER2 tyrosine kinase domain activating mutations and who have received prior systemic therapy. Hernexeos will go up against Enhertu (fam-trastuzumab deruxtecan), from Astrazeneca plc and Daiichi Sankyo Co. Ltd., approved in 2022 for the HER2-mutant NSCLC population.

Trump EO to change the landscape of US grants, awards

Billing it as a necessary reform to protect tax dollars from frivolous government spending, redundancy and waste, U.S. President Donald Trump issued a new executive order (EO) requiring his political appointees to sign off on grants and awards from agencies such as the NIH and to monitor those awards over time. Besides banning the funding of certain types of research, the EO calls for discretionary awards to be made to institutions with the lowest indirect cost rates, all else being equal. It also seeks to create more competition for the awards by extending them to researchers beyond academia.

IO Biotech dented by primary endpoint miss in melanoma with Cylembio

Shares of IO Biotech ApS (NASDAQ:IOBT) were trading at $1.45, down 36 cents, or 19%, on top-line results from the pivotal phase III trial testing its off-the-shelf therapeutic cancer vaccine candidate Cylembio (imsapepimut and etimupepimut, adjuvanted) in unresectable or metastatic melanoma. The trial tested Cylembio in combination with Merck and Co. Inc.’s anti-PD-1 therapy Keytruda (pembrolizumab) vs. Keytruda by itself as a first-line treatment in 407 patients. IO, of Copenhagen, Denmark, and New York, said Cylembio narrowly missed the experiment’s primary endpoint.

Mixed reaction for two companies on Prasad’s return

After about a two-week absence as the U.S. FDA’s CBER director, Vinay Prasad’s return prompted a mixed reaction on Wall Street to two stocks tied to the agency and companies developing gene therapies. Sarepta Therapeutics Inc., which had tangled with Prasad over continued marketing of the Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec), at midday saw its stock (NASDAQ:SRPT) essentially flat since trading opened. Capricor Therapeutics Inc., which recently received a complete response letter for the BLA regarding the gene therapy deramiocel for treating DMD, saw its stock (NASDAQ:CAPR) sink 13% at midday to $7.83 a share.

UK’s DecodeME uncovers genetic link for chronic fatigue

The largest genome-wide association study to date of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has identified eight genetic loci that are significantly associated with the chronic debilitating condition. Onset of ME/CFS often is traced back to an infection and four of the loci involve genes that are expressed in response to viral or bacterial infections. Three other loci have been associated with post-exertion malaise and fatigue, while one loci has a known association with multisite chronic pain. There was no evidence that depression and ME/CFS have shared genetic links, and there was nothing in the genetic evidence to explain why far more women than men (80% vs. 20%) suffer from ME/CFS. The U.K. study DecodeME compared the genomes of 15,579 people with a diagnosis of ME/CFS to 259,909 controls from the UK Biobank.

Syntara’s stock plunges 52% following FDA request for added trial

Syntara Ltd.’s stock plummeted 52% on news that the FDA recommended an additional phase IIb trial following a type C meeting about the company’s clinical development plan for lysyl oxidase inhibitor amsulostat (SNT-5505, formerly PXS-5505) in myelofibrosis. After reviewing a data package that included phase II interim data that was presented at the European Hematology conference in June, the FDA is recommending that Syntara run a phase IIb trial with a control arm to acquire additional safety and efficacy data, Syntara CEO Gary Phillips said during an Aug. 11 conference call with analysts. 

Also in the news

Alkeus, Altos Labs, Annexon, Assembly, Avobis, Bicyle, Biontech, Biovie, Capricor, Curevac, Everest, Genmab, GSK, Heron, Incannex, Junshi, Kedrion, Neuren, Nicox, Pfizer