In the third-largest acquisition of the year, pharma giant Eli Lilly and Co. is buying oral integrin therapies developer Morphic Holding Inc. for $3.2 billion. Morphic stock (NASDAQ:MORF) got a tremendous boost from the acquisition, with shares trading 75% upward at $55.78 each at midday. The company has struggled to recover from underwhelming phase IIa data released in late September 2023 in the Emerald-1 study of MORF-057 in treating moderate to severe ulcerative colitis (UC). The data knocked the wind out of the stock at the time, which plunged from $51.40 per share on Sept. 21 to $21.33 each on Sept. 26. The small molecule will bolster Lilly’s stake in UC that was solidified in October 2023 with the U.S. FDA’s approval of Omvoh (mirikizumab-mrkz) for moderately to severely active UC in adults.

Hillevax plunges on phase IIb norovirus vaccine failure

Shares of Hillevax Inc. plummeted 87% on news that norovirus vaccine candidate HIL-214 missed the primary endpoint in a phase IIb study in infants, showing efficacy of only 5% against moderate or severe acute gastroenteritis events due to GI.1 or GII.4 norovirus genotypes. It also failed to show benefit across any secondary endpoints, prompting the company to discontinue further development of the virus-like particle-based vaccine in infants and, instead, look toward development in adults.

Roche slips in phase II/III TIGIT study as others keep trying

Roche AG’s Genentech unit said July 5 that the phase II/III Skyscraper-06 study failed in its test of anti-TIGIT candidate tiragolumab plus Tecentriq (atezolizumab) and chemotherapy vs. Keytruda (pembrolizumab, Merck & Co. Inc.) and chemo as first-line treatment for non-squamous non-small-cell lung cancer. Skyscraper-06 fell short of the primary endpoints of progression-free survival at its primary analysis and overall survival at its first interim analysis. Others in the rocky TIGIT space lately have had news that’s more encouraging, including Iteos Therapeutics Inc. and Gilead Sciences Inc. with partner Arcus Biosciences Inc.

Ideaya opening a new market with its first-in-class MAT2A inhibitor

Ideaya Biosciences Inc. released data for its phase II study testing its methionine adenosyltransferase 2 alpha (MAT2A) inhibitor, IDE-397, in patients with urothelial and non-small-cell lung tumors that had a methylthioadenosine phosphorylase deletion. Among the 18 evaluable patients treated at the expansion dose of 30 mg once a day, there was one complete response and six partial responses, resulting in an overall response rate of 39%. Ten additional patients had stable disease, including seven that had tumor shrinkage that didn’t meet the RECIST 1.1 partial response criteria. Shares of Ideaya were up $5.07, or 14.8%, to $39.32 in midday trading.

Douglas gears up for slow-release ketamine phase III for depression

On the heels of positive phase II results of its extended-release ketamine (R-107) in treatment-resistant depression, Douglas Pharmaceuticals Ltd. is gearing up to begin phase III trials of its ketamine treatment that is safe enough to take at home without clinical supervision. “Should R-107 perform in phase III studies as in the [phase II] Bedroc study, this would be a life-changing medication for many individuals who suffer from treatment-resistant depression, and one that could be taken safely at home,” Douglas Chief Scientific Officer Peter Surman told BioWorld.

US FDA’s new misinformation draft guidance is an ‘enforcement policy’

Bob Califf, commissioner of the U.S. FDA, has been laser-focused on misinformation recently, and the agency has reissued a 2014 draft guidance which describes an enforcement policy about third-party communications about a drug or device. The draft’s choice of words suggests that device and drug makers must attempt to correct third-party misinformation despite what the agency itself said in 2023 that compliance with agency guidance is “not enforceable, either through administrative actions or the courts.”

Iaso buys out Innovent’s rights to CAR T Fucaso   

Nanjing, China-based Iaso Biotherapeutics Co. Ltd. has bought out global rights to human anti-B cell maturation antigen CAR T Fucaso (equecabtagene autoleucel) from partner Innovent Biologics Inc. Although terms for the global license were not disclosed, Iaso obtained global commercial rights and an intellectual property license for Fucaso (CT-103A) and will be fully responsible for development, manufacturing, and commercialization of the product, while Suzhou, China-based Innovent becomes a strategic shareholder of Iaso Bio, acquiring an 18% stake in the company.

Also in the news

Apeiron, Ascentage, Astrazeneca, Avacta, Boehringer Ingelheim, CNS, Hutchmed, Iaso, Innovent, Kriya, Lexeo, Lexicon, Ligand, Longeveron, Memo, Navidea, Optimind, Ose, Rhythm, Roche, Takeda, Zhiyi