CEO Lynn Seely said Lyell Immunopharma Inc. is going “full steam ahead” with development of rondecabtagene autoleucel (ronde-cel, also known as LYL-314) amid the excitement of the firm’s latest news: the buy of global rights to LYL-273, an autologous guanylyl cyclase-C-targeted CAR T-cell candidate for metastatic colorectal cancer (mCRC), from Innovative Cellular Therapeutics Inc. (ICT) for an up-front payment of $40 million and 1.9 million shares of Lyell common stock.
A primary endpoint failure but with outstanding estimated glomerular filtration rates and impressive safety data in the phase II trial called Bestow are adding up to plans for later-stage work with Eledon Pharmaceuticals Inc.’s tegoprubart (tego) for preventing rejection in de novo kidney transplant.
With strong phase II data in hand from its trial testing EVO-756 in chronic inducible urticaria (CIndU) – hives triggered by a specific cause – Evommune Inc. priced its IPO of about 9.3 million shares at $16 each, granting underwriters a 30-day option to buy as many as about 1.4 million more. Proceeds are expected to total $150 million, and shares of the firm (NYSE:EVMN) came out of the gate strong, closing Nov. 6 at $20.23, up 26%.
Just as investors were looking ahead to news by year-end on Prelude Therapeutics Inc.’s SMARCA2-targeted degraders, the firm said work in the space will be halted, with efforts shifting toward the mutant selective JAK2V617F JH2 inhibitor program by way of a new deal with Incyte Corp.
Uniqure NV is regrouping after a surprise switcheroo by the havoc-beset U.S. FDA regarding phase I/II studies with AMT-130 vs. external control in Huntington’s disease (HD) – news of which pushed down the Lexington, Mass.-based firm’s shares (NASDAQ:QURE) Nov. 3 by $33.40, a loss of 49%, at the closing price of $34.29.
Vera Therapeutics Inc.’s atacicept gained still more airtime at the Cantor Fitgerald health care conference held Sept. 4, and some on Wall Street believe the appetite for the BAFF and APRIL dual inhibitor could bode well for others in the same mechanistic space.
The activin E mechanism of action in obesity is having something of an early stage heyday with such players as Wave Life Sciences Ltd. and Ibio Inc. talking up data that have perked the ears of Wall Street.
Shooting for further proof of durable, drug-free, disease-free remission with a single dose of KYV-101 in generalized myasthenia gravis, Kyverna Therapeutics Inc. plans to start phase III work by the end of this year. The Emeryville, Calif.-based firm rolled out positive interim results from the phase II portion of the registrational Kysa-6 clinical trial testing the drug, a fully human, autologous, CD19 CAR T-cell therapy with CD28 costimulation.
Maplight Therapeutics Inc.’s pricing of a $258.9 million financing this week revived the debate over whether targeting the M1 as well as the M4 muscarinic receptor – as Bristol Myers Squibb Co. does with U.S. FDA-approved Cobenfy (xanomeline and trospium chloride) for schizophrenia – is a better strategy than going after M4 alone.
Intellia Therapeutics Inc. followed up troubling news in May with a similar, and worse, update regarding the Magnitude and Magnitude-2 phase III trials with nexiguran ziclumeran, also known as nex-z, for patients with transthyretin amyloidosis with cardiomyopathy and polyneuropathy, respectively.
