Daily briefings
Editor’s Briefing: September 24, 2026
In Short. Thursday’s tape is China discovery cash, autoimmune cell therapy, and a stalled political grab at NIH grants: Lilly pays InnoCare $100 million upfront for five undisclosed targets (with billions more in milestones), Kyverna’s CD19 CAR-T posts one-year stiff-person and myasthenia data with a clean safety sheet as Novartis and BMS hit autoimmune CAR-T holds, Immunovant scraps a lupus-skin program after a phase 2 miss, Enveda banks $311 million and the Pentagon stakes Flagship, while Lilly claims most of Medicare’s new obesity-drug bridge and a White House plan to put political appointees over NIH awards looks dead.
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Lilly buys five discovery targets from China’s InnoCare
Eli Lilly committed $100 million in upfront and near-term payments to Beijing-based InnoCare Pharma for a five-target drug-discovery pact, with up to $3.25 billion in downstream milestones and single-digit tiered royalties on net sales. The partners have not named the targets or therapeutic areas, only that the programs address “critical unmet medical needs.” InnoCare will run discovery against those targets on its platform. The deal extends Lilly’s 2026 shopping spree, funded in part by GLP-1 obesity cash, across takeovers and licenses. InnoCare’s own pipeline spans blood cancers, autoimmunity, and solid tumors (including a TYK2 inhibitor that has drawn comparisons to Bristol Myers Squibb and Takeda programs, and a VAV1 degrader now in the clinic). CEO Jasmine Cui said on an August earnings call that the company was “not urgent to get the cash” and chooses partners carefully. (Fierce Biotech)
Kyverna’s autoimmune CAR-T holds at one year
Kyverna reported longer follow-up for mivocabtagene autoleucel (miv-cel), its CD19 CAR-T, as Big Pharma peers hit safety snags in the same modality. In the registrational Kysa-8 study in stiff person syndrome (SPS, a rare autoimmune attack on molecules needed for nerve signaling that leaves patients stiff, spasming, and often immobile), 26 treated patients showed a median 49% improvement on the timed 25-foot walk at 12 months versus baseline, a touch firmer than the 46% already significant at week 16. All but one patient who had met the clinically meaningful bar (at least 20% faster) at the primary analysis still held that bar at one year. Eight of 12 who had needed a walking aid before treatment were still without one. Ninety-two percent remained off chronic immunotherapies for SPS. Kyverna counted zero cases of high-grade cytokine release syndrome, ICANS (immune effector cell-associated neurotoxicity), or IEC-HS (a severe inflammatory syndrome) in the update, and plans to fold the one-year package into its FDA rolling submission for SPS, aiming to finish the application in the fourth quarter. In the phase 2 portion of Kysa-6 in generalized myasthenia gravis, all seven patients had clinically meaningful gains on daily-living and quantitative scores at 24 weeks. All five with at least a year of follow-up kept those gains. Minimal symptom expression (MG-ADL score of 0 or 1) held in 57% at last follow-up. Phase 3 enrollment is targeted for mid-2027. The contrast is Novartis, which held its CD19 CAR-T rapcabtagene autoleucel across autoimmune trials after three patient deaths from severe IEC-HS, and Bristol Myers Squibb, which paused enrollment of zolacabtagene autoleucel after “transient and reversible inflammatory events.” Analysts have pointed at rapid manufacturing platforms as a possible shared risk. Kyverna’s CEO argues miv-cel’s construct (including a CD28 co-stimulatory domain unique among autoimmune CD19 CARs, per the company) and process are different. (Fierce Biotech)
Immunovant exits cutaneous lupus after a phase 2 miss
Immunovant stopped development of IMVT-1402, its anti-FcRn antibody, in cutaneous lupus erythematosus (CLE) after a 57-patient phase 2 missed primary endpoints at week 12. Skin area-and-severity scores were statistically no better than placebo. The company flagged numerical trends and a hint that deeper IgG cuts tracked with response, but said the competitive landscape plus the results ended the CLE path. Shares fell about 6% in Wednesday premarket. Johnson & Johnson has midstage FcRn traction in systemic lupus. CLE competition is mostly other mechanisms (Biogen’s litifilimab, AstraZeneca and Merck KGaA late-stage interferon or TLR programs). Immunovant still pushes the same antibody in Graves’ disease, rheumatoid arthritis, myasthenia gravis, CIDP, and Sjögren’s. (Fierce Biotech)
Enveda’s $311 million series E, and a Pentagon Flagship bet
Colorado’s Enveda, which uses AI to mine plants and microbes for drug-like chemistry, raised a $311 million series E to push three clinical programs toward later trials. ENV-294 posted phase 1b eczema data in July (mean 68% reduction in area and severity by day 28, 85% by day 42) and is in phase 2a for atopic dermatitis and asthma. ENV-308, designed as an oral mimic of a post-exercise hormone, is in phase 1 with an eye on weight-loss maintenance after GLP-1s stop. ENV-6946 is in phase 1 for inflammatory bowel disease. Prior rounds already topped $500 million. Separately, the U.S. Department of War awarded Flagship Pioneering a $47 million, five-year contract for medical countermeasures against emerging threats, starting with Flagship-founded Apriori Bio (AI-guided viral-evolution vaccines) and Prologue Medicines (computational protein discovery). (Fierce Biotech; BioPharma Dive; Fierce Biotech)
Capital footnotes: Medicare GLP-1 share, Novo’s NYSE option, Boehringer–Variant
Lilly CEO David Ricks told CNBC that about 700,000 seniors have started treatment on Medicare’s GLP-1 Bridge since the July 1 rollout, and that Lilly holds roughly 70% share in that channel. The demonstration, part of most-favored-nation pricing deals, offers eligible seniors a $50 monthly copay. Separately, Novo Nordisk CEO Mike Doustdar told the Financial Times the company is open to a direct New York Stock Exchange listing that would replace its American depositary receipts, while stressing it is not actively negotiating a change. The U.S. already supplies more than half of Novo’s revenue and a majority of its GLP-1 sales. Boehringer Ingelheim expanded its January genomics pact with Variant Bio into cardiovascular disease, adding an upfront fee and potential license and milestone payments totaling more than $250 million on top of the earlier cardiorenal and kidney collaboration. (Fierce Pharma; Fierce Pharma; Fierce Biotech)
Policy sidebar: NIH political-grant order stalls
STAT reports that a planned White House executive order to put a commission of political appointees, including OMB director Russell Vought, over NIH grant awards is “looking dead,” per a person familiar with the decision and Sen. Susan Collins (R-Maine), chair of Appropriations. Collins wrote Vought and NIH director Jay Bhattacharya urging them not to proceed, arguing the plan would undermine funding by scientific merit. Democrats on the committee and other lawmakers joined the pushback. The idea had surfaced after an Oval Office meeting in which Vought faulted NIH project selection. (STAT News)
What to watch
pdufa.bio now lists Merck Winrevair (sotatercept) HYPERION (recently diagnosed PAH label update) as Decided / Approved, citing Merck’s September 22 news release. Yesterday’s briefing still had that goal date as Awaiting. Ionis Zilganersen (ION373) for Alexander disease now carries an Approved outcome stamp in the same API (decision_date listed as September 3; still no decision_source URL). Next dated PDUFA: Mirum/Incyte zilurgisertib (FOP) September 26. October: Roche Tecentriq adjuvant MSI-H/stage III colon (October 9), Merck/Daiichi I-DXd ES-SCLC (October 10), Roche Enspryng TED (October 15), Viatris/Opus MR-141 phentolamine ophthalmic (October 17). BioProcess International’s Boston conference continues through September 25. Overnight BPI hard-news remained thin beyond the same Sanofi Toronto and Merck KGaA Bengaluru facility notes. (pdufa.bio; BioProcess International)