M&A, Deals, Partnerships:
Aurinia Pharmaceuticals Acquires Kezar Life Sciences (SF) for ~$50M After Tang’s 2024 Bid Rejected
Aurinia Pharmaceuticals (led by new CEO Kevin Tang as of last week) is acquiring South San Francisco-based Kezar Life Sciences for $6.95 cash per share (~$50 million total) plus a contingent value right (CVR) tied to future development or sale of zetomipzomib, an immunoproteasome inhibitor for autoimmune hepatitis, lupus nephritis, and systemic lupus. Tang previously attempted to buy Kezar in 2024 via his Tang Capital Partners/Concentra Biosciences for $1.10/share—rejected by Kezar’s board as “substantially undervaluing” the company—prompting Kezar to adopt a poison pill preventing anyone from acquiring over 10% of shares. The deal comes after Kezar failed to align with FDA on a registrational trial in October 2025 despite “encouraging” Phase 2a results. A January Type C meeting resolved the path forward (agreement on trial duration, endpoints, enrollment), but analysts didn’t expect Kezar to fund the study alone. Tang, who already owned 9.9% of Kezar and joined Aurinia’s board in 2024 before becoming CEO last week, used Aurinia (which markets Lupkynis for lupus and has one Phase 1 asset after 25% layoffs in 2024) as his vehicle to finally acquire Kezar. Tang has built a reputation as a serial biotech acquirer targeting struggling firms.
Infinimmune (10-person team, $22M raised since 2022) signed a deal worth up to $838 million with Merck to identify novel human antibody candidates against Merck’s undisclosed targets. The startup’s platform analyzes “millions of rows” of memory B cells from human blood/tissue samples to match antibodies to targets in about one week, with candidates ready for animal studies in three months. The company runs its AI models locally on two four-year-old Nvidia chips. Infinimmune plans to start human trials next year with lead candidate IFX-101, an IL-22 inhibitor for moderate-to-severe atopic dermatitis designed for quarterly or twice-yearly dosing (versus more frequent administration of competitors). CEO Wyatt McDonnell expects one or two more similar pharma partnerships in coming years, with discussions already underway. The deal validates Infinimmune’s approach of mining human memory B cells to access “novel biology and promising therapeutic candidates,” per Merck’s VP of biologics discovery.
Neurocrine is paying $53/share cash (34% premium) to acquire Soleno Therapeutics and its Vykat XR, approved in 2024 for insatiable hunger in Prader-Willi syndrome. Vykat XR generated over $190 million in first nine months on market with 859 active patients (out of ~10,000 US patients), and analysts project $2 billion peak US sales. Neurocrine won’t launch in Europe despite regulatory review there, focusing only on US opportunity. Analysts questioned the “low” valuation—Soleno’s stock hit ~$90/share last year versus $53 buyout price. The deal adds to March’s M&A bonanza (10 deals, $31.5 billion) as pharmas shore up pipelines. Neurocrine ($2.83 billion 2025 sales from Ingrezza and Crenessity) is diversifying after recent setbacks including Phase 3 cerebral palsy failure and Phase 2 depression flop. Soleno CEO Anish Bhatnagar was among highest-paid CEOs in 2024. Aardvark paused its competing Prader-Willi Phase 3 earlier this month; Acadia failed Phase 3 in September.
Denali Therapeutics regained full rights to DNL593, a frontotemporal dementia (FTD) treatment targeting granulin gene mutations (one of the most common genetic causes), after Takeda returned the program ahead of Phase 1/2 data expected by end of 2026. Takeda’s decision was “not related” to efficacy or safety data. Denali could have earned up to $315 million in milestones under the original 2018 deal ($150 million upfront, over $1 billion total potential). This marks the third and final program scrapped from the Takeda-Denali partnership, following terminations of two Alzheimer’s programs (targeting tau in 2022 and TREM2 in 2025). The move comes amid Takeda’s ongoing restructuring under outgoing CEO Christophe Weber, including layoffs, pipeline cuts, and closure of its San Diego research center, aiming to save $1.3 billion by fiscal year 2028. There are no FDA-approved treatments for FTD, the most common dementia for adults under 60.
Other Interesting News:
Oric selected 400 mg once-daily dose of PRC2 inhibitor rinzimetostat (combined with Bayer’s Nubeqa) for Phase 3 in metastatic castration-resistant prostate cancer patients previously treated with abiraterone, starting first half of 2026. Phase 1b interim showed 33% of patients achieved at least 50% PSA decline (PSA50) and 84% radiographic progression-free survival at 5 months—consistent with Pfizer’s rival EZH2 inhibitor mevrometostat and better than standard-of-care therapies like Novartis’ Pluvicto. Oric chose 400 mg over 600 mg based on comparable efficacy but significantly better safety/tolerability at lower dose (less toxicity and fewer dose modifications). CEO Jacob Chacko said rinzimetostat’s safety profile “looks markedly better” than mevrometostat, which has higher rates of gastrointestinal/hematological adverse events, dysgeusia, and alopecia—Oric’s key differentiator as it trails Pfizer into Phase 3. Stock dropped 24% to $9.60 as investors digested dose choice and efficacy data, though Citi analysts called the dose selection “logical” and said safety data support substantial market share potential post-abiraterone.
Gilead Sciences (SF) Terminates Phase 2/3 HIV Trial After FDA Clinical Hold Over Low T-Cell Counts
Gilead terminated its Phase 2/3 Wonders-2 trial after FDA discussions, “effectively terminating the study” that had enrolled 73 HIV patients testing weekly oral GS-1720 (integrase inhibitor) and GS-4182 (capsid inhibitor prodrug of lenacapavir) against approved HIV med Biktarvy. The FDA placed clinical holds on Wonders-2, its sibling trial Wonders-1 (675 participants), and three Phase 1 studies in June 2025 after some patients developed low CD4+ T-cell levels and reduced white blood cell counts. Measures have since returned to baseline or normal ranges for all Wonders-2 participants. The FDA hold remains in place on all studies. GS-4182 is a prodrug of lenacapavir, Gilead’s twice-yearly HIV preventative approved as Yeztugo around the time of the clinical hold (previously approved as Sunlenca for HIV treatment in 2022). Gilead is now pivoting to develop lenacapavir as a long-acting treatment in partnership with another integrase inhibitor called GS-3242. Gilead is working with investigators to transition Wonders-2 participants to standard-of-care HIV treatments.
Alto Neuroscience is discontinuing ALTO-101, a brain-penetrant PDE4 inhibitor delivered through the skin, after it failed to show statistically significant improvement versus placebo on cognitive impairment in 83 schizophrenia patients after 10 days of treatment (primary endpoint measured by EEG brain activity). While Alto noted “directional improvements” including a “near-significant effect” on theta-ITC biomarker (particularly in 59 more cognitively impaired patients), the company won’t advance either the transdermal or oral formulations unless it finds a partner. Alto will prioritize ALTO-207 (combination of approved Parkinson’s drug pramipexole and nausea drug ondansetron) entering Phase 2b “imminently” for treatment-resistant depression, backed by “strong prior clinical data and external validation.” CEO Amit Etkin acknowledged disappointment but called ALTO-101 “exploratory.” This follows last year’s Phase 2 failure of depression drug ALTO-203 (histamine H3 receptor inverse agonist), though Alto still lists that asset in its pipeline. William Blair analysts called the failure “disappointing” but noted they “ascribed minimal value” given the high-risk, short-term study in a difficult-to-treat population.
Amgen reported Phase 3 data showing injectable Tepezza reduced eye bulging (proptosis) in 77% of thyroid eye disease patients versus 19.6% on placebo at 24 weeks—a 57 percentage-point improvement over placebo, compared to Viridian’s 36 percentage-point improvement reported last week. Amgen’s injectable version (given every 2 weeks via on-body injector) aims to defend Tepezza’s position as the only FDA-approved treatment for the condition ($1.9 billion in 2025 sales, stagnant since $28 billion Horizon acquisition in 2023) against upcoming competition from Viridian’s autoinjector treatments (every 4-8 weeks). Viridian’s stock dropped 20% on the news and is down 47% over the past month. However, Viridian may have a safety advantage—hearing impairment occurred in 5% of patients on its 8-week dosing versus Amgen’s 10%+ rate of tinnitus (a notable side effect for anti-IGF-1R drugs). Other common Amgen side effects included muscle spasms, weight loss, ear discomfort, nausea, diarrhea, and mild-to-moderate injection site reactions. Amgen plans to share data with regulatory authorities.
President Trump signed an executive order implementing 100% tariffs on pharmaceutical products from select countries/manufacturers within 120-180 days, but with significant exemptions: drugs from manufacturers with “most favored nation” (MFN) pricing deals and those onshoring U.S. capacity are exempt. UK (0% with MFN deals like GSK/AstraZeneca), EU, Switzerland, Korea, and Japan face 15% tariffs; generic drugs and biosimilars are currently exempt. UK secured 0% pharma tariffs for at least 3 years. Companies onshoring production to the U.S. face only 20% tariffs, but the levy jumps to 100% if construction isn’t completed by end of Trump’s term. The White House requires “one-for-one” U.S. manufacturing capacity (e.g., selling 1 million pills in U.S. requires factory producing 1 million pills). Drugmakers have pledged nearly $600 billion in U.S. manufacturing commitments since early 2025. The tariffs are issued under Section 232 of the Trade Expansion Act following a Department of Commerce investigation that started April 2025.
