Gilead Sciences Inc. is acquiring partner Arcellx Inc. for up to $7.8 billion, consisting of $115 per share up front and a contingent value right of $5 per share. In 2022, the companies teamed up to develop anitocabtagene autoleucel (anito-cel), a BCMA-directed CAR T-cell therapy for patients with multiple myeloma. The deal is expected to close in the second quarter of 2026, ahead of the PDUFA date for a potential approval of anito-cel as a fourth-line treatment for patients with relapsed or refractory MM in December 2026.

Vanda gets FDA nod for atypical antipsychotic Bysanti

Vanda Pharmaceuticals Inc. gained U.S. FDA approval for Bysanti (milsaperidone), cleared for use in acute bipolar I disorder and schizophrenia and ensuring continuation of the firm’s atypical antipsychotic franchise, with Fanapt (iloperidone) set to start losing patent protection in 2027. It also offered a rare straightforward regulatory win for Vanda, which has tussled with the FDA in recent years. Designated as a new chemical entity, orally administered Bysanti is described as an active metabolite of iloperidone and has been shown to be bioequivalent to iloperidone at both high and low doses in multiple studies. Bysanti is expected to be commercially available in the third quarter of 2026. Pricing was not immediately available.

Gossamer slides on phase III readout of seralutinib in PAH

Gossamer Bio Inc. pointed to an “outsized placebo response” as the reason its phase III study testing seralutinib in pulmonary arterial hypertension (PAH) fell short of statistical significance on the primary endpoint of six-minute walk distance (6MWD), news that sent shares (NASDAQ:GOSS) down 80% at midday. At week 24, patients receiving seralutinib, an inhaled tyrosine kinase inhibitor targeting multiple growth factors implicated in PAH, showed a placebo-adjusted improvement in the 6MWD of 13.3 meters, below the 20-meter improvement most analysts had projected for a successful study. The company, however, intends to move forward, with further data analyses and interaction with the U.S. FDA, though it has paused further enrollment in a second phase III study testing seralutinib in PAH.

Novo’s next-gen obesity drug fails to beat Lilly's Zepbound

Shares in Novo Nordisk A/S took another battering after the company announced its next-generation obesity drug Cagrisema failed to show noninferiority to Eli Lilly and Co. Inc.’s Zepbound in an open-label comparator study. The news prompted a 15% fall in the shares of Novo Nordisk, which, after a series of missteps, have lost 60% of their value in the past year. At midday Feb. 23, shares (NYSE:NVO) were trading at $40.15, down $7.27 from the previous closing. Patients in the Cagrisema arm of the Redefine 4 trial lost on average 23% of their body weight at 84 weeks. But in the Zepbound (tirzepatide, Mounjaro in Europe) arm, patients lost on average 25.5% of their body weight. That means Redefine 4 missed the primary endpoint of showing Cagrisema is at least as effective as Zepbound.

Tariffs far from dead in US

Inquiring minds want to know what’s next after the U.S. Supreme Court shot down President Donald Trump’s reciprocal tariffs issued under the International Emergency Economic Powers Act and Trump immediately responded with a temporary 10% import duty on most goods brought into the country. “The current situation is not conducive to delivering ‘fair, balanced and mutually beneficial’ transatlantic trade and investment, as agreed to by both sides and spelled out in the EU-U.S. Joint Statement of August 2025,” the EU Commission said Saturday. The EU asked for “full clarity” on the steps the U.S. intends to take now. Those steps could include global sector tariffs on both biopharma and med-tech products.

Neurosoft partners with Science Corp. to advance BCI system

Neurosoft Bioelectronics SA has signed an agreement with Science Corp. to gain access to its full stack of clinical-grade neural recording tools as it looks to advance its brain-computer interface (BCI) system. Neurosoft is one of a plethora of companies developing BCI technologies to treat a range of neurological condition. By combining Science’s BCI tools with its own neural data platform, Neurosoft hopes to reduce the time, cost and complexity of developing BCI systems.

Harbour Biomed spins out newco in $1.2B CTLA-4 deal

Harbour Biomed is spinning out newco Solstice Oncology and is outlicensing its CTLA-4 antibody, porustobart (HBM-4003), to the newco in a cash and equity deal worth more than $1.2 billion. Solstice Oncology was established by a syndicate of venture capital investors for the exclusive development and commercialization of HBM-4003 outside greater China. Under the deal terms, Harbour Biomed is eligible to receive $105 million up front, comprised of $50 million in up-front cash, a near-term cash payment of $5 million, and more than $50 million of equity interest in Solstice Oncology. Harbour is also eligible to receive up to $1.1 billion in additional development, regulatory and commercial milestone payments, plus royalties on sales outside greater China.

New FDA guidance details plausible mechanism pathway

The U.S. FDA issued its anticipated plausible mechanism draft guidance, enabling rare disease drug developers, such as those working on genome editing and RNA-based therapies, to generate evidence of effectiveness and safety to support approval when randomized controlled trials are not feasible.

Novartis sells India subsidiary to private equity for $159M

Swiss pharmaceutical giant Novartis AG is selling off its India-listed business unit, Novartis India Ltd. (NIL), to a private equity-led consortium for about ₹14.46 billion (US$159.3 million) as it seeks to grow with “pure-play innovation.” News of the deal sent NIL’s shares (BSE:500672) on the Bombay Stock Exchange up 20% Feb. 20, hitting the daily upper trading limit. Under the terms, Novartis agreed to transfer 70.68% of its stake in NIL to the consortium led by the Chryscapital group, one of India’s largest private equity firms. The transaction is expected to close in the third quarter of 2026.

Also in the news

AC Immune, Agenus, Astrazeneca, Beyond Air, Biocomposites, Biopharma-Middle East and Africa, Brainstorm Cell, Candel, Cigalah, Corcept, Daiichi, Dymicron, Eli Lilly, Fennec, Galapagos, Immunitybio, Janssen, Johnson & Johnson, Oculis, Partner, PDS, Pharaoh, Puretech, Roche, Scandinavian, Seaport, Takeda, Teva, Trisalus