Following a discussion today that focused more on the unique personalized trial strategy rather than the benefits of the therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients, with HR+/HER2- metastatic breast cancer, starting when a tumor ESR1 mutation is detected rather than waiting until radiographic progression, which is the current standard protocol for moving to a new treatment. The no votes all reflected panel members’ concerns with making such a fundamental change in the trial paradigm with little evidence to support it.

$300M IPO prices for Avalyn’s inhaled versions of PF drugs

Avalyn Pharma Inc. priced its IPO of about 16.6 million shares at the high end of the targeted range: $18 each, for proceeds of about $300 million. The firm’s AP-01, an optimized, inhaled form of pirfenidone, is undergoing a phase IIb trial called Mist in progressive pulmonary fibrosis (PPF). A TGF-beta synthesis inhibitor, pirfenidone was approved by the U.S. FDA as Esbriet, then owned by Intermune Inc., in October 2014 for the treatment of patients with idiopathic PF (IPF). Legacy Pharma Inc. SEZC, of George Town, Cayman Islands, bought Intermune and the rights to Esbriet in February of last year for an undisclosed amount. Avalyn’s PPF work is furthest along, but the company is also developing AP-02, an inhaled version of nintedanib, for IPF. The phase II Aura study is underway. A small-molecule tyrosine kinase inhibitor, nintedanib also was cleared in October 2014 for IPF, sponsored by Boehringer Ingelheim GmbH, under the brand name Ofev. The label has expanded since. Avalyn will trade on the Nasdaq market under the ticker AVLN.

Dermatology specialist Leo Pharma makes a $50M move into gene therapy

Dermatology specialist Leo Pharma A/S is moving into gene therapy with the $50 million acquisition of Replay Holding LLC, a seed stage company that is developing high capacity herpes simplex virus (HSV) vectors to treat rare inherited diseases. In addition to the up-front payment, Replay will be entitled to development milestones and royalties on any products that make it to market. Leo also will be investing to move research forward, starting with the lead program in which Replay is developing a topically applied HSV gene therapy formulation for the severe inherited skin disorder treating dystrophic epidermolysis bullosa.

Beone eyes Huahui Health’s trispecific HH-160 with $2B option deal

Beone Medicines Ltd. gained an exclusive option to develop cancer immunotherapy HH-160 worldwide in a deal potentially worth more than $2 billion for Huahui Health Ltd., the developer of the trispecific antibody. Terms call for Beone to pay $20 million up front, and a potential $100 million upon exercising the option, as well as up to $1.9 billion in development, regulatory and sales milestone payments, plus tiered royalties on net sales. If the option is exercised, Beone would take over global development, manufacturing and commercialization. HH-160, a novel symmetrical hexavalent trispecific antibody that targets PD-1, CTLA-4 and VEGF-A, is in preclinical studies. In addition to the financial terms, Beone and Huahui Health agreed to continue discussions regarding Beone’s potential participation in future financings of Huahui Health, which last raised funds in a series B round in 2024.

Quintuple GLP-1–GIP–PPAR agonist for obesity and diabetes control

A new molecule combines the action of two incretins, GLP-1 and GIP, hormones that regulate glucose and appetite, with lanifibranor, a triple agonist of peroxisome proliferator activated receptors (PPAR α/γ/δ). GLP-1–GIP–Lani enables targeted delivery of the PPAR agonist to cells that express incretin receptors, enhancing weight loss, improving glucose control and reducing inflammation in obese mice. In these models, it surpassed the effects of GLP-1 receptor agonists such as semaglutide and GLP-1–GIP co-agonists such as tirzepatide in reducing body weight, improving glycemic control and enhancing metabolic outcomes during active treatment.

EMA launches pilot for breakthrough medical devices in the EU

The European Medicines Agency (EMA) has launched a pilot program to fast track breakthrough medical devices in the EU and get lifesaving technologies to patients sooner. The program will allow for companies to obtain scientific advice from the expert panels intended to support evidence generation and clinical development of their devices.

Day One buyout headlines active Q1 for cancer stocks

The BioWorld Cancer Index posted a 1.39% gain in the first quarter of 2026, reflecting a slower pace after rising 72.35% over 2025. Day One Biopharmaceuticals Inc. jumped 65.9% on March 6 following news of its $2.5 billion acquisition by Servier SAS and underscoring continued M&A momentum in the sector.

Biopharma exec settles with SEC over misappropriation claims

The U.S. SEC filed a settlement Wednesday that it reached with Anthony Cataldo regarding allegations that the former chairman and CEO of a clinical-stage biopharma company misappropriated about $3.2 million from the company and then concealed the misconduct from the company’s auditors. Under the settlement filed with the U.S. District Court for the Central District of California, which must approve it, Cataldo consented to a three-year officer and director bar and to pay a civil penalty of $30,000. Cataldo neither admitted nor denied the SEC’s allegations.

Also in the news

3D Systems, AB Science, Agitated Solutions, Axoft, Beone, Candel, Chest Wall, Circular, CMR, Convergent, Cosette, Dr. Reddy, Earflo, Emalex, Epilepsygtx, Eversana, Expression, GH Research, Gilead, Greywolf, Henlius, Hutchmed, Hypervision Surgical, Immunome, Infinite, Intellia, Neurosense, Norgine, Olympus, Oruka, Pfizer, Phagenesis, Prelude, Psyga, PTC, Ray, Senzime, Strand, Tacalyx, Teva, Vivacta, XTL