Validating Fusion Pharmaceuticals Inc.’s radiopharmaceutical technology and manufacturing capabilities, Astrazeneca plc offered to buy the Canadian firm for $2 billion up front in cash, plus a contingent value right that could raise the total deal value by another $400 million. The two companies first collaborated in 2020 on next-generation radioconjugates (RCs), eventually partnering on FPI-2068 for solid tumors. Through the acquisition, in addition to FPI-2068, Cambridge, U.K.-based Astrazeneca gains Fusion’s lead phase II product, actinium-based RC FPI-2265 for metastatic castration-resistant prostate cancer. It also brings in a pipeline of other RCs, manufacturing capabilities and an actinium-225 supply chain. “I think it’s a loud statement about the field continuing to grow and the opportunity of combining a leader in precision oncology with Astrazeneca” and a radioconjugate biotech company like Fusion, John Valliant, founder and CEO of Hamilton, Ontario, and Boston-based Fusion, told BioWorld. “I think it’s a fantastic day and a way for us to accelerate the development of these medicines.”

Crinetics scores again in phase III with paltusotine in acromegaly

Shares of Crinetics Pharmaceuticals Inc. (NASDAQ:CRNX) were trading at $43.91, up $5.98, or 15%, after the firm disclosed positive top-line results from Pathfindr-2, the second of two successful phase III studies testing the efficacy and safety of oral, once-daily paltusotine for the treatment of acromegaly. The study hit the primary and all secondary endpoints, with 56% of participants on paltusotine achieving insulin-like growth factor-1 levels ≤1 times the upper limit of normal vs. 5% on placebo. San Diego-based Crinetics plans to submit to the U.S. FDA for approval in the second half of 2024. The drug is a selectively targeted somatostatin receptor type 2 agonist designed to give patients a more convenient dosing option than currently used injectables.

China’s NMPA clears Kechow’s tunlametinib in advanced melanoma

China’s National Medical Products Administration (NMPA) approved Kechow Pharma Inc.’s MEK inhibitor, tunlametinib, for treatment of patients with NRAS-mutated advanced melanoma who were previously treated with PD-1/PD-L1 inhibitors. The Center for Drug Evaluation granted tunlametinib a priority review. The approval marks the first targeted therapy for this patient population and the first product that originated from Kechow, a privately held firm founded in 2014 to develop small-molecule therapeutics against cancer.

Seelos misses in an ALS phase II/III study as stock continues downward

Top-line data from Seelos Therapeutics Inc.’s phase II/III study in amyotrophic lateral sclerosis failed to meet statistical significance in its primary and secondary endpoints, continuing the stock’s nearly half-year downward trajectory. SLS-005 (I.V. trehalose), a low molecular weight disaccharide, did however show an improvement in function and mortality, prompting hope from Seelos executives who said they plan to meet with the U.S. FDA to discuss next steps. The company’s stock (NASDAQ:SEEL) shrank dramatically at midday, with shares trading 37% downward at 57 cents each. The stock has struggled since last September, when it dropped from about $30 a share to about $5 each after releasing top-line data from the SLS-002 phase II study of treating adults with major depressive disorder.

At long last, a path to remission for precision psychiatry

Precision psychiatry got some love at two quite different meetings this week, the European Congress of Neuropsychopharmacology’s New Frontiers meeting and BioEurope Spring. The New Frontiers Meeting, an annual two-day meeting dedicated to cutting-edge issues in brain disease research, focused on big-picture and scientific – at times almost philosophical – questions of how to get to a classification scheme for brain disorders that aligns with the underlying biology. At BioEurope, the focus was on the commercial side. The biz buzz has been building around precision psychiatry for a while now, and in December 2023, the acquisitions of Karuna Therapeutics Inc. by Bristol Myers Squibb Co. and Cerevel Therapeutics Inc. by Abbvie Inc. signaled that big pharma companies, which had mostly abandoned the brain disease space for a good long while, are ready to re-enter the fight.

Asieris’ drug-device combo positive in cervical cancer trial

Asieris Pharmaceuticals Co. Ltd. plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia (HSIL). Cevira (aminolevulinic acid hexyl ester, APL-1702), which combines a photosensitizer with light activation of specific wavelength to produce therapeutic effects, is intended for patients 18 years and older with HSIL, including all human papillomavirus (HPV) subtype strains. Data from the phase III showed significant efficacy and a good safety profile, with new advancements in the clearance rate of high-risk HPV16 and HPV18 strains.

Samsung Life Science Fund invests in US ADC biotech Brickbio

Samsung Life Science Fund, created jointly by Samsung Biologics Co. Ltd., Samsung Bioepis Co. Ltd. and Samsung C&T Corp., said it invested in Waltham, Mass.-based antibody-drug conjugate developer Brickbio Inc. on March 18, as its fifth biotech investment. “The financial terms remain confidential,” a Samsung Bioepis spokesperson told BioWorld, while explaining that the fund, managed by Samsung Venture Investment Corp., had made a total of ₩242 billion (US$180.71 million) in global biotech investment since its founding in 2022.

Ruling for Regeneron, US appeals court schools on antitrust market

Real life economics, not functionality, is the standard for determining an antitrust market for distinct versions of a prescription drug, the U.S. Court of Appeals for the Second Circuit said as it schooled a lower court and handed Regeneron Pharmaceuticals Inc. a win in its ongoing litigation with Novartis AG over the prefilled syringe (PFS) market for eye drugs Eylea (aflibercept) and Lucentis (ranibizumab). In lumping vials of a drug together with prefilled syringes into one market, the district court “erred by focusing too heavily on the functional similarities between anti-VEGF vials and PFSs, rather than on the extent to which consumers are willing to substitute one for the other,” the Second Circuit said in reversing the U.S. District Court for the Norther District of New York.

Also in the news

Abeona, Aegis, Aligos, Alivegen, Arch, Arvinas, Astellas, Astrazeneca, Astrivax, Bristol Myers Squibb, Centogene, Citius, Conduit, Cytomx, Engrail, Enliven, Enveric, Eureka, Faron, Fate, Genprex, Geron, Gsk, Heidelberg, Intellia, Journey Medical, Kalvista, LSL, Lundbeck, Madrigal, Mitsubishi Tanabe, Morphic, Neuroderm, Optinose, Otsuka, Outlook, Perspective, Pfizer, Pharma&, Pharvaris, Portal, Rapport, Repligen, Scilex, Shaperon, Takeda