Biopharmaceuticals

Florence – September 21, 2026 -- The European Commission has granted marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination), marking the first global regulatory approval of obicetrapib for NewAmsterdam Pharma (Nasdaq: NAMS) and partner Menarini Group.

EU regulators authorize first CETP inhibitor for elevated LDL-C

The approval covers primary hypercholesterolaemia, including both heterozygous familial hypercholesterolaemia and non-familial or mixed dyslipidaemia. It follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and stands as the first regulatory clearance of obicetrapib anywhere in the world.

Gainesville, Fla. – September 21, 2026 -- Advita Ortho has launched Axis, a clinical research platform drawing on more than 20 years of shoulder arthroplasty data covering over 25,000 patients across 45 clinical sites worldwide.

Two decades of data produce 250 peer-reviewed studies

The dataset behind Axis has generated more than 250 peer-reviewed publications and dozens of first-to-market product innovations, according to the company. Chris Roche, Advita Senior Vice President, Extremities, said the initiative distills findings from the company's highest-impact studies into a format designed for practicing surgeons.

Providence, R.I. – September 21, 2026 -- Nabsys 2.0, LLC has published the first study combining CRISPR/Cas9 with its proprietary Electronic Genome Mapping (EGM) technology, demonstrating a method to both evaluate CRISPR/Cas9 activity and direct EGM to target specific genomic regions rather than only genome-wide analysis.

The preprint, titled 'CRISPR/Cas9 Optimization Using Electronic Genome Mapping: Potential Role for Studying Human Genetic Disease,' was led by John F. Thompson, Ph.D., Principal Application Scientist at Nabsys, and posted on bioRxiv.

Beijing – September 21, 2026 -- T-MAXIMUM Pharmaceutical reported that two of three evaluable patients with refractory brain metastases from lung cancer achieved partial responses with roughly 80% tumor shrinkage after treatment with its allogeneic B7-H3-targeted CAR-T therapy, MT027, according to early data presented at the IASLC World Conference on Lung Cancer (WCLC 2026) in Seoul.

Two of three evaluable patients hit 80% tumor shrinkage in dose-escalation trial

In the prospective, investigator-initiated trial (ChiCTR2500107346), five patients with heavily pretreated, guideline-exhausted brain metastases completed treatment. Of the three with measurable disease, two achieved partial responses and one achieved stable disease. As of the company's September 2026 follow-up, the two responders have survived more than 11 and 13 months, respectively, since their first MT027 dose, and all three evaluable patients remain alive.

Jerusalem – September 21, 2026 -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) has regained compliance with Nasdaq's $1.00 minimum bid price rule after its American Depositary Shares closed at or above that threshold for 19 consecutive business days, Nasdaq Listing Qualifications confirmed in a September 18, 2026 letter.

Nasdaq closes compliance matter after ADS price clears threshold for 19 sessions

The closing bid price of Scinai's ADSs met or exceeded $1.00 per share from August 21, 2026 through September 17, 2026, satisfying Nasdaq Listing Rule 5550(a)(2). Nasdaq had first flagged the deficiency on March 12, 2026, after the ADSs failed to maintain the $1.00 minimum over the prior 30 consecutive business days.

CEO says resolution shifts focus to CDMO commercial execution

"Receiving Nasdaq's confirmation closes an important compliance matter for Scinai,

Bridgewater, N.J. – September 21, 2026 -- The U.S. Food and Drug Administration has accepted Insmed Incorporated's supplemental New Drug Application (sNDA) for full approval of ARIKAYCE (amikacin liposome inhalation suspension) to treat Mycobacterium avium complex (MAC) lung disease, granting Priority Review with a PDUFA target action date of January 28, 2027.

FDA sets January 28, 2027 decision date under Priority Review

The Priority Review designation applies to therapies that could offer significant improvement in safety or efficacy for serious conditions. Insmed said full approval would allow ARIKAYCE, administered via PARI Pharma's Lamira Nebulizer System, to reach patients earlier in their disease course, including newly diagnosed cases and those with recurrent infections.

Germantown, Md. – September 21, 2026 -- The U.S. Food and Drug Administration has granted platform technology designation to Precigen's AdenoVerse immunotherapeutic platform, the technology underlying the company's first commercial product, PAPZIMEOS, approved in August 2025 for recurrent respiratory papillomatosis (RRP) in adults.

FDA designation opens accelerated pathway for future AdenoVerse cancer programs

The designation allows Precigen to leverage manufacturing and preclinical data generated for PAPZIMEOS to support future marketing applications for other AdenoVerse-based candidates, reducing duplicative development work. It also grants the company earlier and more frequent FDA engagement and allows regulators to consider prior manufacturing inspections when reviewing future applications.

Singapore – September 21, 2026 -- WuXi XDC Cayman Inc. (2268.HK) has secured GMP release for its Singapore manufacturing site at Tuas Biomedical Park, marking the bioconjugate CRDMO's first overseas facility just two and a half years after the site was announced in March 2024.

BCM3 dual-function line and DP4 drug product facility clear GMP release

The 25,000-square-meter site achieved GMP release for both its BCM3 antibody intermediate and conjugated drug substance production line and its DP4 drug product facility in August 2026. BCM3 supports batch sizes from 200 L to 2,000 L for antibody intermediates and up to 2,000 L for conjugated drug substances, operating under FDA, EMA and NMPA standards. A second line, BCM4, is slated for GMP release by the end of 2026 with a maximum single-batch capacity of 500 L for conjugated drug substance.

Aachen, Germany – September 21, 2026 -- Grünenthal has agreed to acquire Bayer AG's oncology drug Stivarga® (regorafenib) for up to €375 million, adding an oral cancer treatment sold in more than 90 markets to its portfolio.

Grünenthal expects Stivarga to add up to €100 million to EBITDA in 2027

The German pharmaceutical company said the acquisition is immediately accretive to its business, with an estimated positive impact on consolidated EBITDA of approximately €100 million for the year ending December 31, 2027. That projection assumes the deal closes by the end of 2026 or early 2027 and includes a full year of consolidation.

Boston – September 21, 2026 -- Cellular Intelligence, a Boston-based AI company building a universal foundation model of cell signaling, has appointed Turing Award laureate Yann LeCun, Moderna co-founder Robert "Bob" Langer, BioInnovation Institute CEO Jens Nielsen and Helmholtz Munich computational health director Fabian Theis to its Scientific Advisory Board. Langer also joins the company's Board of Directors as an observer.