BMS’ Arlo-cel Met Its Pivotal Myeloma Trial With the Numbers Withheld as Bayer’s Hyrnuo Won First Line Approval on a 75% Response Rate and Biotech Raised $550M in a Day (September 10, 2026)

Last updated: September 10, 2026

Bristol Myers Squibb’s GPRC5D CAR T arlo-cel met its registrational myeloma trial with response figures withheld, the FDA granted Bayer’s Hyrnuo accelerated first line approval in HER2 mutant lung cancer on a 75% response rate, and three private rounds raised $550 million in one day.

This page covers the QUINTESSENTIAL topline in detail, the Hyrnuo label and its supporting data, the FDA’s new permanent center directors, the September 9 financing cluster, BioMarin’s published hypochondroplasia data, and how the week’s blowups traded on day two.

What did BMS’ arlo-cel show in the QUINTESSENTIAL myeloma trial?

Arlo-cel, a first in class GPRC5D directed CAR T cell therapy, met the primary endpoint of overall response rate in quadruple class exposed relapsed and refractory multiple myeloma. Bristol Myers Squibb withheld all response figures for an unnamed medical meeting.

The registrational Phase 2 QUINTESSENTIAL trial (NCT06297226) enrolled adults with relapsed and refractory multiple myeloma whose prior treatment spanned all four established drug classes: a proteasome inhibitor, an anti CD38 antibody, an immunomodulatory agent, and a BCMA targeted therapy. Per the company’s September 8 release, the trial met its primary endpoint of overall response rate in quadruple class exposed patients who had received four or more prior lines of therapy, and also met secondary endpoints of complete response rate in that group plus overall and complete response rates in patients with three or more prior lines. The company said the safety profile was “consistent with that of other CAR T cell therapies and other GPRC5D-targeting therapies,” and that results “will be presented at an upcoming medical meeting.”

Arlocabtagene autoleucel (arlo-cel, formerly BMS-986393) targets GPRC5D, a receptor expressed on malignant plasma cells, which makes it a distinct target from BCMA, the antigen carried by both of the approved myeloma CAR T products, including BMS’ own Abecma. That distinction is the commercial thesis: patients who relapse after a BCMA CAR T or a BCMA bispecific still express GPRC5D, so arlo-cel is positioned as the next cellular option in a population that has exhausted the current ones. BMO Capital Markets called the readout a “key derisking event” for the BMS cell therapy franchise, per BioSpace, which also noted that Arcellx and Gilead’s competing BCMA CAR T anito-cel carries an FDA action date of December 23, 2026 in fourth line myeloma. That date and the BMO characterization are trade press reporting, not company confirmed.

Why does an ex vivo CAR T win matter for the cell therapy sector right now?

Because the same sponsor has an autoimmune CAR T program sitting in a voluntary pause after patient deaths, and the sector’s financing has split: oncology cell therapy keeps delivering registrational data and raising money while the autoimmune side works through a safety reckoning.

BMS paused its autoimmune CD19 program zola-cel in early September after patient deaths, alongside a parallel Novartis pause of rap-cel, and neither company has published a primary document on restart criteria as of this writing. QUINTESSENTIAL is the other half of that picture: in oncology, where the risk tolerance calculus is different, the same modality just produced a registrational win in a heavily pretreated population with limited options. The pattern matches the financing signal from earlier this week, when BrainChild Bio raised $116 million for a pediatric CNS tumor CAR T while autoimmune programs sat paused. Ex vivo cell therapy is not out of favor; it is being repriced by indication.

What did the FDA approve for Bayer’s Hyrnuo in lung cancer?

The FDA granted accelerated approval on September 9 for Hyrnuo (sevabertinib) as a first line treatment for locally advanced or metastatic non squamous non small cell lung cancer with HER2 (ERBB2) tyrosine kinase domain activating mutations, detected by an FDA authorized test.

The approval rests on the treatment naive Cohort F of the Phase 1/2 SOHO-01 trial (NCT05099172), and Bayer’s release carries the numbers in full, which is worth noting in a week when toplines have mostly arrived without them.

Continued approval may be contingent on verification of clinical benefit in the ongoing Phase 3 SOHO-02 confirmatory trial. Hyrnuo, an oral HER2 targeted tyrosine kinase inhibitor, first won FDA approval in November 2025 for previously treated HER2 mutant lung cancer; the new label moves it to the front of the treatment sequence. It lands about seven months behind Boehringer Ingelheim’s Hernexeos, which took a first line HER2 mutant NSCLC approval in February 2026, per Fierce Pharma, setting up a two way race in a mutation found in roughly 2% to 4% of non small cell lung cancers. HER2 mutation testing at diagnosis, rather than at progression, now decides whether either drug finds its patients.

Who did HHS make permanent at the FDA?

Michael Davis is now permanent director of the Center for Drug Evaluation and Research and Karim Mikhail permanent director of the Center for Biologics Evaluation and Research, per BioSpace and Fierce Pharma reporting on the HHS announcement. Both had been acting since mid May.

The moves fill the vacuum left by the departures of former Commissioner Marty Makary, CBER’s Vinay Prasad, and CDER’s Tracy Beth Høeg earlier this year. HHS also named Brent Koplow permanent director of the Center for Tobacco Products and created a Deputy Commissioner for Technology and Artificial Intelligence role for Jared Seehafer. RBC Capital Markets read the appointments as a signal of “stability that should help ease concerns that the FDA will see major shifts in policy,” per BioSpace. Heidi Overton, the White House’s nominee for commissioner, still awaits a confirmation hearing; analysts quoted in the coverage expect a confirmed commissioner to delegate substantial authority to the now permanent center directors. For sponsors, the practical question is whether permanence at CDER and CBER compresses the review variance this column has tracked through Replimune, uniQure, and Etcamah, three approvals this summer that each reversed a contested review posture.

Who raised money in biotech on September 9, 2026?

Three private rounds announced on September 9 total $550 million by our arithmetic: Solstice Oncology’s $225 million Series A, Encoded Therapeutics’ $275 million Series F, and Caspian Therapeutics’ $50 million launch round. Each figure traces to a company release.

The Solstice deal construction deserves the close read. Harbour BioMed receives approximately $105 million at signing, but the release breaks that into a $50 million upfront payment, $5 million in near term cash, and a $50 million equity stake in Solstice itself, with up to $1.1 billion in milestones tied to ex China commercial sales. Roughly half of the “at signing” value is paper in the NewCo rather than cash, which is exactly the structure to check whenever a China licensing headline number crosses the wire. Porustobart brings Phase 1b data of a 30% objective response rate (7 of 23 patients) with a median response duration of 8.4 months, per the company. Caspian, meanwhile, is a spinout: Kura Oncology retains roughly half the company on a fully diluted basis and board representation, moving a diabetes application of its menin franchise into a separately financed vehicle with Eli Lilly participating as an investor.

What did BioMarin’s Voxzogo show in hypochondroplasia?

BioMarin published detailed Phase 3 results in NEJM Evidence showing Voxzogo (vosoritide) improved annualized growth velocity by 2.33 cm per year versus placebo in children with hypochondroplasia. An FDA filing has been submitted, targeting a 2027 launch.

The CANOPY-HCH-3 trial, which reported topline results in May, also showed a 2.35 cm gain in standing height and a 1.03 cm gain in arm span over placebo, with most adverse events mild and no treatment related serious adverse events, per the company and Fierce Pharma. BioMarin estimates roughly 14,000 children with hypochondroplasia across its geographic footprint. The expansion matters because Voxzogo’s achondroplasia base is under pressure from Ascendis Pharma’s Yuviwel, approved in March 2026; hypochondroplasia would be territory Voxzogo holds alone, at least initially, and BioMarin also collects a royalty on US Yuviwel sales under the companies’ settlement, per Fierce Pharma.

How did the week’s blowups trade on day two?

They did not bounce. Amgen closed down again on September 9, Novartis held at its post crash level, and the market gave no ground back on any of the week’s surrogate linked selloffs. Official exchange closes below; no cause is assigned to any move without a company disclosure.

Amylyx logged its eighth consecutive close below the $35.50 offering price from August 19, with the closing of the $500.2 million offering still unannounced as of our September 9 night check; the greenshoe window forces disclosure by roughly September 18. Bristol Myers Squibb’s move on the day its arlo-cel analysis coverage ran was modest at −0.4%; we assign no cause. The Lilly and Sangamo asset sale close also remained unconfirmed by any primary source as of September 9 night.

Frequently asked questions

What is arlo-cel?

Arlocabtagene autoleucel (arlo-cel, formerly BMS-986393) is Bristol Myers Squibb’s autologous CAR T cell therapy directed at GPRC5D, a receptor on malignant plasma cells. It would be the first approved CAR T in multiple myeloma that does not target BCMA.

What does quadruple class exposed mean in multiple myeloma?

It describes patients whose disease has been treated with all four established drug classes: a proteasome inhibitor, an immunomodulatory agent, an anti CD38 antibody, and a BCMA targeted therapy. These patients have few remaining options, which is why regulators accept single arm response data in this setting.

Did BMS report response rates for QUINTESSENTIAL?

No. The September 8 release says the trial met its overall response rate primary endpoint and complete response secondary endpoints, but every figure was withheld for presentation at a medical meeting the company has not yet named.

When could arlo-cel be approved?

BMS has not disclosed a regulatory timeline. QUINTESSENTIAL is registrational, so a filing on these data is the expected next step, but no submission or action date has been announced.

What is Hyrnuo and who makes it?

Hyrnuo (sevabertinib) is Bayer’s oral HER2 targeted tyrosine kinase inhibitor. It was first approved in November 2025 for previously treated HER2 mutant non small cell lung cancer and, as of September 9, 2026, is approved first line under the accelerated pathway.

How common are HER2 mutations in lung cancer?

Roughly 2% to 4% of non small cell lung cancers carry HER2 tyrosine kinase domain activating mutations, per Fierce Pharma. Patients are identified with an FDA authorized test, so upfront molecular testing determines access.

What response rate supported Hyrnuo’s first line approval?

A 75% objective response rate (95% CI, 64 to 85) in the 69 patient treatment naive Cohort F of the Phase 1/2 SOHO-01 trial, with 6% complete responses and 73% of responses lasting at least six months, per Bayer’s release.

How does Hyrnuo compare with Boehringer Ingelheim’s Hernexeos?

Both are oral HER2 targeted agents approved first line in HER2 mutant non small cell lung cancer. Hernexeos won its first line approval in February 2026, about seven months earlier. No head to head data exist; label details and testing practice will shape share.

Who now leads CDER and CBER?

Michael Davis is permanent director of the Center for Drug Evaluation and Research and Karim Mikhail permanent director of the Center for Biologics Evaluation and Research, per BioSpace and Fierce Pharma reporting on the HHS announcement. Both had served in acting capacity since mid May.

Is Heidi Overton confirmed as FDA commissioner?

No. Overton, the nominee, still awaits a Senate confirmation hearing as of September 9, 2026. The center director appointments were made while the commissioner seat remains filled on an acting basis.

What is porustobart?

Porustobart is a next generation CTLA-4 antibody developed by China’s Harbour BioMed and now licensed to Solstice Oncology for ex China development. Solstice plans a Phase 2 trial combining it with Keytruda in neoadjuvant colon cancer, enrolling from Q4 2026.

What does Caspian Therapeutics do?

Caspian is a Kura Oncology spinout advancing KO-7246, an oral selective menin inhibitor, as a potential disease modifying treatment for type 1 and type 2 diabetes. The mechanism aims to regenerate insulin producing pancreatic beta cells rather than supplement insulin. Eli Lilly participated in the $50 million launch financing.

What is ETX101?

ETX101 is Encoded Therapeutics’ gene therapy for SCN1A+ Dravet syndrome, a severe genetic epilepsy. The new $275 million Series F funds its pivotal study in infants and young children, an expansion study up to age 18, and manufacturing scale up.

What did BioMarin’s hypochondroplasia trial show?

In the Phase 3 CANOPY-HCH-3 trial, published in NEJM Evidence, Voxzogo improved annualized growth velocity by 2.33 cm per year versus placebo in children with hypochondroplasia, with no treatment related serious adverse events. BioMarin has submitted a US filing.

Is the Amylyx offering closed?

Not as of our September 9 night check. The $500.2 million offering priced August 19 at $35.50 per share has no announced closing, and AMLX has now closed below the offer price in eight consecutive sessions, ending September 9 at $32.40.

Sources

Primary sources: Bristol Myers Squibb press release on QUINTESSENTIAL topline results (September 8, 2026); Bayer press release on the FDA accelerated approval of Hyrnuo (September 9, 2026); Kura Oncology press release on the launch of Caspian Therapeutics (September 9, 2026); Solstice Oncology and Harbour BioMed press release on the $225 million Series A (September 9, 2026); Encoded Therapeutics press release on the $275 million Series F (September 9, 2026); BioMarin press release on NEJM Evidence publication of Phase 3 CANOPY-HCH-3 results (September 9, 2026); official exchange closing prices, September 9, 2026.

Trade press: BioSpace on the arlo-cel readout, the BMO note, the anito-cel action date, and FDA leadership (September 9, 2026); Fierce Pharma on the Hyrnuo approval, Hernexeos competitive context, FDA leadership, and BioMarin (September 9, 2026); Fierce Biotech on Evommune, Kura’s spinout, and the day’s venture activity (September 9, 2026); MedTech Dive on the Labcorp acquisition of MLM Medical Labs (September 9, 2026) and Oura’s IPO filing (September 8, 2026); TCTMD on Lp(a)HORIZON (September 8, 2026).

Related coverage

• Wednesday’s briefing on the del-desiran failure, the Amgen readacross selloff, and the Etcamah approval
• The pelacarsen Lp(a) outcomes failure that set this week’s through line
• The Novartis and BMS autoimmune CAR T pauses that frame the arlo-cel win
• TScan’s in vivo pivot, a contrasting answer to the question Kura solved with a spinout