Etentamig’s Median PFS Went Unreached in Phase 3 Myeloma Data at IMS as the FDA Approved Four Drugs in One Day and Novo Signed an Up to €1.165B Delivery Deal (September 28, 2026)

Last updated: September 28, 2026

At the IMS meeting, AbbVie’s etentamig posted a response rate of 74.0% versus 45.7% for standard therapy with median progression free survival not reached, while the FDA approved four drugs in one day and Novo Nordisk signed an up to €1.165 billion long acting injectable deal with Nanexa.

This report covers the weekend of September 26 and 27, 2026, plus the Friday, September 25 session, including the IMS myeloma data, four FDA approvals, the Novo Nanexa deal, the ADARx debut, and the week ahead at EASD in Milan.

What did the CERVINO trial show for etentamig at IMS 2026?

Etentamig, AbbVie’s anti BCMA T cell engager, beat standard available therapy on both primary endpoints in the randomized Phase 3 CERVINO trial, with a 74.0% overall response rate and median progression free survival not reached at a median follow up of 11.4 months, as presented Friday at the International Myeloma Society annual meeting in Glasgow.

The data, presented by Peter Voorhees and reported by OncLive and Targeted Oncology, cover 393 patients with triple class exposed, anti BCMA naive relapsed or refractory multiple myeloma, randomized one to one against standard available therapy after a median of three prior lines. AbbVie’s September 3 topline release had confirmed both primary endpoints were met but withheld the figures; the medians came due at IMS.

A single step up dosing cohort of 113 patients showed cytokine release syndrome in 28.3% with no events of grade 3 or higher, a figure that matters for the drug’s prospects in community settings where CAR T logistics do not reach. Discontinuations for adverse events were 3.6% versus 9.6% for standard therapy, and fatal adverse events 2.6% versus 5.7%, per the presentation. Overall survival has not crossed its prespecified efficacy boundary and remains formally immature.

How does the IMS data change the BCMA landscape in multiple myeloma?

The myeloma field now has a randomized, off the shelf bispecific with an unreached progression free survival median in the anti BCMA naive setting, five year survival follow up for an approved CAR T, and a third BCMA challenger with an action date in December. Sequencing, not any single asset, is the strategic question.

Alongside CERVINO, Johnson & Johnson and Legend Biotech presented long term follow up from Cohort A of the Phase 2 CARTITUDE-2 study of Carvykti: at a median 60.7 months, 10 of 20 patients remained alive and progression free, with overall survival of 69.2%, per BioSpace’s report from the meeting. A matching adjusted indirect comparison presented by K. Patel suggested anito-cel, the Arcellx and Gilead CAR T with a December 23 action date, has higher response odds and lower grade 3 or 4 ICANS than approved bispecifics, per Targeted Oncology; indirect comparisons are hypothesis generating, not head to head evidence.

Which four drugs did the FDA approve on September 25, 2026?

The FDA cleared four products in one day: Mirum and Incyte’s Atebrioz for fibrodysplasia ossificans progressiva, Lilly’s once weekly insulin Onswik, Merck and Eisai’s Welireg plus Lenvima combination in kidney cancer, and a pediatric expansion for Lilly’s Olumiant in severe alopecia areata.

The Atebrioz approval is the industry story of the four. Fibrodysplasia ossificans progressiva, an ultra rare disorder in which soft tissue progressively turns to bone, had no approved treatment until late August. It now has two in five weeks: Regeneron’s Pasatru, an intravenous Activin A blocker, and Atebrioz, a once daily oral ALK2 inhibitor whose label reaches down to age 12. In the Phase 2 Progress trial of 63 patients, one Atebrioz patient developed new heterotopic bone over 24 weeks versus five on placebo, and new lesion volume was more than 99% lower than placebo, per Fierce Biotech’s report of the data. Mirum licensed the compound from Incyte in April 2026 for $16 million upfront, per Fierce; five months later it holds an approval. Pricing is expected at the October launch, and no pricing document exists yet.

What are the terms of Novo Nordisk’s Nanexa deal, and why does dosing interval matter?

Novo Nordisk licensed Nanexa’s PharmaShell delivery platform for up to five programs in obesity, type 2 diabetes, and other cardiometabolic diseases, paying up to €615 million in upfront and development and regulatory milestones plus up to €550 million in sales milestones, a total of up to €1.165 billion, with low single digit royalties, per Nanexa’s September 25 release.

PharmaShell coats individual drug particles with an ultra thin inorganic layer built by atomic layer deposition. The coated particles form a depot at the injection site and release drug as the shell dissolves. Novo said it is targeting monthly and quarterly dosing. The strategic read is plain: the company that fell 8% on its capital markets day earlier this month is paying platform scale money for dosing interval, not for a new molecule. Injectable weekly incretins are heading toward molecular parity; the delivery layer is where the next moat gets dug.

How does Lilly’s Onswik compare with Novo’s Awiqli in once weekly insulin?

Onswik, approved Friday, is Lilly’s once weekly basal insulin for adults with type 2 diabetes and the second entrant in the category after Novo’s Awiqli, which won US approval March 31, 2026 and launched August 11, giving Novo roughly a five month head start, per Fierce Pharma.

The approval rests on the QWINT program, which enrolled more than 3,400 patients across trials. In QWINT-1, insulin naive patients cut A1C by 1.31% versus 1.27% for daily insulin glargine at 52 weeks; QWINT-3 and QWINT-4 showed noninferior A1C reductions against degludec and glargine in patients switching from existing insulin regimens, per Lilly’s release. Lilly plans a US launch in the coming months in 500 and 1,000 units per mL concentrations. The once weekly basal category is now a two player race heading into EASD, and adherence arithmetic, not molecule chemistry, will decide it.

What should you watch at EASD 2026 in Milan this week?

The European Association for the Study of Diabetes meeting runs Monday, September 28 through Friday, October 2 in Milan. Novo Nordisk alone brings 44 abstracts, and the readouts land on a schedule, per Novo’s September 16 curtain raiser.

Viking Therapeutics, which closed Friday 1.6% above its $35.00 offering price after the $500 million raise, and Roche, with enicepatide Phase 3 starts planned for the first half of 2027, both trade on readacross from the amylin and oral data.

How did the ADARx IPO price and trade, and where is biotech capital flowing?

ADARx priced an upsized initial public offering of 26,250,000 shares at $17.00 for gross proceeds of about $446.3 million, with AbbVie buying up to $100 million more in a concurrent private placement at the same price, and the stock closed its first Nasdaq session Friday at $19.35, 13.8% above the offer by our arithmetic. The offer figures come from the company’s pricing release; BioSpace called it the third largest biotech IPO of 2026.

ADARx develops siRNA medicines, with onvuzosiran in Phase 3 for hereditary angioedema and agazisiran, a factor B silencer, in Phase 2. Precision Neuroscience’s raise is the private medtech print of the week: its Layer 7 cortical interface packs 1,024 electrodes onto a film thinner than a human hair and already holds FDA clearance for 30 day use. Earendil, an AI antibody design company, has now signed its third billion dollar scale partnership in a year after Sanofi and WuXi XDC. The counterweight sits in the same tape: Electra closed at a new low of $11.55, 23.0% below its $15.00 issue price by our arithmetic. The IPO window is open and selective at the same time; quality of asset, not sector beta, is setting the clearing price.

What happened in medtech and manufacturing?

Intuitive received a CE mark for its da Vinci 5 robot in adult cardiac surgery in Europe, including coronary artery bypass, and said it will build training programs with cardiac societies, per MedTech Dive. The system already holds US clearances for nine heart procedures. Robotic cardiac surgery has been a graveyard of prior attempts; Intuitive is betting its installed base and training infrastructure change the equation.

Two quieter items matter for operators. Laboratory groups are pressing Congress for Medicare payment reform of the PAMA fee schedule, per MedTech Dive, with the CMS clinical lab fee schedule finalization due in November, the same window in which Grail’s Galleri awaits its FDA decision; the reimbursement rules for the diagnostics category are being written at the same moment as its first flagship approval. And BioSpace’s biomanufacturing feature detailed how vaccine and biologics manufacturers are redesigning for preparedness that pays for itself between emergencies, from HIPRA’s EU funded SPEEDCELL modular platform to CEPI’s February plan to embed platform technologies with regional manufacturers and the EU HERA crisis procurement handbook issued this month.

Which stocks moved on Friday’s news?

Under our movers only convention, five closes carried a story on Friday, September 25. All prices are exchange settled closes.

What else happened, and what lands Monday?

Beyond the headliners, the weekend closed several tracked threads and set up a loaded Monday.

Travere named its next CEO. Bradley Campbell, who led Amicus Therapeutics through its $4.8 billion acquisition by BioMarin, replaces Eric Dube effective December 1, per Fierce Biotech. Nektar prevailed against Lilly in the litigation over their broken rezpeg partnership, per BioSpace. Lundbeck is moving its US headquarters to Boston, per Fierce Pharma. Lepu Medical sued consultant Su Zhang and her firm CoDevCo in the Eastern District of New York, alleging she served as a competitor’s acting business chief while acting as Lepu’s exclusive dealmaker; the suit reaches into the NewCo model Zhang helped pioneer, the structure behind Kailera’s $625 million April IPO, per Fierce Biotech’s report of the filing. HUTCHMED dosed its global trial of HMPL-A830, a KRAS and EGFR targeting antibody conjugate, per a Sunday release. Roche proposed former Takeda chief Christophe Weber for its board, per Endpoints.

Monday brings two dated readouts: Kodiak Sciences reports topline Phase 3 DAYBREAK results for Zenkuda (tarcocimab tedromer) and KSI-501 (tabirafusp alfa tedromer) in wet age related macular degeneration at 8:30 am Eastern, and Mirum hosts a call on Phase 3 AZURE-1 topline results for brelovitug in chronic hepatitis delta. Neither outcome has been disclosed as of Sunday night; we will grade both in Tuesday’s edition. Section 232 pharmaceutical tariffs for remaining importers take effect Tuesday, September 29, and the GENEROUS Medicaid signing deadline falls Wednesday, September 30.

Frequently asked questions

What is etentamig and how does it work?

Etentamig is AbbVie’s off the shelf T cell engager that binds BCMA on myeloma cells and CD3 on T cells, directing the patient’s own T cells to kill the tumor without the manufacturing wait of CAR T therapy.

What were the CERVINO trial results presented at IMS 2026?

As presented at IMS, etentamig produced a 74.0% overall response rate versus 45.7% for standard therapy, with median progression free survival not reached versus 6.2 months and a hazard ratio of 0.40, at a median follow up of 11.4 months.

Is etentamig approved by the FDA?

No. Etentamig is investigational. CERVINO is the randomized Phase 3 trial expected to support regulatory filings; AbbVie has not announced a submission date.

How does etentamig compare with CAR T therapies like Carvykti?

There is no head to head trial. Carvykti showed half of CARTITUDE-2 Cohort A patients alive and progression free at 60.7 months of follow up, while etentamig offers off the shelf availability and showed no grade 3 or higher cytokine release syndrome with single step up dosing.

What is anito-cel and when is its FDA decision due?

Anito-cel is an autologous BCMA CAR T from Arcellx and Gilead with an FDA action date of December 23, 2026. An indirect comparison presented at IMS favored it over approved bispecifics on response and neurotoxicity.

Which drugs did the FDA approve on September 25, 2026?

Four: Atebrioz (zilurgisertib) for fibrodysplasia ossificans progressiva, Onswik (insulin efsitora alfa-gobe) once weekly basal insulin, the Welireg plus Lenvima combination for previously treated advanced clear cell kidney cancer, and Olumiant (baricitinib) expanded to patients 12 and older with severe alopecia areata.

What is fibrodysplasia ossificans progressiva?

FOP is an ultra rare genetic disorder in which muscle and connective tissue progressively turn to bone. It had no approved therapy until August 2026; it now has two, Regeneron’s Pasatru and Mirum’s Atebrioz.

What is Onswik and how is it different from daily insulin?

Onswik is insulin efsitora alfa-gobe, a basal insulin injected once weekly instead of once daily. Across the QWINT program it lowered A1C at least as much as daily glargine or degludec in more than 3,400 patients.

How much is Novo Nordisk paying Nanexa?

Up to €1.165 billion in total: up to €615 million in upfront and development and regulatory milestones plus up to €550 million in sales milestones, with low single digit royalties, for up to five programs using the PharmaShell platform.

What is PharmaShell technology?

PharmaShell uses atomic layer deposition to coat individual drug particles with an ultra thin inorganic shell. Injected particles form a depot that releases drug as the shell dissolves, which could stretch dosing to monthly or quarterly.

What data will Novo Nordisk present at EASD 2026?

Novo brings 44 abstracts to Milan, including CagriSema REIMAGINE 1 body composition data Tuesday, zenagamtide Phase 2b results Wednesday, real world Wegovy pill data Wednesday, and pooled oral semaglutide liver data Thursday.

How much did ADARx raise in its IPO?

About $446.3 million gross from 26,250,000 shares at $17.00, plus up to $100 million from AbbVie in a concurrent private placement, for combined gross proceeds of about $535.2 million. Shares closed their first session at $19.35.

What is Precision Neuroscience’s Layer 7 interface?

Layer 7 is a brain computer interface film thinner than a human hair carrying 1,024 electrodes, cleared by the FDA for 30 day use in 2025. The company raised a $250 million Series D to fund clinical work and commercialization.

What Phase 3 results are due Monday, September 28?

Kodiak Sciences reports DAYBREAK topline results for Zenkuda and KSI-501 in wet age related macular degeneration, and Mirum reports AZURE-1 topline results for brelovitug in chronic hepatitis delta. Neither outcome was public as of Sunday night.

Who is Travere’s next CEO?

Bradley Campbell, formerly chief executive of Amicus Therapeutics, becomes Travere’s CEO on December 1, 2026, succeeding Eric Dube.

Sources

Primary sources (September 24 to 27, 2026): AbbVie topline release on CERVINO (September 3, 2026); CERVINO full results as presented at the IMS 23rd Annual Meeting, Glasgow (September 25, 2026); Mirum and Incyte approval release on Atebrioz (September 25); Eli Lilly releases on Onswik and Olumiant (September 25); FDA approved drugs notice and Merck/Eisai release on Welireg plus Lenvima (September 25); Nanexa license agreement release (September 25); ADARx IPO pricing release (September 24); Earendil Labs collaboration release (September 24); Precision Neuroscience funding release (September 24); Novo Nordisk EASD curtain raiser (September 16); Kodiak Sciences media advisory (September 25); Mirum AZURE-1 call advisory (September 27); HUTCHMED trial initiation release (September 27). Exchange settled closing prices for September 25, 2026.

Trade press and corroboration: OncLive and Targeted Oncology (CERVINO and IMS coverage, September 25 to 27); BioSpace (Carvykti CARTITUDE-2, ADARx, Nektar, biomanufacturing, September 25); Fierce Biotech and Fierce Pharma (Atebrioz, Onswik, Nanexa, Earendil, Travere, Lepu suit, Lundbeck, September 25); MedTech Dive (Intuitive CE mark, Precision Neuroscience, lab payment reform, September 25); Endpoints News (Roche board, September 25).

Related coverage

• Grail’s first reaction session, Viking’s $500M raise, and the Lilly InnoCare deal (September 25)
• Galleri’s panel votes and Roche’s sefaxersen win in IgA nephropathy (September 24)
• Panel day morning: the 35% sensitivity question, Celldex, and Viking’s maintenance data (September 23)
• Grail’s briefing documents, Telix buys ITM, and Novo’s strategy day (September 22)