Amgen Named No Readout Dates at Morgan Stanley as the FDA Approved the First Lutathera Equivalent and Sanofi Handed 20 Medicines to Cheplapharm (September 16, 2026)

Last updated: September 16, 2026

Amgen presented at the Morgan Stanley Global Healthcare Conference on September 15 without naming an OCEAN(a) readout window or a congress for DeLLphi-305, while the FDA approved Curium’s Bexlutry as the first radioligand equivalent to Lutathera and Sanofi agreed to transfer 20 mature medicines and three plants to Cheplapharm.

This page covers the September 15, 2026 news cycle: what Amgen said and did not say at Morgan Stanley, the first radioligand equivalent approval, the Sanofi and Cheplapharm transaction, Novo Nordisk’s exit from its Ascendis collaboration, Scholar Rock’s Isembyld pricing disclosures, and the day two reversals across Monday’s readout winners.

What did Amgen actually say at Morgan Stanley about olpasiran and tarlatamab?

Based on the only session transcript available Tuesday night, Amgen described olpasiran as progressing in Phase 3 without naming a readout window, and discussed tarlatamab’s commercial performance and older maintenance data without naming a congress or date for the DeLLphi-305 full dataset.

Amgen’s fireside chat at the Morgan Stanley Global Healthcare Conference ran Tuesday at 11:30 am ET, with chief financial officer Peter Griffith and senior vice president of global marketing Kaveh Niksefat speaking. We assessed the session through the transcript summary published by Investing.com, which as of Tuesday night was the only account of the session we could locate. That transcript contains machine transcription artifacts, including a garbled rendering of olpasiran’s name, so we treat its specific figures as unusable and grade only on what topics the summary shows were and were not addressed.

On olpasiran and the OCEAN(a) Outcomes cardiovascular trial, the transcript shows Niksefat describing the molecule’s known profile, its quarterly dosing, and the unmet need in elevated Lp(a). Asked about the readacross from Novartis’ failed pelacarsen trial, he said, per the transcript, that Amgen would “add it to the body of evidence on Lp(a)” but would probably not make determinations based on the Novartis result. What does not appear anywhere in the summary is a readout window, an event count update, or any forward looking specificity about when OCEAN(a) Outcomes delivers.

On tarlatamab, the transcript shows the discussion centering on commercial trajectory and on DeLLphi-303, the Phase 1b study of tarlatamab as first line maintenance in extensive stage small cell lung cancer whose survival data circulated at congresses in 2025. DeLLphi-305, the Phase 3 first line trial Amgen announced as positive in early September with all figures withheld, received no congress name and no presentation date in the summary. The full dataset remained unpresented through the World Conference on Lung Cancer, which closed September 15 in Seoul.

Scope statement: this assessment reflects the Investing.com transcript summary reviewed Tuesday night, September 15, US time. If Amgen’s own materials or a fuller transcript surface with a named window for either program, the grade changes, and we will say so.

How did the market respond to Amgen’s session?

Amgen closed Tuesday at $375.65, down 1.5 percent, resuming the slide that had stopped the day before the conference. Royalty Pharma, the flagged beneficiary if Amgen had anchored its Lp(a) program with specifics, closed down 1.0 percent. Exchange closes only; no cause is assigned to either move.

The context makes the juxtaposition notable. Amgen’s four session slide had snapped on Monday, the day before its scheduled appearance. The appearance came and went without the specificity that we argued last week separates anchored programs from discounted ones, and the stock resumed its decline the same session. AstraZeneca, which printed a failed trial and an adverse interim survival number at the same congress where Amgen presented nothing, rose 2.3 percent on Monday. The market’s message across the two sponsors is consistent: disclosure is being priced as an asset, and silence as a liability.

What is Bexlutry, and why does the first radioligand equivalent matter?

Bexlutry is Curium’s lutetium Lu 177 dotatate injection, approved by the FDA through the 505(b)(2) pathway referencing Novartis’ Lutathera. Curium calls it the first radioligand equivalent for gastroenteropancreatic neuroendocrine tumors. It is available immediately, per the company’s September 14 release.

Curium announced the approval at 5:49 pm ET on September 14. The label covers somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut tumors, in adults, matching the population Lutathera has treated since 2018. Curium chief executive Renaud Dehareng called the approval “a defining milestone” as the company expands from diagnostics into oncology therapeutics, and the release leans on Curium’s position as what it describes as the only vertically integrated lutetium based neuroendocrine tumor therapy manufacturer.

The strategic significance is larger than one product. Radiopharmaceuticals have been treated as a moat business: complex isotope supply chains, short half lives, and manufacturing logistics were assumed to protect branded franchises from generic style competition long after patent expiry. A 505(b)(2) equivalent reaching the market against the category’s flagship therapy tests that assumption directly. Pricing pressure on Lutathera is now a live question, and every radiopharma business case built on durable post patent economics, including the acquisition math behind the sector’s infrastructure deals, has a new variable. Curium did not disclose Bexlutry pricing in the release.

What are the terms of the Sanofi and Cheplapharm transaction?

Sanofi will transfer 20 mature medicines, including Lovenox outside the United States, plus manufacturing sites in Hungary, Singapore, and France to Cheplapharm. In exchange Sanofi receives a 26.4 percent equity stake in Cheplapharm. Transfers begin in the first quarter of 2027.

The September 14 announcement is structured as a partnership rather than a cash sale: Sanofi’s consideration is the 26.4 percent stake, with further financial details promised later and no purchase price disclosed. The three sites are Csanyikvölgy in Hungary with roughly 400 employees, Jurong in Singapore with roughly 100, and Ploërmel in France with roughly 65, and Sanofi says existing employment arrangements carry over. Commercial transfer of the medicines starts in the first quarter of 2027, with completion targeted by the third quarter of 2027. Sanofi says the deal does not change its 2026 financial guidance.

The transaction extends a pattern we have tracked all quarter: large pharma is shedding mature tails to concentrate capital on launches and late stage pipelines, and specialist consolidators keep absorbing them. Taking equity in the consolidator rather than cash is the notable wrinkle, since it keeps Sanofi exposed to the economics of its own divested tail.

Why is Novo Nordisk walking away from the Ascendis monthly GLP-1 collaboration?

Ascendis announced September 14 that its collaboration with Novo Nordisk is terminating, with all rights in metabolic and cardiovascular diseases, including the once monthly TransCon semaglutide program, reverting to Ascendis. Neither company retains financial obligations to the other. Neither company detailed its reasons in the release.

The collaboration was signed November 4, 2024, and carried no upfront payment: Ascendis was eligible for up to $285 million in development and regulatory milestones on the lead program, a once monthly GLP-1 receptor agonist targeting obesity and type 2 diabetes, plus up to $77.5 million per additional candidate, with royalties on top. The structure means Novo’s exit costs it little in sunk cash and costs Ascendis a partner rather than a payment stream it had already banked.

Ascendis chief executive Jan Mikkelsen said the company now plans to initiate multiple new cardiovascular and metabolic programs, including obesity, on its own. For Novo, the exit removes an external monthly GLP-1 option in the same month the company rebranded its operating identity and continued pruning its cardiovascular outcomes footprint. Novo’s American depositary receipts closed at $42.53, down 2.1 percent, with no cause assigned. For the obesity dosing convenience race more broadly, a monthly semaglutide asset is now in the hands of a small company that must fund it, partner it again, or sell it.

What did Scholar Rock say Isembyld will cost?

Scholar Rock executives disclosed Isembyld pricing on a Monday investor call, resolving the disclosure gap we flagged at approval. Reporting on the numbers conflicts: BioPharma Dive reports an annual list price of about $310,000, while Citeline’s Scrip reports a wholesale acquisition cost above $450,000 with $310,000 as the net figure.

Because Scholar Rock has published no pricing document, and the two trade accounts characterize the same $310,000 figure differently, we print both attributions and neither as settled fact. BioPharma Dive’s account is that executives put the annual list price at about $310,000, varying with patient weight and coverage. Scrip’s account is that the wholesale acquisition cost exceeds $450,000 per year and that $310,000 is the expected net cost after discounts. Both accounts agree the disclosure came from company executives on Monday’s call. We checked for a primary source Tuesday night, September 15, and found none.

Either characterization lands in the same commercial frame: Isembyld stacks on top of six figure SMN2 targeted therapies rather than replacing them, so the payer conversation is about incremental cost on an already expensive disease. The pricing disclosure is the first data point for the payer friction question that will decide the launch curve. Scholar Rock closed at $50.00, down 3.6 percent in the second session after the Friday evening approval, no cause assigned.

What happened to Monday’s readout winners on Tuesday?

Every notable Monday gainer or readout sponsor gave ground Tuesday: Definium fell 8.5 percent, Corbus 14.4 percent, and Ionis 8.2 percent, all with no cause assigned, while Sionna fell 16.7 percent on disclosed restructuring news. Beta Bionics, trading on a fresh FDA clearance, rose 14.9 percent.

The moves, exchange closes only: Definium closed at $36.82, down 8.5 percent one day after its third pivotal psychedelic win. Corbus closed at $6.92, down 14.4 percent; Monday’s session had closed flat on roughly four times normal volume after the CANYON-1 data, and Tuesday resolved that churn downward. Ionis closed at $47.25, down 8.2 percent after Monday’s $51.44, a two session slide with no company disclosure we could locate Tuesday night. Cullinan, whose zipalertinib win was pre run before WCLC, edged up 0.7 percent to $20.54. We do not assign causes to moves without company disclosures; the pattern itself, Monday readout strength bleeding into Tuesday weakness across unrelated names, is the observation.

What is Sionna’s plan after cutting 46 percent of its staff?

Sionna Therapeutics announced September 14 that it is reducing its workforce by 46 percent and advancing a dual combination of SION-451 and SION-2222 toward a Phase 2a proof of concept trial expected to start in the first quarter of 2027.

The restructuring follows August’s failure of SION-719, which we covered when it happened. The company’s case for a second attempt rests on post hoc analyses of the PreciSION CF subset showing a mean placebo adjusted sweat chloride reduction of up to 8.6 mmol/L, which Sionna reads as evidence of NBD1 biological activity. Post hoc subgroup signals after a failed primary are hypothesis generating, not confirmatory; the Phase 2a is the test. Shares closed Tuesday at $6.88, down 16.7 percent. Background on the original failure is in our August coverage of the SION-719 miss and what it meant for Vertex.

What else moved on September 15?

A Contineum depression miss, a new FDA Phase 1 acceleration pilot, two medtech items, and a BioMarin pipeline cut rounded out the day.

Contineum and J&J missed in depression. JNJ-5120, also called PIPE-307, a selective inhibitor of the M1 receptor, missed the primary endpoint of the MOONLIGHT-1 Phase 2 trial in major depressive disorder, change in MADRS score at day 5 versus placebo, per Contineum’s September 14 release. The drug was well tolerated with no new safety signals, and Johnson & Johnson is analyzing prespecified exploratory endpoints to inform next steps. Contineum closed down 6.8 percent at $13.82.

The FDA opened an Expedited IND Pilot. The agency announced September 15 that it is accepting applications for a pilot pairing sponsors with qualified research institutions such as CROs, academic medical centers, and regulatory advisors. Per Fierce Biotech’s account, roughly eight to ten sponsor and institution pairs will be selected, applications are due October 30, and the goal is cutting Phase 1 timelines by six to twelve months to compete with startup speeds in China and Australia. The program sits under Operation Trial Blazer, announced in June.

Beta Bionics got its patch pump cleared. The FDA cleared Mint, Beta Bionics’ patch pump, alongside the company’s unveiling of its 3D Intelligence dosing algorithm, per the company’s September 14 release. Shares rose 14.9 percent to $19.23 in the first session after the announcement.

J&J’s Laminar device found a new home. Jaguar, a newly formed company backed by members of the original Laminar management team and Santé Ventures, acquired the Laminar catheter based left atrial appendage closure assets from Johnson & Johnson, per Fierce Biotech, which notes J&J had bought Laminar for $400 million in 2023. Terms were not disclosed.

BioMarin shelved Voxzogo in Noonan syndrome. Fierce Pharma reported September 15 that BioMarin is dropping Voxzogo development for Noonan syndrome, citing competitive pressure; we found no company release Tuesday night. The hypochondroplasia filing program, backed by the positive Phase 3 BioMarin reported September 9, is a separate track. BioMarin closed down 3.0 percent at $64.45.

What catalysts are live this week?

Three forced disclosure clocks run through Friday: Amylyx’s offering close must surface around Thursday as the greenshoe window ends, Ultragenyx’s UX111 PDUFA lands Friday September 19, and Grail’s advisory committee briefing documents are expected around September 21 ahead of the September 23 panel.

On Amylyx: the company presented at Morgan Stanley Tuesday, and the August offering’s closing remained unannounced as of Tuesday night; shares closed at $33.15, a twelfth consecutive close below the $35.50 offering price. On Grail: as of Tuesday night the FDA meeting page for the September 23 Molecular and Clinical Genetics Panel carried only conflict of interest waiver documents, no briefing books. On Ultragenyx: shares closed down 4.0 percent at $13.07 ahead of Friday’s decision, no cause assigned. Still open elsewhere: AstraZeneca has not disclosed SERENA-4 medians or hazard ratios, Etcamah’s launch price remains unpublished twelve days after approval, Exelixis has issued no primary document on zanzalintinib’s reported March 3, 2027 action date, GSK’s mRNA flu Phase 3 start announcement has not appeared, and Electra’s IPO had not priced.

Frequently asked questions

Did Amgen give a date for the OCEAN(a) Outcomes readout at Morgan Stanley?

No. Per the Investing.com transcript summary of the September 15 session, the only account available Tuesday night, Amgen described olpasiran as progressing in Phase 3 without naming a readout window or timeline for OCEAN(a) Outcomes.

Did Amgen say when DeLLphi-305 data will be presented?

No. The transcript summary shows no congress name or presentation date for DeLLphi-305, whose topline Amgen announced as positive in early September with figures withheld. The dataset also went unpresented through WCLC, which closed September 15 in Seoul.

What is Bexlutry and how is it different from Lutathera?

Bexlutry is Curium’s lutetium Lu 177 dotatate injection, approved via the 505(b)(2) pathway referencing Novartis’ Lutathera for SSTR positive gastroenteropancreatic neuroendocrine tumors in adults. It is the same active radiotherapeutic agent supplied by Curium; the company calls it the first radioligand equivalent.

What does a 505(b)(2) approval mean?

A 505(b)(2) application relies in part on data the applicant did not generate, such as the FDA’s prior findings for a reference product, rather than repeating a full standalone development program. It is a common route for follow on versions of approved drugs that are not exact generics.

How much does Isembyld cost per year?

Scholar Rock executives disclosed pricing on a September 14 investor call, but published accounts conflict: BioPharma Dive reports an annual list price of about $310,000, while Citeline’s Scrip reports a wholesale acquisition cost above $450,000 with about $310,000 as the expected net cost. No company pricing document existed as of September 15.

How many medicines is Sanofi transferring to Cheplapharm?

Twenty mature medicines, including Lovenox/Clexane outside the United States, plus three manufacturing sites in Hungary, Singapore, and France. Sanofi receives a 26.4 percent equity stake in Cheplapharm, with transfers beginning in the first quarter of 2027.

What happens to the once monthly semaglutide program after Novo’s exit?

All metabolic and cardiovascular rights under the collaboration, including the once monthly TransCon semaglutide program, revert to Ascendis, which says it plans to pursue obesity and cardiometabolic programs itself. Neither company owes the other further payments.

How much was the Novo and Ascendis deal worth?

The November 2024 agreement carried no upfront payment. Ascendis was eligible for up to $285 million in development and regulatory milestones on the lead once monthly GLP-1 program, plus up to $77.5 million per additional candidate, with sales milestones and royalties.

Why did Sionna cut 46 percent of its staff?

The company is conserving capital after SION-719 failed its midstage trial in August. It is advancing a dual combination of SION-451 and SION-2222 into a Phase 2a proof of concept trial expected to begin in the first quarter of 2027.

What is the FDA’s Expedited IND Pilot?

A program announced September 15 under Operation Trial Blazer that pairs drug sponsors with qualified research institutions to speed Phase 1 trial startup. Per Fierce Biotech, roughly eight to ten pairs will be selected, applications close October 30, and the goal is cutting Phase 1 timelines by six to twelve months.

Is the Ultragenyx UX111 decision still expected Friday?

Yes. The PDUFA date for UX111, Ultragenyx’s gene therapy for Sanfilippo syndrome type A, is Friday September 19. It is the next test of an FDA review queue that just delivered Scholar Rock’s approval 19 days early.

When does the Grail advisory committee meet, and where are the briefing documents?

The Molecular and Clinical Genetics Panel meets September 23 on Grail’s Galleri premarket approval application. As of Tuesday night September 15, the FDA meeting page carried only conflict of interest waivers; briefing documents are expected around September 21.

Did the Amylyx offering ever close?

No announcement had appeared as of Tuesday night September 15. Shares closed at $33.15, a twelfth consecutive close below the $35.50 August offering price. The underwriters’ option window forces disclosure around September 18.

What did the Contineum depression trial miss?

MOONLIGHT-1, a Phase 2 proof of concept trial of JNJ-5120/PIPE-307 in major depressive disorder, missed its primary endpoint of MADRS improvement at day 5 versus placebo. The drug was well tolerated, and J&J is analyzing exploratory endpoints before deciding next steps.

Sources

Primary sources (September 14 to 15, 2026): Curium press release on Bexlutry approval (GlobeNewswire, September 14); Sanofi press release on the Cheplapharm partnership (September 14); Ascendis Pharma press release on TransCon rights reversion (GlobeNewswire, September 14) and Ascendis November 4, 2024 collaboration announcement; Sionna Therapeutics September 14 release; Contineum Therapeutics September 14 release on MOONLIGHT-1; Beta Bionics September 14 release on Mint clearance; FDA press announcement on the Expedited IND Pilot (September 15); FDA advisory committee meeting page for the September 23 Molecular and Clinical Genetics Panel; Amgen November 2025 release on Imdelltra full approval (for regulatory status context).

Trade and market coverage (attributed where used): Investing.com transcript summary of Amgen’s Morgan Stanley session (September 15); BioPharma Dive and Citeline Scrip on Isembyld pricing; Fierce Biotech on the Novo and Ascendis exit, the FDA pilot, and the Jaguar and J&J transaction; Fierce Pharma on BioMarin’s Noonan syndrome decision; Endpoints News on Sionna. Market data are exchange closes for September 15, 2026; no cause is assigned to any move without a company disclosure.

Related coverage

• Scholar Rock’s Isembyld won FDA approval 19 days early as Enhertu stretched first line PFS to 14.3 months (September 15, 2026)
• AstraZeneca’s Etcamah missed its first line trial eight days after FDA approval (September 14, 2026)
• Sionna’s cystic fibrosis trial failure: what happened and what it means for Vertex
• Replimune’s Tudriqev approval and the $8 billion radiopharma infrastructure bid
• Definium’s LSD pill beat placebo by 5.4 points in Phase 3 anxiety: the Voyage data
• Retatrutide vs CagriSema: why 2026 is the year of the triple agonist