Why the FDA Rejected ITM’s Radiopharma Therapy and Stalled Scholar Rock’s SMA Filing in August 2026

Last updated: August 12, 2026

The FDA rejected ITM’s radioligand therapy ITM-11 and forced Scholar Rock to drop a fill finish site from its apitegromab filing in the same news cycle. Neither action questioned clinical data. Both turned entirely on manufacturing and facility compliance.

This page covers the ITM complete response letter, the Scholar Rock filing change and its September 30 action date, the Novo Nordisk owned Bloomington facility at the center of it, AbCellera’s ABCL635 Phase 2 menopause data, and the day’s deal and financing news.

Why did the FDA reject ITM’s radiopharma therapy ITM-11?

The FDA issued a complete response letter for ITM-11 citing chemistry, manufacturing and controls items and inspection findings at a third party commercial facility. The agency identified no clinical safety or efficacy issues and asked for no new clinical data.

ITM, the Munich based radiopharmaceutical company formally known as ITM Isotope Technologies Munich, announced the letter on August 10, 2026. ITM-11 is no carrier added lutetium-177 edotreotide, a radioligand therapy for gastroenteropancreatic neuroendocrine tumors, known as GEP-NETs. The drug delivers a beta emitting isotope to tumors by targeting somatostatin receptors on the cancer cell surface.

The clinical package was not the problem. The pivotal Phase 3 COMPETE trial met its primary endpoint, showing a clinically and statistically significant improvement in progression free survival compared with everolimus in patients with inoperable, progressive GEP-NETs. A second Phase 3, COMPOSE, is ongoing in higher grade tumors. Chief executive Dr. Andrew Cavey said the COMPETE data package stands and that the company intends to resubmit the application. ITM has not given a resubmission timeline.

What happened to Scholar Rock’s apitegromab filing?

Scholar Rock removed the Catalent Indiana fill finish facility in Bloomington, now owned by Novo Nordisk, from its apitegromab application after the FDA classified an April 2026 inspection of the site as Official Action Indicated. The review continues with a second facility, with an action date of September 30, 2026.

Apitegromab is a myostatin inhibitor for spinal muscular atrophy, designed to improve motor function on top of existing SMN targeted treatments. Scholar Rock announced the filing change on August 7, and the story moved through analyst notes and trade coverage this week as the inspection classification became public. The company says its remaining fill finish site is a US based facility with a consistent record of successful FDA and EMA inspections, and that commercial supply has already been produced and is awaiting packaging and labeling. Chief executive David L. Hallal said the company is ready to launch on approval.

The practical effect is that a drug with accepted clinical data spent months of its review cycle managing a problem that had nothing to do with the drug. The FDA can act on the application at any point up to the September 30 date.

How do the two setbacks compare?

Both companies had their science left untouched and their commercial timelines set back by facility compliance. The comparison below is the clearest way to see the pattern.

One caution on reading these together: ITM has not named the third party facility in its letter, and no disclosed connection exists between ITM’s manufacturing issue and the Bloomington plant. The pattern is regulatory, not geographic.

What is wrong with the Novo Nordisk fill finish plant in Bloomington?

The FDA classified its April 2026 inspection of the former Catalent site as Official Action Indicated, the agency’s most serious inspection outcome, meaning objectionable conditions were found and regulatory action is warranted. Applications naming an OAI facility face approval risk until the site resolves its findings.

Novo Holdings acquired Catalent in a deal completed in December 2024, with Novo Nordisk taking three fill finish sites, including Bloomington, for $11 billion. The plant fills and finishes sterile injectable products for many companies, which is exactly why its compliance status matters beyond any single application. BioSpace has reported that quality problems at the site have contributed to FDA rejections of other companies’ applications over the past two years. When one shared facility carries deficiencies, every filing that names it inherits the risk, which is how Scholar Rock ended up restructuring a filing for reasons unrelated to apitegromab itself.

Why does manufacturing keep blocking radiopharmaceutical approvals?

Radioligand therapies depend on isotope production, short half life logistics, and specialized sterile manufacturing that only a small number of facilities can perform. That concentration makes the category unusually exposed to single facility inspection outcomes, as ITM’s CRL shows.

Lutetium-177 based drugs decay continuously from the moment they are made, so commercial supply requires precisely scheduled production runs and rapid distribution. Third party manufacturing capacity that meets FDA standards is scarce, and the companies that control it have become acquisition targets. That scarcity is part of the investment logic behind Curium’s agreement to acquire Lantheus for up to approximately $8.0 billion, covered in our analysis of the radiopharma infrastructure bid, and behind the broader wave of capital moving into the infrastructure layer of drug development, including contract manufacturing for advanced therapies.

How strong is AbCellera’s ABCL635 menopause data?

In a 92 patient Phase 2 trial, a single 600 mg injection of ABCL635 cut moderate to severe hot flashes by 8.8 episodes per day at week four versus 3.5 for placebo, a placebo adjusted reduction of 5.3 episodes per day, statistically significant at p<0.001.

AbCellera Biologics announced topline results on August 10. ABCL635 is a monoclonal antibody antagonist of the neurokinin 3 receptor, the same target validated by the approved oral drugs in the class, acting on KNDy neurons in the hypothalamus that drive vasomotor symptoms. The trial was randomized, double blind, and placebo controlled, enrolling postmenopausal women who averaged roughly ten moderate or severe hot flashes per day at baseline.

Tolerability was clean over four weeks: no serious or severe adverse events and no discontinuations, with headache, fatigue, and injection site reactions the most common events. Longer follow up data from the same study are expected to show how durable a single dose is, which will determine the dosing interval for late stage development.

How does ABCL635 compare with Veozah and Lynkuet?

ABCL635 is the first antibody in a class built on oral small molecules. Astellas’ Veozah (fezolinetant) and Bayer’s Lynkuet (elinzanetant) are daily pills against the same neurokinin pathway, while ABCL635 delivered four weeks of effect from one injection in Phase 2.

BMO Capital Markets analysts wrote that the results appear differentiated versus current oral agents and put a peak sales estimate of $2.3 billion worldwide on the program, a figure AbCellera has not issued itself. The unanswered questions are durability beyond four weeks, pricing for a biologic in a symptom driven market, and how many women will prefer an infrequent injection to a daily tablet. AbCellera plans to take longer follow up data into discussions with regulators about late stage development, according to BioSpace reporting.

What are the terms of the Mereo and Sentynl alvelestat deal?

Sentynl Therapeutics took an option to license US rights to alvelestat, Mereo BioPharma’s oral neutrophil elastase inhibitor for alpha-1 antitrypsin deficiency associated lung disease, in a deal worth up to $475 million in payments plus double digit tiered royalties on US sales.

Alpha-1 antitrypsin deficiency associated lung disease affects an estimated 50,000 to 80,000 people in the United States, and alvelestat would be the first oral treatment if approved. Sentynl is the US subsidiary of India’s Zydus Lifesciences and already markets three approved rare disease therapies. For Mereo, the agreement funds a Phase 3 program the company could not comfortably finance alone.

Who raised money in biotech on August 11, 2026?

Three private rounds landed across three different stages of development: a $152 million Series B funding a Phase 3, a $90 million Series C heading into pivotal studies, and a $75 million Series A backed by a large strategic investor.

The stage distribution is worth noting against the year’s financing pattern, in which roughly two thirds of first half venture rounds went to companies already in human testing. Two of the three rounds fit that late stage tilt. The exception, Infinimmune’s Series A, carries a strategic investor rather than generalist money, a wrinkle we examine in today’s Pro brief.

Frequently asked questions

What is a complete response letter from the FDA?

A complete response letter, or CRL, is the FDA’s formal notice that it will not approve an application in its current form. It lists the deficiencies the sponsor must resolve. A CRL can rest on clinical, manufacturing, labeling, or inspection issues, and it does not necessarily question a drug’s data.

Did the FDA find problems with ITM-11’s clinical data?

No. ITM stated that the FDA identified no clinical safety or efficacy issues and requested no additional clinical or nonclinical data. The letter cited chemistry, manufacturing and controls items and inspection related matters at a third party commercial facility.

When will ITM resubmit the ITM-11 application?

ITM says it intends to resubmit the new drug application and is reviewing the FDA’s feedback with external partners to determine the path forward. The company has not announced a resubmission date.

What is n.c.a. 177Lu-edotreotide and how does it work?

It is a radioligand therapy combining no carrier added lutetium-177, a beta emitting radioisotope, with edotreotide, a molecule that binds somatostatin receptors found on gastroenteropancreatic neuroendocrine tumor cells. The construct delivers radiation directly to tumor tissue while limiting exposure elsewhere.

What does Official Action Indicated mean in an FDA inspection?

Official Action Indicated is the most serious of the FDA’s three inspection classifications. It means investigators found objectionable conditions significant enough that regulatory or administrative action is recommended. Facilities under OAI status can hold up approval of applications that rely on them.

Is apitegromab still on track for approval in 2026?

The FDA’s action date is September 30, 2026, and Scholar Rock says the agency can act at any time up to that date. The review is proceeding with the company’s second fill finish facility, which has a consistent record of successful FDA and EMA inspections.

What is apitegromab and how does it treat spinal muscular atrophy?

Apitegromab is a monoclonal antibody that inhibits myostatin, a natural brake on muscle growth. In spinal muscular atrophy it is designed to improve motor function when added to SMN targeted therapies, addressing muscle weakness that those treatments do not fully resolve.

Why does Novo Nordisk own the former Catalent plant in Bloomington?

Novo Holdings, the parent of Novo Nordisk, completed its acquisition of contract manufacturer Catalent in December 2024. Novo Nordisk took ownership of three fill finish facilities from the transaction for $11 billion, largely to expand sterile injectable capacity for its own products. The Bloomington site continues to serve outside customers.

Are ITM’s manufacturing problems and the Bloomington plant related?

No connection has been disclosed. ITM has not named the third party facility cited in its letter, and nothing in either company’s statements links the two situations. They are separate cases that happen to show the same category of risk.

What is ABCL635 and how is it different from Veozah and Lynkuet?

ABCL635 is a monoclonal antibody that blocks the neurokinin 3 receptor to reduce menopausal hot flashes. Veozah and Lynkuet are daily oral small molecules against the same pathway. ABCL635 showed four weeks of effect from a single injection in Phase 2, which could translate into infrequent dosing.

How effective was ABCL635 in its Phase 2 trial?

At week four, a single 600 mg dose reduced moderate to severe hot flash frequency by 8.8 episodes per day versus 3.5 for placebo, and severity by 58 percent from baseline versus 12 percent for placebo. Both differences were statistically significant at p<0.001.

Is ABCL635 approved?

No. ABCL635 is investigational and has completed a Phase 2 trial. AbCellera is gathering longer follow up data and plans to discuss late stage development with regulators. Any approval would follow successful Phase 3 trials.

What is alvelestat and what does Sentynl get in the deal?

Alvelestat is an oral neutrophil elastase inhibitor for lung disease caused by alpha-1 antitrypsin deficiency, a genetic disorder that destroys lung tissue. Sentynl, a Zydus Lifesciences subsidiary, gains an option on exclusive US commercialization rights plus global manufacturing rights, while Mereo runs the global Phase 3 program.

What is hereditary hemorrhagic telangiectasia, the disease Vaderis is targeting?

Hereditary hemorrhagic telangiectasia, or HHT, is a rare genetic disorder of blood vessel formation causing recurrent nosebleeds, malformed vessels, and bleeding complications. It has no approved disease modifying therapy. Vaderis’ engasertib, an AKT inhibitor, enters Phase 3 with its new financing.

What do these manufacturing setbacks mean for biotech investors?

They show that approval risk does not end with positive Phase 3 data. Facility compliance, especially at shared third party sites, can delay or derail applications on its own. Diligence on where a company’s drug is filled and finished, and on that site’s inspection history, now belongs in any late stage investment case.

Sources

Primary sources

• ITM press release, August 10, 2026: ITM Receives Complete Response Letter for 177Lu-edotreotide (ITM-11)
• Scholar Rock press release, August 7, 2026: FDA Review of Apitegromab BLA to Progress with Second Fill Finish Facility; Approval Decision Anticipated by September 30, 2026 Action Date
• AbCellera Biologics press release, August 10, 2026: Positive Top Line Phase 2 Clinical Trial Results for ABCL635
• Mereo BioPharma and Sentynl Therapeutics joint press release, August 11, 2026: Option and License Agreement for alvelestat in AATD associated lung disease
• Vaderis Therapeutics press release, August 11, 2026: Oversubscribed $152 Million Series B Financing and Initiation of the Global Phase 3 HEROIC Study
• Epicrispr Biotechnologies press release, August 10, 2026: $90 Million Oversubscribed Series C Financing
• Infinimmune press release, August 11, 2026: $75 Million Series A Financing

Trade press and analyst coverage, August 11, 2026

• BioSpace: FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues; Scholar Rock rejigs approval filing after FDA flags violations at Novo plant; AbCellera’s menopause medicine sets new efficacy bar
• Fierce Biotech: Zydus’ Sentynl pens $475M deal for Mereo’s rare lung disease drug; Regeneron backs $75M series A for Infinimmune; Vaderis lands $152M
• BMO Capital Markets analyst commentary via BioSpace
• Endpoints News: AbbVie, Novartis and Bristol Myers Squibb file 340B lawsuits in Illinois

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