TScan Cut 75% of Its Staff to Go In Vivo as Novartis Signed an Up to $3.2B Alteogen Deal and uniQure Filed the First Huntington’s Gene Therapy BLA (September 3, 2026)

Last updated: September 3, 2026

TScan Therapeutics cut approximately 75% of its staff on September 2, 2026 to pivot to in vivo TCR T therapy, Novartis signed an option and license deal with Alteogen worth up to $3.2 billion for subcutaneous delivery, and uniQure submitted the first BLA for a Huntington’s disease gene therapy.

This page covers the September 2, 2026 news in detail: TScan’s reorganization and what it says about ex vivo cell therapy a day after the Novartis and BMS autoimmune CAR T pauses, Cellares’ additional cuts, the Alteogen deal terms, uniQure’s AMT-130 filing and its regulatory history, the Medicare GLP-1 bridge program uptake figures, Teva’s TEV-408 celiac data, the SEC and FDA information sharing agreement, and the day’s closes.

What did TScan Therapeutics announce on September 2, 2026?

TScan Therapeutics announced a strategic reorganization that cuts approximately 75% of its workforce, pauses enrollment in its Phase 3 ALLOHA-2 trial of TSC-101 in hematologic malignancies, and refocuses the company on in vivo engineered TCR T cell therapies for solid tumors, targeting PRAME and MAGE-A4.

Per the company’s press release, the reorganization delivers cumulative cost savings of $55.0 million through the end of 2027 and extends the cash runway into Q4 2027. The two prioritized in vivo candidates are entering IND enabling studies, with preclinical data expected in Q1 2027, a first IND filing in Q3 2027, and Phase 1 development starting in Q4 2027. Fierce Biotech reported that the seven patients already enrolled in ALLOHA-2, which dosed its first patient in June 2026, will continue to be monitored, and that CEO Gavin MacBeath cited insufficient capital for the enrollment pause.

Context: two weeks earlier, Amgen terminated its collaboration with TScan on a Crohn’s disease program, a deal that had been worth up to $500 million, with the termination effective November 10. TScan’s shift follows ArsenalBio’s pivot to in vivo CAR T announced September 1, the same day Novartis and BMS paused their autoimmune CAR T trials.

How do TScan’s cuts connect to the autoimmune CAR T safety pauses?

TScan’s announcement landed one day after Novartis paused eight autoimmune trials of rapcabtagene autoleucel following three patient deaths and BMS paused enrollment in its zola-cel autoimmune studies, per company statements reported by Fierce Biotech and BioSpace. No primary Novartis document had appeared as of the evening of September 2, and no FDA action converting the voluntary pauses into formal holds had been reported.

The reorganizations now cluster. ArsenalBio laid off a majority of staff to go in vivo, per BioSpace. TScan is exiting ex vivo development entirely, pausing a Phase 3 it started three months ago and shopping its autoimmune program for strategic partnerships. And Cellares, the automated cell therapy manufacturer, cut 68 more roles in Bridgewater, New Jersey after losing its largest pharmaceutical customer, which multiple outlets including Fierce Pharma identify as Bristol Myers Squibb, bringing its announced reductions to 168 across New Jersey and South San Francisco. Cellares had described the customer only as a large pharmaceutical company; BMS had partnered with Cellares since 2024 in a deal reported at up to $380 million.

What did Novartis agree to pay Alteogen, and for what?

Novartis entered an option and license agreement with Alteogen giving it multiple options to obtain exclusive rights to develop and commercialize subcutaneous formulations of selected Novartis products using ALT-B4 (berahyaluronidase alfa), Alteogen’s Hybrozyme hyaluronidase platform. Per Alteogen’s release, the deal is worth up to US$3,223 million if all options are exercised and all milestones are achieved.

Two things in the release are worth reading carefully. First, no upfront payment is disclosed anywhere in it. Second, the up to $3,223 million figure explicitly includes option exercise fees, development and commercial milestone payments, and royalties on net sales. Most headline deal totals in this industry exclude royalties, so this total is constructed more generously than the usual biobucks number. The release does not name which Novartis products are covered.

Novartis closed at $162.46, up 0.75%. Novartis carried multiple same day stories, including roughly 130 telegraphed job cuts in Switzerland reported by Fierce Pharma, so no cause is assigned to the move.

What did uniQure file for AMT-130 in Huntington’s disease?

uniQure submitted a biologics license application to the FDA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), its gene therapy for Huntington’s disease, and simultaneously submitted a Marketing Authorisation Application to the UK’s MHRA. It is the first license application ever filed for a Huntington’s disease gene therapy. The company requested priority review, which if granted would set a six month review clock after the FDA’s 60 day filing review.

The application rests on the three year Phase 1/2 data analysis comparing treated patients against a propensity score matched external control built from the Enroll-HD natural history database. The filing release publishes no efficacy figures; the previously announced topline from September 2025 reported 75% slowing of disease progression, a company reported figure. BioSpace notes the FDA said in November 2025 that it no longer agreed the data were adequate for filing, then reversed in June 2026 after leadership changes at the agency, and that William Blair analysts model peak sales of $3.2 billion in 2035 with a measured launch given the surgical administration. If priority review is granted, a decision would be expected around late April or early May 2027, per BioSpace.

What do the new Medicare GLP-1 bridge program numbers show?

Per statements from CMS Administrator Mehmet Oz reported September 2, 600,000 seniors signed up for the Medicare GLP-1 bridge program in its first two months. The White House separately said more than 500,000 seniors have used the program and saved $216 million on the medicines. Both are government claims and are reported here as such.

The program, effective July 1, 2026 under the most favored nation pricing agreements with Eli Lilly and Novo Nordisk, offers eligible Medicare beneficiaries weight loss drugs at $50 per month, with a net price to CMS of $245 per month. Covered drugs are Lilly’s Zepbound and oral Foundayo and Novo’s Wegovy in injectable and oral forms. KFF estimates roughly 3.8 million Part D beneficiaries are eligible; Lilly has suggested as many as 20 million could qualify. Jefferies analyst Akash Tewari estimates the program annualizes at $1.5 billion to $1.8 billion in revenue, with Lilly capturing $900 million to $1.2 billion on its roughly 60% share, per Fierce Pharma. Lilly closed flat at $1,160.08; Novo Nordisk’s ADR closed at $46.77, up 3.7%. No cause is assigned to either move.

What did Teva report for TEV-408 in celiac disease?

Teva said its anti IL-15 antibody TEV-408 met the primary endpoint of a 50 patient Phase 2a study in celiac disease, reducing gluten induced intestinal damage significantly more than placebo, with no safety signals observed, per the company’s announcement reported by Fierce Biotech. Patients received a single dose of TEV-408 or placebo and then consumed gluten daily for six weeks starting two weeks later.

No effect sizes were published. That places TEV-408 in the same disclosure pattern we have tracked all week, though at Phase 2a the stakes are smaller than for the registrational toplines in the series. Teva’s chief medical officer Eric Hughes said the results underscore the potential to address celiac disease at its biological source; the company says dose ranging analysis and a Phase 2 data review come before any Phase 3. There is no approved drug for celiac disease. Teva closed at $37.49, up 3.6%.

What does the SEC and FDA information sharing agreement do?

The SEC and FDA signed a three year memorandum of understanding, dated August 31 and announced September 2, that lets the agencies exchange non public information and coordinate investigations involving FDA regulated activities of publicly traded companies, with designated points of contact and streamlined information requests. SEC Chairman Paul S. Atkins and Acting FDA Commissioner Kyle Diamantas signed it.

Atkins said FDA related disclosures by public companies have a significant impact on markets. Former SEC enforcement counsel David Oliwenstein told Fierce Biotech the MOU signals SEC vigilance on biotech insider trading and should make investigations involving clinical trial information faster. For issuers, the practical read is that the SEC now has a faster path to the FDA’s non public record of what a company knew and when it knew it.

What else happened on September 2, 2026?

Fortrea acquired the early phase services division of Worldwide Clinical Trials for $45 million, adding a 200 bed clinical pharmacology unit, a 60,000 square foot GLP bioanalytical laboratory, and a biospecimen storage facility, all in Texas, per Fortrea’s release. Fortrea shares closed at $18.36, up 3.6%.

ARPA-H committed $125 million in aggregate to five teams under its GIVE program (Genetic Medicines and Individualized Manufacturing for Everyone) to build automated, distributed manufacturing and rapid quality control for personalized RNA based medicines, naming Centillion Biosciences, HDT Bio, Waterfall Scientific, Massachusetts General Hospital, and the University of Utah, per the agency’s announcement reported by Fierce Pharma. ARPA-H says it will work with the FDA on regulatory guidelines for the approach.

Biopharma reverse mergers jumped from one in Q2 to 17 completed or planned in Q3, a 1,600% increase, per Leerink Partners data reported by BioSpace. Year to date the count stands at 20 biotech IPOs and 19 reverse mergers. The Obsidian Therapeutics and Galera merger, which closed July 31 with a $350 million concurrent private placement, is the reference example.

Amylyx closed at $34.49, up 2.0%, a fourth consecutive close below its $35.50 offering price. The $500.2 million offering’s closing, expected on or about August 21, remained unannounced on the company’s release index as of the evening of September 2.

Which catalysts delivered on September 2, and how did sponsors close?

One tracked catalyst delivered: uniQure’s AMT-130 BLA filing, promised for Q3 2026, arrived inside its window, and QURE closed down 3.4%. That brings the running tally we have kept since Friday August 28 to one sponsor closing higher out of 13 delivered catalysts. The full week’s tally publishes Friday.

All closes are exchange closes. Market data carries no assigned cause unless a company disclosure exists.

Frequently asked questions

Why did TScan Therapeutics cut 75% of its workforce?

TScan said it is reorganizing to focus on in vivo engineered TCR T cell therapies for solid tumors and cited capital constraints for pausing Phase 3 enrollment. The cuts save $55.0 million through the end of 2027 and extend its cash runway into Q4 2027.

Is TScan abandoning TSC-101?

Enrollment in the Phase 3 ALLOHA-2 study is paused, not terminated. The seven patients already enrolled will continue to be monitored. CEO Gavin MacBeath cited insufficient capital, per Fierce Biotech.

What are PRAME and MAGE-A4?

They are cancer testis antigens expressed on solid tumors. PRAME appears in more than 90% of melanomas, and MAGE-A4 is prevalent in non small cell lung, ovarian, and head and neck cancers, per Fierce Biotech. TScan’s prioritized in vivo TCR T candidates target them.

What is in vivo cell therapy and why is everyone pivoting to it?

In vivo approaches engineer a patient’s T cells inside the body, typically with a delivered genetic payload, instead of extracting, engineering, expanding, and reinfusing cells. It removes the manufacturing step that makes ex vivo autologous therapy slow and expensive. TScan and ArsenalBio both pivoted to in vivo within days of safety pauses hitting ex vivo autoimmune CAR T programs.

Did the FDA place a clinical hold on the Novartis or BMS CAR T trials?

No formal FDA hold had been reported as of the evening of September 2, 2026. Both pauses remain voluntary company actions, and no primary Novartis document had appeared.

How much is the Novartis Alteogen deal worth?

Up to US$3,223 million per Alteogen’s release, but that figure includes option exercise fees, milestones, and royalties on net sales. No upfront payment was disclosed. The real near term cash is unknown.

What is ALT-B4?

ALT-B4, generic name berahyaluronidase alfa, is Alteogen’s engineered hyaluronidase. Co formulating it with a biologic lets an intravenous drug be given as a subcutaneous injection. Merck selected it for subcutaneous Keytruda in 2020, and AstraZeneca, Biogen, and GSK have signed ALT-B4 deals since 2025.

Is AMT-130 approved for Huntington’s disease?

No. uniQure has submitted a BLA seeking accelerated approval; the FDA must first accept the filing, then review it. If priority review is granted, a decision could come around late April or early May 2027, per BioSpace. It is the first license application for any Huntington’s gene therapy.

What data supports the AMT-130 filing?

Three year Phase 1/2 results compared with a propensity score matched external control from the Enroll-HD natural history database. The company’s September 2025 topline reported 75% slowing of disease progression; the filing release itself publishes no figures.

What is the Medicare GLP-1 bridge program?

A program effective July 1, 2026 under the administration’s most favored nation agreements with Lilly and Novo Nordisk that offers eligible Medicare beneficiaries covered weight loss drugs at $50 per month, with a net price to CMS of $245 per month. CMS says 600,000 seniors enrolled in two months, a figure from administrator statements.

Does TEV-408 mean a celiac drug is coming?

Not soon. The Phase 2a met its primary endpoint on intestinal damage after gluten challenge, but Teva published no effect sizes and says dose ranging and further Phase 2 review come before Phase 3. There is currently no approved celiac disease drug.

What does the SEC FDA memorandum of understanding change?

It gives the SEC streamlined access to non public FDA information and coordination on investigations involving public companies’ FDA regulated activities, which former enforcement counsel say is aimed squarely at insider trading around clinical and regulatory events.

Who lost Bristol Myers Squibb as a manufacturing customer?

Cellares, per reporting from Fierce Pharma and others; the company itself described the departed client only as a large pharmaceutical customer. Cellares has now announced 168 job cuts across New Jersey and South San Francisco.

Did Boston Scientific restore shipping this week?

Unconfirmed. The company’s September 1 update targeted partial restoration of shipping for some products this week; no newer public update had been found as of the evening of September 2.

Are reverse mergers replacing biotech IPOs?

They are running alongside them. Per Leerink Partners data reported by BioSpace, 2026 has produced 20 biotech IPOs and 19 reverse mergers year to date, with 17 of the reverse mergers landing in Q3 alone.

Sources

Primary sources: TScan Therapeutics press release, September 2, 2026 (strategic reorganization). Alteogen press release, September 2, 2026 (Novartis option and license agreement, PR Newswire). uniQure press release, September 2, 2026 (AMT-130 BLA and MAA submissions, GlobeNewswire). Fortrea investor release, September 2, 2026. SEC press release and MOU document, signed August 31, 2026. Amylyx release index checked the evening of September 2, 2026. Exchange closing prices, September 2, 2026.

Trade press and other reporting (September 2, 2026): Fierce Biotech (TScan, Teva TEV-408, SEC FDA MOU, Alteogen deal context). Fierce Pharma (Cellares, Medicare GLP-1 bridge program and Jefferies estimates, ARPA-H GIVE, Novartis Switzerland). BioSpace (uniQure filing context and regulatory history, reverse merger data from Leerink Partners). Government figures on bridge program uptake are CMS administrator and White House statements, attributed as such.

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