Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

Rhea-AI Summary

Alpha Tau (NASDAQ: DRTS) submitted the first module of a PMA application to the FDA on Jan 5, 2026, using a modular submission approach allowed by the FDA to enable ongoing review and feedback.

The submitted module focuses on non-clinical study documentation for Alpha DaRT® to treat recurrent cutaneous squamous cell carcinoma (cSCC) in patients not eligible for surgery or standard radiation.

Alpha Tau is running the multi-center pivotal ReSTART study, expects to complete patient recruitment in Q1 2026, and holds Breakthrough Device Designation for recurrent cSCC, recurrent GBM, and recurrent oral cavity SCC.

Positive

• First PMA module submitted to FDA on Jan 5, 2026
• FDA-approved modular PMA approach enables ongoing review
• Breakthrough Device Designation for cSCC, GBM, oral cavity SCC
• ReSTART pivotal study recruitment expected to finish Q1 2026

Negative

• Submitted module covers non-clinical data only, not clinical outcomes
• PMA submission is a regulatory milestone, not an approval

News Market Reaction

+8.07%

11 alerts

+8.07% News Effect

+6.4% Peak in 23 hr 27 min

+$37M Valuation Impact

$499M Market Cap

1.1x Rel. Volume

On the day this news was published, DRTS gained 8.07%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.4% during that session. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $37M to the company's valuation, bringing the market cap to $499M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

ReSTART recruitment target date: Q1 2026 U.S. clinical trials: 5 trials First PMA module: 1 module submitted

3 metrics

ReSTART recruitment target date Q1 2026 Expected completion of patient recruitment in pivotal ReSTART study

U.S. clinical trials 5 trials Number of Alpha DaRT clinical trials currently approved in the U.S.

First PMA module 1 module submitted Initial non-clinical documentation module for Alpha DaRT PMA to FDA

Market Reality Check

Price: $7.24 Vol: Volume 183,437 vs 294,101...

low vol

$7.24 Last Close

Volume Volume 183,437 vs 294,101 20-day average, indicating subdued trading interest pre-announcement. low

Technical Price $4.83 is trading above the $3.45 200-day moving average, reflecting a prior uptrend.

Peers on Argus

Biotech peers show mixed weakness, with several down (e.g., ALDX -8.79%, AUTL -8...

Biotech peers show mixed weakness, with several down (e.g., ALDX -8.79%, AUTL -8.33%) and one modest gainer (IMRX +0.30%), suggesting stock-specific factors rather than a uniform sector move.

Historical Context

5 past events · Latest: Dec 18 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 18	Conference participation	Neutral	+4.2%	J.P. Morgan 2026 Healthcare Conference corporate overview announcement.
Dec 09	Clinical trial update	Positive	+8.7%	First patient treated in U.S. recurrent GBM Alpha DaRT pilot study.
Dec 04	Scientific presentations	Positive	+4.6%	Two pancreatic cancer Alpha DaRT abstracts accepted for ASCO GI 2026.
Dec 02	Regulatory clearance	Positive	+2.4%	FDA IDE approval for pilot study in locally recurrent prostate cancer.
Dec 01	Investor outreach	Neutral	-4.8%	Participation in December 2025 investor conferences and 1x1 meetings.

Pattern Detected

Recent news with clinical or strategic progress has often coincided with positive next-day price moves, while investor-relations-only updates have shown at least one negative divergence.

Recent Company History

Over the last month, Alpha Tau has reported several development milestones, including FDA IDE approval for a recurrent prostate cancer study on Dec 2, 2025 and first-patient treatment in a recurrent GBM trial on Dec 9, 2025. Additional updates highlighted pancreatic cancer data presentations and investor conference participation. Against this backdrop, today’s first PMA module submission to the FDA represents a further regulatory step, extending the pattern of advancing Alpha DaRT across multiple tumor indications.

Market Pulse Summary

The stock moved +8.1% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +8.1% in the session following this news. A strong positive reaction aligns with the company’s pattern of favorable moves following clinical and regulatory milestones. The first PMA module submission adds to recent IDE approvals and trial initiations, reinforcing a trajectory of pipeline advancement. Investors would have weighed this against typical biotech risks, such as regulatory review outcomes and future financing needs, when assessing how sustainable any sharp upside might be.

Key Terms

pre-market approval, pma, u.s. food and drug administration, fda, +3 more

7 terms

pre-market approval regulatory

"announced the submission of the first module of its pre-market approval (PMA) application"

Official government authorization required before a regulated product can be legally sold to the public; commonly used for high-risk medical devices and certain drugs where regulators review safety and effectiveness. It matters to investors because obtaining or failing to obtain this clearance determines whether a product can start earning revenue, affects company value and timelines, and often prompts significant stock moves—like needing a building permit before opening a shop.

pma regulatory

"first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration"

PMA stands for Premarket Approval, the U.S. Food and Drug Administration’s highest-level review for high-risk medical devices. It’s a thorough evaluation to confirm a device is safe and effective before it can be sold, like a final safety inspection and license to operate. Investors care because receiving PMA can open a significant revenue stream, while delays or rejection can postpone sales and reduce a company’s value.

u.s. food and drug administration regulatory

"pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"decision by the FDA to allow us to submit our PMA in a modular form"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

pivotal study medical

"module submitted in parallel to execution of ReSTART pivotal study"

A pivotal study is a large, definitive clinical trial designed to show whether a medical product works and is safe enough for regulators to approve and for doctors to use. Think of it as the final exam that determines whether a drug or device moves from testing into the market; its results can dramatically change a company’s approval chances, future sales prospects, and therefore its stock value.

breakthrough device designation regulatory

"Alpha Tau has received Breakthrough Device Designation from the FDA in this indication"

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

total product life cycle advisory program regulatory

"also part of the FDA Total Product Life Cycle Advisory Program (TAP)"

A total product life cycle advisory program is a structured service that guides a product through every stage from initial design and regulatory approval to manufacturing, market launch, and ongoing safety monitoring. For investors it matters because continuous expert oversight can reduce costly regulatory surprises, speed time to market and help maintain sales over time — like having an experienced coach manage a product’s career so it stays compliant and competitive.

AI-generated analysis. Not financial advice.

- Initial module submission marks an important milestone in the pre-market approval process - 

- Flexible modular submission framework granted to Alpha Tau by the FDA allows for streamlined review and feedback from the FDA as each module is submitted -

- Module submitted in parallel to execution of ReSTART pivotal study (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), which is expected to complete recruiting patients in Q1 2026 -

JERUSALEM, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT^® today announced the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA’s previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. This module is focused on comprehensive documentation with respect to non-clinical studies as required under the PMA application.

Uzi Sofer, CEO of Alpha Tau, stated, “Alpha Tau continues its fast pace of activity, charging forward in our pursuit of potential marketing authorizations across a wide range of tumors, with an eye toward future commercialization. The decision by the FDA to allow us to submit our PMA in a modular form will hopefully allow for ongoing FDA review and feedback as each module is submitted, and we look forward to this dynamic and efficient authorization review process with the FDA.”

Yaniv Sagie, VP Quality and Regulatory Affairs, added, "Thank you to our outstanding team for this great accomplishment, our first PMA module submission, and for all of the other achievements working with regulators around the world. I appreciate the support of our advisors who work closely with us and hope to accomplish great things for Alpha Tau together."

Alpha Tau is currently conducting its multi-center pivotal ReSTART study exploring the use of Alpha DaRT in recurrent cSCC, one of five clinical trials currently approved in the U.S., and anticipates completing patient recruitment in Q1 2026. Alpha Tau has received Breakthrough Device Designation from the FDA in this indication as well as for recurrent glioblastoma multiforme (GBM) and recurrent squamous cell carcinoma of the oral cavity with similar criteria, and is also part of the FDA Total Product Life Cycle Advisory Program (TAP) to accelerate market access for the potential treatment of recurrent GBM.

About Alpha Tau Medical Ltd. 

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

About Alpha DaRT^®

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “being,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, including with respect to the ReSTART study, patient recruitment, FDA review and approval process, commercialization and market access are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March 12, 2025, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release.

Investor Relations Contact: 

IR@alphatau.com

FAQ

What did Alpha Tau announce about its PMA submission on Jan 5, 2026 for DRTS?

Alpha Tau submitted the first PMA module to the FDA for Alpha DaRT in recurrent cSCC on Jan 5, 2026.

What does the FDA modular PMA approach mean for Alpha Tau (DRTS)?

The modular approach allows ongoing FDA review and feedback as each PMA module is submitted.

Which PMA module did Alpha Tau submit for DRTS and what does it cover?

The submitted module focuses on comprehensive non-clinical study documentation required under the PMA.

When will Alpha Tau complete recruitment for the ReSTART pivotal study for DRTS?

Alpha Tau expects to complete patient recruitment for ReSTART in Q1 2026.

Does Alpha Tau (DRTS) have any FDA designations for Alpha DaRT?

Yes; Alpha Tau has Breakthrough Device Designation for recurrent cSCC, recurrent GBM, and recurrent oral cavity SCC.