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Biotech catalyst, news and analysis PDUFA tracker

Merlintrader Trading Pub
Biotech catalyst, news and analysis PDUFA tracker
AI transparency: articles and reports are produced with the help of artificial intelligence and checked through a process that does not constitute specialist validation. They may contain errors: verify relevant information with independent sources. Read the full disclaimer.
Oct 29, 2026, 12:21 PM ET
Alpha Tau announced its ordinary shares will be included in the TA-90 and TA-125 indices of the Tel Aviv Stock Exchange, effective Nov. 5, 2026.
Nasdaq: $DRTSAlpha DaRT · clinical developmentREGAIN · ReSTART · IMPACTSmall-cohort and financing risk
DRTS Stock Hub: Alpha Tau Medical News, REGAIN and ReSTART
Alpha Tau is developing Alpha DaRT across several cancer programs. New REGAIN data are scheduled for SNO on November 13, 2026, while ReSTART topline remains in a late-2026 or early-2027 company window and initial IMPACT data are targeted for early 2027. June cash and short-term deposits totaled $100.639 million, excluding restricted deposits. Low reported first-half operating cash use benefited from the Tolmar transaction and does not establish recurring cash generation.
Research Library
The complete DRTS research report
23 pages · Research as of October 26, 2026 · Dated snapshot
Scheduled clinical presentation · company announcement
REGAIN at SNO · November 13, 2026
The company schedules new recurrent brain-tumor trial data for 7:30–9:30 p.m. ET in Philadelphia. The expanded protocol and a separately planned interim analysis do not establish a marketing approval. October 19 announcement →
Before that: ordinary shares enter the TASE TA-90 and TA-125 indices on November 5, 2026, according to the October 29 announcement. This is a market-structure event, separate from clinical progress.
DRTS daily chart
DRTS stock: dated key data
Closing price
$13.16
Nasdaq · October 23, 2026.
Calculated market value
~$1.217B
October 23 close × 92,478,154 shares in the August 10 disclosure; later changes excluded.
Cash and deposits
$100.639M
June 30, 2026; cash and short-term deposits, excluding $4.133M restricted deposits.
H1 operating cash use
$0.745M
Six months ended June 30, 2026; includes the Tolmar deferred-revenue effect.
Illustrative adjustment
$3.271M/mo
(Reported $0.745M outflow + $18.878M deferred-revenue support) ÷ 6. Calculation, not normalized burn or company guidance.
Bank borrowing
$6.804M
June 30, 2026; principal due January 2028.
Ordinary shares
92.478M
92,478,154 in the August 10, 2026 disclosure.
Short interest
3.447M
September 30, 2026 settlement; 3,447,381 shares and 6.63 days to cover.
Financial data: June 30 accounts; shares: August 10 dual-listing disclosure; dated market observations: Nasdaq historical prices and short interest. Adjusting one cash-flow component does not create a comprehensive recurring-burn estimate.
Where Alpha Tau stands now
Larger datasets are the next test of early Alpha DaRT observations. The May glioblastoma report concerned three U.S. patients and the head-and-neck combination report nine response-evaluable patients. Those signals support further investigation, not conclusions for broad populations. The October protocol expansion allows additional REGAIN patients and follow-up.
Main risk: Small clinical cohorts, uncertain durability and non-recurring funding effects require context. FDA permission to expand an investigational study is distinct from commercial authorization; an MOU for another study is distinct from an initiated trial.
Constructive case
Durable responses in the larger skin-cancer study, supportive pancreatic results and additional brain-tumor evidence could improve the development case. A successful Tolmar supply and commercialization relationship could demonstrate a practical partner model.
Cautious case
Weaker durability, toxicity in larger groups or delayed readouts could undermine the early signal before meaningful recurring revenue appears. Development and manufacturing obligations, warrants and future financing can affect per-share outcomes.
DRTS stock news: six latest updates
Oct 29, 2026
TA-90 and TA-125 inclusion effective November 5
The company announced inclusion of its ordinary shares in the TASE indices from November 5. Expected index-fund purchases and liquidity benefits are company expectations, not confirmed trading outcomes. Index membership is separate from clinical or regulatory progress.
Oct 22, 2026
Samsung Medical Center MOU for a potential Korean study
The parties signed an MOU to explore a pancreatic-cancer trial in South Korea. Regulatory and ethics approvals would be required. The announcement gave no enrollment target or start date and does not establish an initiated trial or commercial agreement.
Oct 19, 2026
Expanded REGAIN protocol and SNO presentation
The FDA-authorized IDE supplement expands the study from 10 to up to 20 U.S. patients and adds protocol measures and follow-up. An additional interim analysis is planned six months after the fifth patient’s July treatment. New data are scheduled at SNO on November 13, 7:30–9:30 p.m. ET.
Sep 9, 2026
Management reviews the clinical and commercial programs
The CEO letter reviews previously announced clinical progress, Japan authorization, the Tolmar relationship and the dual listing. It does not supply a new combined clinical-response dataset.
Aug 31, 2026
IMPACT reaches 48 treated pancreatic-cancer patients
The company announced enrollment completion with 48 treated patients after expansion from an initial plan of 12. Initial data are targeted for early 2027, a company expectation rather than an approval date.
Aug 10, 2026
Results update sets ReSTART and financial context
The update confirms ReSTART enrollment of 88 patients and a late-2026 or early-2027 topline window. The financial period ended June 30; cash-flow measures reflect the Tolmar transaction, while no revenue had been recognized by that reporting date.
DRTS stock catalysts: dated milestones
- November 5, 2026 · TASE index inclusionCompany-announced effective date
TA-90 and TA-125 membership; potential fund demand and liquidity effects remain expectations.
- November 13, 2026 · REGAIN data at SNOScheduled presentation
7:30–9:30 p.m. ET in Philadelphia. A presentation is not a marketing decision.
- Late 2026 / early 2027 · ReSTART toplineCompany guidance
Clinical readout window after completed enrollment; outcome and timing remain uncertain.
- Early 2027 · Initial IMPACT dataCompany target
Initial pancreatic-cancer data, distinct from an approval date.
- January 2028 · Bank-loan principalDisclosed debt terms
Maturity of the bank borrowing described in the June accounts.
Alpha DaRT: three separate evidence programs
ReSTART
Larger skin-cancer dataset
Enrollment of 88 patients was completed May 8. The guided topline window is late 2026 or early 2027. Durability and safety matter alongside response.
REGAIN
Recurrent brain tumors
The expanded U.S. study permits up to 20 patients. The earlier report involved only three; additional data and follow-up are needed before generalizing the signal.
IMPACT
Pancreatic cancer
The company reports 48 treated patients and targets initial results in early 2027. The Samsung MOU describes a separate potential study, not an extension already under way.
DRTS cash, Tolmar funding and warrant dilution
Cash and short-term deposits of $100.639M exclude restricted deposits and do not represent entirely unconstrained spending capacity. Reported first-half operating cash use of $0.745M benefited from $18.878M of deferred-revenue contribution. Removing that component illustrates the funding effect; it is not a complete recurring-burn forecast.
Public and private warrants carry an $11.50 exercise price and expire in March 2027 under the disclosed terms. Exercise is conditional on holder choices and contractual provisions; potential proceeds are not current cash. Options, RSUs and separate ATM capacity also matter to the ownership denominator.
Merlintrader Health Score · DRTS
3.2out of 5
Assessment dated October 26, 2026: weighted score 3.2/5. It describes financial and operational robustness, not value, a price target or an investment recommendation.
DRTS red flags
- Very small early cohorts and uncertain durability in larger groups.
- Different studies, indications and regulatory jurisdictions cannot be treated as one approval pathway.
- Readout windows are company guidance, not guaranteed results or approvals.
- Tolmar receipts affect reported cash flow without proving recurring cash generation.
- Warrants, equity awards and future issuance can dilute ownership.
- Collateral, development and manufacturing commitments constrain a simple cash-runway interpretation.
DRTS Stock FAQ: Alpha Tau Medical Questions Answered
When is the next DRTS stock catalyst?
Alpha Tau schedules new REGAIN trial data at SNO on November 13, 2026 from 7:30–9:30 p.m. ET. ReSTART topline remains in a late-2026 or early-2027 company window, with initial IMPACT data targeted for early 2027. The presentations and later readouts address separate cancer studies. REGAIN presentation schedule. ReSTART guidance. Updated IMPACT timing.
Is Alpha Tau’s Alpha DaRT FDA approved for glioblastoma?
No: Alpha Tau’s October 19, 2026 announcement concerns FDA authorization to expand the investigational REGAIN study from ten to twenty patients. It is an IDE supplement, rather than U.S. marketing approval for glioblastoma. Alpha DaRT’s regulatory position differs across indications and jurisdictions. IDE supplement and investigational study.
How much cash does Alpha Tau have, and how long will it last?
Alpha Tau held $100.639 million cash and short-term deposits at June 30, 2026, excluding $4.133 million restricted deposits. H1 operating cash use of $0.745 million benefited from $18.878 million deferred-revenue support from Tolmar. This unusually low outflow does not establish recurring burn; clinical investment, collateral and borrowing obligations affect funding capacity. Cash, deposits, cash flows and Tolmar accounting.
Is DRTS stock at risk of dilution?
Yes: Alpha Tau’s August 10, 2026 disclosure reports 92,478,154 ordinary shares and separate warrants, options and RSUs that can increase ownership dilution. Public and private warrants carry an $11.50 exercise price and March 2027 expiry under the disclosed terms. Exercise choices and contractual provisions determine issuance and cash proceeds; other award and financing capacity is separate. Ordinary shares and potential issuance. Warrant terms and capital structure.
When does Alpha Tau Medical report earnings?
As of November 2, 2026, Alpha Tau had not announced its next earnings date. Its latest financial update, released August 10, covered June 30, 2026. The November SNO appearance is a clinical presentation. Company news room. Investor events. Latest half-year results.
What does Alpha Tau Medical do?
Alpha Tau develops Alpha DaRT, a cancer-treatment platform that places radium-224 sources inside solid tumors to deliver localized alpha radiation. It is studying several cancer indications through distinct clinical programs, with development and regulatory status depending on the treatment setting and country. Technology and company overview.
What changed in Alpha Tau’s expanded REGAIN trial?
Alpha Tau’s October 19, 2026 announcement allows up to twenty REGAIN patients, adds progression-free survival and quality-of-life measures, and permits an additional interim analysis six months after the fifth patient’s July treatment. The study also opens to IDH-mutant grade 4 tumors. These protocol changes broaden evidence collection, without establishing treatment efficacy in a larger population. Expanded protocol and interim analysis.
When will Alpha Tau report IMPACT pancreatic-cancer data?
Alpha Tau’s August 31, 2026 update targets initial IMPACT data for early 2027 after completing enrollment of 48 patients. The pilot combines Alpha DaRT with first-line chemotherapy and is intended to inform a planned pivotal study. This later guidance is more specific than the earlier late-2026 or early-2027 window. Completed enrollment and current data window.
Primary sources
Disclaimer. This content is published by Merlintrader for educational and informational purposes only. It is independent journalism and research. It does not constitute investment advice, an investment recommendation, an offer or a solicitation to buy or sell any security, and it is not a research report within the meaning of applicable United States securities regulation. Nothing here should be read as a recommendation to buy, sell or hold $DRTS or any other security.
Figures are taken from public filings with the U.S. Securities and Exchange Commission, company press releases and market-data providers, and are stated with their reference dates. Data can change without notice, and figures published before a results release become outdated the moment that release is issued. Merlintrader makes no representation that the information is complete or current at the time of reading. Readers should verify every figure against the primary source before acting on it.
Biotechnology and healthcare companies carry binary risk. Clinical trials fail, regulatory decisions go against the applicant, approval does not guarantee commercial uptake, and development-stage companies frequently raise equity at whatever price the market will bear. A single readout can change the value of the business overnight in either direction, and companies at this stage can lose all of their value. Every reader is responsible for their own decisions and should consult a licensed financial adviser where appropriate.
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