Three biotech stories this week that most people missed. A clinical-stage oncology company posted Phase 2 lung cancer data that sent its stock up 16% and earned an ASCO podium. A under-the-radar stock with a real FDA-approved product secured national pharmacy coverage and launched a real-world evidence study. And a micro-cap developing a stroke drug hit 75% enrollment in its pivotal trial.
Different stages. Different diseases. All moving forward.
Black Diamond Therapeutics (Nasdaq: BDTX)
On May 21, Black Diamond reported Phase 2 results for silevertinib in frontline non-small cell lung cancer patients with EGFR non-classical mutations (genetic variants in a cell receptor that drives tumor growth, affecting roughly 10 to 15% of NSCLC patients and historically difficult to treat). Forty-three treatment-naive patients. Preliminary median progression-free survival (the time before a tumor grows or spreads) of 15.2 months. Overall response rate of 60%. CNS response rate of 86% in patients with brain metastases. Not one patient developed new brain metastases during treatment. Fifty-three percent remain on therapy.
The stock jumped 16.28% on the day. Data will be presented at the ASCO Annual Meeting on May 30 by Dr. Julia Rotow from Dana-Farber Cancer Institute. Cash of $135.5 million funds operations into H2 2028. Market cap around $200 million. Clinical stage, no revenue. All trial data is preliminary and subject to change as the study continues.
Milestone Pharmaceuticals (Nasdaq: MIST)
Share price $0.88. CARDAMYST (etripamil nasal spray, the first self-administered treatment for paroxysmal supraventricular tachycardia approved by the FDA in over 30 years) launched in retail pharmacies in Q1 2026 after FDA approval in December 2025. More than two million Americans have PSVT, a condition that causes sudden episodes of abnormally rapid heartbeat. Until now, most patients had to go to an emergency department to get treated.
This week Milestone announced the RESET-PSVT Phase 4 real-world evidence study, to be led by the Duke Clinical Research Institute, enrolling around 450 patients at cardiology sites across the US. Express Scripts national formulary (coverage on one of the largest pharmacy benefit networks in the country) was secured ahead of launch. Q1 results published May 13 showed a net loss of $26.1 million and cash of $184 million. The AFib-RVR Phase 3 trial (testing CARDAMYST in a second heart rhythm condition) has been initiated with enrollment starting H2 2026. Full financials on SEC EDGAR.
DiaMedica Therapeutics (Nasdaq: DMAC)
DiaMedica hit 75% enrollment in the ReMEDy2 Phase 2/3 trial of DM199 for acute ischemic stroke (stroke caused by a blood clot blocking flow to the brain). DM199 is a recombinant human tissue kallikrein-1 protein being developed to protect brain tissue and improve outcomes after stroke. Tissue plasminogen activator is the only FDA-approved acute stroke treatment and works only within a few hours of onset. DiaMedica is targeting a patient population with limited options beyond that narrow window.
Micro-cap. Share price under $2. Clinical stage, no revenue. The 75% enrollment milestone brings top-line data measurably closer. Full details on SEC EDGAR. Stroke is one of the leading causes of long-term disability in the US. If DM199 works in the pivotal trial, the addressable patient population is substantial.
What to Watch
ASCO Annual Meeting opens May 30. Black Diamond presents silevertinib data Saturday May 30 at 1:15 PM CDT. Watch for any commentary from Dr. Rotow on durability of response and updated patient numbers as the trial continues to mature.
Milestone prescription data: early commercial traction is the number that matters for MIST right now. Any investor update disclosing prescription volume or new formulary wins in the coming weeks will signal whether CARDAMYST is gaining ground with cardiologists.
DiaMedica enrollment completion: the final 25% of ReMEDy2 enrollment is the last major operational milestone before the trial moves into follow-up and readout. Watch for a 100% enrollment announcement in the coming months.
Sources
- GlobeNewswire: Black Diamond Therapeutics Phase 2 silevertinib results, May 21, 2026
- StockTitan: Black Diamond Phase 2 NSCLC results, May 21, 2026
- TipRanks: Black Diamond silevertinib Phase 2 data highlights, May 21, 2026
- StockTitan: Milestone Pharmaceuticals Q1 2026 results, CARDAMYST launch update, May 13, 2026
- Simply Wall St: Milestone Pharmaceuticals MIST RESET-PSVT Phase 4 study announcement, May 2026
- Yahoo Finance: Milestone Pharmaceuticals FDA approval CARDAMYST December 2025
- StockTitan: Clinical trial results live feed, DiaMedica ReMEDy2 enrollment milestone, May 2026
- SEC EDGAR: Black Diamond Therapeutics 8-K Phase 2 results filing, May 21, 2026
Editorial Disclosure
This roundup is based entirely on publicly available information including press releases, regulatory filings, and clinical trial disclosures. Securities discussed include Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), Milestone Pharmaceuticals Inc. (Nasdaq: MIST), and DiaMedica Therapeutics Inc. (Nasdaq: DMAC). aktiego.com has not received any compensation from any company mentioned, their management, investor relations representatives, or any third party. No staff member or principal of aktiego.com holds a position in any security mentioned at the time of publication. All information is sourced from SEC EDGAR filings and company press releases via named wire services. Clinical trial results for BDTX and DMAC are from investigational studies. Investigational drugs have not been approved by the FDA and their safety and efficacy have not been established. BDTX silevertinib Phase 2 data is preliminary, based on a data cutoff of April 11, 2026, and subject to change as the study matures. MIST CARDAMYST is an FDA-approved commercial product; CARDAMYST for AFib-RVR is investigational and not approved. DiaMedica DM199 is investigational and not approved. Milestone Q1 2026 results were released May 13, 2026, just prior to the primary May 18-24 coverage window, and are included given their direct relevance to commercial developments announced within the window. These are speculative investments carrying significant risk including potential total loss of capital. Coverage on aktiego.com is provided for informational and educational purposes only. aktiego.com is not a registered investment advisor. Nothing in this article constitutes financial, investment, or professional advice. Readers are encouraged to conduct their own due diligence and consult a qualified financial advisor before making any investment decisions. For more information please see our full DISCLAIMER.
