Every 8-K that Relmada Therapeutics, Inc. (RLMD) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow RLMD and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full RLMD filings page.
RELMADA THERAPEUTICS, INC. (RLMD) reports that the employment of Dr. Raj S. Pruthi as Chief Medical Officer – Urology ended on September 3, 2026. The company filed this update as an other event and provided no additional detail about the circumstances around the end of his employment.
Relmada Therapeutics reported Q2 2026 results and a business update centered on its oncology and CNS pipeline. For the three months ended June 30, 2026, it recorded a net loss of $12,914,185 on $8,393,789 in research and development expenses. Cash, cash equivalents and short‑term investments totaled $217.7 million as of June 30, 2026, and the company raised $159,999,996 from common stock issuance during the first half.
Lead candidate NDV‑01, a sustained‑release intravesical gemcitabine/docetaxel therapy for non‑muscle invasive bladder cancer, showed Phase 2a data in high‑risk patients with high complete response rates. Efficacy‑evaluable participants achieved complete response rates of 95% anytime and 76% at 12 months, with no progression to muscle‑invasive disease or radical cystectomy reported. In a BCG‑unresponsive subgroup, complete response rates were 94% anytime and 80% at 12 months. The company expects to file an NDV‑01 IND by year‑end 2026 and to initiate the Phase 3 RESCUE registrational program after IND clearance. Relmada also plans a year‑end 2026 IND filing for sepranolone, aiming to start a Phase 2 trial in Prader‑Willi syndrome.
Relmada Therapeutics, Inc. appointed Bipin Dalmia, PhD, MBA as chief business officer, as disclosed in a current report dated July 28, 2026. He will lead corporate strategy, commercial planning and business development, reporting directly to chief executive officer Sergio Traversa.
Dalmia brings nearly three decades of biopharmaceutical leadership, including a 14-year tenure at Ferring Pharmaceuticals, where he led the uro-oncology franchise and launch of ADSTILADRIN, described as the first FDA-approved intravesical gene therapy for BCG-unresponsive non-muscle invasive bladder cancer. Relmada describes itself as a clinical-stage biotechnology company developing NDV-01, a novel sustained-release intravesical therapy for NMIBC, and sepranolone for central nervous system conditions; both are characterized as mid-stage programs with potential to address significant unmet needs. The press release detailing the appointment is furnished, not filed, under Regulation FD.
Relmada Therapeutics, Inc. reported that stockholders approved a Charter Amendment increasing authorized common shares from 150,000,000 to 200,000,000. This expands the company’s capacity to issue new stock in the future for financing, compensation, or other corporate purposes.
At the 2026 Annual Meeting, 66,571,711 of 104,888,223 eligible common shares, or about 63.47%, were represented. Stockholders elected two Class II directors, ratified CBIZ CPAs P.C. as independent auditor for 2026, and approved an amendment to the 2021 Equity Incentive Plan, lifting its share pool by 3,000,000 to a total of 18,052,942 shares.
Relmada Therapeutics reported a first quarter 2026 net loss of $19.1M, with operating expenses of $19.5M. Research and development was $8.1M and general and administrative expenses were $11.4M.
After a $160M PIPE financing that generated roughly $150M in net proceeds, cash, cash equivalents and short-term investments rose to $235.3M as of March 31, 2026, and management states this should fund operations through 2029. Common shares outstanding increased to 104.9 million.
The company highlighted Phase 2 data for NDV-01 in high-risk non-muscle invasive bladder cancer, showing a 95% anytime complete response rate and 76% 12‑month complete response rate among 38 efficacy-evaluable patients, with no progressions to muscle-invasive disease or cystectomies reported. A BCG-unresponsive subgroup showed similar durability. Safety appeared manageable, with no grade 3 or higher treatment-related adverse events and no treatment discontinuations for safety.
Relmada has written FDA feedback supporting two registrational pathways for NDV-01 and plans to initiate the Phase 3 RESCUE program and a Phase 2 study of sepranolone in Prader‑Willi syndrome in mid‑2026. A provisional NDV‑01 patent filing could support protection into 2047.
Relmada Therapeutics reported audited 2025 results and a major strategic shift toward oncology, led by NDV-01 for non-muscle invasive bladder cancer. For 2025, the company recorded a net loss of $57.4 million, an improvement from $80.0 million in 2024, as total operating expenses fell to $59.1 million from $83.9 million. Research and development spending declined to $26.9 million and general and administrative costs to $32.2 million.
Total assets rose to $94.0 million as of December 31, 2025, driven by cash and short-term investments of about $94.0 million and common shares outstanding increasing to 73.3 million. A separate $160 million PIPE financing and the year-end balance sheet underpin management’s view that cash resources should fund operations through 2029.
Clinically, 12‑month Phase 2a data for NDV‑01 showed high complete response rates in high‑risk NMIBC, including a 3‑month complete response in 95% of evaluable patients and 76% at 12 months, with no Grade 3 or higher treatment‑related adverse events and no treatment‑related discontinuations. The FDA has agreed to two registrational pathways for NDV‑01, and Relmada plans to start the Phase 3 RESCUE program and a Phase 2b trial of sepranolone in Prader‑Willi syndrome in mid‑2026.
Relmada Therapeutics entered into a private placement securities purchase agreement with institutional and accredited investors for approximately $160.0 million, selling 29,474,569 common shares at $4.75 and pre-funded warrants for 4,210,527 shares at $4.749 with a $0.001 exercise price. Closing is expected on March 11, 2026, and proceeds are earmarked for working capital and to advance research and development of its product candidates. Investors receive registration rights for resale and liquidated damages if registration timelines are missed.
The company also reported 12‑month interim Phase 2 NDV‑01 data in high‑risk non‑muscle invasive bladder cancer, showing a 12‑month complete response rate of 76% overall and 80% in the BCG‑unresponsive subgroup, with no progression to muscle‑invasive disease or radical cystectomies. These results support moving NDV‑01 into the Phase 3 RESCUE registrational program across both adjuvant intermediate‑risk and second‑line BCG‑unresponsive settings.
Relmada Therapeutics, Inc. reported that its Board of Directors approved amended and restated employment agreements for its executive officers on December 12, 2025. The updated contracts cover Chief Executive Officer Sergio Traversa, Chief Operating Officer Paul Kelly, Chief Financial Officer Maged Shenouda, and Chief Accounting and Compliance Officer Charles Ence, and are stated to become effective as of January 1, 2026. The company explains that, except for the revisions reflected in these new agreements, the material terms remain the same as those previously described in earlier SEC disclosures, and the complete agreements are filed as exhibits.
Relmada Therapeutics (RLMD) furnished an update and preliminary, unaudited quarterly financial results via a press release and scheduled a conference call to discuss them. The company plans to file complete unaudited financial statements and notes in its upcoming Form 10‑Q.
The press release was provided as Exhibit 99.1 and a refreshed corporate presentation as Exhibit 99.2. Under the furnished status, this information is not deemed filed under the Exchange Act except as specifically incorporated by reference. A conference call and webcast were set for November 13, 2025 at 4:30 PM ET to review the update and results.
Relmada Therapeutics (RLMD) priced an underwritten equity offering of 40,142,000 common shares at $2.20 per share and pre-funded warrants to purchase up to 5,315,000 shares at $2.199 per warrant. The company expects approximately $100 million in net proceeds after underwriting discounts and expenses.
Pre-funded warrants are immediately exercisable at an exercise price of $0.001 per share, with a beneficial ownership cap of 9.99% (or 4.99% at the purchaser’s election). Company insiders, including the CEO, CFO, and other officers and directors, will purchase about $2.6 million of common stock at the same price as other investors.
Relmada plans to use proceeds for working capital and general corporate purposes, including clinical studies to gain regulatory approvals, further product development, licensing, and potential investments or acquisitions. The company agreed to customary indemnification provisions and 90-day restrictions on issuing additional equity or convertible securities.
Relmada Therapeutics (RLMD) reported FDA feedback on its proposed Phase III program for NDV-01 in non-muscle invasive bladder cancer and shared nine-month Phase II safety and efficacy data. The FDA indicated a single-arm trial may be acceptable in BCG‑unresponsive patients refractory to other therapies, and a randomized post‑TURBT adjuvant study versus observation in intermediate‑risk NMIBC with a time‑to‑event primary endpoint is generally acceptable, subject to submission of the intended designs. The company plans to request Type B meetings.
In Phase II high‑risk NMIBC, NDV‑01 showed no Grade ≥3 treatment‑related adverse events among 36 patients; 61% had treatment‑related adverse events, primarily transient dysuria (62%), asymptomatic positive urine culture (9%), and hematuria (7%). Complete response rates were 92% (anytime; 23/25), 84% at 3 months (21/25), 87% at 6 months (20/23), and 85% at 9 months (17/20), with two of two patients in CR at 12 months. Relmada expects approximately $13.9 million in cash, cash equivalents and short‑term investments as of September 30, 2025.
Relmada Therapeutics, Inc. filed a current report to note that it updated its corporate presentation on September 17, 2025. The updated presentation is provided as Exhibit 99.1 and is incorporated by reference into the Regulation FD disclosure section of the report.
The company states that this information, including Exhibit 99.1, is being furnished under Regulation FD and is not deemed filed for purposes of certain liability provisions of the federal securities laws. No financial results, transactions, or other operational changes are described in this excerpt beyond the availability of the new corporate presentation.
Relmada Therapeutics, Inc. reported that it has regained compliance with Nasdaq’s minimum bid price requirement. The company received a written notice of compliance from Nasdaq’s Listing Qualifications Department stating that, for 10 consecutive trading days from August 29, 2025 to September 12, 2025, the closing bid price of its common stock was at or above $1.00 per share, satisfying Nasdaq Listing Rule 5550(a)(2).
Nasdaq informed Relmada that it now considers the listing compliance matter closed, meaning the company’s common stock remains listed on the Nasdaq Capital Market under the symbol RLMD. Relmada issued a press release on September 15, 2025 to communicate this development, which is referenced as an exhibit in the filing.
Relmada Therapeutics, Inc. filed a current report to share updated communications with investors. On September 10, 2025, the company issued a letter to shareholders describing its recent progress, which is furnished as Exhibit 99.1. On the same date, Relmada also updated its corporate presentation, furnished as Exhibit 99.2. The company notes that these materials are provided under Regulation FD and are considered "furnished" rather than "filed" under securities laws, meaning they are not automatically incorporated into other SEC filings unless specifically referenced.
Relmada Therapeutics reported that its Chief Medical Officer-Urology, Raj S. Pruthi, MD, purchased 55,000 shares of the Company’s common stock in open market transactions on August 29, 2025. This insider purchase reflects a direct acquisition of additional equity by a senior executive using the public market rather than through company grants or option exercises. The disclosure is provided under Regulation FD as furnished information, meaning it is not treated as filed under certain Exchange Act liability provisions or automatically incorporated into other securities law filings.
Relmada Therapeutics, Inc. (NASDAQ: RLMD) filed a Form 8-K on 7-Aug-2025 announcing Item 2.02 (Results of Operations) and Item 7.01 (Reg FD).
- The company furnished, but did not file, a press release (Ex. 99.1) containing a corporate update and preliminary, unaudited Q2 2025 results for the period ended 30-Jun-2025.
- A conference call and webcast are scheduled for 7-Aug-2025 at 4:30 PM EDT to discuss the update.
- Full unaudited financial statements will appear in the forthcoming Form 10-Q.
- An updated corporate presentation (Ex. 99.2) was also furnished.
- No quantitative financial metrics, guidance, or transactional details are included in the 8-K itself; all figures reside in the referenced exhibits.
The furnished information is not deemed “filed” under the Exchange Act and therefore carries reduced liability. Investors must consult Exhibits 99.1 and 99.2 or the upcoming 10-Q for substantive financial data.