On April 2, 2025 Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology (Press release, Alpha Tau Medical, APR 2, 2025, View Source [SID1234651748]).

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"This is very exciting news for patients suffering from glioblastoma, a highly aggressive form of brain cancer with an extremely poor prognosis and survival rate. In this trial, we will introduce a completely novel approach, which is specifically designed to deliver Alpha DaRT sources into brain tumors that are not amenable to surgery," said Dr. Robert B. Den, Alpha Tau Chief Medical Officer. "According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months."

The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment following the Company’s promising results from pre-clinical studies.

"This IDE approval follows the FDA’s continued recognition of the huge promise that this technology holds for patients with recurrent glioblastoma; after having already received the FDA’s Breakthrough Device Designation, followed by acceptance into the FDA’s prestigious Total Product Life Cycle Advisory Program to accelerate the Alpha DaRT treatment to market and to the GBM patients who may stand to benefit greatly," added Alpha Tau Chief Executive Officer Uzi Sofer.

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.

On April 2, 2025 Allakos Inc. ("Allakos") (Nasdaq: ALLK), a biotechnology company that has been developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, reported it has entered into a definitive merger agreement (the "Merger Agreement") whereby Concentra Biosciences, LLC ( "Concentra") will acquire Allakos for $0.33 in cash per share of Allakos common stock ("Allakos Common Stock") (Press release, Allakos, APR 2, 2025, View Source [SID1234651747]).

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Allakos’ Board of Directors has unanimously determined that the acquisition by Concentra is in the best interests of all Allakos shareholders and, following the unanimous recommendation of Allakos’ Transaction Committee, has approved the Merger Agreement and related transactions.

Pursuant and subject to the terms of the Merger Agreement, a wholly owned subsidiary of Concentra will commence a tender offer (the "Offer") by April 15, 2025 to acquire all outstanding shares of Allakos Common Stock.

Closing of the Offer is subject to certain conditions, including the tender of Allakos Common Stock representing at least a majority of the total number of outstanding shares (including any shares held by Concentra), the availability of at least $35.5 million of cash (net of transaction costs, wind-down costs and other liabilities) at closing, and other customary closing conditions. Allakos officers, directors and their respective affiliates holding approximately 8.07% of Allakos Common Stock have signed support agreements under which such parties have agreed to tender their shares in the Offer and support the merger transaction. The merger transaction is expected to close in May 2025.

On April 2, 2025 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a webcast panel discussion "Development of Orexin Receptor Agonist in Sleep-Wake Disorders" at the upcoming 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025 at 11:45 a.m. EDT (4:45 p.m. BST) (Press release, Alkermes, APR 2, 2025, View Source [SID1234651746]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On April 1, 2025 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, reported the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on Oncopeptides’ next-gen drug OPD5 (Press release, Oncopeptides, APR 1, 2025, View Source [SID1234655619]).

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Based on the company’s proprietary Peptide Drug Conjugate (PDC) platform, OPD5 is a follow-on molecule to Oncopeptides’ flagship drug melflufen (branded in Europe as Pepaxti) with a potentially improved risk/benefit profile and enhanced intellectual property protection. OPD5 would initially target multiple myeloma and could potentially be expanded with other indications and diseases over time.

"We continue to see a strong medical need for a PDC in the U.S. confirmed by leading experts in the country," says Sofia Heigis, CEO of Oncopeptides. "With the go-ahead from the regulator, we are now able to move ahead with plans for clinical development."

As a next step, Oncopeptides will continue to prepare for a new clinical study, OP-502, to assess the safety, tolerability and efficacy of OPD5. Given its similarities to melflufen and the experience gained from its’ U.S. approval process, Oncopeptides believes that OPD5 can fulfill an important medical need in U.S. as well as in the EU. To support continued development including a phase 1 study, the company is assessing various financing options, including partnerships.

For more information including a Q&A for investors, please visit Oncopeptides.com.

For more information, please contact:
David Augustsson, Director of IR and Communications, Oncopeptides AB (publ)
E-mail: [email protected]
Cell phone: +46 76 229 38 68

On April 1, 2025, AIM ImmunoTech Inc., a Delaware corporation (the "Company") entered into an Equity Distribution Agreement (the "Sales Agreement") with Maxim Group LLC ("Maxim"), to sell shares of its common stock, par value $0.001 per share (the "Common Stock") for an aggregate offering price of up to $3,000,000 of Common Stock (the "Shares") from time to time, through an "at the market offering" program (the "ATM Offering") under which Maxim will act as an exclusive sales agent (Filing, 8-K, AIM ImmunoTech, APR 1, 2025, View Source [SID1234651802]). At the current time, the Company can only sell $663,329 due to the limitations of General Instruction I.B.6 of Form S-3.

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On April 1, 2025, the Company filed a universal shelf registration statement on Form S-3 (File No. 333286319) (the "Registration Statement") which includes a prospectus relating to the ATM Offering (the "Prospectus") with the Securities and Exchange Commission (the "SEC"). Once the SEC declares the Registration Statement effective, the Company will be able to offer and sell Shares in the ATM Offering under the Prospectus through Maxim pursuant to the Sales Agreement.

Sales of the Shares under the Sales Agreement may be made by any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended ("Securities Act"), or by any other method permitted by law. Maxim will make all sales using commercially reasonable efforts consistent with its normal trading and sales practices. The compensation payable to the Maxim for sales of Shares pursuant to the Sales Agreement will be 3.0% of the gross proceeds for any Shares sold to or through Maxim. In addition, the Company has agreed to reimburse Maxim for certain expenses it incurs in the performance of its obligations up to a maximum of $50,000, and $5,000 per quarter thereafter, under the Sales Agreement. The Sales Agreement may be terminated by the Company or Maxim in accordance with the terms therein. The Company made certain customary representations, warranties and covenants concerning the Company and the Shares in the Sales Agreement and agreed to indemnify Maxim against certain liabilities, including liabilities under the Securities Act.

The Company has no obligation to sell any of the Shares, and may at any time suspend offers under the Sales Agreement. The ATM Offering will terminate upon the earlier of (i) the sale of Shares under the Distribution Agreement having an aggregate offering price of $3 million, 24 months from the date of the Sales Agreement or the termination of the Sales Agreement by either the Company or Maxim upon the provision of fifteen (15) days written notice. In addition, sales of Shares under the ATM Offering shall not exceed $3 million, unless and until the Company files an amended or new Prospectus Supplement.

The Company intends to use the net proceeds from the sale of Shares for working capital and general corporate purposes.

The description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the Sales Agreement, which is filed as an exhibit hereto and incorporated herein by reference.

The legal opinion of Silverman Shin & Schneider PLLC relating to the Shares is filed as Exhibit 5.1 hereto and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.