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Bio-Thera and STADA Extend Biosimilars Alliance to Tocilizumab

On August 22, 2025 Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG reported to have agreed to extend their biosimilars alliance to cover tocilizumab, an immunosuppressant monoclonal antibody indicated for certain inflammatory conditions (Press release, BioThera Solutions, AUG 22, 2025, View Source [SID1234655432]). The effectiveness of the agreement covering tocilizumab is subject to shareholder approval.

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Bio-Thera will maintain responsibility for development, manufacturing, and supply of the tocilizumab biosimilar to Roche’s RoActemra reference brand. STADA, including its affiliates, will have exclusive rights to commercialize the biosimilar in the European Union (EU), the UK, Switzerland and selected other countries under its own marketing authorization.

This agreement for tocilizumab builds upon an existing partnership on similar terms for BAT2506, a biosimilar candidate to Simponi (golimumab), that the two companies announced in May 20241. A marketing authorization application (MAA) for BAT2506 has subsequently been accepted by the European Medicines Agency (EMA).

"Benefiting from a proven track record in immunology, STADA ranks among the premier biosimilar companies in Europe," said Dr. Shengfeng Li, CEO of Bio-Thera. "We look forward to extending our partnership to bring biosimilar tocilizumab to patients in Europe."

"With global RoActemra/Actemra sales in 2024 reported at approximately €2.8 billion, including around US$700 million in Europe despite the advent of biosimilar competition, tocilizumab represents a compelling opportunity to broaden patient access to biological treatments and build scale in immunology alongside our approved adalimumab and ustekinumab biosimilars that hold leading positions in several European countries. Bio-Thera’s expertise in developing and manufacturing biologic medicines makes it an appealing partner for STADA," commented STADA’s head of Global Specialty, Ian Henshaw.

In June 2024, tocilizumab 20mg/ml concentrate for solution developed by Bio-Thera under the BAT1806 code received a marketing authorization for the vials that is valid throughout the EU2. This followed a positive opinion issued by the European Medicines Agency that the biosimilar to Roche’s RoActemra reference brand be approved as a medicine to treat several arthritic conditions.

Entry Into a Material Definitive Agreement

On August 22, 2025, Iovance Biotherapeutics, Inc. (the "Company") reported to have entered into an Amended and Restated Open Market Sale Agreement (the "Agreement") with Jefferies LLC ("Jefferies") with respect to an at the market offering program, under which the Company may, from time to time in its sole discretion, issue and sell through Jefferies, acting as sales agent, up to $350.0 million of shares of the Company’s common stock, par value $0.000041666 per share (the "Common Shares") (Filing, Iovance Biotherapeutics, AUG 22, 2025, View Source [SID1234655431]).

The issuance and sale, if any, of the Common Shares by the Company under the Agreement will be made pursuant to a prospectus supplement, dated August 22, 2025, to the Company’s registration statement on Form S-3ASR, originally filed with the Securities and Exchange Commission on June 16, 2023, which became effective immediately upon filing.

Pursuant to the Agreement, Jefferies may sell the Common Shares by any method permitted by law deemed to be an "at the market" offering as defined in Rule 415 of the Securities Act of 1933, as amended (the "Securities Act"). Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose).

The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the Agreement.

The Company is not obligated to make any sales of Common Shares under the Agreement. The offering of Common Shares pursuant to the Agreement will terminate upon the termination of the Agreement in accordance with its terms.

The Agreement contains representations, warranties and covenants that are customary for transactions of this type. In addition, the Company has agreed to indemnify Jefferies against certain liabilities, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The legal opinion of DLA Piper LLP (US) as to the legality of the Common Shares is being filed as Exhibit 5.1 to this Current Report on Form 8-K.

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

Lilly to participate in Wells Fargo 20th Annual Healthcare Conference

On August 22, 2025 Eli Lilly and Company (NYSE:LLY) reported it will participate in the Wells Fargo 20th Annual Healthcare Conference on Sept. 5, 2025 (Press release, Eli Lilly, AUG 22, 2025, View Source [SID1234655430]). Patrik Jonsson, executive vice president and president of Lilly International, will take part in a fireside chat at 9:30 a.m., Eastern time.

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Oncopeptides publishes Q2 report 2025

ON August 21, 2025 Oncopeptides, a biotech company focused on difficult-to-treat cancers, reported the financial report for the second quarter 2025 (Press release, Oncopeptides, AUG 21, 2025, View Source [SID1234655620]).

"This is our third consecutive quarter of more than 30 percent quarter-on-quarter sales growth," says Sofia Heigis, CEO of Oncopeptides. "The results reflect robust organic growth in our largest market, Germany, combined with faster-thanexpected market access in both Spain and Italy. With July sales also confirming our strong topline momentum with tripled sales compared to the same month last year, we remain confident we are on track to profitability by the end of 2026."

Financial overview April – June
• Net sales amounted to SEK 19.2 (8.2) million
• Operating profit amounted to SEK -56.2 (-73.3) million
• Profit after tax amounted to SEK -62.8 (-73.2) million
• Earnings per share, before and after dilution -0.30 (-0.48) SEK
• Cash and cash eq

Significant events April – June
• New Real-World Data support effectiveness and tolerability of Pepaxti in heavily pretreated Multiple Myeloma patients.
• Oncopeptides launches new Real-World Evidence study of Pepaxti in Spain, first patient enrolled.
• U.S. Food and Drug Administration removes clinical hold of OPD5.

Events after the period
• Oncopeptides’ drug Pepaxti included in European Guidelines for the treatment of multiple myeloma.
• Oncopeptides announces acceptance of poster presentations of Spanish and Italian Real-World data at IMS Annual Meeting.
• Oncopeptides Partners with SD Pharma to further broaden Pepaxti’s reach in Spain.
• Oncopeptides announces rights issue.

Oncopeptides publishes Q2 report 2025

On August 21, 2025 Oncopeptides reported second quarter 2025 financial results (Presentation, Oncopeptides, AUG 21, 2025, View Source [SID1234655618]).