On February 27, 2026 Novartis AG (NYSE: NVS) reported that it has successfully completed its acquisition of Avidity Biosciences, Inc. ("Avidity"). With the completion of the acquisition, Avidity is now an indirect, wholly owned subsidiary of Novartis.

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"Avidity’s breakthrough science combined with Novartis capabilities will help reimagine what’s possible for people with devastating genetic neuromuscular diseases," said Vas Narasimhan, CEO of Novartis. "Avidity’s muscle-directed AOC platform and late-stage programs advance our RNA therapeutics and have the potential to deliver first-in-disease therapies. With the close of the acquisition, we’re excited to welcome Avidity to Novartis and accelerate this next generation of medicines."

Novartis completed the acquisition of Avidity through the merger of its indirect wholly owned subsidiary, Ajax Acquisition Sub, Inc., with and into Avidity. As a result of the merger, holders of Avidity common stock became entitled to receive USD 72.00 per share in cash, valuing the company at approximately USD 12bn on a fully diluted basis and representing an enterprise value of approximately USD 11bn. Avidity’s shares of common stock have also ceased trading on the Nasdaq Stock Market LLC. The transaction was originally announced on Oct. 26, 2025.

(Press release, Novartis, FEB 27, 2026, View Source [SID1234663129])

On February 27, 2026 OPKO Health, Inc. (Nasdaq: OPK) reported that management will be participating in the Jefferies Biotech on the Beach Summit, being held March 10-11, 2026, at 1 Hotel South Beach in Miami. Management will be holding one-on-one meetings with investors registered for the event on Wednesday, March 11th.

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Investors interested in scheduling a meeting with OPKO management should contact their Jefferies representative.

(Press release, Opko Health, FEB 27, 2026, View Source [SID1234663130])

On February 27, 2026 PharmaMar Group (MSE:PHM) reported to have closed the 2025 financial year with a 27% increase in total revenues, reaching €221.4 million. Recurring revenues, resulting from the sum of net sales plus royalties received from its partners, increased by 12% compared to the previous year, reaching €143.5 million. Non-recurring revenues increased by 66% compared to the end of December 2024, reaching €77.9 million.

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Net sales in oncology closed the year with a growth of 20%, reaching €79.7 million. This growth was driven by a 31% increase in revenue from Zepzelca (lurbinectedin) in Europe to €37.5 million. This section saw growth in revenue both from the compassionate use program, which totaled €26.2 million (+18%) and sales in Switzerland, which reached €11.3 million in 2025 (+77%).

Sales of raw materials to our partners of both lurbinectedin and Yondelis (trabectedin) grew by 37% to €27.5 million. Commercial sales of trabectedin in Europe were €14.7 million, compared to €18.0 million in the same period last year.

As of December 31st, 2025, oncology royalty income increased by 4% to €63.8 million compared to the same period last year.

Royalties received from our partners for sales of lurbinectedin, mainly from our partner Jazz Pharmaceuticals in the US, reached €51.6 million compared to €56.1 million in December 2024. In this regard, it is important to note that last October, lurbinectedin in combination with atezolizumab (Tecentriq) was approved by the US Food and Drug Administration (FDA) to expand its use to first-line maintenance treatment in extensive-stage small cell lung cancer. As a result, lurbinectedin revenues in the fourth quarter in the US were approximately $90 million, making it the highest quarterly sales since the launch of lurbinectedin in the US and representing a 15% year-on-year growth compared to the fourth quarter of 2024. This sales growth was primarily driven by the initial demand for first-line maintenance treatment.

It is also worth noting the significant increase in royalties received from sales of trabectedin in the US, which more than doubled the €4.5 million recorded in 2024 to achieve €11.6 million. These sales have been boosted since its inclusion in the NCCN treatment guidelines in that country for first-line use following positive results from a Phase III trial in combination with doxorubicin.

As for non-recurring income from licensing agreements, at the end of 2025, this increased by 67% to €77.8 million. Of this total amount, €42.5 million ($50 million) corresponds to the milestone payment achieved for FDA’s full approval of lurbinectedin, €21.3 million relates to the upfront payment for the lurbinectedin licensing agreement in Japan and another €8.6 million ($10 million) corresponds to the payment of a commercial milestone established in the trabectedin licensing agreement in the US. In addition, €4.0 million correspond to the deferred revenue portion of the 2019 agreement with Jazz Pharmaceuticals, another €1.3 million correspond to revenue from several minor agreements.

As of December 31st, 2025, PharmaMar Group’s investment in R&D stood at €95.2 million, compared to €103.5 million as of December 31st, 2024. This investment represents 43% of PharmaMar Group’s total revenue.

Of the total investment in R&D during the year, the oncology segment reached €92.4 million, compared to €94.4 million in December 2024. This difference is due to the completion of patient recruitment for the Phase III LAGOON trial for second-line treatment of small cell lung cancer, with results expected in the third quarter of 2026. Meanwhile, the Phase III SaLuDo clinical trial with lurbinectedin in the first-line treatment of metastatic leiomyosarcoma continues to progress, with recruitment expected to be completed in the middle of this year with data expected in the 1st half of 2027.

In addition, the Company continues to invest in the clinical development of other molecules at earlier stages. Phase I clinical trials are underway with PM534 and PM54 for the treatment of solid tumors. In December 2025, the FDA approved the start of a Phase I/II trial with PM54 in combination with immunotherapy in solid tumors.

The significant growth in revenues enabled PharmaMar Group to achieve EBITDA of €68.1 million at December 31st, 2025, compared with €13.0 million in 2024.

As a result, the Company will increase its net profit by 187% to €75.0 million.

As of December 31st, 2025, PharmaMar Group’s cash and cash equivalents balance increased by €10.8 million to €167.8 million. Total financial debt was reduced by €1.3 million to €46.6 million. As a result, the net cash position at year-end stood at €121.2 million.

The Board of Directors of Pharma Mar, S.A. will propose to the General Shareholders’ Meeting the distribution of a dividend of €1.00 per outstanding share that will be charged to unrestricted reserves (share premium), up to a maximum amount of 18,000,000.00 Euros.

PharmaMar is organizing a conference call with analysts and investors on February 27th, 2026, at 1:30 p.m. (CET). To join the conference call, please register at this link to receive the access numbers and a personalized PIN.

To access without prior registration, use the following numbers: +34 919 01 16 44 (Spain), +1 646 233 4753 (US or Canada), or +44 20 3936 2999 (UK). Conference number: 636061.

(Press release, PharmaMar, FEB 27, 2026, View Source [SID1234663131])

On February 27, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative, non-surgical therapies for urothelial and specialty cancers, reported new post-hoc analyses from the Phase 3 ENVISION trial showing that ZUSDURI (mitomycin) for intravesical solution (formerly known as UGN-102) achieved durable complete response (CR) rates across European Organization for Research and Treatment of Cancer (EORTC) recurrence score groups in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). A poster including the ENVISION trial EORTC recurrence score analysis will be presented at ASCO (Free ASCO Whitepaper)-GU 2026, which is being held February 26-28, 2026, in San Francisco, CA, and virtually.

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CR rates at three months were 83.9%, 81.2%, and 60.0% in patients with low (1-4), intermediate (5-9), and high (10-17) EORTC recurrence scores, respectively, with the majority of responders across all groups remaining recurrence-free at 24 months.

"These results are particularly meaningful because they demonstrate that ZUSDURI can achieve robust complete response rates, even in patients with a higher baseline risk of recurrence," said Sandip M. Prasad, MD, M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. "Importantly, the durability of response observed with ZUSDURI across EORTC risk categories highlights a meaningful advance for patients with recurrent LG-IR-NMIBC, a population with limited treatment options."

The Phase 3 ENVISION (NCT05243550) trial evaluated ZUSDURI, a reverse thermal hydrogel administered intravesically containing 75 mg mitomycin, in patients with recurrent LG-IR-NMIBC. In the overall study population, ZUSDURI achieved a CR rate of 79.6% at three months (95% CI: 73.9–84.5), with a Kaplan-Meier probability of remaining event-free at 24 months of 72.2% (95% CI: 64.1–78.8).

In the post-hoc analysis of 240 treated patients stratified by EORTC recurrence score, high CR rates were observed across all risk groups at three months. CR rates were 83.9% (95% CI: 66.3–94.5) in patients with EORTC scores of 1–4, 81.2% (95% CI: 74.9–86.4) in patients with EORTC scores of 5–9, and 60.0% (95% CI: 32.2–83.7) in patients with EORTC scores of 10–17. Among patients achieving a CR, the majority remained recurrence-free at 24 months across all groups, with a Kaplan-Meier probability of remaining event-free of 67.4% (95% CI: 43.2–83.1), 73.7% (95% CI: 64.6–80.8), and 66.7% (95% CI: 28.2–87.8) for the EORTC score groups of 1–4, 5–9, and 10–17, respectively. Across the subgroups, Kaplan-Meier estimate of median duration of response was not reached, reflecting low recurrence event rates during follow-up.

"The consistency of response we’re seeing across EORTC recurrence score groups reinforces the therapeutic benefit of ZUSDURI," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "These findings build on the strong primary results from ENVISION and further support ZUSDURI as a non-surgical treatment option designed to address the chronic and recurrent nature of this disease."

Despite the post-hoc design and small sample sizes in some subgroups, the results suggest that ZUSDURI may provide durable and clinically meaningful benefit, regardless of baseline recurrence risk. Patients in ENVISION will continue to be followed for recurrence and progression for up to five years. The EORTC is an international academic research organization that conducts large multicenter clinical trials and develops widely validated prognostic and risk-stratification tools. Its bladder cancer recurrence score tables are commonly used to estimate recurrence risk based on established clinical and pathological factors.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

(Press release, UroGen Pharma, FEB 27, 2026, View Source [SID1234663132])

On February 27, 2026, the U.S. Food and Drug Administration ("FDA") reported a Complete Response Letter ("CRL") for the supplemental Biologics License Application ("sBLA") for Zynyz (retifanlimab-dlwr) injection (375mg) for an additional indication for the treatment of adult patients with metastatic non-small cell lung cancer ("NSCLC") in combination with platinum-based chemotherapy. The sBLA was supported by positive efficacy and safety data from the Phase 3 POD1UM-304 trial announced in December 2024.

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The CRL cited inspection findings (not specific to Zynyz) at Catalent Indiana, LLC ("Catalent Indiana"), part of Novo Nordisk, the third-party fill-finish facility referenced in the sBLA. The CRL cited the regulatory compliance of Catalent Indiana as the sole approvability issue, and did not cite other approvability concerns, including Zynyz’s efficacy and safety data in NSCLC or the third-party drug substance manufacturer.

Incyte Corporation is working closely with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission of Zynyz in NSCLC.

(Press release, Incyte, FEB 27, 2026, View Source [SID1234663336])