On May 2, 2025 Zonhon Biopharma Institute reported the Investigational New Drug (IND) application for ZHB114 for Injection—a Class I innovative biologic drug independently developed by Zonhonbio with proprietary intellectual property rights—was officially approved by the U.S. Food and Drug Administration (FDA) (Press release, Zonhon Biopharma Institute, MAY 2, 2025, View Source [SID1234656085]). The newly approved indication covers advanced malignant tumors.

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On May 2, 2025 Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company") reported its results for the first quarter ended March 31, 2025 (Press release, Amneal Pharmaceuticals, MAY 2, 2025, View Source [SID1234654251]).

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"Amneal delivered another strong quarter to start 2025, with broad-based growth across all three segments driven by our team’s outstanding execution. We are very pleased with the commercial uptake of CREXONT for Parkinson’s Disease and the momentum of our recently launched injectable products, which are delivering tremendous value to patients, caregivers and customers. As a leading U.S.-based biopharmaceutical company, Amneal is proud to provide millions of Americans with access to affordable and innovative treatments—and we believe we are just getting started. With our diverse portfolio, expansive footprint in the U.S. and globally, and a resilient management team, we are confident in our ability to deliver sustainable growth and value creation for our stakeholders in 2025 and beyond as we embark on our exciting next chapter of growth and success," said Chirag and Chintu Patel, Co-Chief Executive Officers.

First Quarter 2025 Results

Net revenue in the first quarter of 2025 was $695 million, an increase of 5% compared to $659 million in the first quarter of 2024. Affordable Medicines net revenue increased 6% driven by strong performance of our complex product portfolio and new product launches. Specialty net revenue increased 3% driven by key branded products, including CREXONT and UNITHROID. AvKARE net revenue increased 6% driven by growth in the government label sales channel.

Net income attributable to Amneal Pharmaceuticals, Inc. was $12 million in the first quarter of 2025 compared to a net loss of $92 million in the first quarter of 2024, reflecting higher revenue and gross profit, and a legal settlement charge of $94 million in the first quarter of 2024.

Adjusted EBITDA in the first quarter of 2025 was $170 million, an increase of 12% compared to the first quarter of 2024, reflective of strong revenue performance, higher gross margin and operating expense leverage.

Diluted income per share in the first quarter of 2025 was $0.04 compared to diluted loss per share of $0.30 for the first quarter of 2024, due to higher operating income and lower interest expense. Adjusted diluted earnings per share in the first quarter of 2025 was $0.21, an increase of 50%, compared to $0.14 for the first quarter of 2024.

The Company presents GAAP and adjusted (non-GAAP) quarterly results. Please refer to the "Non-GAAP Financial Measures" section and the accompanying GAAP to non-GAAP reconciliation tables for more information.

Affirming Full Year 2025 Financial Guidance

The Company is affirming its previously provided full year 2025 guidance.

On May 2, 2025 HAYA Therapeutics, SA, a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics that reprogram disease-driving cell states for rare, common, chronic and age-related diseases, reported the presentation of data at the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in New Orleans from May 13-17, 2025 (Press release, Haya Therapeutics, MAY 2, 2025, View Source [SID1234652482]).

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The company will showcase its latest advances in an invited presentation focused on HAYA’s lead program, HTX-001, an antisense oligonucleotide designed to target the long non-coding RNA (lncRNA) Wisper, the master regulator of fibrosis in the heart, currently in Investigational New Drug-enabling studies and in development for the treatment of non-obstructive hypertrophic cardiomyopathy (nHCM). Additionally, HAYA will have a poster presentation on its innovative multimodal omics approach for profiling and designing antisense oligonucleotide-based therapeutics that enables a precise and potent silencing of novel lncRNA targets.

"Unlike traditional approaches that block single genes or proteins, we have built a platform to reprogram the fundamental biology that underlies disease," said Samir Ounzain, Ph.D., Co-founder and CEO of HAYA Therapeutics. "We are identifying and drugging novel regulatory genome-derived drivers of disease pathogenesis to reprogram sick cells into healthy ones."

"Over the past years, we’ve made significant progress on our lead program, HTX-001, targeting myocardial fibrosis and we anticipate initiating clinical trials in the near future. This forward momentum brings us closer to our ultimate mission: bringing disease-modifying medicines to patients," said Daniel Blessing, Ph.D., Co-founder and CTO of HAYA Therapeutics.

Poster Presentation:

Title: Harnessing Functional Genomics to Advance the Discovery and Development of Oligonucleotide-Based Therapies Targeting the Regulatory Genome
Presenter: Rudi Micheletti, HAYA’s Senior Director of Biology and Functional Genomics
Presentation Date/Time: Tuesday, May 13, 2025, 6:00 PM – 7:30 PM CDT
Location: Poster Hall I2
Abstract Number: 660

Scientific Symposium:

Title: A Wisper from the Heart: Targeting a Cardiac Myofibroblasts-specific LncRNA to Treat Myocardial Fibrosis
Presenter: Daniel Blessing, HAYA’s CTO and Co-founder
Session Title: Targeting Myocardium: To The Heart Of The Matter (Organized by the Cardiovascular CGT Committee)
Presentation Date/Time: Wednesday, May 14, 2025, 3:45 PM – 5:30 PM CDT
Location: Room 388-390

HAYA’s RNA-guided therapeutic platform represents a new approach to treating disease by targeting the root causes at the cellular level. At its core is HAYA’s Regulatory Genome Atlas, which maps the connection between noncoding regulatory genome elements, or lncRNAs, and disease-driving cell states by integrating multimodal functional genomics with a stack of proprietary computational tools and machine learning methodologies. This enables the development of genetic medicines that reprogram diseased cells back to healthy ones.

On May 2, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported that the Company granted stock options to four new employees to purchase an aggregate of 104,400 shares of the Company’s common stock, effective as of May 1, 2025 (Press release, Olema Oncology, MAY 2, 2025, View Source [SID1234652480]). These awards were approved by the Compensation Committee of Olema’s Board of Directors and granted under the Company’s 2022 Inducement Plan as an inducement material to the new employees entering into employment with Olema, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options vest over four years, with 25 percent vesting on the first anniversary of the vesting commencement date for such employee and the remainder vesting in 36 equal monthly installments over the following three years, subject to the employee being continuously employed by Olema as of such vesting dates. The stock options have a 10-year term and an exercise price of $5.29 per share, equal to the last reported sale price of the Company’s common stock as reported by Nasdaq on May 1, 2025. The stock options are subject to the terms of the Olema Pharmaceuticals, Inc., 2022 Inducement Plan.

Olema is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

On May 2, 2025 Kura Oncology, Inc. (the "Company") (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that on May 1, 2025, the Compensation Committee of the Company’s Board of Directors (the "Compensation Committee") granted inducement awards consisting of nonstatutory stock options to purchase 433,950 shares of common stock to sixteen (16) new employees under the Company’s 2023 Inducement Option Plan, as amended (Press release, Kura Oncology, MAY 2, 2025, View Source [SID1234652479]). The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each stock option has an exercise price equal to $6.49 per share, the Company’s closing sales price on May 1, 2025, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2023 Inducement Option Plan, as amended, and the terms and conditions of an applicable stock option agreement covering the grant.