GARDEN CITY, N.Y., July 22, 2025 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, has been awarded a national group purchasing agreement for therapeutic gases with Premier, Inc. Effective July 15th, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated b ...

PALO ALTO, Calif., July 22, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced that it will release its second quarter financial results and business updates after the market closes on Tuesday, August 5, 2025. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day. To access the live webcast of BridgeBio’s presentation ...

Here are three stocks added to the Zacks Rank #5 (Strong Sell) List today:Belite Bio (BLTE) is a clinical stage biopharmaceutical drug development company which focused on novel therapeutics targeting currently untreatable eye diseases involving retinal degeneration, such as atrophic age-related macular degeneration and autosomal recessive Stargardt disease, and metabolic diseases. The Zacks Consensus Estimate for its current year earnings has been revised 59.1% downward over the last 60 days.3D Systems (DD ...

Core Insights - Telix Pharmaceuticals reported a significant increase in Q2 2025 revenue, reaching approximately $204 million, a 63% increase year-over-year, and reaffirmed its FY 2025 revenue guidance of $770 million to $800 million [3][6][22]. Financial Performance - Group revenue for Q2 2025 was $204 million, compared to $125 million in Q2 2024, marking a 63% increase. Revenue for Q1 2025 was $186 million, showing a 10% increase quarter-over-quarter [3][6]. - Global Illuccix® revenue was $154 million in Q2 2025, up 25% from $123 million in Q2 2024, and slightly increased by 2% from $151 million in Q1 2025 [3]. - RLS revenue reached $46 million in Q2 2025, with no revenue reported in Q2 2024, and a 39% increase from $33 million in Q1 2025 [3]. Business Highlights - Dose volumes for Illuccix rose 7% quarter-on-quarter in the U.S., indicating strong market demand despite competitive pricing pressures [4]. - The launch of Gozellix in the U.S. has commenced, with the product assigned a Level II HCPCS code, a key step towards reimbursement [6]. - The ProstACT Global Phase 3 trial achieved a milestone with all 30 patients consented for Part 1, and the trial is expanding into China, Japan, and Canada [7]. Therapeutics Development - TLX591 (Lu-rosopatamab tetraxetan) is progressing in its Phase 3 trial, with dosing completed for patients in two of the three arms [7]. - TLX592 (Ac-PSMA-RADmAb) has submitted an application for a Phase 1 study in Australia [7]. - TLX101 (I-iodofalan) received HREC approval in Australia for an international pivotal trial [7]. - TLX250 (¹⁷⁷Lu-DOTA-girentuximab) is enrolling patients in a Phase 1b/2 clinical trial for clear cell renal cell carcinoma [7]. Regulatory and Corporate Updates - Telix is cooperating with the U.S. SEC regarding a subpoena for documents related to its prostate cancer therapeutic candidates [11][12]. - The company has received country-level approvals for Illuccix in multiple European countries and is launching on a market-by-market basis [13]. - Telix has completed enrollment for the Illuccix China Phase 3 study, aiming for marketing authorization in Q4 2025 [13]. Manufacturing and R&D - Telix announced a GMP manufacturing facility in Yokohama, Japan, enhancing its global manufacturing strategy [14]. - The TMS facility in Brussels South, Belgium, has produced its first GMP commercial radiopharmaceutical doses [14]. - The company expects a 20% to 25% increase in R&D expenditure for FY 2025 compared to FY 2024 [22].

Core Viewpoint - A class action lawsuit has been filed against Biohaven Ltd. for allegedly misleading investors regarding the viability of its drug candidates, particularly troriluzole and BHV-7000, during the period from March 24, 2023, to May 14, 2025 [1][2]. Group 1: Company Overview - Biohaven Ltd. is a biopharmaceutical company focused on developing therapies in immunology, neuroscience, and oncology [1]. - The company is working on several product candidates, including troriluzole for spinocerebellar ataxia (SCA) and BHV-7000 for bipolar disorder [1]. Group 2: Allegations and Legal Proceedings - The lawsuit alleges that Biohaven overstated the regulatory prospects and data sufficiency for troriluzole's approval for SCA [2]. - It is also claimed that the efficacy and clinical prospects of BHV-7000 for bipolar disorder were similarly overstated [2]. - The complaint suggests that the revelation of these issues could significantly negatively impact Biohaven's business and financial condition [2]. Group 3: Class Action Participation - Shareholders interested in serving as lead plaintiffs must file their papers by September 12, 2025 [3]. - Participation in the class action is not required to be eligible for recovery; shareholders can remain absent class members if they choose [3].

Core Viewpoint - A class action lawsuit has been filed against Alto Neuroscience, Inc. for allegedly misleading investors regarding the effectiveness of its drug candidate ALTO-100 during its IPO and subsequent period [1][2]. Group 1: Company Overview - Alto Neuroscience, Inc. is a clinical-stage biopharmaceutical company based in the U.S. with a product pipeline that includes ALTO-100, which was in a Phase 2b clinical trial for treating major depressive disorder (MDD) at the time of its IPO [1]. - The IPO occurred on or about February 2, 2024, and the class period for the lawsuit extends from this date to October 22, 2024 [1]. Group 2: Allegations and Misleading Information - The lawsuit alleges that the Offering Documents related to the IPO were negligently prepared and that the company failed to disclose critical information about ALTO-100's effectiveness [2]. - Specifically, it is claimed that ALTO-100 was less effective in treating MDD than represented, leading to overstated clinical, regulatory, and commercial prospects, which in turn inflated Alto's business and financial outlook [2]. Group 3: Impact of Clinical Trial Results - On October 22, 2024, Alto announced that ALTO-100 did not meet its primary endpoint in the Phase 2b trial, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo [3]. - Following this announcement, Alto's stock price plummeted by $10.17 per share, a decrease of 69.99%, closing at $4.36 per share on October 23, 2024 [3]. Group 4: Legal Proceedings - Shareholders interested in participating in the class action have until September 19, 2025, to seek lead plaintiff status, which allows them to represent other class members in the litigation [4]. - Participation in the case is not required to be eligible for recovery, and shareholders can choose to remain absent class members [4].

WARREN, N.J., July 21, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the company will host a webcast conference call to report its second quarter 2025 financial results and provide an update on the company's business and outlook on Thursday, August 7, at 4:30 p.m. ET.To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in for the conference call 15 minutes prior to the start ...

Board of Directors Unanimously Recommend Approving Merger Agreement With Vyome Therapeutics and Asset Purchase Agreement With Biorad Medisys Shareholders are encouraged to vote FOR Proposals 1, 2, and 3 by Calling 1-877-750-8310 IRVINE, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced it will host a Special Meeting of Stockholders of ReShape Lifesciences Inc. to be held at 11:30 am ET ...

Core Insights - Daré Bioscience, Inc. has developed a proprietary topical formulation of sildenafil, the active ingredient in Viagra, specifically for women, aimed at addressing female sexual arousal issues [1][2] - The product, named DARE to PLAY™, is expected to be available by prescription in the fourth quarter of 2025 [1][5] - A live webinar is scheduled for August 6, 2025, to discuss the clinical evidence supporting the product and its potential impact on women's sexual health [2][3] Company Overview - Daré Bioscience focuses on women's health, aiming to bridge the gap between scientific advancements and practical solutions [1][9] - The company is committed to developing innovative, evidence-based solutions for various women's health issues, including sexual health, contraception, and menopause [9][10] - Daré's first FDA-approved product is XACIATO™, a vaginal gel for bacterial vaginosis, indicating the company's capability in bringing women's health products to market [10] Product Details - DARE to PLAY™ is clinically shown to improve genital blood flow and sexual response in women, distinguishing it from untested compounded products [2][7] - The formulation is designed to deliver sildenafil effectively, addressing a long-standing gap in women's sexual health solutions [2][7] - The product aims to provide a credible, evidence-based option for women experiencing difficulties with sexual arousal, orgasm, and desire [7][9] Webinar Information - The webinar titled "The DARE to PLAY™ Difference: The Sildenafil Cream That Raises the Bar" will feature leading sexual health experts [3][6] - Participants will have the opportunity to join a product alert list to receive updates on the availability of DARE to PLAY™ [5][6] - The event is open to clinicians, investors, and women interested in science-based approaches to improving sexual response [6]

PHILADELPHIA, July 21, 2025 (GLOBE NEWSWIRE) -- Berger Montague PC advises investors that a securities class action lawsuit has been filed against Organon & Co. (“Organon” or the “Company”) (NYSE: OGN) on behalf of purchasers of Organon securities between November 3, 2022 through April 30, 2025, inclusive (the “Class Period”). Investor Deadline: Investors who purchased or acquired Organon securities during the Class Period may, no later than JULY 22, 2025, seek to be appointed as a lead plaintiff representa ...