The Company will Host a Conference Call and Webcast on Thursday, August 7, 2025, at 8:30 AM ETCORAL GABLES, Fla., July 22, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that it will release its second quarter 2025 financial results after the market close on Wedne ...

Core Insights - Reunion Neuroscience Inc. announced the publication of Phase 1 study results for RE104, highlighting its favorable safety profile and short duration psychoactive experience [1][3] - The company is currently conducting the RECONNECT Phase 2 trial for RE104 in postpartum depression, with topline results expected in Q3 2025 [1][2] Group 1: Phase 1 Study Findings - The Phase 1 study involved administering a single subcutaneous dose of RE104 ranging from 5mg to 40mg to healthy adult volunteers, with psychoactive effects lasting 3-4 hours for doses above 5mg [2][6] - RE104 demonstrated a favorable safety and tolerability profile, with no serious adverse events reported, and treatment-emergent adverse events were mostly mild to moderate [3][6] - The active metabolite 4-OH-DiPT appeared rapidly in plasma, correlating with clinical assessments of drug effect [3][6] Group 2: Future Trials and Indications - Reunion Neuroscience plans to initiate the REKINDLE Phase 2 trial for adjustment disorder in Q3 2025, following the RECONNECT trial [5][7] - The company is also conducting a clinical lactation study to assess the elimination of RE104 and its metabolites in breastfeeding mothers, with final data expected in the second half of 2025 [4][5] Group 3: Company Overview - Reunion Neuroscience is focused on developing next-generation psychedelic-inspired therapeutic solutions for mental health disorders, having transitioned to a private company in 2023 and completed Series A financing in 2024 [8] - The lead product candidate, RE104, is designed to provide a shorter duration psychedelic experience compared to traditional psychedelics like psilocybin, while maintaining a similar safety profile [6][8]

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 ...