Core Viewpoint - A securities class action has been initiated against Soleno Therapeutics, Inc. due to alleged misrepresentations regarding the integrity of clinical trials and drug safety, particularly concerning its product DCCR (VYKAT XR) [1][3][6] Group 1: Lawsuit Details - The class action seeks to recover damages for investors who purchased Soleno securities between March 26, 2025, and November 4, 2025 [2] - Investors have until May 5, 2026, to seek lead plaintiff status in the lawsuit [3] Group 2: Product and Clinical Trials - DCCR is a diazoxide choline extended-release tablet aimed at treating hyperphagia in patients with Prader-Willi syndrome, with its FDA approval reliant on a pivotal Phase 3 clinical trial [3] - The pivotal study, a randomized withdrawal period of Study C602, is critical as it underpins the drug's approval and commercial viability [3] Group 3: Allegations of Clinical Trial Issues - The lawsuit claims that Soleno's Phase 3 program had systematic issues that were either known or recklessly ignored by the defendants [4] - Allegations include the downplaying of serious side effects such as fluid retention, which could lead to pulmonary edema and heart failure [4] - The complaint highlights a linear increase in prediabetes and diabetes markers over three years of treatment, raising concerns about the drug's safety profile [5] Group 4: Criticism from Medical Community - Endocrinologists and investigators have expressed skepticism regarding the drug's safety, with some indicating they would not prescribe it due to trial conduct issues [5] - The original 13-week Phase 3 trial did not meet its primary endpoint for hyperphagia improvement, and the pivotal study had a small sample size of only 77 participants, heavily skewed towards one clinical site [5] Group 5: Management's Communication - Despite the concerns raised, Soleno's management reportedly assured investors of the drug's "well-established safety profile" and claimed that "no new safety signals" had emerged post-marketing [6]

Know Your Rights: How Basic Inc. v. Levinson Enables Investor Recovery NEW YORK, March 18, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP announces that a securities class action has been filed against Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE). YOU MAY BE AFFECTED IF YOU: The Efficient Market Hypothesis In Basic Inc. v. Levinson, 485 U.S. 224 (1988), the Supreme Court recognized that in an efficient market, publicly available information is rapidly incorporated into stock prices. This means that when a comp ...

Ovid Therapeutics (NasdaqGS:OVID) Q4 2025 Earnings call March 18, 2026 08:30 AM ET Speaker7 Good afternoon, everyone. My name is Angela, and I will be your conference operator today. At this time, I would like to welcome you to Ovid Therapeutics Business and Pipeline Update Call. This conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speakers' prepared remarks, there will be a question-and-answer session. At this time, I would like to turn the call o ...

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

AI-powered autonomous research agents to be deployed in support of PEX010 clinical development strategy, leveraging Kala Bio’s purpose-built agentic AI platform for the biotechnology industry TORONTO and ARLINGTON, Mass., March 18, 2026 (GLOBE NEWSWIRE) -- Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) (“Red Light” or the “Company”) and Kala Bio, Inc. (NASDAQ: KALA) (“Kala Bio”) today announced that Red Light has engaged Kala Bio’s with its Researgency.ai agentic artificial intelligence platf ...

IRON Drops Up to 39% After FDA CRL for Bitopertin -- LEVI & KORSINSKY, LLP Investigates Accessibility StatementSkip NavigationDisc Medicine investors who lost money after the FDA issued a Complete Response Letter for bitopertin are encouraged to contact Levi & KorsinskyNEW YORK, March 18, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP is investigating Disc Medicine, Inc. (NASDAQ: IRON) regarding whether the company adequately communicated risks regarding its bitopertin program before the FDA's issuance of a Com ...

Wall Street Reassessment: Analyst Opinion Evolution on AQST NEW YORK, March 18, 2026 /PRNewswire/ -- On January 9, 2026, Cantor slashed its price target on Aquestive Therapeutics, Inc. (NASDAQ: AQST) from $15 to $8, warning that "the history of CRLs following similar letters increases the risk of a potential delay for Anaphylm." Shareholders who purchased AQST securities between June 16, 2025 and January 8, 2026 lost over 37% of their investment value in a single trading session. Find out if you qualify to ...

AIM also intends to pursue Japanese Orphan Drug Designation for Ampligen in treatment of pancreatic cancerOCALA, Fla., March 18, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the Japan Patent Office has fully approved a Japanese patent covering the Company’s proprietary use of Ampligen (rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer. The patent was granted in September ...

The U.S. Food and Drug Administration has approved Johnson & Johnson's oral pill for psoriasis, the company said on Wednesday, paving the way for a more convenient treatment option for patients with... ...

DUBLIN and BRIDGEWATER, N.J., March 18, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) (“Amarin”), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, applauded the recommendation that the treatment of CV risk in patients with hypertriglyceridemia be part of a broader dyslipidemia management as discussed in the 2026 American College of Cardiology (ACC) / American Heart Association (AHA)/Multisociety Dyslipidemia Guideline Update.i These newly-issued, evid ...