KALA BIO Inc. (NASDAQ:KALA) jumped 37.87% to $0.88 in after-hours trading on Tuesday.Check out the current price of KALA stock here.According to Benzinga Pro data, the stock closed the regular session at $0.64, up 3.45%.Securities Purchase Agreement DetailsLast week, the Massachusetts-based biopharmaceutical company entered into a Securities Purchase Agreement with investor David Lazar to raise up to $6 million through a private placement, according to a Securities and Exchange Commission (SEC) Form 8-K fil ...

Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to regulatory setbacks and significant stock declines, with allegations of misleading statements regarding its business operations and therapeutic candidates [1][2][3]. Allegations - The lawsuit claims that Telix overstated the developmental progress and commercial prospects of its prostate cancer therapeutic candidates, specifically TLX591 and TLX592 [3]. - It is alleged that the company misrepresented the stability, quality, and regulatory compliance of its third-party supply chain and manufacturing partners, which were critical to its regulatory applications [4]. Regulatory Events Impacting Stock - The first significant stock decline occurred after Telix disclosed receiving a subpoena from the SEC on July 22, 2025, leading to a more than 13% drop in the price of Telix's American Depositary Shares (ADSs) over two trading sessions [5]. - A more severe decline followed the announcement of a Complete Response Letter (CRL) from the FDA on August 28, 2025, regarding TLX250-CDx (Zircaix), which identified deficiencies in the Chemistry, Manufacturing, and Controls (CMC) package, resulting in a further decline of over 21% in the stock price [6][7]. Investigation - Hagens Berman is actively investigating the claims against Telix, focusing on the discrepancies between the company's long-term assurances and the regulatory revelations that followed [8].

– Prescription Drug User Fee Act (PDUFA) goal date extended by three months to February 28, 2026 COPENHAGEN, Denmark, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) notified the Company that information submitted on November 5, 2025, related to the post-marketing requirement, in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia, constitut ...

 VANCOUVER, BC, November 25, 2025 – TheNewswire - BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (“BioVaxys” or the “Company”) announces that, further to its news release dated November 14, 2025, it has issued 1,792,387 common shares in the capital of the Company (each a “Settlement Share”), at a deemed value of $0.23 per Settlement Share, in full and final settlement of accrued and outstanding indebtedness in the aggregate amount of $412,249 (the “Debt Settlement Transaction”). All securities issued in ...

Core Insights - BioAge Labs, Inc. is a clinical-stage biotechnology company focused on developing therapeutic products for metabolic diseases by targeting human aging biology [1][3] - The company will present at the Piper Sandler 37th Annual Healthcare Conference in New York from December 2-4, 2025 [1][2] - Key executives, including CEO Kristen Fortney and CFO Dov Goldstein, will participate in a fireside chat and one-on-one meetings during the conference [2] Company Overview - BioAge's lead product candidate, BGE-102, is an orally available small-molecule NLRP3 inhibitor aimed at treating obesity and cardiovascular risk factors [3] - A Phase 1 SAD/MAD trial for BGE-102 is currently underway, with initial SAD data expected by the end of the year [3] - The company is also developing long-acting injectable and oral small molecule APJ agonists for obesity, alongside additional preclinical programs targeting metabolic aging pathways [3]

SAN DIEGO, Nov. 25, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that Daniel Faga, president and chief executive officer of Anaptys, and/or other members of its executive leadership team, are scheduled to participate in multiple upcoming investor conferences: Piper Sandler 37th Annual Healthcare Conference, New York, NY Format – Fireside chat and 1x1 investor meetingsDate and Time – ...

ROCKVILLE, MD, Nov. 25, 2025 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced that Eric Risser, President and CEO of MacroGenics, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Thursday, December 4, at 7:55 am ET in Miami, FL. A webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations se ...

SAN DIEGO, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, announced that it will present at the following conferences during December: Piper Sandler 37th Annual Healthcare Conference in New YorkPresentation: Wednesday, December 3 at 8:00 a.m. ETEvercore ISI 8th Annual Healthcare Conferenc ...

Accessibility StatementSkip Navigation SAN DIEGO, Nov. 25, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that it will participate at the Piper Sandler 37 Annual Healthcare Conference. The conference will take place December 2-4, 2025, in New York, New York. Details are as follows: Piper Sandler 37 Annual Healthcare ConferenceDetails: Vik ...

Two late-breaking podium presentations and three posters continue to demonstrate cretostimogene as a potential backbone therapy for a broad range of NMIBC patientsIRVINE, Calif., Nov. 25, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced two late breaking podium presentations on the topline results from BOND-003 ...