Pharmaceuticals & Biopharmaceuticals

Los Angeles – September 11, 2026 -- Schall, Brown & Schwartz LLP (SBS) has issued a reminder to shareholders of Capricor Therapeutics, Inc. (NASDAQ: CAPR) of a securities class action lawsuit alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The lead plaintiff deadline is set for September 11, 2026.

Lawsuit covers CAPR shares purchased between September 11, 2026 and September 11, 2026

The class action targets investors who purchased Capricor shares during this roughly seven-month window. Appointment as lead plaintiff is not a prerequisite for shareholders to participate in any eventual recovery.

Yongin, South Korea – September 11, 2026 -- GCCL (Global Clinical Central Lab), a South Korea-based clinical trial sample analysis provider, served as a Platinum Sponsor at the Asia Bio Partnering Forum 2026 (ABP 2026) in Singapore, held from August 31 to September 2, as it pursued expansion of its assay development and sample analysis services across the Asia-Pacific region.

ABP 2026 drew 650 industry professionals and 2,500 one-on-one partnering meetings

The forum brought together approximately 650 pharmaceutical and biotechnology executives, investors and life sciences stakeholders, with roughly 2,500 one-on-one partnering meetings held over three days. GCCL used the event to hold discussions with drug developers, contract research organizations (CROs) and regional stakeholders from Korea, China, Japan, Singapore, Vietnam and Europe.

Los Angeles – September 11, 2026 -- DJS Law Group has reminded shareholders of a class action lawsuit filed against Beta Bionics, Inc. (NASDAQ: BBNX) alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The suit covers investors who purchased BBNX shares between September 11, 2026 and September 11, 2026, with a lead plaintiff filing deadline set for September 11, 2026.

Complaint alleges Beta Bionics downplayed FDA findings on its iLet insulin pump

The complaint centers on the iLet Bionic Pancreas insulin pump, Beta Bionics' sole commercialized product. After the company disclosed that the FDA had issued a Form 483 following a manufacturing facility inspection, defendants allegedly told investors the agency's observations were limited to complaint-reporting criteria and did not reflect underlying device problems.

San Francisco – September 11, 2026 -- Hagens Berman Sobol Shapiro LLP has filed a securities class action against Regeneron Pharmaceuticals (NASDAQ: REGN) after the failure of a Phase 3 melanoma trial wiped out $11 billion in market capitalization. The suit covers investors who purchased Regeneron shares between September 11, 2026, and September 11, 2026, with a lead plaintiff deadline set for September 11, 2026.

Regeneron's Fianlimab-Libtayo combination failed to hit its primary endpoint

The complaint centers on Regeneron's Phase 3 trial testing Fianlimab combined with Libtayo as a first-line treatment for metastatic or locally advanced melanoma, a therapy management repeatedly called a "potential blockbuster." On September 11, 2026, Regeneron disclosed the trial did not reach statistical significance on its primary endpoint of progression-free survival.

San Francisco – September 11, 2026 -- Investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) have until September 11, 2026, to seek lead plaintiff status in a securities class action tied to the company's Duchenne muscular dystrophy therapy, deramiocel, as the FDA extends its review timeline.

FDA pushes deramiocel decision to September 11, 2026

On September 11, 2026, Capricor disclosed that the FDA extended the PDUFA target action date for its lead cell therapy deramiocel from September 11, 2026, to September 11, 2026. The agency classified the company's post-Advisory Committee submission as a major amendment, which included 24-month open-label extension data from the Phase 3 HOPE-3 study and a bid to narrow the therapy's indication to upper limb function.

Sheridan, Wyo. – September 11, 2026 -- The global stem cells market is projected to expand from USD 18.9 billion in 2026 to USD 32.57 billion by 2031, growing at a compound annual rate of 11.5%, according to a new study by Wissen Research.

Manufacturing gains, not new discoveries, drive the current growth phase

Analysts say the market's momentum stems largely from improvements in how cells are harvested, cultured, isolated, expanded and cryogenically preserved, rather than from newly identified therapeutic uses. Induced pluripotent stem cells (iPSCs) are drawing particular attention because they can be generated from adult tissue, avoiding sourcing and ethical issues tied to embryonic cells. Allogeneic, donor-derived therapies are also gaining share because they allow bulk, off-the-shelf manufacturing instead of custom batches per patient.

San Francisco – September 10, 2026 -- Hagens Berman Sobol Shapiro LLP has opened an investigation into Aardvark Therapeutics, Inc. (NASDAQ: AARD) over allegations that the company misled investors about the safety of its lead drug candidate ARD-101, ahead of an October 13, 2026 deadline for shareholders to seek lead plaintiff status in a pending securities class action.

Investors who bought Aardvark stock between February 13, 2025 and May 14, 2026 are covered by the class period

The lawsuit targets purchasers who acquired shares pursuant to Aardvark's February 13, 2025 initial public offering, as well as those who bought securities through May 14, 2026. The complaint alleges the company's offering documents failed to disclose that ARD-101 was significantly less safe than represented, including reversible cardiac observations such as QRS prolongation at above-target doses during clinical trials.

Bangkok -- September 10, 2026 -- Wooree Group, a South Korean biotechnology and lighting conglomerate with 60 years of history, has called for a scientific validation standard for the liposomal health products market, following its participation in Vitafoods Asia 2026 held September 2-4 in Bangkok.

Seoul – September 10, 2026 -- The Ministry of Food and Drug Safety of Korea (MFDS) concluded the 12th Global Bio Conference (GBC) on August 28, drawing roughly 5,600 participants from 19 countries to the Grand InterContinental Seoul Parnas for three days of talks on biopharmaceutical regulation and technology.

Forums drew hundreds of specialists across vaccines, proteins and advanced therapies

Held from August 26-28 under the theme 'The Great Leap in Bio, Accelerating Innovation,' the event featured 75 biopharmaceutical experts delivering presentations across specialized tracks. The Recombinant Protein Products Forum attracted 591 attendees, the Advanced Biopharmaceuticals Policy and Quality Forum drew 483, and the Vaccine Forum logged 462 participants, combining online and offline sessions.

Hamilton, Ontario – – September 10, 2026 -- AtomVie Global Radiopharma has officially opened a new manufacturing plant at 10 Aeropark Boulevard in Hamilton, Ontario, representing an investment exceeding $160 million and marking the largest contract development and manufacturing organization (CDMO) site in North America dedicated to radiopharmaceutical production.

Facility spans 6,700 square meters and multiplies output tenfold

The site covers more than 6,700 square meters and increases AtomVie's production capacity by more than tenfold, supporting variable low-to-high throughput manufacturing. Modular spaces are designed to allow a smooth transition from early-stage clinical development to full commercial-scale production of radiopharmaceuticals.