Biotech Watch: iSpecimen Shareholder Votes, Genelux’s Olvi-Vec Milestone, and Biofrontera’s Pending FDA Ruling

Biotech and pharmaceutical stocks to watch on Tuesday include iSpecimen, which surged more than 37% in overnight trading on Monday despite no specific corporate news; Genelux, with a key clinical catalyst for its lead candidate Olvi-Vec expected in the coming months; Anixa Biosciences, which is scheduled to present at the Nasdaq & LD Micro Inaugural SF Summit; and Biofrontera, which has an important FDA regulatory decision expected later this month, among others.

iSpecimen Inc. (ISPC), an online global marketplace that connects medical researchers who need biological samples with healthcare providers that supply them, gained over 37% in overnight trading Monday on no specific news.

The company is scheduled to hold a virtual special meeting of stockholders on October 9, 2026, at 10:00 a.m. Eastern Time, where shareholders will vote on four main proposals:

• allowing the company to issue additional shares related to its existing financing, which could result in issuing more than 19.99% of its outstanding shares and potentially at a price below Nasdaq’s Minimum Price;
• approving a reverse stock split of between 1-for-10 and 1-for-100, with the Board deciding the exact ratio;
• allowing the company to issue shares in certain future financing transactions during the next 12 months, potentially at a price reflecting a discount of up to 80% from the applicable lowest volume-weighted average price; and
• approving the planned acquisition of assets from Foldlab AI Ltd., with part of the consideration to be paid in iSpecimen common stock. Shareholders may also vote to adjourn the meeting if more votes are needed to approve these proposals.

ISPC closed Friday’s trading at $1.53, down 0.65%.

Genelux Corp. (GNLX), a late clinical-stage immuno-oncology company, has a key clinical catalyst for its lead candidate Olvi-Vec approaching in the coming months. Olvi-Vec is a modified virus designed to fight cancer in three ways: by killing cancer cells directly, activating the immune system, and turning the tumor environment from “cold” to “hot” so it can better attack the cancer.

A Phase 3 study of Olvi-Vec, called OnPrime/GOG-3076, is evaluating Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab versus physician’s-choice chemotherapy and bevacizumab in women with platinum-resistant or platinum-refractory ovarian cancer, including fallopian tube and primary peritoneal cancer. Topline results are expected in the second half of 2026.

Olvi-Vec is also being studied in the following trials:

• A Phase 1b/2 trial in small-cell lung cancer (SCLC), where it is being tested with platinum and etoposide chemotherapy in patients whose disease has returned or stopped responding to previous treatment. The trial is being conducted in China by Genelux’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd.
• A Phase 2 study called VIRO-25 is evaluating Olvi-Vec in combination with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent non-small-cell lung cancer (NSCLC) whose disease has progressed after initial treatment with platinum chemotherapy and an ICI. The trial is being conducted in the U.S. and aims to expand Olvi-Vec’s use in NSCLC.

GNLX closed Friday’s trading at $2.44, down 3.17%. In overnight trading on Monday, the stock is up 3.28% at $2.52.

Anixa Biosciences Inc. (ANIX), a biotechnology company focused on the treatment and prevention of cancer, is scheduled to make a presentation at the Nasdaq & LD Micro Inaugural SF Summit on Wednesday, September 9, 2026. Chairman and CEO Dr. Amit Kumar will highlight the company’s clinical progress and collaborations with leading cancer research institutions, Cleveland Clinic and Moffitt Cancer Center.

Anixa’s pipeline includes a CAR-T therapy for recurrent and resistant ovarian cancer, currently being evaluated in an ongoing Phase 1 trial in collaboration with Moffitt Cancer Center, which has shown encouraging survival data with no dose-limiting toxicities observed to date. The company also recently completed a Phase 1 trial of its therapeutic and prophylactic breast cancer vaccine at Cleveland Clinic, funded by the U.S. Department of Defense, which met all primary endpoints. Dr. Kumar is also expected to discuss the company’s plans for the vaccine’s Phase 2 trial.

ANIX closed Friday’s trading at $3.07, up 0.66%.

Atara Biotherapeutics Inc. (ATRA) anticipates providing a further regulatory update later this quarter related to resubmission of the Biologics License Application (BLA) for Tabelecleucel, held by its partner, Pierre Fabre Laboratories. Tabelecleucel (tab-cel; Ebvallo) is proposed for treatment of patients 2 years and older with relapsed or refractory Epstein-Barr virus-positive posttransplant lymphoproliferative disease (EBV+ PTLD) who have received at least 1 prior therapy, including an anti-CD20-containing regimen.

The FDA had declined to approve Tabelecleucel twice—in January 2025 and January 2026. In the first Complete Response Letter (CRL), issued in January 2025, the FDA identified only one issue related to Good Manufacturing Practice (GMP) compliance and raised no concerns about the drug’s safety, efficacy, or trial design. In the second CRL, received on January 9, 2026, the FDA confirmed that the GMP issues had been resolved and again raised no safety concerns. However, the FDA reversed its earlier position, stating that the Phase 3, single-arm ALLELE trial, on which the BLA was based and which the FDA had previously agreed was adequate to support the filing, was no longer sufficient to support accelerated approval. The FDA also said that the trial’s results were difficult to interpret because of issues with its design, conduct, and analysis.

Pierre Fabre Pharmaceuticals had a productive Type A meeting with the FDA this May and discussed the issues raised by the FDA in the Complete Response Letter received in January 2026. Pierre Fabre intends to resubmit the BLA for Tabelecleucel with an updated dataset from the pivotal Phase 3, single-arm ALLELE study, including additional patients and longer follow-up, along with supportive data.

Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $31 million milestone payment upon FDA approval of the tabelecleucel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales of tabelecleucel.

ATRA closed Friday’s trading at $9.76, up 2.41%. In overnight trading on Monday, the stock was up 4% at $10.15.

Biofrontera Inc. (BFRI), a commercial-stage dermatology company specializing in the field of photodynamic therapy, has a regulatory catalyst to watch this month. The FDA is expected to announce its decision by September 28, 2026, on the company’s supplemental New Drug Application seeking to expand the use of Ameluz photodynamic therapy (PDT) for the treatment of superficial basal cell carcinoma (sBCC).

Basal cell carcinoma is the most common skin cancer in the U.S., with more than 3 million cases diagnosed annually. It is estimated that 10-25% of these cases are of the superficial subtype. The current treatment options often rely on surgical or destructive approaches, which may not be appropriate or preferred for all patients.

If approved for superficial basal cell carcinoma, Ameluz will be the first photodynamic therapy in the United States approved for the treatment of cancerous tumors. Ameluz, a topical gel, in combination with photodynamic therapy (PDT) using BF-RhodoLED, a narrowband, red light illumination source, is already approved for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

BFRI closed Friday’s trading at $1.61, up 6.62%.

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