On January 30, 2026, vTv Therapeutics LLC ("vTv LLC" or the "Company"), a subsidiary of vTv Therapeutics Inc., reported to have entered into the Second Amendment to License Agreement with Newsoara Biopharma Co., Ltd. ("Newsoara") (the "Second Amendment") to amend the License Agreement previously entered into between vTv LLC and Newsoara on May 31, 2018 (the "Original Agreement"). Although the Company had previously entered into an amendment with Newsoara to expand the Original Agreement, that amendment became null and void in June 2025. Under the new Second Amendment, Newsoara’s rights in the Company’s PDE4 inhibitor, HPP737, will expand to include all countries of the world upon Newsoara’s payment of the upfront fee of $20 million. The Second Amendment also requires Newsoara to pay vTv LLC up to $50 million in development milestones, $65 million in sales-related milestones and royalties in the mid single digits depending upon sales volumes.

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The foregoing description of the License Amendment is qualified in its entirety by reference to the Second Amendment, which the Company intends to file with the SEC as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

(Filing, vTv Therapeutics, JAN 30, 2026, View Source [SID1234662402])

On January 30, 2026 Incyte (Nasdaq:INCY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).

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"Today’s positive CHMP opinion is an important step towards addressing the urgent need for new treatment options for patients in Europe with advanced SCAC, a disease which has seen limited innovation for decades," said Lee Heeson, Executive Vice President and Head of Incyte International. "If approved, Zynyz in combination with platinum-based chemotherapy has the potential to become a new standard-of-care for patients living with this rare and difficult-to-treat cancer."

The positive CHMP opinion was based on data from the Phase 3 POD1UM-303/InterAACT2 trial evaluating Zynyz in combination with (platinum-based chemotherapy) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.5

Results from POD1UM-303/InterAACT2 (NCT04472429) published in The Lancet showed a statistically significant 37% reduction in the risk of progression or death (P=0.0006).4 Patients in the Zynyz and (platinum-based chemotherapy) combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in the placebo combination group.4 No new safety signals were identified. Serious adverse reactions occurred in 47% of patients receiving Zynyz in combination with chemotherapy.4 The most frequent serious adverse reactions (≥ 2% of patients) were sepsis, pulmonary embolism, diarrhoea and vomiting.4

SCAC is the most common type of anal cancer, accounting for approximately 85% of all anal cancer cases.6 Globally, the prevalence of SCAC is estimated at around 1 or 2 cases per 100,000 people, with a higher incidence in women than in men.

The CHMP opinion is now being reviewed by the European Commission, which has the authority to grant approval for all centrally authorized products in the EU.

About Squamous Cell Carcinoma of the Anal Canal (SCAC)
Worldwide, SCAC is the most common type of anal cancer, making up 85% of cases.6 It is a rare disease for which the incidence increases approximately 3% per year.7,8,9,10 About 90% of cases are associated with human papillomavirus (HPV) infection—the number one risk factor for anal cancer.10 HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it.11,12 Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.13

About POD1UM
The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-303, POD1UM-202 and several other Phase 1, 2 and 3 studies for patients with solid tumors.

For more information about the study, please visit View Source

About Zynyz (retifanlimab)
Zynyz (retifanlimab) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) in the U.S. and Japan and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

Zynyz is also indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S, EU, Canada, and Switzerland.

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

For more information, see the Zynyz SmPC.

(Press release, Incyte, JAN 30, 2026, View Source [SID1234662374])

On January 30, 2026 Cycle Group Holdings Limited ("Cycle" or "Parent") reported that AT2B, Inc., a Delaware corporation ("Purchaser") and indirect wholly owned subsidiary of Cycle, has extended the expiration date of its tender offer to purchase all of the outstanding shares of common stock, par value $0.0001 per share of Applied Therapeutics, Inc., a Delaware corporation ("Applied") for (i) $0.088 per share, net to the seller in cash, without interest, plus (ii) one non-tradeable contingent value right per share.

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The offer, which was previously scheduled to expire at one minute following 11:59 p.m., Eastern time, on January 29, 2026 is extended until one minute following 11:59 p.m., Eastern time, on February 2, 2026.

Equiniti Trust Company, LLC, the depositary for the offer, has advised Cycle that, as of 11:59 p.m., Eastern time, on January 29, 2026, approximately 75,895,437 shares (which include 2,429,370 shares subject to guaranteed delivery) have been validly tendered and not properly withdrawn pursuant to the offer, representing approximately 49.21% of the outstanding shares of Applied. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to this extension.

The offer is being made pursuant to the terms and conditions described in the offer to purchase, filed on December 29, 2025 (together with any amendments and supplements hereto), copies of which are attached to the tender offer statement on Schedule TO filed by Cycle and Purchaser with the US Securities and Exchange Commission, as amended.

The offer is conditioned upon the fulfilment of certain conditions described in Section 15—"Conditions to the Offer" of the offer to purchase, including, but not limited to, the tender of a majority of the then-outstanding shares of Applied’s common stock.

MacKenzie Partners, Inc. is acting as information agent for the offer. Requests for documents and questions regarding the offer may be directed to MacKenzie Partners, Inc by telephone, toll-free at 1-800-322-288. Bankers and Brokers may call at 212-929-5500.

(Press release, Cycle Pharmaceuticals, JAN 30, 2026, View Source [SID1234662375])

On January 30, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 being held from February 11-12, 2026 in New York.

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Details of the event are as follows:
Date: Thursday, February 12, 2026
Time: 2:00p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

(Press release, Adicet Bio, JAN 30, 2026, View Source [SID1234662376])

On January 29, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that it has entered into a securities purchase agreement with new and existing healthcare focused institutional investors and certain insiders of the Company to sell an aggregate of 6,288,857 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 6,288,857 shares of common stock, in a private placement priced at-the-market under Nasdaq rules (the "Offering"). The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrant to be issued is $0.89. The warrants to be issued will have an exercise price of $0.765 per share, will be exercisable immediately upon issuance, and will expire on the two-year anniversary from the effectiveness date of the registration statement covering the resale of the securities purchased in the Offering.

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The gross proceeds to the Company from the Offering are estimated to be approximately $5.6 million before deducting the placement agent’s fees and other estimated Offering expenses. The Company intends to use the upfront net proceeds from the private placement for general corporate purposes and for research and development expenses. The Offering is expected to close on or about January 30, 2026, subject to the satisfaction of customary closing conditions.

"We believe this financing will enable us to proactively backfill patients at key dose levels in our ongoing ACESOT-1 dose-escalation study evaluating APR-1051, our WEE1 kinase inhibitor, and this may increase the likelihood of successful dose optimization," said Oren Gilad, CEO of Aprea Therapeutics. "By adding more patients to our safety and early efficacy dataset, we expect to accelerate our ability to define the optimal dose and patient population, which we believe will drive the program toward clinical and value-creating inflection points."

Maxim Group LLC is acting as the sole placement agent in connection with the Offering.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, Aprea, JAN 29, 2026, View Source [SID1234662348])