On November 24, 2025 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that Bob Jahr, Chief Executive Officer of Outlook Therapeutics, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 10:00 AM ET.

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In addition to the fireside chat, management will be available to participate in one-on-one in-person meetings with qualified members of the investor community who are registered to attend the conference.

A live webcast of the fireside chat will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

(Press release, Outlook Therapeutics, NOV 24, 2025, View Source [SID1234660903])

On November 24, 2025 Pin Therapeutics, a clinical-stage biotechnology company specializing in targeted protein degradation, reported that it has administered the first dose of its CK1α-selective degrader PIN-5018 in a Phase 1 clinical trial. The first patient enrolled has adenoid cystic carcinoma (ACC), a rare malignancy with limited treatment options.

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PIN-5018 is an oral CK1α degrader developed based on the novel hypothesis of "synthetic activation of p53." The company is evaluating PIN-5018 as both a monotherapy and in multiple combination regimens. The Phase 1 study employs a dose-escalation design to assess safety, pharmacokinetics (PK), and target engagement/pharmacodynamics (PD). Pin Therapeutics also plans to expand development into additional indications.

PIN-5018 Achieves Complete Response in ACC PDX Models
The company highlighted compelling preclinical data in ACC, a disease with no approved standard-of-care therapy. In two patient-derived xenograft (PDX) models, treatment with PIN-5018 resulted in a complete response (CR) in one model and marked tumor regression in the other, demonstrating robust antitumor activity and supporting clinical translation.

Expansion Planned into mCRPC, Colorectal Cancer, and Other Rare Tumors
Pin Therapeutics notes that CK1α plays a key biological role in resistance mechanisms that emerge during androgen receptor (AR) inhibitor therapy. Based on this insight, the company is pursuing a strategy aimed at enabling rapid entry into the first-line (1L) setting for metastatic castration-resistant prostate cancer (mCRPC) through combination therapy with an AR signaling inhibitor (ARSI). In colorectal cancer, the company is advancing a clinical program based on the innovative concept of "synthetic activation of WNT signaling."

Advancing Mechanism-Based Precision Oncology
Pin Therapeutics emphasized its commitment to mechanism-based precision oncology across its entire pipeline by applying sophisticated biological mechanisms. Ongoing initiatives include mode-of-action studies, integrated PK/PD analysis, and biomarker development to identify the most appropriate patient populations for each indication.

"Our goal is to leverage our innovative degradation modality and novel biological frameworks to provide meaningful therapeutic options for cancer patients with limited or no existing treatments," Pin Therapeutics CEO Hyunsun Jo said. "We look forward to demonstrating the clinical value of PIN-5018 across multiple tumor types."

(Press release, Pin Therapeutics, NOV 24, 2025, View Source [SID1234660919])

On November 24, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (BsADC).

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The designation was granted for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin. There are no approved antibody-drug conjugates for patients previously treated with enfortumab vedotin.

"Receiving Fast Track designation for AVZO-103 highlights the significant need for treatment options for patients with urothelial cancer who have progressed on enfortumab vedotin," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "We believe AVZO-103 has the potential to become a promising treatment option for patients and we are committed to rapidly advancing its clinical development."

AVZO-103 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors.

About Fast Track Designation
Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
Rolling Review of a Biologic License Application or New Drug Application by the FDA

(Press release, Avenzo Therapeutics, NOV 24, 2025, View Source [SID1234660888])

On November 24, 2025 Pasithea Therapeutics Corp. (Nasdaq: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), reported positive safety, PK and PD data from Cohort 7 (37mg capsules) in its ongoing first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or in patients who have failed prior BRAF/MEK inhibition (NCT06299839).

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Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea commented, "We are highly encouraged by the initial safety data generated in Cohort 7 (37mg capsules), where zero treatment-related adverse events have been observed during the DLT period. Furthermore, PD data demonstrates the pharmacological profile we believe is necessary to achieve consistent pathway inhibition over the 24-hour dosing period, while avoiding both periods of excessive suppression and periods of insufficient target engagement. We believe this balanced profile will be critical for achieving clinical efficacy while minimizing the most commonly observed adverse events associated with MEK inhibitors. We believe PAS-004 is particularly well suited for the treatment of diseases involving the MAPK pathway that require chronic dosing over long periods of time, where sustained long-term pathway suppression at safe and well-tolerated doses is required."

PAS-004 has demonstrated in Cohort 7 (37mg capsules):

Safety and Tolerability Results:

PAS-004 was safe and well tolerated with no dose limiting toxicities (DLTs), and no treatment-related adverse events observed during the DLT period.

After reviewing cohort 7 data, the Safety Review Committee recommended to proceed to Cohort 8, 45mg capsules, without modification.

Pharmacodynamics (PD) Results:

At steady-state, individual patient plasma data showed PAS-004 inhibiting phosphorylated extracellular signal-regulated kinase (pERK) at a level of 80% near Cmax.

At steady-state, individual patient plasma data showed PAS-004 inhibiting pERK at a level above 60% at Cmin (24-hour postdose).

Pharmacokinetics (PK) Results:

Linear PK and dose-proportionality.

PK curve with Cmax/Cmin ratio <2.

AUC: 6,690 ng*h/mL; Cmax: 313 ng/mL; Cmin: 260 ng/mL.

Graph 1 below represents the complete PAS-004 dose escalation curve at steady state in our ongoing Phase 1 trial in advanced cancer patients.

(Press release, Pasithea Therapeutics, NOV 24, 2025, View Source [SID1234660904])

On November 24, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the closing of its previously announced underwritten public offering of 4,950,496 shares of Class A common stock at a price to the public of $101.00 per share. The offering closed on November 20, 2025. The gross proceeds to Nuvalent from the offering were approximately $500.0 million, before deducting underwriting discounts and commissions and other offering expenses.

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On November 20, 2025, the underwriters exercised in full their option to purchase an additional 742,574 shares of Class A common stock (the "Additional Shares") from Deerfield Healthcare Innovations Fund, L.P. and Deerfield Private Design Fund IV, L.P. (together, the "Selling Stockholders") at the public offering price less underwriting discounts and commission. The sale of the Additional Shares by the Selling Stockholders closed on November 24, 2025. Nuvalent did not receive any proceeds from the sale of the Additional Shares by the Selling Stockholders.

J.P. Morgan, Jefferies, TD Cowen and Cantor acted as joint book-running managers for the offering.

The shares were offered by Nuvalent pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 16, 2023. The offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus can be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Nuvalent, NOV 24, 2025, View Source [SID1234660920])