Nuvalent, Inc. - NUVL STOCK NEWS

Nuvalent (Nasdaq: NUVL) has successfully closed its upsized public offering of Class A common stock. The biopharmaceutical company, focused on developing targeted cancer therapies, sold 5,750,000 shares at $100.00 per share, including the full exercise of the underwriters' option to purchase additional shares. The offering generated gross proceeds of approximately $575.0 million, before deducting underwriting discounts, commissions, and other expenses.

The offering was conducted through an automatically effective shelf registration statement filed with the SEC. J.P. Morgan, TD Cowen, Jefferies, and Stifel acted as joint book-running managers for the transaction. The shares were offered pursuant to a prospectus and prospectus supplement, which are available on the SEC's website and from the underwriters.

Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, has announced the pricing of an upsized public offering of 5,000,000 shares of Class A common stock at $100.00 per share. The offering is expected to generate gross proceeds of approximately $500.0 million for Nuvalent. The underwriters have a 30-day option to purchase up to an additional 750,000 shares. The offering is anticipated to close on September 18, 2024, subject to customary closing conditions. J.P. Morgan, TD Cowen, Jefferies, and Stifel are acting as joint book-running managers for the offering.

Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, has announced a $350 million public offering of Class A common stock. The company is offering all shares and plans to grant underwriters a 30-day option to purchase up to an additional 15% of shares. J.P. Morgan, TD Cowen, Jefferies, and Stifel are acting as joint book-running managers for the offering.

The offering is being made through an automatically effective shelf registration statement filed with the SEC. A preliminary prospectus supplement will be filed, detailing the terms of the offering. The completion, size, and terms of the offering are subject to market conditions and cannot be guaranteed.

Nuvalent (NUVL) presented updated Phase 1 data for its lead ROS1 and ALK inhibitors at ESMO 2024, highlighting potential best-in-class profiles. Key updates include:

1. Rapid enrollment in Phase 2 trials for both programs, with pivotal data now expected in 2025.

2. Zidesamtinib (ROS1 inhibitor) showed 44% ORR in pre-treated ROS1+ NSCLC patients, with 83% having 6+ month response duration.

3. NVL-655 (ALK inhibitor) demonstrated 38% ORR in heavily pre-treated ALK+ NSCLC patients at the recommended Phase 2 dose.

4. Both drugs were well-tolerated with favorable safety profiles.

5. A Phase 3 trial (ALKAZAR) for NVL-655 in treatment-naïve ALK+ NSCLC patients is planned for H1 2025.

These updates suggest accelerated development timelines and potential for both drugs to address unmet needs in ROS1+ and ALK+ NSCLC treatment paradigms.

Nuvalent (Nasdaq: NUVL) has published a manuscript in Cancer Discovery detailing the design and characterization of NVL-655, their ALK-selective inhibitor for ALK-positive non-small cell lung cancer (NSCLC). The publication highlights:

1. NVL-655's activity against ALK single and compound resistance mutations
2. Its selectivity for ALK over TRK family, potentially reducing neurological adverse events
3. Preclinical studies demonstrating brain penetrance and intracranial activity
4. Three case studies from the ALKOVE-1 trial showing tumor responses without CNS effects

The ongoing global Phase 2 portion of the ALKOVE-1 trial is designed with registrational intent. Updated Phase 1 data will be presented at the ESMO Congress 2024 in Barcelona.

Nuvalent (NUVL) announced updated Phase 1 data for its ALK-selective inhibitor NVL-655 and ROS1-selective inhibitor zidesamtinib at ESMO Congress 2024. Key highlights:

- NVL-655 showed 38% overall response rate (ORR) in heavily pre-treated ALK+ NSCLC patients, with 9.2 month median duration of response (DOR)

- Zidesamtinib demonstrated 38% ORR in ROS1+ NSCLC patients previously treated with ROS1 TKIs, with median DOR not reached

- Both drugs showed promising intracranial activity and favorable safety profiles

- Phase 2 trials with registrational intent are ongoing for both drugs in TKI-naïve and pre-treated patients

The company believes these results support the potential for NVL-655 and zidesamtinib to become best-in-class therapies for ALK+ and ROS1+ NSCLC, respectively.

Nuvalent, a clinical-stage biopharmaceutical company (Nasdaq: NUVL), has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event will take place on September 5, 2024, at 1:05 p.m. ET in New York City.

Key details:

• CEO James Porter, Ph.D., and CFO Alexandra Balcom will participate in a fireside chat
• A live webcast will be available on the company's website
• The webcast will be archived for 30 days after the presentation

Nuvalent focuses on developing precisely targeted therapies for clinically proven kinase targets in cancer. This conference participation provides an opportunity for investors and stakeholders to gain insights into the company's progress and future plans.

Nuvalent (Nasdaq: NUVL) reported Q2 2024 financial results and pipeline progress. Key highlights include:

- $658.0 million in cash, cash equivalents, and marketable securities, expected to support operations into 2027

- Ongoing enrollment in Phase 2 trials for NVL-655 (ALK program) and zidesamtinib (ROS1 program)

- FDA breakthrough therapy designation granted for both NVL-655 and zidesamtinib

- Initiation of HEROEX-1 trial for NVL-330 (HER2 program)

- Plans to present updated Phase 1 data at ESMO Congress 2024

Financial results for Q2 2024:

- R&D expenses: $49.2 million

- G&A expenses: $16.0 million

- Net loss: $57.2 million

Nuvalent aims to deliver at least one pivotal dataset in 2025 towards potential product approval in 2026.

Nuvalent (Nasdaq: NUVL) has announced the initiation of HEROEX-1, a Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). The trial aims to assess the safety, tolerability, and preliminary anti-tumor activity of NVL-330, as well as determine the recommended Phase 2 dose and characterize its pharmacokinetic profile.

NVL-330 has shown potential in preclinical studies to maintain activity against HER2 exon 20 mutations, be selective for HER2 versus wild-type EGFR, and demonstrate brain penetrance. These characteristics address key needs in HER2-mutant NSCLC treatment, for which there are currently no approved tyrosine kinase inhibitors (TKIs).

This marks Nuvalent's third program to enter clinical development in under three years, highlighting the company's commitment to rapid progress in developing targeted cancer therapies.