NUVB

Insider Trading Activity: David Hung, CEO of $NUVB, purchased 300,000 shares for approximately $487,500, increasing his holdings by about 0.5%. In the last six months, there have been three insider trades, with two purchases and one sale.

Institutional Investor Movements: In the latest quarter, 87 institutional investors increased their positions in $NUVB, while 59 reduced theirs. Analysts have issued one buy rating and no sell ratings on the stock recently.

Nuvation Bio Insider Purchase: Robert Mashal purchased 100,000 shares of Nuvation Bio (NUVB) for $166,985 at $1.67 each, while the stock is down about 4.8% on Friday. This follows a previous purchase of $220,000 shares at $2.20 each within the last year.

Adverum Biotechnologies Insider Purchase: Braden Michael Leonard bought $147,076 worth of Adverum Biotechnologies (ADVM), acquiring 34,775 shares at $4.23 each, despite the stock being down approximately 1.8% on Friday. Leonard's total investment over the past year amounts to $2.48M at an average price of $6.98 per share.

Real-time Market Intelligence: Benzinga Pro offers the fastest and most accurate stock market alerts, helping traders stay informed and make winning trades daily.

Community of Traders: Over 10,000 serious traders are part of the Benzinga Pro community, gaining access to exclusive stories and insights from Benzinga reporters.

Analyst Coverage Initiation: JonesResearch analyst Danya Ben-Hail has initiated coverage of Nuvation Bio (NUVB) with a Buy rating and a price target of $10, highlighting the company's focus on developing targeted therapeutics for lung cancer and glioma, led by experienced CEO Dr. David Hung.

Key Programs and Updates: The analysis emphasizes Nuvation Bio's acquisition of two promising drug programs from AnHeart Therapeutics, with significant updates expected in 2025 regarding the ROS1 inhibitor taletrectinib and IDH1 inhibitor safusidenib.

Company Milestones: Nuvation Bio Inc. reported significant achievements in 2024, including the acquisition of AnHeart Therapeutics, positive pivotal data for taletrectinib, and submission of its NDA for FDA Priority Review, with a potential U.S. commercial launch expected by mid-2025.

Financial Overview: The company experienced a net loss of $49.4 million in Q4 2024, an increase from $13.8 million in the same period in 2023, while securing up to $250 million in non-dilutive financing to support its clinical pipeline and commercial efforts.

FDA Approval and Commercialization Plans: The U.S. FDA has accepted the New Drug Application for taletrectinib, a treatment for advanced ROS1-positive non-small cell lung cancer, granting it Priority Review with a goal date of June 23, 2025. Innovent Biologics is commercializing the drug in China, while Nippon Kayaku has submitted a Marketing Authorization Application in Japan.

Financial Performance and Pipeline Updates: Nuvation Bio reported a net loss of $49.4 million for Q4 2024, alongside securing up to $250 million in non-dilutive financing to support the commercialization of taletrectinib and further development of its clinical pipeline, which includes other promising candidates like safusidenib and NUV-1511.

Nuvation Bio's Financial Moves: Nuvation Bio (NUVB) has filed for an automatic mixed securities shelf, indicating potential future financing options.

Recent Developments: The company reported a Q4 EPS of 15 cents, received bullish support from RBC due to a royalty deal, and is initiating an expanded access program for taletrectinib in the U.S. for advanced ROS1+ NSCLC.

Nuvation Bio Financing: Nuvation Bio has secured non-dilutive financing of up to $250M with Sagard Healthcare Partners to support the U.S. launch of taletrectinib, which includes an upfront cash payment contingent on FDA approval.

Analyst Rating: RBC Capital maintains an Outperform rating for Nuvation Bio shares with a price target increase to $10, highlighting the deal's potential to enhance financial flexibility and validate the drug's commercial prospects.

Financing Announcement: Nuvation Bio has secured up to $250 million in non-dilutive financing from Sagard Healthcare Partners, which includes $150 million in royalty interest financing and a senior term loan of up to $100 million, aimed at funding the U.S. commercial launch of taletrectinib upon FDA approval.

Strategic Positioning: This financing is expected to fully support the development of Nuvation Bio's clinical-stage pipeline and provide a pathway to profitability without additional fundraising, enhancing the company's flexibility for future capital deployment.

Investigation Announcement: Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of Nuvation Bio Inc. related to self-dealing, which may entitle shareholders to damages and governance reforms.

Call for Shareholder Participation: Long-term shareholders of Nuvation Bio Inc. are encouraged to contact Kuehn Law for a free consultation, emphasizing the importance of their involvement in maintaining market integrity.

Expanded Access Program Initiation: Nuvation Bio Inc. has launched an Expanded Access Program (EAP) for taletrectinib, allowing U.S. patients with advanced ROS1-positive non-small cell lung cancer to access the treatment outside of clinical trials when no other satisfactory options are available.

FDA Review and Approval Status: The U.S. FDA has accepted Nuvation Bio's New Drug Application for taletrectinib, granting it Priority Review with a goal date for approval set for June 23, 2025, based on results from pivotal Phase 2 studies.

Analyst Upgrades and Downgrades: Several Wall Street analysts have adjusted their price targets for various companies, with notable increases for Amphenol Corporation, Fortinet, Tractor Supply Company, and Meta Platforms, while Apple Inc. and DENTSPLY SIRONA saw reductions in their targets.

Current Stock Performance: The article provides the latest closing prices for each mentioned stock, highlighting movements in share values alongside the analysts' ratings and target adjustments.

NASDAQ 100 After Hours Performance: The NASDAQ 100 is down by -16.91 points to 21,836.09 with a total after-hours volume of 152,196,831 shares traded, featuring active stocks like Apple Inc. (AAPL) and NVIDIA Corporation (NVDA) showing mixed results.

Earnings Reports and Forecasts: Verizon Communications (VZ) and NextEra Energy Partners (NEP) are set to report earnings soon, with VZ expected to see a significant increase in EPS, while Bank of America (BAC) has had positive revisions in its earnings forecast for the upcoming quarter.

Stock Market Overview: U.S. stocks declined, with the Nasdaq Composite dropping about 150 points, while several companies like UniFirst Corporation and Getty Images saw significant share price increases due to acquisition proposals and mergers.

Notable Stock Performances: Companies such as Aurora Innovation, Inari Medical, and Enovix Corporation experienced substantial gains following partnerships and acquisitions, reflecting positive market activity despite the overall decline in U.S. stocks.

Company Presentation: Nuvation Bio Inc. will have its CEO, Dr. David Hung, present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, in San Francisco, with a live webcast available on their website.

About Nuvation Bio: Founded in 2018, Nuvation Bio focuses on developing innovative oncology treatments and has several product candidates in its pipeline, including taletrectinib and safusidenib.

Real-time Intelligence for Traders: Benzinga Pro offers the fastest news alerts and exclusive stories to help traders make informed decisions in the stock market.

Community of Serious Traders: Over 10,000 traders are part of the Benzinga Pro community, benefiting from accurate market intelligence and timely updates.

Approval of DOVBLERON®: Innovent Biologics announced that China's National Medical Products Administration has approved DOVBLERON® (taletrectinib adipate capsule) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), based on positive results from the TRUST-I trial showing high response rates.

Innovent's Commitment to Oncology: The approval marks the 13th addition to Innovent's portfolio, highlighting their focus on innovative precision therapies in oncology, with plans to enhance treatment options for patients suffering from ROS1-positive NSCLC.

Approval of DOVBLERON®: Innovent Biologics announced that China's National Medical Products Administration has approved DOVBLERON® (taletrectinib adipate capsule) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), based on positive results from the TRUST-I trial showing high response rates.

Innovent's Commitment to Oncology: The approval marks the 13th addition to Innovent's portfolio, highlighting their focus on innovative precision therapies in oncology, with plans to enhance treatment options for patients suffering from ROS1-positive NSCLC.

Biotechnology Investment Opportunities: Goldman Sachs highlights biotechnology stocks as a promising investment sector due to their sensitivity to interest rate changes, improved fundamentals, and ongoing clinical advancements, despite being under-owned by hedge funds.

Nuvation Bio Inc. Overview: Nuvation Bio Inc. is recognized as a leading biotech penny stock with significant growth potential, focusing on innovative cancer therapies, particularly its lead candidate Taletrectinib, which has received FDA Priority Review and shows superior outcomes in clinical trials.

FDA Acceptance of NDA: Nuvation Bio's NDA for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor for advanced ROS1+ NSCLC, has been accepted by the U.S. FDA with Priority Review status, aiming for a decision by June 23, 2025.

Clinical Data and Future Plans: Taletrectinib has shown promising results in clinical trials involving over 300 patients, and Nuvation Bio is preparing for a potential launch in mid-2025 while establishing itself as a commercial oncology organization.