Checkpoint Therapeutics

Checkpoint Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the acquisition, development, and commercialization of novel treatments for patients with solid tumor cancers. Its product portfolio includes CK-301, CK-101, CK-103, CK-302, and Anti-CAIX. The company was founded on November 10, 2014 and is headquartered in Waltham, MA.

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A PDUFA date of January 3, 2024 has been established by which FDA will decide upon by then whether or not cosibelimab should be approved for the treatment of cSCC. It is said that the cutaneous squamous cell carcinoma market in the U.S. alone could reach $1.6 billion. Company plans to compete with other PD-1/PD-L1 inhibitors in terms of mechanism of action, which gives cosibelimab an improved safety profile over other drugs in the same class.

Checkpoint: PDUFA Date Catalyst Makes This A Must Watch

WALTHAM, Mass., July 31, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,236,248 shares of its common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to 3,236,248 shares of common stock and Series B warrants to purchase up to 3,236,248 shares of common stock, at a purchase price of $3.09 per share of common stock (or pre-funded warrant in lieu thereof) and associated warrants, in a registered direct offering priced at-the-market.

Checkpoint Therapeutics Announces $10 Million Registered Direct Offering Priced At-the-Market

Checkpoint Therapeutics announced updated, longer-term data for cosibelimab from their pivotal trial in locally advanced and metastatic cutaneous squamous cell carcinoma “cSCC”. The data revealed improved response over time with higher complete response rates compared to previous readouts. The responses were durable with the median duration of response not yet reached. Checkpoint believes cosibelimab has a shot at a $1.6B market opportunity, yet, CKPT continues to trade in the gutter with a market cap of around $61M.

Checkpoint Therapeutics: Cosibelimab Data Bolsters Case For Dual-Approval In cSCC

55% objective response rate; 23% complete response rate in locally advanced cSCC 50% objective response rate; 13% complete response rate in metastatic cSCC Cosibelimab continues to demonstrate a favorable safety profile Biologics License Application currently under review by U.S. FDA; PDUFA goal date of January 3, 2024 WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”).

Checkpoint Therapeutics Announces Cosibelimab Longer-Term Results Demonstrating Substantial Increases in Complete Response Rates in Advanced Cutaneous Squamous Cell Carcinoma

Results support comparability of cosibelimab 800 mg every-two-week and 1200 mg every-three-week dosing regimens Biologics License Application for cosibelimab under review by U.S. FDA; PDUFA goal date of January 3, 2024 WALTHAM, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that new pharmacokinetic (“PK”) modeling data on cosibelimab supporting the extension to an every-three-week dosing regimen were presented today at the Population Approach Group Europe (“PAGE”) 2023 annual meeting, taking place in A Coruña, Spain.

Checkpoint Therapeutics Announces Presentation of New Cosibelimab Pharmacokinetic Data Supporting Extended-Interval Dosing

WALTHAM, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,256,269 shares of its common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to 3,256,269 shares of common stock and Series B warrants to purchase up to 3,256,269 shares of common stock, at a purchase price of $3.071 per share of common stock (or pre-funded warrant in lieu thereof) and associated warrants, in a registered direct offering priced at-the-market under Nasdaq rules.

Checkpoint Therapeutics Announces $10 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

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FDA accepted for filing the Biologics License Application for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of January 3, 2024 FDA accepted for filing the Biologics License Application for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of January 3, 2024

Checkpoint Therapeutics Reports First Quarter 2023 Financial Results and Recent Corporate Highlights

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WALTHAM, Mass., March 31, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 1,700,000 shares of its common stock at a purchase price of $3.60 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules.

Checkpoint Therapeutics Announces $6.1 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Checkpoint Therapeutics Reports Full-Year 2022 Financial Results and Recent Corporate Highlights

Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024 FDA indicates that it does not currently plan to hold an advisory committee meeting

Checkpoint Therapeutics Announces FDA Filing Acceptance of Biologics License Application for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

WALTHAM, Mass., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 1,428,572 shares of its common stock (or common stock equivalents) at a purchase price of $5.25 per share of common stock (or common stock equivalent) in a registered direct offering priced at-the-market under Nasdaq rules.

Checkpoint Therapeutics Announces $7.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

WALTHAM, Mass., Jan. 17, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that James Oliviero, President and Chief Executive Officer, will participate in a fireside chat at the B. Riley Securities' 3rd Annual Oncology Conference, taking place on Wednesday, January 18, 2023, at 11:00 a.m. EST.

Checkpoint Therapeutics to Participate in the B. Riley Securities' 3rd Annual Oncology Conference

We are checking back in on a small developmental company called Checkpoint Therapeutics, Inc. The company is planning to submit a BLA targeting two indications for its lead product candidate cosibelimab later this month.

Checkpoint Therapeutics: An Updated Analysis

Positive and clinically meaningful pivotal clinical results announced in 2022 in both metastatic and locally advanced indications Positive and clinically meaningful pivotal clinical results announced in 2022 in both metastatic and locally advanced indications

Checkpoint Therapeutics Submits Biologics License Application to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

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WALTHAM, Mass., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 1,734,105 shares of its common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to 1,734,105 shares of common stock and Series B warrants to purchase up to 1,734,105 shares of common stock, at a purchase price of $4.325 per share of common stock (or pre-funded warrants in lieu thereof) and accompanying warrants, in a registered direct offering priced at-the-market under Nasdaq rules. The Series A warrants will be exercisable immediately upon issuance and will expire five years following the issuance date and have an exercise price of $4.075 per share and the Series B warrants will be exercisable immediately upon issuance and will expire eighteen months following the issuance date and have an exercise price of $4.075 per share.

Checkpoint Therapeutics Announces $7.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

WALTHAM, Mass., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it will effect a 1-for-10 reverse stock split of its issued and outstanding common stock. Checkpoint expects its common stock to begin trading on a split-adjusted basis on the Nasdaq Capital Market as of the commencement of trading on December 6, 2022.

Checkpoint Therapeutics Announces Reverse Stock Split

Successful completion of pre-BLA meetings in July

Checkpoint Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights

WALTHAM, Mass., Sept. 22, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that James Oliviero, President and Chief Executive Officer, will participate in two upcoming investor conferences. Details are as follows:

Checkpoint Therapeutics to Participate in Two Upcoming Investor Conferences

CKPT produced strong data for cosibelimab. However, data was ex-US and from an open-label trial.

Checkpoint: Strong Data, But Comes With Risks

Positive interim results from registration-enabling study of cosibelimab in locally advanced cutaneous squamous cell carcinoma announced in June 2022

Checkpoint Therapeutics Reports Second Quarter 2022 Financial Results and Recent Corporate Highlights

Checkpoint Therapeutics Inc (NASDAQ: CKPT) announced positive interim efficacy results from its registration-enabling trial of cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation.  The.

Checkpoint' Cancer Therapy Shows Almost 55% Response Rate In Skin Cancer Patients

WALTHAM, Mass., June 16, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced positive interim efficacy results from its registration-enabling clinical trial evaluating its anti-PD-L1 antibody, cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. The design of the interim analysis incorporated recent feedback from the U.S. Food and Drug Administration (FDA) and is intended to potentially support the approval of cosibelimab in this indication. As of the March 2022 data cutoff, the objective response rate (ORR) determined by independent central review (ICR) in 31 patients was 54.8% (95% CI: 36.0, 72.7), substantially exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval of 25%.

Checkpoint Therapeutics Announces Positive Interim Results from Registration-Enabling Trial of Cosibelimab in Locally Advanced Cutaneous Squamous Cell Carcinoma

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