On February 12, 2024 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that  the Compensation Committee of Crinetics’ Board of Directors granted non-qualified stock option awards to purchase an aggregate of 73,000 shares of its common stock to nine new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") (Press release, Crinetics Pharmaceuticals, FEB 12, 2024, View Source [SID1234639979]). The stock options were granted as inducements material to the employees entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

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The 2021 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Crinetics, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Crinetics, pursuant to Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $39.46 per share, which is equal to the closing price of Crinetics’ common stock on The Nasdaq Global Select Market on February 9, 2024. The shares subject to the stock options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to each employee’s continued employment with Crinetics on such vesting dates. The options are subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of a stock option agreement covering the grant.

On February 12, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults (Press release, Cidara Therapeutics, FEB 12, 2024, View Source [SID1234639978]).

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This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the standard of care, caspofungin, dosed once daily. The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options.

"The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "With the payment we’ve received from this milestone, we remain committed to advancing our Cloudbreak platform to develop targeted immunotherapies for cancer patients."

Cidara is currently advancing its Cloudbreak drug-Fc conjugate (DFC) platform to design targeted immunotherapies that inhibit specific diseases while simultaneously engaging the immune system. Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells. An IND is anticipated this year.

On February 12, 2024 Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (Nasdaq: RYZB) reported the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, or HSR Act, in connection with Bristol Myers Squibb’s previously reported tender offer to acquire all of the outstanding shares of RayzeBio common stock for a purchase price of $62.50 per share in cash, or approximately $4.1 billion (Press release, Bristol-Myers Squibb, FEB 12, 2024, View Source [SID1234639977]). The expiration of the waiting period occurred at 11:59 p.m. EST on February 9, 2024.

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Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the transaction, including the tender offer and the merger, which remains subject to the tender of a majority of the outstanding shares of RayzeBio’s common stock, as well as other customary closing conditions. Unless the tender offer is extended, the offer will expire one minute after 11:59 p.m. New York City time, on February 22, 2024.

On February 12, 2024 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its fourth quarter 2023 financial results on Monday, February 26, 2024 (Press release, BioCryst Pharmaceuticals, FEB 12, 2024, View Source [SID1234639976]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

On February 12, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported that treatment has commenced for the fourth patient in the ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, FEB 12, 2024, View Source [SID1234639975]). The study is being conducted through a research partnership with Moffitt Cancer Center.

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The first-in-human trial is enrolling patients with recurrent/resistant ovarian cancer who have progressed on at least two prior therapies. The CAR T was safe and tolerable in the first three patients treated. The fourth patient, the first patient enrolled in the second cohort, received triple the dose of CAR-T cells compared with the dose of the first cohort. Anixa’s Follicle Stimulating Hormone Receptor (FSHR)-mediated CAR-T technology, also known as chimeric endocrine receptor T-cell (CER-T), differs from traditional CAR-T therapy by targeting FSHR, which research indicates is expressed on ovarian cells, as well as in the vasculature of tumors.

Dr. Amit Kumar, Chairman and CEO of Anixa, commented, "With no safety issues observed in the first cohort of patients, we have successfully advanced to the next cohort to evaluate a 3x higher dose. As the trial progresses, we seek to demonstrate efficacy of our cell therapy in solid tumors—a difficult challenge for traditional CAR-T therapies that have been shown to be efficacious in hematological tumors and lymphoma."

Dr. Robert Wenham, the Principal Investigator of the trial and the Chair of Gynecologic Oncology at Moffitt, stated, "First, we have the advantage of a target that is much more specific to our tumor tissue, which should minimize any on-target, off-tumor effect. Additionally, we are administering the engineered T-cells directly into the peritoneum (IP), which is the location of most of the ovarian tumor lesions. We hope that this delivery approach will enable direct trafficking of the CER-T-cells to the tumor sites and minimize adverse events such as cytokine release syndrome (CRS)".