On January 3, 2023 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that its proprietary Oral Paclitaxel formulation did not receive regulatory approval from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for metastatic breast cancer based solely on CMC issues (Press release, Athenex, JAN 3, 2023, View Source [SID1234625721]). The MHRA application was not rejected based on any clinical efficacy or safety concerns expressed by the MHRA. MHRA regulations allow an applicant to request a re-examination of an opinion by an independent board which the Company plans to pursue. The Company views the identified CMC issues as addressable.

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"While we are disappointed by the MHRA decision, we are encouraged that we have satisfactorily addressed any major concerns related to the clinical efficacy and safety of Oral Paclitaxel. We believe the iSPY 2 study is an important data set that further characterizes the safety profile of Oral Paclitaxel and we plan to amend our metastatic breast cancer NDA with the iSPY 2 safety data this quarter," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "To maximize the value of Oral Paclitaxel, we expect to re-engage the FDA by amending our metastatic breast cancer NDA with the iSPY 2 data, and pursue opportunities to advance development of Oral Paclitaxel in the neoadjuvant breast cancer setting in light of recent graduation of Oral Paclitaxel from the iSPY 2 program."

On January 3, 2023 Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company leveraging its nanomedicine technology, hydroxyl dendrimers (HDs), to develop a new class of precision medicines, reported that the Company will provide a corporate overview at Biotech Showcase 2023 taking place in San Francisco, California, from January 9-11, 2023 (Press release, Ashvattha Therapeutics, JAN 3, 2023, View Source [SID1234625720]).

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Presenter Jeffrey Cleland, Ph.D., Chairman, Chief Executive Officer and President of Ashvattha, and members of the Ashvattha senior management team will be available for one-on-one meetings throughout the conference. Conference attendees should schedule meetings on the Biotech Showcase website.

Details for the presentation are as follows:

Date: Tuesday, January 10, 2023
Time: 3:15 pm PT
Location: Franciscan-A, Ballroom Level, Hilton San Francisco Union Square

On January 3, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported that the Company is scheduled to present at the 41st Annual J.P. Morgan Healthcare Conference (Press release, Ascendis Pharma, JAN 3, 2023, View Source [SID1234625719]).

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Details:

Event 41st Annual J.P. Morgan Healthcare Conference
Location San Francisco, CA
Date Monday, January 9, 2023
Time 12:00-12:40 p.m. Eastern Time / 9:00-9:40 a.m. Pacific Time

A live webcast of the event will be available via the Investors & News section of the Ascendis Pharma website at View Source A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On January 3, 2023 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, reported that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer, will present a company overview at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10 at 10:30 am PT at the Westin St. Francis in San Francisco (Press release, ALX Oncology, JAN 3, 2023, View Source [SID1234625718]).

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A live webcast of the presentation is available here and can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast will be archived for up to 30 days following the presentation date.

On January 3, 2023 AbbVie (NYSE: ABBV) reported that it will participate in the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023 (Press release, AbbVie, JAN 3, 2023, View Source [SID1234625717]). Richard A. Gonzalez, chairman and chief executive officer, will present at 5:00 p.m. CT.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.