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Tuesday, August 9, 2022
Dem $700+ B Partisan Spend Scheme Fuels Inflation; Raises Taxes; Cuts Jobs; Kills Cures
Relmada Secures FDA Fast Track Status For Depressive Disorder Candidate
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’
lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD).REL-1017 is being investigated in an on-going monotherapy Phase 3 clinical trial under Reliance III study in patients with major depressive disorder (MDD). REL-1017 is also being evaluated in the ongoing Reliance I and Reliance II studies as a potential adjunctive treatment for MDD.
Paolo Manfredi, Chief Scientific Officer, commented: "The receipt of Fast Track Designation represents a significant milestone for our promising late-stage REL-1017 development program. This designation further supports the potential of REL-1017 as a paradigm shifting novel stand-alone treatment for MDD and highlights the significant unmet medical need in a therapeutic area where little has changed over the last several decades: available treatments remain inadequate for the majority of patients with MDD.”
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Moderna, EC Amend Covid Vax Agreement to Supply Omicron-Containing Bivalent
Contractually remaining doses of Moderna's COVID-19 vaccine (Spikevax, mRNA-1273) will be converted to Moderna's next generation Omicron-containing bivalent vaccines
https://finance.yahoo.com/news/moderna-european-commission-ec-amend-103000832.html
Bausch Health Stock Sinks on Earnings Miss and Lowered Guidance
Bausch Health BHC –8.65% stock was plummeting Tuesday after the company delivered disappointing quarterly results and slashed its full-year financial outlook.
The pharmaceutical firm posted earnings of 40 cents a share, lower than the 91 cents a share consensus among analysts tracked by FactSet. Revenue of $1.97 billion for the quarter, which ended in June, also missed expectations of $2.03 billion.
https://www.barrons.com/articles/bausch-health-earnings-stock-price-51660047675
Design Therapeutics Highlights Upcoming Milestones
Initial Data from Friedreich Ataxia Phase 1 Trial of DT-216 Expected in the Fourth Quarter of 2022
Strong Financial Position with $359.4 Million in Cash and Securities to Support Multi-Year Operating Runway
https://finance.yahoo.com/news/design-therapeutics-highlights-upcoming-milestones-200500801.html
Mersana, GSK Option Co-development of Immunosynthen ADC Targeting HER2
GSK receives exclusive global license option for XMT-2056
Mersana to receive $100 million upfront option purchase fee
If GSK exercises its option, Mersana to receive exercise payment; potential for additional development, regulatory and commercial milestone payments, plus tiered double-digit royalties on net sales
Mersana to co-develop XMT-2056; retains options for U.S. profit-sharing and U.S. co-promotion
Conference call today at 4:30 p.m. ET
Verona Pharma Corporate Update
Ensifentrine met primary and secondary endpoints of evaluating lung function in Phase 3 ENHANCE-2 trial for COPD
Top-line Phase 3 ENHANCE-1 data expected around the end of 2022
Conference call today at 8:30 a.m. EDT / 1:30 p.m. BST
Verona Pharma will host an investment community webcast and conference call at 8:30 a.m. EDT / 1:30 p.m. BST on Tuesday, August 9, 2022, to discuss the ENHANCE-2 results, its second quarter financial results and the corporate update.
To participate, please dial one of the following numbers and reference conference ID 2165062:
+1-888-317-6003 for callers in the United States
+1-412-317-6061 for international callers
A live webcast will be available on the Events and Presentations link on the Investors page of the Company's website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the second quarter 2022 results press release will also be made available today on the Company’s website.
For further information please contact:
Verona Pharma plc | US Tel: +1-833-417-0262 |
Victoria Stewart, Director of Investor Relations and Communications | |
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Argot Partners | Tel: +1-212-600-1902 |
Kimberly Minarovich / Michael Barron |
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Optimum Strategic Communications | Tel: +44 (0)203 882 9621 |
Mary Clark / Rebecca Noonan / Zoe Bolt |
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