Today’s Research Reports on Stocks to Watch: AcelRx Pharmaceuticals and TherapeuticsMD
NEW YORK, NY / ACCESSWIRE / March 9, 2018 / Biotech stocks AcelRx and TherapeuticsMD both saw gains on Thursday with the gains extended into after-hours trading. AcelRx moved higher despite reporting a loss in its 2017 Q4 and full year financial report as traders focused on the company's FDA meeting about Dsuvia. Shares of Therapeutics moved higher after announcing the FDA has accepted the NDA for TX-001HR, its investigational bio-identical hormone therapy.
RDI Initiates Coverage on:
AcelRx Pharmaceuticals, Inc.
https://rdinvesting.com/news/?ticker=ACRX
TherapeuticsMD, Inc.
https://rdinvesting.com/news/?ticker=TXMD
AcelRx Pharmaceuticals, Inc. shares closed up 11.76% and soared even higher in after-hours trading on Thursday after the company reported its fourth quarter 2017 results. The drugmaker reported a loss of 20 cents per share on revenue of $740,000 for the quarter. For the full year, revenue was $8 million, and a loss widened to $51.5 million, or $1.10 per share. Despite the loss, traders were more impressed with the company's FDA type A meeting that happened in January. Company CEO Vince Angotti commented, "We had a constructive meeting with the FDA regarding DSUVIA at the end of January 2018. In summary, based on the meeting outcome and official meeting minutes, we plan to resubmit our DSUVIA NDA in the second quarter of this year. The AcelRx team, including our consultants and our partners at the Department of Defense, did an exceptional job collaborating to reach consensus on a path forward to resubmission. We also continued to demonstrate financial discipline through control of our spending, and ended the year with over $60 million in cash and investments, which provides sufficient liquidity heading into an expected PDUFA date later in the year." Dsuvia is a new drug in development for the treatment of moderate-to-severe acute pain.
Access RDI's AcelRx Pharmaceuticals, Inc. Research Report at:
https://rdinvesting.com/news/?ticker=ACRX
TherapeuticsMD, Inc. shares closed up 3.66% yesterday on nearly 1.9 million shares traded, with the stock soaring even more in after-hours trading. The women's healthcare company announced yesterday that the U.S. Food and Drug Administration has accepted the NDA for TX-001HR, the company's investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral soft gel. The therapy is used for the treatment of moderate-to-severe vasomotor symptoms due to menopause. CEO Robert G. Finizio remarked, "The acceptance of the NDA for TX-001HR is another important milestone for TherapeuticsMD and reaffirms the strength and commitment of our organization. If approved, TX-001HR has the potential to be the first and only combination of bio-identical estradiol and bio-identical progesterone in a single, oral soft gel to meet the needs of patients, physicians, and pharmacies as an FDA-approved, third-party reimbursed treatment option for women suffering from moderate-to-severe vasomotor symptoms due to menopause."
Access RDI's TherapeuticsMD, Inc. Research Report at:
https://rdinvesting.com/news/?ticker=TXMD
Our Actionable Research on AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) and TherapeuticsMD, Inc. (NASDAQ: TXMD) can be downloaded free of charge at Research Driven Investing.
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