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Old 07-14-2017, 09:16 AM   Nav to Top  #1
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Default ACRX (MC $97 M) Cash $72 M / FDA Decision on Oct 12 / P3 results this month

Very attractive and dirt cheap FDA Play .....

ACRX has 2 Products including potential Blockbuster under review by FDA and MAA (Europe) . Upcoming Milestones : Zalviso (Pain) final Phase 3 results this month // DSUVIA (Pain) with FDA Decision on October 12 and EU approval likely in 1H 2018 . If everything goes well this low float stock could move close or above $10 in the coming months . GL

AcelRx Pharma (ACRX)

Market Cap $97.5 Million
Cash: $72 Million
Price $2.15

Shares Out: 45 Million (more than half of that held alone by insiders and institutions)


Anticipated Upcoming 2017 Milestones:

Top-line data results from the IAP312 clinical study in mid-2017.

Joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee for DSUVIA this summer.

FDA decision on the NDA for DSUVIA this fall.

Resubmission of ZALVISO® NDA by year-end.



Biotech Catalyst Play: AcelRx Pharmaceuticals Inc (NASDAQ:ACRX)
https://insiderfinancial.com/biotech...inc-nasdaqacrx


There is what we are watching out for.

So, the first catalyst, the July catalyst, derives from an ongoing phase 3 study of a drug called Zalviso.

So that is the first catalyst; for the second one we have to move to the start of the final quarter, specifically, October.

In parallel to Zalviso, AcelRx is also trying to get a drug called DSUVIA approved in the US. This one is also a pain drug, this time designed for the treatment of moderate-to-severe pain in a medically supervised setting. The company submitted an NDA for the asset at the end of last year and, in February this year, the FDA accepted the submission for consideration. On acceptance, the agency set a PDUFA day of October 12, 2017, meaning it will make a decision as to whether it is willing to approve the drug before or on that date.

While Zalviso is our near-term catalyst, the DSUVIA decision probably holds more weight from a valuation perspective. Why? Because peak sales for this one are estimated at a little over $1.1 billion in the US alone. If FDA gives a green light for commercialization to the asset, therefore, the company could have a blockbuster drug on its hands. Combine that with the close to $400 million in revenues potential from Zalviso, and AcelRx could very justifiably become a multibillion-dollar biotech company before the end of the decade.



Investor Presentation (Juni)
http://phx.corporate-ir.net/External...R5cGU9MQ==&t=1


STRONG Insider & Institutional Ownership:

Three Arch Partners 9 367 041
Perceptive Advisors LLC 4 533 728
BlackRock Fund Advisors 2 032 631
The Vanguard Group, Inc. 1 539 535
Palo Alto Investors LLC 1 032 715
SSgA Funds Management, Inc. 512 877
Pamela Pierce Palmer MD, PhD 405 801
Northern Trust Investments, Inc. 366 387
Bridgeway Capital Management, Inc. 244 150
Oppenheim Asset Management Services SARL 232 341
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Old 07-14-2017, 12:50 PM   Nav to Top  #2
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In a research report issued Friday, Jefferies analyst Matthew Andrews assumed coverage on shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX), with a Buy rating and a $7.00 price target, which implies an upside of 208% from current levels.

In early June 2017, the FDA canceled a tentative joint Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committee meeting in connection with its review of the Company’s New Drug Application (NDA) for DSUVIA for the treatment of moderate-to-severe acute pain. Andrews believes the reason in part has to do with the uncontroversial product profile; thus the analyst believes Dsuvia will be approved on its October 12, 2017, PDUFA date.

"While the FDA under Dr. Gottlieb is focused on addressing the U.S.’s opioid crisis, we believe this will largely focus on the appropriate use and duration of chronic (not acute) opioid therapy. The CHMP’s decision on the Dsuvia MAA in Europe is expected in H1 2018, and the EMA has already approved Zalviso (a 15mcg tablet of sufentanil). We probability weight our U.S. and Europe Dsuvia estimates at 75% and 80%, respectively," Andrews said.

The analyst concluded, "ACRX is under-valued due to potent oral opioid Dsuvia's promise in medicallysupervised acute pain markets (~92M patients) and we see high likelihood of U.S./EU approvals in Q4'17/H1'18. Risk/reward is favorable into H1'18 with floor of ~$1.25 (no approvals) vs. $12/share (upside scenario)."

https://finance.yahoo.com/news/jeffe...145225845.html
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Old 07-17-2017, 08:32 AM   Nav to Top  #3
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Nice jump in Pre-Mkt and we are just days away before phase 3 results will be released and 3 months before FDA decision so there is good chance for a run close or maybe even over $10 .GL

Upcoming Major Milestones

Zalviso Phase 3 Results in July 2017
DSUVIA PDUFA Date October 12, 2017
Zalviso NDA Resubmission in Q4 2017
DSUVIA CHMP Opinion in 1H 2018 (EU Approval)
Zalviso FDA approval expected in Q2 2018


AcelRx: Undervalued Heading Into A Phase 3 Catalyst....Jul.16.17
https://seekingalpha.com/article/408...ase-3-catalyst


Summary

AcelRx is a relatively unknown biotech company focused on the development and eventual commercialization of treatments for moderate-severe acute pain.

Shares are trading at $2.40 while the company has $1.59/share in cash alone, assuming they maintain their cash burn rate, they should have enough cash to last until early 2019.

Peak annual sales for both Dsuvia and Zalviso could exceed $1.7 billion annually, both drugs have near-term binary catalysts which will decide the fate of AcelRx.

Zalviso has already conducted three positive phase 3 trials and will be reporting topline data from a 4th by the end of July, Zalviso is already approved in the EU.

With such a low market cap of 100 million and annual drug sales which could potentially exceed $1.5 billion in the future, AcelRx offers an asymmetric risk/reward ratio for investors.

Investment Thesis

AcelRx (ACRX) shares are deeply undervalued, the true potential of their pipeline is not being priced into the share. Shares are currently trading at $2.40 giving AcelRx a market cap of $104.07 million while they have over $72 million in cash and cash equivalents alone. Their pipeline consists of two drugs which are in late stage development, Zalviso and Dsuvia. Dsuvia is pending FDA approval in October and there is a phase 3 data readout for Zalviso due by the end of July, these two drugs have combined annual peak sales revenue of $1.7 billion. It simply makes no sense for AcelRx shares to be trading at such a low valuation when both drugs are so close to approval; if both catalysts go well, shareholders will be greatly awarded. If the Zalviso data is not good, then there is still the upcoming FDA approval decision on Dsuvia to look forward to, AcelRx's strong cash position should also provide cushion for shareholders in case of bad news. The bottom line is that AcelRx shares are deeply undervalued and overlooked by the market, the current valuation of AcelRx by the market has created a very compelling opportunity which has low risk relative to the potential return for investors.
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