Post by bernstein on Jul 14, 2017 13:19:02 GMT
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)
insiderfinancial.com/biotech-catalyst-play-acelrx-pharmaceuticals-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)
phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjczNjExfENoaWxkSUQ9MzgxNTY1fFR5cGU9MQ==&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
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)
insiderfinancial.com/biotech-catalyst-play-acelrx-pharmaceuticals-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)
phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjczNjExfENoaWxkSUQ9MzgxNTY1fFR5cGU9MQ==&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