Talphera Inc. (TLPH)

[BioSpecialist]

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/4087901-acelrx-undervalued-heading-phase-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.