Replies to post #215667 on Biotech Values

[anesthesia doc]

Allergan Shares Tumble as Revance Reports Positive Data for Botox Rival - TheStreet

https://www.thestreet.com/story/14411279/1/allergan-shares-tumble-botox-rival.html

[randychub]

Hoping they wait to raise cash. With $153 million the only reason to rush would be if you are concerned about the longevity trial results. Having said that most companies will play it safe. If they raise cash I hope they also aggressively go after more indications .

[linhdtu]

Tx Dew for your diligence lol. with PF top line due at yrend17, pps may go up a little more , how much i have no idea before mgt dilutes. that is what i would do if i were them. mgt has shown to be careful with sh count and i don't expect them to behave differently.

so to wait and enter rvnc later counting on rvnc secondary to get a cheaper entry price, may not be practical. pps will pull back perhaps (not in the case of fgen i noticed) but could be from a higher level

[Titan V]

Piper ups Revance price target to $51 on 'impressive' data
https://thefly.com/landingPageNews.php?id=2650761

Piper Jaffray analyst David Amsellem raised his price target for Revance Therapeutics (RVNC) to $51 from $28 saying this morning's Phase III results for RT002 are "impressive." The stock in afternoon trading is up 38%, or $10.00, to $36.00. The company can now credibly claim that its "frown lines" treatment confers "significant benefit" for a sizable group of patients out to six months, Amsellem tells investors in an intraday research note. He thinks RT002 could offer the potential not only for less frequent procedures compared to Allergan's (AGN) Botox but also the potential for better treatment outcomes. Allergan in afternoon trading is down $2.13 to $164.72. The analyst believes the question now for RT002 is not approvability, but rather what a differentiated label would look like. Amsellem also feels the data "should embolden" Revance to "cast a wider net in terms of the pursuit of additional indications." He reiterates an Overweight rating on the shares.

[marthambles]

RVNC BAML commentary (they only cover AGN)

Botox competitor Phase 3 results; focus on label

Today, Botox competitor Revance reported positive Phase 3 topline results for its RT- 002, a long-acting facial injectable for temporary treatment of glabellar (frown) lines. Revance reported the Phase 3 results showed: 1) RT-002 definitively satisfies the primary (regulatory) endpoint evaluating the efficacy of the drug through a 4-week patient and investigator assessment. This does not come as a surprise based on supportive Phase 2 data which had previously shown; 2) duration of therapy: RT-002 response rates on secondary endpoint at week 24 (month 6) on investigator responder analysis (none to mild wrinkles) was on par with response rates with approved toxins which carry 3-4 month duration of use. Questions include 1) whether the RT-002 data will translate to label language calling for 6 month duration of use, since the regulatory development guidance changed (2014) post Botox approval (2002); 2) whether an incremental 1-2 months duration of benefit will meaningfully change prescribing patterns; 3) will RT-002 be brought to market by Revance which lacks aesthetics presence/portfolio or licensed to established medical aesthetics player. We are making no changes to our Botox forecasts for Allergan and maintain our Buy rating.

Duration label claim unclear given FDA’s vague guidance

How Revance’s secondary endpoint results will translate to product labeling remains a critical question. The FDA guidance states that the assessment measures for effect duration “should” be the same as for the primary efficacy endpoint. It remains unclear 1) what RT-002’s primary efficacy would be beyond Week 4; and 2) how the FDA will assess effect duration based on RT-002’s secondary efficacy. On its conference call this morning, Revance management commented their meeting with the FDA led them to focus on the secondary endpoint (% subjects with none or mild wrinkle severity) as key for duration claim (Botox label indicates 3-4 months duration in Section 2 of its label). Tolerability wise, Revance indicated RT-002 looks comparable to Botox. AGN derives ~$800m (5% topline) in US Botox cosmetic sales and the competitive impact of RT-002 on Allergan will depend largely on marketing strategy in our view.
.
Path to regulatory filing: long term safety study remains
Revance anticipates its open-label (all subjects will be drug treated) long-term safety study to readout in 2H18E, and the company plans to file for FDA approval in late 2018E / early 2019E and suggested 2020E US launch.

[masterlongevity]

Masterlongevity means I’m always looking for long term investment