Hot Watch List (comments).
03.21.12 by BiotechInvest
I always have MAPP in my hot watch list and never write any comments about this biotech.
MAPP has a PDUFA for LEVADEX® (dihydroergotamine mesylate, USP) inhalation aerosol next week (March 26, 2012). And MAPP pps is $15 today. Question is a trivial as usually: to buy or not to buy?
If you read this the answer is clear:
LEVADEX met all four primary endpoints in the efficacy portion of our Phase 3 clinical trial, showing statistically significant improvement in pain relief, freedom from phonophobia (sensitivity to sound), freedom from photophobia (sensitivity to light) and freedom from nausea as reported two hours after dosing. Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing. LEVADEX was well tolerated, with the most common adverse event reported being medication aftertaste at 6%, with 2% of patients receiving placebo also reporting medication aftertaste. The next most common adverse event was nausea at 5%, compared with 2% for placebo. There were no mean decreases in lung function, as measured by spirometry, between the LEVADEX and placebo groups. There were no drug-related serious adverse events reported in the trial.
So, why MAPP pps decays during last several day? Funds and institutions have all 30M of MAPP shares (% Held by Inst 101.64) and they bought MAPP long time ago. Price was dropped on 2-3M volume so may be it's just weak hands? Or something else?
MAPP market cap is just $462M so it’s easy target for big pharma acquisition.
May be funds are just playing a dirty game here? And decrease pps for MAPP buyout?
100% premium will drive cap to less than $1B
Disclosure: I don’t have MAPP positions today but will open it tomorrow. The probability of FDA approval is very high (>80%) and price spike 50-80% is possible.
03.26.12 by BiotechInvest
If you want to be often correct in FDA prediction always say "CLR"
"MAP Pharmaceuticals Receives Complete Response Letter from FDA for LEVADEX® (dihydroergotamine) NDA
7:23p ET March 26, 2012 (PR NewsWire) MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for LEVADEX® (dihydroergotamine) inhalation aerosol.
In the Complete Response letter, the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.
The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval. The Company is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the LEVADEX trade name. The Company continues to pursue approval of LEVADEX for the acute treatment of migraine in adults.
MAP Pharmaceuticals plans to request a meeting with the FDA to discuss the issues raised in the Complete Response letter.
"MAP is committed to making this important new therapy available to people who experience migraine. We will continue to work closely with the FDA to finalize our product labeling and to address the issues raised in the Complete Response letter as quickly as possible," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals.
Conference Call Information
MAP Pharmaceuticals management will host a conference call on Tuesday, March 27, 2012 at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) and individuals may participate in the conference call by dialing (877) 291-1367 (domestic) or (253) 237-1128 (international). To access the webcast, please visit the Company's website at www.mappharma.com and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call."
Well, this time CRL = approval.
"FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval"
With this CRL MAPP is a perfect buyout target now: panic sell off will decrease pps 20-30% (to $11-12) and then 100% premium offer. $25 per share or $750M will be very cheap price for MAPP.
Disclosure: will keep MAPP for a long.
01.23.13 by BiotechInvest
Well, MAPP was acquired for 60% premium, $25 a share and $958 million. It's very close to my prediction.
Sold MAPP today and will buy Luminex Corporation (LMNX). I think that LMNX at current pps $18 and cap $760M is a perfect acquisition target in 2013. 50-60% premium and $1B deal.
Allergan Will Buy Map Pharmaceuticals for $958 Million
By Andrew Pollack - Jan 23, 2013 3:02 PM CT
Allergan Inc. (AGN), the maker of the wrinkle filler Botox, agreed to buy Map Pharmaceuticals Inc. (MAPP) in a deal valued at $958 million to gain an experimental inhalable migraine treatment.
Allergan will pay Map investors $25 a share, a 60 percent premium over yesterday’s closing price in New York, the companies said in a statement. The boards of both companies unanimously approved the deal, which is expected to close late in the first quarter or in the second quarter.