Thu, May 21, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Tue, Mar. 10, 10:24 AM
- Akorn (AKRX -14.4%) slumps on double normal volume in response to Actavis' (ACT -1.2%) after hours announcement of its U.S. launch of a generic version of Fougera's Temovate (clobetasol cream 0.05%) for the relief of inflammatory and pruritic dermatoses. Akorn's generic version was one of its top sellers last quarter.
- To assuage investors, Akorn reaffirms its 2015 revenue guidance of $960M - 980M and Non-GAAP EPS of $1.88 - 1.98.
Wed, Feb. 18, 6:43 AM
Thu, Feb. 5, 4:32 AM
- AstraZeneca (NYSE:AZN) reported a fourth-quarter loss this morning, but stressed that it was on track to return to growth by 2017.
- The company's fourth-quarter net loss came in at $321M, down 38% from $524M a year earlier, while sales for the last three months of the year fell 2% to $6.68B.
- Actavis (NYSE:ACT) also confirmed that AstraZeneca would buy its branded respiratory business in the U.S. and Canada for an initial $600M.
- ACT -1.7% premarket
Dec. 24, 2014, 8:52 AM
- The FDA approves the New Drug Application (NDA) for Namzaric, a fixed dose combination of memantine HCl extended release and donepezil hydrochloride, for the treatment of moderate-to-severe dementia of the Alzheimer's type.
- Memantine is an NMDA receptor agonist which blocks the activity of the neurotransmitter glutamate. At normal levels, glutamate aids memory and learning but it the levels are excessive, it overstimulates and eventually kills nerve cells via excitotoxicity.
- Donepezil is a reversible acetylcholinesterase inhibitor. It inhibits the hydrolysis of acetylcholine which is a process associated with cognitive impairment.
- Namzaric was co-developed by Adamas Pharmaceutics (NASDAQ:ADMS) and Forest Laboratories (NYSE:ACT) under the terms of an agreement signed in November 2012.
- Adamas is due a $30M milestone payment from Forest for the approval.
- ADMS is up 19% premarket on moderate volume.
Nov. 21, 2014, 1:51 AM
- Valeant Pharmaceuticals (NYSE:VRX) has slashed its stake in Allergan (NYSE:AGN) to 0.1% from 9.7%, three days after Actavis (NYSE:ACT) trumped its offer for the Botox maker.
- Pershing Square and Valeant have now sold all 2.2M Allergan in PS Fund 1, a shell fund that was set up by the two to act as a joint acquisition vehicle.
- VRX -0.8% AH
Nov. 17, 2014, 5:40 PM
Nov. 11, 2014, 4:16 PM
- The presence of Pershing Square's Bill Ackman on the list of major investors in Zoetis (NYSE:ZTS) sends a clear signal that it may be an acquisition target by none other than Valeant Pharmaceuticals (NYSE:VRX). A deal is not out of the question in light of its diminishing prospects of acquiring Allergan (NYSE:AGN) since Actavis (NYSE:ACT) joined the mix.
- In after hours trading, VRX is up a fraction and ZTS is unchanged, both on higher-than-normal volume.
- Previously: Zoetis jumps 6% on report of Ackman stake
Oct. 6, 2014, 8:37 AM
- Actavis (NYSE:ACT) acquires Durata Therapeutics (NASDAQ:DRTX) for $675M ($23/share) in cash and contingent value rights entitling the holder to receive up to an additional $5 per share if certain Dalvance (dalbavancin)-related regulatory or commercial milestones are met. Actavis expects the acquisition to be accretive by the end of the first year.
Oct. 2, 2014, 6:16 PM
- Bloomberg reports Salix (NASDAQ:SLXP) is now in talks to sell itself to Actavis (NYSE:ACT), and that M&A talks with Allergan (NYSE:AGN) have faded.
- A tangled web: The WSJ previously reported Allergan was in "advanced talks" to buy Salix after turning down Actavis. Since then, speculation has grown Actavis will bid for Salix.
- SLXP +3.9% AH.
Sep. 23, 2014, 5:35 PM
Sep. 23, 2014, 2:27 PM
- Pfizer (PFE -0.6%) approached Actavis (ACT +3.3%) to "express its interest in an acquisition," sources tell Bloomberg. However, the news service adds the companies "aren’t currently in formal talks and Pfizer hasn’t made an offer."
- Actavis has spiked on the report. Pfizer, interested in doing a tax inversion deal, made a rejected bid to acquire AstraZeneca earlier this year. Actavis was reported yesterday to have made a rejected offer for Allergan (AGN +1.4%), which is reportedly in advanced talks to buy Salix.
- Yesterday, the Treasury Department announced it's close to finalizing rules meant to discourage U.S. companies from doing inversion deals.
Sep. 22, 2014, 6:27 PM
- The WSJ reports Allergan (NYSE:AGN) is "in advanced talks" to buy Salix (NASDAQ:SLXP) in an all-cash deal after turning down an offer from Actavis (NYSE:ACT). The paper adds an Allerga/Salix deal, meant to thwart Valeant's (NYSE:VRX) hostile bid for Allergan, could be announced "late this week or next."
- A source says Actavis is still interested in buying Allergan, but only through a "friendly" deal. Whereas Valeant has suggested it would pare back Allergan's R&D spend should its hostile bid succeed, Actavis has reportedly promised to keep Allergan's R&D spend intact.
- The WSJ originally reported of Allergan's interest in Salix in August. Soon after that, Bloomberg reported talks were "dormant" for the time being.
- SLXP +15.8% AH. AGN +1.4%. ACT +0.6%.
Apr. 30, 2014, 2:55 PM
- Shares of Avanir Pharmaceuticals (AVNR +39.5%) pop on slightly higher volume after the Delaware District Court rules that Actavis' generic product specified in its ANDA infringes on Nuedexta's '282 and '484 patents, but not the '115 patent. The court also upheld the validity of the three patents.
- The two firms signed a settlement agreement on the matter eight months ago whereby Actavis (ACT +3.6%) would have the right to sell a generic version beginning July 30, 2026.
Apr. 28, 2014, 7:58 AM
- Forest Laboratories (FRX) has agreed to acquire Furiex Pharmaceuticals (FURX) for $1.1B in cash in a deal that Forest says will enable it to strengthen its position in Gastroenterology.
- Forest, which is being bought by Actavis (ACT) is offering $95 a share vs Furiex's close of $80.15 on Friday.
- Forest has also proposed up to $30 a share ($360M) in a Contingent Value Right (CVR) that may be payable based on the status of eluxadoline, Furiex's lead product, as a controlled drug following approval
- Forest has also agreed to sell Furiex's royalties on alogliptin and Priligy to Royalty Pharma for $415M once Forest has bought Furiex.
- Furiex's shares are +28.51%. (PR)
Feb. 18, 2014, 9:13 AM
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