Mon, Jul. 27, 12:48 PM
Mon, Jul. 27, 9:14 AM
Mon, Jul. 27, 7:09 AM
- Mylan (NASDAQ:MYL) drops 12% premarket on increased volume in response to Teva's (NYSE:TEVA) $40.5B deal for Allergan's (NYSE:AGN) generics business, dashing investors' hopes that it would pursue its hostile bid for Mylan.
- In a statement, Mylan reaffirms its interest in Perrigo. A vote on the combination by Mylan shareholders is expected to happen in the next few weeks.
Mon, Jul. 6, 12:25 PM
Wed, Jul. 1, 9:25 AM
- Thinly traded micro cap Xenon Pharmaceuticals (NASDAQ:XENE) drops 22% premarket on increased volume in response to its announcement that a Phase 2b trial run by development partner Teva Pharmaceutical Industries (NYSE:TEVA) evaluating TV-45070 (formerly XEN402) in patients with pain due to osteoarthritis of the knee failed to demonstrate a statistically significant difference from placebo.
- TV-45070, a small molecule inhibitor of the sodium channel Nav1.7 and other sodium channels that are expressed in the pain-sensing peripheral nervous system, is a topical cream being developed for the treatment of nociceptive (pain arising from nerve cell stimulation) pain.
- Top-line results from another Phase 2b study in post-herpetic neuralgia are expected in H2 2016.
Tue, Jun. 16, 2:12 PM
- Receptos (NASDAQ:RCPT) has jumped, +4.4%, to $182.35 on chatter that Wedbush has raised its price target on the stock to $348 and says a takeover is coming.
- The company has been subject to takeover speculation, including suitors like AstraZeneca (NYSE:AZN) talking about a $200/share bid, as well as Teva (NYSE:TEVA) and Gilead (NASDAQ:GILD) discussing $280/share bids.
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%)
Mon, Apr. 27, 3:42 PM
- Teva Pharmaceutical Industries (TEVA -4.3%) is allegedly scheduled to meet with institutional holders of Mylan (MYL -5.5%) this week in an effort to clarify the valuation necessary to close the deal. Some observers think a revised bid will be in the $85 - 95 range. Teva's first offer, which Mylan rejected, was $82.
Tue, Apr. 21, 8:48 AM
- 50% stock and 50% cash
- The proposal gives Mylan (NASDAQ:MYL) shareholders a 37.7% premium to the stock price of Mylan on April 7, 2015, the last day of trading prior to Mylan's press release regarding its unsolicited proposal for Perrigo (NYSE:PRGO), and a 48.3% premium to the unaffected stock price of Mylan on March 10, 2015, which is the last day of trading prior to widespread speculation of a transaction between Teva (NYSE:TEVA) and Mylan.
- Expected to be significantly accretive to Teva non-GAAP EPS, starting in the mid-teens in year 1 and approaching 30% by year 3.
- Teva/Mylan product offerings would create a combined pipeline of over 400 pending ANDAs and over 80 first-to-files in the U.S.
- MYL +9.3% premarket to $74.40. TEVA +2.8% premarket.
- Source: Press Release
- Previously: Bloomberg: Teva offer for Mylan could come today (Apr. 21)
- Previously: Mylan says rumored Teva marriage would not makes sense (Apr. 20)
- Related: Why Does Mylan Want To Buy Perrigo? (Apr. 9)
Tue, Apr. 21, 6:17 AM
- Teva (NYSE:TEVA) could make an unsolicited offer for rival Mylan (NASDAQ:MYL) as soon as today, Bloomberg reports, in what could be the drug industry's largest takeover attempt this year. Mylan has a market value of $33.3B.
- Teva has been working with Barclays on the approach and has contacted other banks about financing a potential deal.
- On Friday, Mylan said it's not interested in a sale and doesn't expect a potential combination to clear antitrust hurdles.
- TEVA +3.9%; MYL +12% premarket
- Previously: Mylan says rumored Teva marriage would not makes sense (Apr. 20 2015)
- Previously: Teva reportedly weighing bid for Mylan; shares jump (Apr. 17 2015)
Fri, Apr. 17, 2:30 PM
- The WSJ and Bloomberg report Teva (TEVA +3.4%) is weighing a bid to acquire fellow generic drug giant Mylan (MYL +5.5%), while adding no decision has been made yet. Shaes of both companies have spiked higher.
- Bloomberg's sources state Teva "hasn't made a formal approach yet," though Mylan is aware of Teva's interest. Many analysts have long expected Teva to go after Mylan, given many perceived top and bottom-line synergies. Teva is currently worth $66.2B, and Mylan $34.3B.
- Perrigo (PRGO -2.8%), which Mylan announced a $28.9B ($205/share) bid for last week, has moved lower on the news.
Mon, Mar. 30, 7:18 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) acquires Auspex Pharmaceuticals (NASDAQ:ASPX) for $101 per share ($3.2B) in an all-cash transaction. The deal will enhance Teva's revenue and earnings growth profile as well as strengthen its central nervous system franchise.
- Auspex's lead product candidate is SD-809, a small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2), that is designed to regulate the levels of dopamine in the brain. It is being investigated for the treatment of various movement disorders.
- Shares are up 42% premarket on average volume.
- Previously: Auspex Pharma completes enrollment in tardive dyskinesia trial (Feb. 3)
- Previously: Auspex chorea treatment candidate successful in Phase 3, shares jump (Dec. 17, 2014)
- Previously: Auspex candidate for TS tagged an Orphan Drug (Jan. 14)
Thu, Feb. 5, 3:23 PM
- The resignation of prominent healthcare investor/entrepreneur Dr. Phillip Frost, M.D., from Teva Pharmaceutical Industries' (TEVA +1.8%) Board of Directors prompts aggressive buying from speculators who think a potential deal is afoot with Opko Health (OPK +4.6%). Teva is up on 50% higher volume while Opko's turnover is 3x average.
Sep. 24, 2014, 10:52 AM
- Lipocine's (LPCN +40.8%) oral testosterone replacement therapy candidate, LPCN 1021, achieves its primary efficacy endpoint in a Phase 3 clinical trial.
- The FDA guidelines for primary efficacy success stipulate a minimum of 75% of trial subjects on active treatment achieve a serum testosterone concentration within the normal range of 300-1140 ng/dL and the lower bound of the 95% CI (confidence interval) must be greater than 65%.
- In the Phase 3 study, 88% of LPCN 1021-treated patients achieved testosterone levels in the normal range with a lower bound CI of 82%.
- LPCN 1021's safety profile was acceptable as well. Three percent of the subjects reported a serious adverse event, though none were drug-related. All drug-related adverse events were mild or moderate. The safety extension phase of the trial is ongoing.
- One aspect of the value proposition of oral TRT therapy is the elimination of the risk of inadvertent testosterone transfer associated with transdermal gels (before the gel dries).
- Related tickers: (LLY +0.6%)(ABBV +1.1%)(RPRX +8.1%)(AUXL -0.2%)(TEVA +0.4%)
Jul. 8, 2014, 3:59 PM
- Shares of Zogenix (ZGNX -12.9%) tumble today on more than a 2x surge in volume in response to the competitive threat from Purdue. The FDA granted its tamper-resistant hydrocodone product Priority Review which means that it could debut in the U.S. by the end of 2014.
- Zogenix is working on its own abuse deterrent version of Zohydro. It plans to submit an sNDA in October. The time frame for regulatory review may delay its U.S. launch until the mid-2015, however.
- Related tickers: (ABBV -3%) (TEVA -1.7%) (ALKS -2.4%) (MNK -2.2%) (PFE -1.1%)
May 15, 2014, 3:51 PM
- Shares of Momenta Pharmaceuticals (MNTA +11.3%) are up on slightly higher volume in response to a federal judge's tossing of Teva's (TEVA -0.9%) lawsuit accusing the FDA of acting improperly by not demanding additional testing of generic forms of Copaxone before clearing them for marketing.
- Teva gets a "A" for effort in trying to stop competitors from selling their generic offerings especially since it is usually on the other side of the aisle. The U.S. Supreme Court has yet to rule on its patent infringement case vs Mylan and Sandoz.
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