Fri, Jul. 24, 3:48 PM| 8 Comments
Fri, Jul. 24, 2:31 PM
- Esperion Therapeutics (NASDAQ:ESPR) has taken a dive, -20.4%, as the FDA approves Praluent (alirocumab), the competing cholesterol-lowering drug developed by Regeneron (NASDAQ:REGN) and Sanofi (SNY +0.2%).
- Praluent is the first cholesterol-lowering treatment in the PCSK9 inhibitor class.
- Esperion fell sharply in June in response to a positive FDA AdComm vote for Praluent, which stands to compete against Esperion's ETC-1002 cholesterol drug candidate (provided it's approved).
- Regeneron shares remain halted.
Fri, Jul. 10, 9:12 AM
Wed, Jun. 10, 10:25 AM
- Esperion Therapeutics (ESPR -24%) drops on a 3x surge in volume as investors apparently perceive more modest prospects for the company's cholesterol-lowering drug candidate, ETC-1002, after yesterday's positive Ad Comm vote for Regeneron (REGN -4.9%) and Sanofi's (SNY +0.7%) Praluent (alirocumab), which is now poised for approval sometime this summer.
- UBS analyst Andrew Peters remains undeterred. He maintains his Buy rating and $140 price target.
- Previously: Esperion cholesterol-lowering drug candidate successful in Phase 2 study (March 17)
Wed, Jun. 10, 8:41 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) slumps 4% premarket on light volume in response to yesterday's Ad Comm vote on its cholesterol-lowering med Praluent (alirocumab), co-developed with Sanofi (NYSE:SNY).
- The committee voted 13-3 in favor of approval, but only in combination with a statin or as monotherapy in patients who cannot tolerate statins. Ideally, the vote would have supported the use of alirocumab as unconditional monotherapy.
- SNY is up a fraction premarket on modest volume.
Wed, May 27, 10:01 AM
- Retrophin (RTRX +9.4%) jumps out the gate this morning goosed by the news that it has agreed to sell its Rare Pediatric Disease Priority Review Voucher to Sanofi (SNY +2%) for $245M. Under the terms of the sale, Sanofi will pay $150M upon the signing of the contract, $47.5M a year later and another $47.5M two years later.
- The voucher, which Retrophin acquired from Askepion Pharmaceuticals, can be sold or transferred an unlimited number of times. It shortens the FDA's review clock for a New Drug Application (NDA) from 10 months to six, clearly valuable to drug makers.
- Previously: Retrophin acquires rights to bile acid disorder drug; shares up 38% premarket (March 18)
Thu, Mar. 19, 7:41 AM
- Amicus Therapeutics (NASDAQ:FOLD) jumps 20% premarket on higher-than-normal volume in response to its announcement of accelerated schedules for its migalastat regulatory applications for the treatment of Fabry disease in the U.S. and Europe.
- Based on a Type C (late development stage) meeting with the FDA, the company intends to submit its New Drug Application (NDA) in H2. The agency agreed to review the application under its Accelerated Approval pathway. A Phase 4 (post-approval study) will be required so several protocol designs were discussed.
- Based on a meeting with the European Commission (EC), Amicus intends to submit its Marketing Authorization Application (MAA) in Q2 instead of mid-year. The company will request Accelerated Assessment of the MAA, which Rapporteurs (EC representatives assigned to provide guidance to application sponsors) indicated support for.
- Amicus will host a conference call this morning at 8:00 am ET to discuss its global regulatory strategy for migalastat monotherapy for Fabry disease.
- Related tickers: (NYSE:SNY) (NASDAQ:SHPG) (NYSEMKT:PLX)
Thu, Mar. 5, 8:52 AM
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
Tue, Mar. 3, 11:46 AM
- As Ben Levisohn reports, Goldman Sachs analyst Jay Olson downgraded MannKind (MNKD -9.6%) after he revised his valuation model to include net discounts to Afrezza of 40% instead of 20% in light of the downward price pressure from payers to other diabetes product makers.
- He cites the recent launches of Boehringer Ingelheim's Jardiance (empagliflozin) tablets and Eli Lilly's (LLY -1%) Trulicity (dulaglutide injection) that came in 75% below his Q4 estimates. Afrezza's launch trajectory based on script data, albeit early stage, is also falling short of expectations.
- Mr. Olson has lowered his 2025 sales projection 50% for Afrezza to $1B from $2B and reduced EPS estimates from 2017 onward. He believes that MannKind will achieve the sales targets required to capture $925M in milestones from commercial partner Sanofi (SNY -0.1%), however.
- His $3 price target leaves a 50% downside from the current price.
- Previously: MannKind off 10% premarket on Goldman downgrade (March 3)
Thu, Feb. 5, 6:16 AM
Thu, Jan. 22, 9:21 AM
- Thinly-traded nano cap Minerva Neurosciences (NASDAQ:NERV) is up 20% premarket (volume unknown) in response to its report of positive results from a Phase 1 trial assessing MIN-202 for the treatment on insomnia. Trial subjects with co-morbid insomnia related to major depressive disorder (MDD) experienced significant improvements in sleep onset and duration.
- The Phase 1b portion was a double-blind, placebo-controlled, randomized, four-way crossover, single dose trial involved 20 male and female patients with MDD and insomnia. The primary endpoint was latency to persistent sleep (LPS). Preliminary results showed a statistically significant effect on LPS in all three doses tested (10 mg, 20 mg and 40 mg) and prolonged sleep duration of ~45 minutes.
- MIN-202 is an orexin-2 antagonist. Its value proposition is improved safety, better restoration of sleep architecture and improved continuity compared to GABA-mimetics like Ambien (NYSE:SNY).
- MIN-202 is being developed in collaboration with Janssen Pharmaceutica NV.
Nov. 17, 2014, 7:19 AM
- GCVRZ is up 135% to $1.20 in early premarket action after the FDA approved Lemtrada late on Friday. The deadline for a $1 payment with FDA approval has passed, so the next milestone would be for $2 if the drug exceeds $400M in worldwide sales over a four-quarter period.
- The question: Is GCVRZ a better buy at $1.20 with approval in hand than at $0.50 without yet having approval?
- GCVRZ forum
- Previously: Genzyme's Lemtrada approved by the FDA
- SNY -0.2% premarket
Nov. 14, 2014, 9:47 PM
- Lemtrada was originally rejected by the FDA at the end of last year, but the Sanofi (NYSE:SNY) subsidiary resubmitted the application several months ago. With the FDA's action today, the U.S. joins pretty much the entirety of the rest of the globe in approving Lemtrada for treating relapsing forms of multiple sclerosis.
- Source: Press Release
- The contingent value rights on the drug (NASDAQ:GCVRZ) were trading at nearly $2 each before the FDA's rejection last year and closed today's session at $0.52. Monday should be interesting.
- GCVRZ Forum
Oct. 29, 2014, 9:15 AM
Oct. 29, 2014, 4:21 AM
- Sanofi (NYSE:SNY) says Christopher Viehbacher has resigned as CEO after its board unanimously decided to remove him.
- Chairman Serge Weinberg will take over as CEO on a temporary basis. SNY will re-split the roles once a permanent replacement is found.
- The move follows widespread speculation. SNY's directors were reportedly upset at being caught off guard by Viehbacher's attempts to sell an $8B drug portfolio. SNY had until now downplayed the speculation, saying Viehbacher's termination was "not on the agenda."
- Investors are likely to be disconcerted by the change. Viehbacher is seen as an investor-friendly shareholder, notwithstanding SNY's poor Q3 earnings yesterday, which saw shares drop 9%.
- Shares are -3.9% in Paris following today's news.
- Source: press release
- Previously: Sanofi downplays speculation over CEO's future
- Previously: Sanofi off premarket on soft diabetes forecast
Oct. 28, 2014, 12:46 PM
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