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BHVN

Biohaven Pharmaceutical

$44.16

-0.61 (-1.36%)

18:12
07/19/19
07/19
18:12
07/19/19
18:12

Biohaven receives CRL from FDA for application seeking NURTEC approval

Biohaven Pharmaceutical Holding Company announced that it has received a Complete Response Letter from the FDA for the 505b2 application seeking approval for NURTEC for ALS. The sole issue identified in the CRL relates to an FDA concern regarding the use of an active pharmaceutical ingredient that was manufactured by Apotex Pharmachem India Private Limited between 2014 to 2016 and used in the drug product supplies for the bioequivalence study in 2017. Of note, concerns with Apotex manufacturing recently led to the withdrawal of 31 Apotex drug products from the US market last Wednesday, July 10th 2019. In the CRL, the FDA stated that it provided recommendations to Apotex regarding the information that would be needed to qualify previous API batches manufactured at Apotex during the time period in question. Apotex did not provide Biohaven with notice of the FDA communication, either during the course of its bioequivalence trial or during the submission of its 505b2 application for Nurtec. Biohaven has been subsequently informed by the manufacturer that they had an exemption from the FDA to supply riluzole to the U.S. market during that time period. Today, Biohaven has been in contact with the FDA's CMC group and Apotex to resolve the matter and Biohaven has already submitted additional information to the FDA regarding this issue. Biohaven notes that the API for commercial supply of Nurtec is currently sourced from another supplier, with whom no CMC issues have been identified. Further, the FDA did not cite any other concerns in their CRL regarding Nurtec. Biohaven will be working with the FDA to develop a timely path forward. While timelines are developed to resolve this matter, Biohaven will re-deploy the associated funds for Nurtec commercialization to other commercial needs of the organization.

  • 09

    Sep

BHVN Biohaven Pharmaceutical
$44.16

-0.61 (-1.36%)

06/18/19
LEER
06/18/19
NO CHANGE
LEER
Outperform
Biohaven equity raise could be negotiation tactic, says SVB Leerink
SVB Leerink analyst Marc Goodman says that while the $300M equity raise announced last night by Biohaven Pharmaceutical will disappoint investors, the offering could be a negotiation tactic whereby management is showing potential buyers that it is serious about possibly going it alone. Biohaven shares in premarket trading are down 29%, or $16.62, to $40.74. The stock was around $50 in early April before Bloomberg reported that the company was in early stages of considering a sale or partnerships, and the news brought the stock up 20% to around $60, Goodman tells investors in a research note. Since then, the stock rose another 20% when Biohaven cancelled its scheduled attendance at a healthcare conference last week, adds the analyst. Goodman still likes the company's fundamentals and keeps an Outperform rating on the shares with a $67 price target.
06/18/19
ADAM
06/18/19
NO CHANGE
Target $89
ADAM
Buy
Biohaven downside over past few days a buying opportunity, says Canaccord
Canaccord analyst Sumant Kulkarni said he believes it would have been better if the narrative for Biohaven Pharmaceutical "could have somehow been different or perhaps controlled differently" after a "curious mix of events," but he sees the weakness of the last few days presenting a buying opportunity. The "curious" events began with a buyout rumor in April, the company pulling out of an investor conference last week, and then weakness yesterday that the company said it could not explain followed by a $300M stock offering, which he acknowledges could leave investors "shaken." However, Kulkarni sees several important catalysts over the next 6-9 months, including the potential approval of rimegepant for the acute treatment of migraine and Phase 3 data on migraine prevention. The analyst, who contends that the fundraising rationale "appears valid IF emotion is set aside," keeps a Buy rating and $89 price target on Biohaven shares.
06/25/19
ADAM
06/25/19
NO CHANGE
Target $84
ADAM
Buy
Biohaven Pharmaceutical weakness a buying opportunity, says Canaccord
Canaccord analyst Sumant Kulkarni hosted meetings with Biohaven Pharmaceuticals management and came away with a heightened confidence in his thesis. The analyst recommended buying the stock on the recent pullback ahead of the crucial migraine prevention data that is expected in Q4. Kulkarni reiterated his Buy rating and $84 price target on Biohaven Pharmaceuticals shares.
07/01/19
PIPR
07/01/19
NO CHANGE
PIPR
Overweight
Piper says concerns about rimegepant's filing status 'put to bed' by Biohaven
Piper Jaffray analyst Tyler Van Buren noted that Biohaven Pharmaceutical issued a press release about the first patient being enrolled in the Phase 2 trial of rimegepant for the treatment of refractory trigeminal neuralgia, calling "the more interesting disclosure" the company's confirmation of the filing of the rimegepant NDAs for the oral pill and ODT formulations. There had recently been some uncertainty among investors on the status of the rimegepant NDA filings, but he thinks those concerns "can now officially be put to bed." Van Buren, who keeps an Overweight rating Biohaven said he has a high level of confidence in the eventual launch of rimegepant.

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$NYE

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ZIOP

Ziopharm

$5.09

-0.06 (-1.17%)

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SNY

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WFC

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ILMN

Illumina

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  • 03

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OSTK

Overstock.com

$21.84

2.34 (12.00%)

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OSTK

Overstock.com

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AMGN

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  • 13

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OSTK

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OSTK

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SPY

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$292.12

-0.28 (-0.10%)

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