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PAVM Plunges On FDA News, AKRX Awaits D-Day, LCI Keeps Hitting New Lows

pharma losers 082318 lt

The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. PAVmed Inc. (PAVM)

Lost 19.57% to close Thursday's (Aug.23) trading at $1.11.

News: The lead FDA branch reviewing the Company's CarpX product has not reached a consensus with the consulting FDA branch.

A 510(k) premarket notification submission for CarpX product was filed last November. The Company has been asked to take the appropriate steps to extend the review process through a resubmission.

2. Akorn Inc. (AKRX)

Lost 17.56% to close Thursday's trading at $14.93.

News: Closing arguments in the trial related to Fresenius Kabi AG's decision to terminate the $4.3 billion deal to buy generic-drug maker Akorn were heard today (Thursday).

Fresenius Kabi had inked an agreement to acquire Akorn for US$34 per share, equivalent to a total acquisition price US$4.3 billion, plus approximately US$450 million of net debt, last April. The acquisition was supposed to close in early 2018. But in February of this year, Akorn came under scrutiny for possible violations of FDA data integrity rules.

On February 26, 2018, Fresenius started conducting an independent investigation, using external experts, into alleged breaches of FDA data integrity requirements relating to product development at Akorn. In April of this year, the German pharmaceutical firm terminated its agreement to acquire Akorn.

Akorn, on its part, filed a complaint in a Delaware court against Fresenius the same month for abandoning the deal.

Now that the closing arguments have concluded, a verdict is expected to be delivered in 90 days.

3. KalVista Pharmaceuticals Inc. (KALV)

KalVista is a clinical-stage company developing drugs for hereditary angioedema, diabetic macular edema, and other plasma kallikrein-associated diseases.

Lost 14.99% to close Thursday's trading at $15.20.

News: No news

Clinical Trials & Near-term Catalysts:

-- The Company's most advanced program is KVD001, an intravitreally administered plasma kallikrein inhibitor, under phase II trial in patients with diabetic macular edema, with data expected to be reported in the second half of 2019.
-- A phase II trial of KVD900 as an on-demand treatment for acute Hereditary Angioedema attacks is expected to be initiated in late 2018, with completion anticipated in mid-2019.

4. Lannett Company Inc. (LCI)

Lost 12.84% to close Thursday's trading at $4.75.

News: The Company announced that it will perform an analysis to determine the potential for impairment of goodwill and certain long-lived assets in the first quarter of fiscal 2019, following the loss of Jerome Stevens Pharmaceuticals' contract.

As of June 30, 2018, the carrying value of goodwill was $339.6 million. The Company believes that its impairment assessment will likely result in a material impairment of its goodwill. Any impairment would result in a noncash charge to earnings in the first quarter of fiscal 2019, noted Lannett.

5. Sonoma Pharmaceuticals Inc. (SNOA)

Lost 11.68% to close Thursday's trading at $1.74.

News: No news

Recent event:

On August 8, the Company announced financial results for the first quarter FY 2019 ended June 30, 2018.

Total revenue for the first quarter ended June 30, 2018 was $4.4 million, up 14% when compared to $3.8 million for the same period last year. Net loss for the recent first quarter narrowed to $3.46 million or $0.55 per share from $3.51 million or $0.82 per share in the year-ago quarter.

As of June 30, 2018, Sonoma had cash and cash equivalents of $7.7 million.

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